WorldWideScience

Sample records for submacular surgery trials

  1. Health- and vision-related quality of life among patients with ocular histoplasmosis or idiopathic choroidal neovascularization at enrollment in a randomized trial of submacular surgery: Submacular Surgery Trials Report No. 5.

    Science.gov (United States)

    2005-01-01

    To (1) summarize vision-targeted and general health-related quality-of-life scores at baseline and quantify the effect of the ophthalmic problem, (2) evaluate the strength of relations between visual acuity and interview scores, and (3) compare scores for patients who also had choroidal neovascular lesions in the fellow eye (bilateral cases) with those of patients who had choroidal neovascularization in only the study eye (unilateral cases) at time of enrollment in a randomized trial of surgical removal of subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or of idiopathic origin. Eligible patients had subfoveal choroidal neovascularization (including some classic choroidal neovascularization) and a visual acuity of 20/50 to 20/800 (Snellen equivalent), inclusive, in the eye to be assigned randomly to surgery or observation. Interviews that incorporated the 39-item version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ) and 2 other instruments were conducted by telephone by trained interviewers before patients enrolled and were assigned randomly to surgery or observation. Information from baseline clinical examinations and fluorescein angiograms interpreted centrally by masked readers was used to classify patients as unilateral or bilateral cases and to provide potential explanations for variability of interview responses using linear regression models. The median overall NEI-VFQ score was 75 (interquartile range, 60-84). The median scores on individual subscales ranged from 55 (general vision) to 100 (color vision). The visual acuity of the better-seeing eye accounted for much of the variability in scores on most NEI-VFQ subscales; a 3-line difference in visual acuity was associated with a 10-point or greater difference in scores on 5 subscales after adjustment for other characteristics of patients and eyes. Scores on most scales of all 3 instruments differed between unilateral cases (n = 167

  2. Patients' perceptions of the value of current vision: assessment of preference values among patients with subfoveal choroidal neovascularization--The Submacular Surgery Trials Vision Preference Value Scale: SST Report No. 6.

    Science.gov (United States)

    Bass, Eric B; Marsh, Marsha J; Mangione, Carol M; Bressler, Neil M; Childs, Ashley L; Dong, Li Ming; Hawkins, Barbara S; Jaffee, Harris A; Miskala, Päivi

    2004-12-01

    To improve understanding and awareness of the impact of subfoveal choroidal neovascularization (CNV) on health-related quality of life, we sought to measure the preference value that patients with subfoveal CNV assigned to their health and vision status. Patients with subfoveal CNV completed telephone interviews about their quality of life prior to enrollment and random treatment assignment in the Submacular Surgery Trials, a set of multicenter randomized controlled trials evaluating outcomes of submacular surgery compared with observation. The interviewers asked patients to rate their current vision on a scale from 0 (completely blind) to 100 (perfect vision). The interviewers also asked them to rate complete blindness and then perfect vision, assuming their health otherwise was the same as it was at the time of the interview, on a scale from 0 (dead) to 100 (perfect health with perfect vision). Scores were converted to a 0 to 1 preference value scale for health and vision status, where 0 represents death and 1 represents perfect health and vision. Of 1015 participants enrolled in the Submacular Surgery Trials, 996 completed interviews that included the rating questions, and 792 (80%) answered all 3 rating questions in a manner permitting calculation of a single overall preference value for their current health and vision status on a scale from 0 (dead) to 1 (perfect). The mean preference value was 0.64 (median, 0.68; interquartile range, 0.51-0.80). The preference values correlated with age (Pearson correlation coefficient, -0.11; P = .002), patients' self-rated perception of overall health (Spearman correlation coefficient, 0.36; Pperception of vision (Spearman correlation coefficient, 0.47; PDepression Scale or the Physical or Mental Component Summary scales of the Short Form-36 Health Survey but did not differ significantly by gender or other baseline characteristics such as race, treatment assignment, or size of the CNV lesion. Vision loss from subfoveal CNV

  3. Submacular hemorrhage secondary to congenital toxoplasmosis.

    Science.gov (United States)

    Costa, Ana Luiza Fontes de Azevedo; Martins, Thiago Gonçalves Dos Santos; Moncada, Francisco Javier Solano; Motta, Mário Martins dos Santos

    2014-01-01

    We report the case of a patient with congenital toxoplasmosis and submacular hemorrhage caused by a neovascular membrane who underwent an intravitreal injection of C3F8 and bevacizumab, and had a good visual recovery.

  4. Submacular hemorrhage secondary to congenital toxoplasmosis

    OpenAIRE

    Costa,Ana Luiza Fontes de Azevedo; Martins,Thiago Gonçalves dos Santos; Moncada, Francisco Javier Solano; Motta,Mário Martins dos Santos

    2014-01-01

    We report the case of a patient with congenital toxoplasmosis and submacular hemorrhage caused by a neovascular membrane who underwent an intravitreal injection of C3F8 and bevacizumab, and had a good visual recovery. Relatamos o caso de uma paciente com toxoplasmose congênita e hemorragia submacular por uma membrana neovascular submetida à injeção intravítrea de C3F8 e bevacizumabe, com boa recuperação visual.

  5. Trial registration in pediatric surgery trials.

    Science.gov (United States)

    Rokhsefat, Sana; Morra, Deanna E; Offringa, Martin; Askie, Lisa M; Kelly, Lauren E

    2017-10-23

    Prospective clinical trial registration serves to increase transparency and to mitigate selective reporting bias. An assessment of adult surgical trials revealed poor trial registration practice with incomplete provision of information in registries and inconsistent information in the corresponding publication. The extent and completeness of pediatric surgical trial registration are unknown. We aimed to determine the proportion and adequacy of clinical trial registration in pediatric surgery trials published in 2014. Using sensitive search strategies in MEDLINE, abstracts and full-texts of prospective pediatric intervention studies published in 2014 were screened in duplicate. Pediatric surgical trials were included. Clinical trial registration numbers obtained from publications were searched in trial registries. Data were extracted based on WHO 20-item minimum data set to determine the completeness of registration data. The proportion of registered trials was recorded and registration data were compared to reported data in the corresponding publication. Our search and abstract screening identified 3375 articles for full text review. Following coding, a total of 54 pediatric surgical trials were included and analyzed; 28% (15/54) of which published a registration number. In trials which reported a registration number, 40% (6/15) were retrospectively registered and 40% (6/15) had made changes to their registered primary and/or secondary outcome measures. One included published trial reported an incorrect registration number. Analysis of pediatric surgery trials published in 2014 revealed a poor prospective trial registration rate and incomplete registration data. Our study supports future initiatives for improved registration behaviors in pediatric surgery trials to ensure high-quality, transparent, reproducible evidence is generated. Therapeutic (clinical trials), level II. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Submacular hemorrhage in neovascular age-related macular degeneration: A synthesis of the literature.

    Science.gov (United States)

    Stanescu-Segall, Dinu; Balta, Florian; Jackson, Timothy L

    2016-01-01

    Large submacular hemorrhage, an uncommon manifestation of neovascular age-related macular degeneration, may also occur with idiopathic polypoidal choroidal vasculopathy. Submacular hemorrhage damages photoreceptors owing to iron toxicity, fibrin meshwork contraction, and reduced nutrient flux, with subsequent macular scarring. Clinical and experimental studies support prompt treatment, as tissue damage can occur within 24 hours. Without treatment the natural history is poor, with a mean final visual acuity (VA) of 20/1600. Reported treatments include retinal pigment epithelial patch, macular translocation, pneumatic displacement, intravitreal or subretinal tissue plasminogen activator, intravitreal anti-vascular endothelial growth factor (VEGF) drugs, and combinations thereof. In the absence of comparative studies, we combined eligible studies to assess the VA change before and after each treatment option. The greatest improvement occurred after combined pars plana vitrectomy, subretinal tissue plasminogen activator, intravitreal gas, and anti-vascular endothelial growth factor treatment, with VA improving from 20/1000 to 20/400. The best final VA occurred using combined intravitreal tissue plasminogen activator, gas, and anti-vascular endothelial growth factor therapy, with VA improving from 20/200 to 20/100. Both treatments had an acceptable safety profile, but most studies were small, and larger randomized controlled trials are needed to determine both safety and efficacy. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  7. Submacular hemorrhage: A study amongst Indian eyes

    Directory of Open Access Journals (Sweden)

    Ekta Rishi

    2012-01-01

    Full Text Available Aim: To evaluate the management outcomes amongst various treatment modalities for submacular hemorrhage (SMH in Indian subjects. Settings and Design: Retrospective, single-center study. Materials and Methods: Patients presenting with SMH between 1999 and 2006 were included. Treatment modalities included: vitrectomy with subretinal recombinant tissue plasminogen activator (r-tPA assisted SMH evacuation (group 1, n = 14; pneumatic displacement with intravitreal r-tPA and gas (group 2, n = 25; and pneumatic displacement with intraocular gas (group 3, n = 7. Favorable anatomical outcome was defined as complete displacement of SMH from fovea and favorable functional outcome was defined as a gain of >2 Snellen lines from the baseline. Kruskal-Wallis, analysis of variance (ANOVA, and Chi-square tests were used to compare the three groups, while Mann-Whitney and independent t-test were used to evaluate the influence of duration and size of SMH on outcomes. Results: There was no difference amongst groups in terms of favorable anatomical (P = 0.121 or functional outcomes (P = 0.611. Eyes with median duration of SMH less than 7.5 days had a significantly higher probability of achieving favorable anatomical outcome compared to eyes with SMH >14.5 days (P = 0.042. However, duration of SMH did not influence functional outcome (P = 0.595. Similarly, size of SMH did not affect anatomical (P = 0.578 or functional (P = 0.381 outcome. Median follow-up was 31.5, 6.5, and 2.5 months in the three groups, respectively. Conclusions: Co- existing posterior segment conditions and duration of SMH may influence the choice of treatment modality and treatment outcomes. Pneumatic displacement with r-tPA and r-tPA assisted vitrectomy appear to be favorable options for the management of SMH.

  8. Clinical trials in Surgery | Mwachaka | Annals of African Surgery

    African Journals Online (AJOL)

    Annals of African Surgery. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 11, No 2 (2014) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Clinical trials in Surgery. P Mwachaka, JWM Kigera. Abstract.

  9. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have...

  10. Fundus Autofluorescence Patterns of Submacular Fluid Resolution Following Repair of Macula-Involving Rhegmatogenous Retinal Detachments.

    Science.gov (United States)

    Simonett, Joseph M; Grewal, Dilraj S; Fawzi, Amani A; Lyon, Alice T; Gill, Manjot K

    2016-11-01

    Submacular fluid (SMF) can persist for months to years following rhegmatogenous retinal detachment (RD) repair. The authors' objective was to describe fundus autofluorescence (FAF) and optical coherence tomography (OCT) findings associated with the absorption of persistent submacular fluid (SMF) following RD repair. Retrospective review of clinical data and FAF and OCT imaging from sequential postoperative visits in a cohort of patients with persistent SMF following RD repair. In 11 of 13 eyes with persistent SMF, patches of decreased FAF signal corresponded to SMF on OCT. In eight eyes, there was a hypo- to hyperautofluorescence transition at the time of SMF resolution. These areas of increased FAF signal correlated with inner segment/outer segment (IS/OS) junction loss on OCT. FAF imaging can be informative when following SMF after RD repair; a hypo- to hyper-FAF signal transition correlates with SMF resolution and photoreceptor loss. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:1020-1029.]. Copyright 2016, SLACK Incorporated.

  11. Fetal surgery for myelomeningocele: trials and tribulations. Isabella Forshall Lecture.

    Science.gov (United States)

    Adzick, N Scott

    2012-02-01

    The rationale for in utero repair of myelomeningocele (MMC) in the context of pathologic observations, animal models, and outcomes from the initial experience with human fetal MMC repair is presented. This has now culminated in a randomized trial, Management of Myelomeningocele Study, the findings of which are listed. The story is focused on the milestone contributions of members of the Center for Fetal Diagnosis and Treatment at the Children's Hospital of Philadelphia on the road to successful fetal surgery for spina bifida. This is now performed in selected patients and presents an additional therapeutic alternative for expectant mothers carrying a fetus with MMC. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth; Lohmander, Anette; Persson, Christina

    2017-01-01

    for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark...... in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed. TRIAL REGISTRATION: ISRCTN29932826....

  13. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    ) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10...... of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed. TRIAL REGISTRATION: ISRCTN29932826....

  14. Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial

    DEFF Research Database (Denmark)

    Nielsen, Per Rotbøll; Jørgensen, Lars Damkjær; Dahl, Benny

    2010-01-01

    To evaluate the outcome after spinal surgery when adding prehabilitation to the early rehabilitation.......To evaluate the outcome after spinal surgery when adding prehabilitation to the early rehabilitation....

  15. Tissue plasminogen activator-assisted vitrectomy for submacular hemorrhage due to age-related macular degeneration

    Directory of Open Access Journals (Sweden)

    Mustafa Gok

    2017-01-01

    Full Text Available Purpose: The purpose of this study was to evaluate the treatment efficacy of vitrectomy combined with subretinal recombinant tissue plasminogen activator (r-tPA and factors affecting visual improvement in patients with submacular hemorrhage (SMH due to neovascular age-related macular degeneration (nAMD. Materials and Methods: Medical records of 17 consecutive patients diagnosed with SMH secondary to nAMD were retrospectively reviewed. The initial surgical procedure involved a 23-gauge transconjunctival vitrectomy, subretinal r-tPA application through a self-sealing inferior retinotomy, and sulfur hexafluoride gas for tamponade in all patients. The duration, size, and thickness of the hemorrhage and the pre- and post-operative visual acuity (VA using a Snellen chart were recorded. VA was converted to logMAR for statistical analysis. Results: The average duration and size of the SMH were 12.8 ± 18.2 days and 8.6 ± 5.3 disc areas, respectively. The mean follow-up time was 16.9 ± 4.7 months. A statistically significant visual improvement was found when comparing initial VA with postoperative best-corrected VA (BCVA and final BCVA (Wilcoxon rank test, P ≤ 0.01. There was no significant correlation between the size of the hemorrhage and postoperative BCVA and final BCVA (Spearman's rho test. There was no statistically significant correlation between the initial VA and postoperative BCVA and final BCVA (Spearman's rho test. There was no significant correlation between the duration of hemorrhage and postoperative BCVA and final BCVA (Spearman's rho test. The preoperative thickness of hemorrhage (747.5 ± 30 μm was not correlated with postoperative BCVA or final BCVA (Pearson's test. Conclusions: Vitrectomy combined with subretinal r-tPA injection and gas tamponade is an effective surgical intervention to preserve VA in selected patients with apparent SMH.

  16. A randomized trial of Rapid Rhino Riemann and Telfa nasal packs following endoscopic sinus surgery

    NARCIS (Netherlands)

    Cruise, A. S.; Amonoo-Kuofi, K.; Srouji, I.; Kanagalingam, J.; Georgalas, C.; Patel, N. N.; Badia, L.; Lund, V. J.

    2006-01-01

    OBJECTIVES: To compare Telfa with the Rapid Rhino Riemann nasal pack for use following endoscopic sinus surgery. DESIGN: Prospective, randomized, double-blind, paired trial. SETTING: Tertiary otolaryngology hospital. PARTICIPANTS: Forty-five adult patients undergoing bilateral endoscopic sinus

  17. Preoperative Lifestyle Intervention in Bariatric Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    Kalarchian, Melissa A.; Marcus, Marsha D.; Courcoulas, Anita P.; Cheng, Yu; Levine, Michele D.

    2015-01-01

    Background Studies of the impact of pre-surgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. Objective To evaluate whether a pre-surgery behavioral lifestyle intervention improves weight loss through 24-months post-surgery. Setting Bariatric Center of Excellence at a large, urban medical center. Methods Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual pre-surgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions followed by 16 weeks of face-to-face and telephone sessions prior to surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted at 6-, 12- and 24-months post-surgery. Results Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average BMI was 47.5 kg/m2 at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12- and 24 month assessments, respectively. Percent weight loss from study enrollment to 6- and 12-months post-surgery was comparable for both groups, but at 24-months post-surgery, the lifestyle group had significantly smaller percent weight loss than the usual care group (26.5% vs. 29.5%, respectively, p = 0.02). Conclusions Pre-surgery lifestyle intervention did not improve weight loss at 24 months post-surgery. Findings raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. PMID:26410538

  18. Robotic mitral valve surgery: a United States multicenter trial.

    Science.gov (United States)

    Nifong, L Wiley; Chitwood, W R; Pappas, P S; Smith, C R; Argenziano, M; Starnes, V A; Shah, P M

    2005-06-01

    In a prospective phase II Food and Drug Administration trial, robotic mitral valve repairs were performed in 112 patients at 10 centers by using the da Vinci surgical system. The safety of performing valve repairs with computerized telemanipulation was studied. After institutional review board approval, informed consent was obtained. Patients had moderate to severe mitral regurgitation. Operative technique included peripheral cardiopulmonary bypass, a 4- to 5-cm right minithoracotomy, a transthoracic aortic crossclamp, and antegrade cardioplegia. The successful study end point was grade 0 or 1 mitral regurgitation by transthoracic echocardiography at 1 month after surgery. Valve repairs included quadrangular resections, sliding plasties, edge-to-edge approximations, and both chordal transfers and replacements. The average age was 56.4 +/- 0.09 years (mean +/- SEM). There were 77 (68.8%) men and 35 (31.2%) women. Valve pathology was myxomatous degeneration in 105 (91.1%), and 103 (92.0%) had type II leaflet prolapse. Leaflet repair times averaged 36.7 +/- 0.2 minutes, with annuloplasty times of 39.6 +/- 0.1 minutes. Total robot, aortic crossclamp, and cardiopulmonary bypass times were 77.9 +/- 0.3 minutes, 2.1 +/- 0.1 hours, and 2.8 +/- 0.1 hours, respectively. On 1-month transthoracic echocardiography, 9 (8.0%) had grade 2 mitral regurgitation, and 6 (5.4%) of these had reoperations (5 replacements and 1 repair). There were no deaths, strokes, or device-related complications. Multiple surgical teams performed robotic mitral valve repairs safely early in development of this procedure, with a reoperation rate of 5.4%. Advancements in robotic design and adjunctive technologies may help in the evolution of this minimally invasive technique by decreasing operative times.

  19. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

  20. Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

    Science.gov (United States)

    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D

    2016-01-01

    Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  1. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial

    DEFF Research Database (Denmark)

    Vester-Andersen, Morten; Waldau, Tina; Wetterslev, Jørn

    2013-01-01

    . The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients.Methods and design: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency......ABSTRACT: BACKGROUND: Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality...... laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure...

  2. Crossover clinical trial of pain relief in cataract surgery.

    Science.gov (United States)

    Choi, Suvin; Park, Sang-Gue; Bellan, Lorne; Lee, Hyung-Hwan; Chung, Sung Kun

    2017-06-20

    To determine the effects of intra-operative Korean traditional music on pain experienced by Korean patients undergoing sequential bilateral cataract surgery. This was a two-sequence, two-period, and two-treatment crossover study. Fifty-two patients with cataracts were divided into two groups by block randomization, and bilateral cataract surgery was performed. In group 1, patients listened to Korean traditional music (KTM) during their first but not second cataract surgery. This sequence was reversed for patients in group 2. After each surgery, patients scored their pain intensity (PI) using a visual analog scale (VAS) ranging from 0 to 10, where 0 was 'no pain' and 10 was 'unbearable pain.' There was a statistically significant reduction in the mean VAS score with KTM (3.1 ± 2.0) compared to that without KTM (4.1 ± 2.2; p = 0.013). However, there were no statistically significant differences in blood pressure or pulse rates. KTM had a significant effect on reducing pain experienced by patients during cataract surgery. This may be useful in the context of other surgical procedures to reduce pain in Korean patients.

  3. Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

    Science.gov (United States)

    Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

    2017-11-23

    Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

  4. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Friede, Hans

    2017-01-01

    with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. METHOD: Ten established national or regional......BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born...... cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12...

  5. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Paulin, Gunnar

    2017-01-01

    with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. Method: Ten established national or regional......Background and aims: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born...... cleft centres participated. Lip and soft palate closure at 3–4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3–4 months and hard and soft palate closure at 12...

  6. Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial.

    Science.gov (United States)

    Bell, Lauren; Hooper, Richard; Bunce, Catey; Pasu, Saruban; Bainbridge, James

    2017-06-13

    The treatment of idiopathic full-thickness macular holes involves surgery to close the hole. Some surgeons advise patients to adopt a face-down position to increase the likelihood of successful macular hole closure. However, patients often find the face-down positioning arduous. There is a lack of conclusive evidence that face-down positioning improves the outcome. The 'Positioning In Macular hole Surgery' (PIMS) trial will assess whether advice to position face-down after surgery improves the surgical success rate for the closure of large (≥400 μm) macular holes. The PIMS trial is a multicentre, parallel-group, superiority clinical trial with 1:1 randomisation. Patients (n = 192) with macular holes (≥400 μm) will be randomised after surgery to either face-down positioning or face-forward positioning for at least 8 h (which can be either consecutive or nonconsecutive) a day, for 5 days following surgery. Inclusion criteria are: presence of an idiopathic full-thickness macular hole ≥400 μm in diameter, as measured by optical coherence tomography (OCT) scans, on either or both eyes; patients electing to have surgery for a macular hole, with or without simultaneous phacoemulsification and intraocular lens implant; ability and willingness to position face-down or in an inactive face-forward position; a history of visual loss suggesting a macular hole of 12 months' or less duration. The primary outcome is successful macular hole closure at 3 months post surgery. The treatment effect will be reported as an odds ratio with 95% confidence interval, adjusted for size of macular hole and phakic lens status at baseline. Secondary outcome measures at 3 months are: further surgery for macular holes performed or planned (of those with unsuccessful closure); patient-reported experience of positioning; whether patients report they would still have elected to have the operation given what they know at follow-up; best-corrected visual acuity (BCVA) measured

  7. The Challenges of Recruiting Patients into a Sham Surgery Trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer Borbjerg; Lohmander, Stefan; Roos, Ewa M.

    the challenges in recruiting patients into a placebo controlled surgical trial of arthroscopic partial meniscectomy. Materials and Methods Results presented are from an ongoing RCT where patients aged 35-55 with an MRI confirmed degenerative medial meniscus tear were randomized to arthroscopic partial...

  8. Clinical Trial of Manual Small Incision Surgery and Standard Extracapsular Surgery

    Directory of Open Access Journals (Sweden)

    Parikshit Gogate

    2003-01-01

    Full Text Available Introduction. Manual small incision cataract surgery (MSICS is used increasingly for cataract extraction and intraocular lens implantation. It is thought that the small wound heals faster than a conventional incision, leading to less astigmatism and a better uncorrected visual acuity. This is important as many patients do not wear or cannot afford spectacles after surgery, which means that their uncorrected visual acuity is what they rely on to carry out their every day functions. Often this is less than 6/18 on the Snellen’s chart, which would fall below the WHO ‘good outcome’ category for post-operative visual impairment. A post-operative vision of 6/18 or better without spectacles is a goal which appears to be within the reach of small incision techniques for cataract surgery. However, there are concerns that the method used to remove the nucleus in MSICS may be more traumatic to the corneal endothelium than conventional ECCE surgery.

  9. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  10. RANDOMIZED CONTROLLED TRIALS OF MATERNAL-FETAL SURGERY : A CHALLENGE TO CLINICAL EQUIPOISE

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; van den Berg, P. P.

    2014-01-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception

  11. Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

    DEFF Research Database (Denmark)

    Vester-Andersen, M; Waldau, T; Wetterslev, J

    2015-01-01

    BACKGROUND: Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care......·16; P = 0·828). Thirty (20·8 per cent) of 144 patients assigned to intermediate care and 37 (26·1 per cent) of 142 assigned to ward care died within the total observation period (hazard ratio 0·78, 95 per cent c.i. 0·48 to 1·26; P = 0·310). CONCLUSION: Postoperative intermediate care had...... ward within 24 h of emergency abdominal surgery. Participants were randomized to either intermediate care or standard surgical ward care after surgery. The primary outcome was 30-day mortality. RESULTS: In total, 286 patients were included in the modified intention-to-treat analysis. The trial...

  12. Publication bias in oral and maxillofacial surgery journals: an observation on published controlled trials.

    Science.gov (United States)

    Pitak-Arnnop, Poramate; Sader, Robert; Rapidis, Alexander D; Dhanuthai, Kittipong; Bauer, Ute; Herve, Chistian; Hemprich, Alexander

    2010-01-01

    Publication bias (PB) diminishes the full distribution of research, distorts and discredits the scientific record, and thus compromises evidence-based practice. The objective of this study was to analyse published controlled trials with regard to PB in leading oral and maxillofacial surgery (OMS) journals. All controlled trials published in the International Journal of Oral and Maxillofacial Surgery, Journal of Cranio-Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, and British Journal of Oral and Maxillofacial Surgery in 2008 were analysed for a primary outcome, country of authors, sample size, gender of the first author, funding source and location of the study. Of 952 published articles, 53 controlled trials (5.7%) were identified. The OMS journals preferentially published controlled trials with a positive outcome (77.4%) and from high-income countries (73.6%). Single-centred trials (86.8%) with low sample size (n<100; 69.8%) were published more frequently. The majority of the first authors were male (75.5%). Funding source disclosure was missing in most studies (73.6%) [corrected]. Our results suggest the possible existence of PB in the OMS literature. Hence, it should be borne in mind that the published articles may not be representative of all scientific works, especially when systematic reviews and meta-analyses are conducted or read. In the meantime, journals should establish measures to eliminate PB to uphold scientific integrity. However, this study was an observation based on the published articles. An analysis of all submitted manuscripts would provide more accurate estimates of PB. Ethical considerations on PB are also discussed.

  13. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer.

    Science.gov (United States)

    Kelsen, David P; Winter, Katryn A; Gunderson, Leonard L; Mortimer, Joanne; Estes, Norman C; Haller, Daniel G; Ajani, Jaffer A; Kocha, Walter; Minsky, Bruce D; Roth, Jack A; Willett, Christopher G

    2007-08-20

    We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

  14. Hair removal policies in clean surgery: systematic review of randomized, controlled trials.

    Science.gov (United States)

    Niël-Weise, B S; Wille, J C; van den Broek, P J

    2005-12-01

    To determine whether certain hair removal policies are better than others to prevent surgical-site infections in patients undergoing clean surgery. Publications were retrieved by a systematic search of Medline, the Cochrane Library, and EMBASE up to February 2005. Additionally, the reference lists of all identified trials were examined. All randomized trials, quasi-randomized trials, and systematic reviews or meta-analyses of randomized or quasi-randomized trials comparing hair removal policies in clean surgery were selected. Trials involving patients undergoing cranial neurosurgery were excluded. Two reviewers independently assessed trial quality and extracted data. Disagreements were resolved by discussion with a third reviewer. Data from the original publications were used to calculate the relative risk or risk difference of surgical-site infection. Data for similar outcomes were combined in the analysis, where appropriate, with the use of a random effects model. Four trials were included in the review. No eligible systematic review or meta-analysis of randomized or quasi-randomized trials was found. The quality of the trials and how they were reported were generally unsatisfactory. Evidence regarding whether preoperative hair removal has any effect was inconclusive. When hair removal was considered necessary, evidence about the best time for removal was inconclusive. There was some evidence that hair removal by clipper is superior to removal by razor. Because of insufficient evidence as a basis for recommendations, the practical consequences for ward management were essential when the Dutch Working Party on Infection Prevention formulated its recommendations for hair removal policies. Large randomized, controlled trials are needed to determine the optimal policy for preoperative hair removal.

  15. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial.

    Science.gov (United States)

    Shakouri, Seyed Kazem; Salekzamani, Yaghoub; Taghizadieh, Ali; Sabbagh-Jadid, Hamed; Soleymani, Jamal; Sahebi, Leyla; Sahebi, Roya

    2015-01-01

    Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B's, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG). Thirty nine males (65%) and 21 females (35%) with mean age of 8.10 ± 9.56 were analyzed. The mean differences were statistically significant for predicted forced vital capacity (FVC) (CI 95%:1.3 to 8.7) and Predicted Peak Flow indices (PEF) (CI 95%: 1.9 to 9.4) of spirometry indicator, PCO2 index (of ABG parameter) (CI 95%: 1.4 to 8.9) and mean oxygen saturation (mean Spo2) (CI 95%: 0.6 to 1.7) of ABG index in two groups. The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  16. Surgery in the treatment of malignant pleural mesothelioma: recruitment into trials should be the default position.

    Science.gov (United States)

    Datta, Avijit; Smith, Rhiannon; Fiorentino, Francesca; Treasure, Tom

    2014-02-01

    Europe is at the peak of an epidemic of malignant pleural mesothelioma and the burden of disease is likely to continue rising in the large areas of the world where asbestos remains unregulated. Patients with mesothelioma present with thoracic symptoms and radiological changes so respiratory physicians take a leading role in diagnosis and management. Belief that the modest survival times reported after radical surgery, whether alone or as part of multimodal therapy, are longer than they it would have been without surgery relies on data from highly selected, uncontrolled, retrospectively analysed case series. The only randomised study, the Mesothelioma and Radical Surgery (MARS) trial showed no benefit. A simple modelling study of registry patients, described here, shows that an impression of longer survival is eroded when patients who were never candidates for operation on grounds of histology, performance status and age are sequentially excluded from the model. Whenever the question arises `Might an operation help me?' there are two responses that can and should be given. The first is that there is doubt about whether there is any survival or symptomatic benefit from surgery but we know that there is harm. The second is that there are on-going studies, including two randomised trials, which patients should be informed about. The authors suggest that the default position for clinicians should be to encourage recruitment into these trials.

  17. Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

    Science.gov (United States)

    2011-01-01

    Background Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. Methods/design In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study

  18. Tissue engineering and surgery: from translational studies to human trials

    Directory of Open Access Journals (Sweden)

    Vranckx Jan Jeroen

    2017-06-01

    Full Text Available Tissue engineering was introduced as an innovative and promising field in the mid-1980s. The capacity of cells to migrate and proliferate in growth-inducing medium induced great expectancies on generating custom-shaped bioconstructs for tissue regeneration. Tissue engineering represents a unique multidisciplinary translational forum where the principles of biomaterial engineering, the molecular biology of cells and genes, and the clinical sciences of reconstruction would interact intensively through the combined efforts of scientists, engineers, and clinicians. The anticipated possibilities of cell engineering, matrix development, and growth factor therapies are extensive and would largely expand our clinical reconstructive armamentarium. Application of proangiogenic proteins may stimulate wound repair, restore avascular wound beds, or reverse hypoxia in flaps. Autologous cells procured from biopsies may generate an ‘autologous’ dermal and epidermal laminated cover on extensive burn wounds. Three-dimensional printing may generate ‘custom-made’ preshaped scaffolds – shaped as a nose, an ear, or a mandible – in which these cells can be seeded. The paucity of optimal donor tissues may be solved with off-the-shelf tissues using tissue engineering strategies. However, despite the expectations, the speed of translation of in vitro tissue engineering sciences into clinical reality is very slow due to the intrinsic complexity of human tissues. This review focuses on the transition from translational protocols towards current clinical applications of tissue engineering strategies in surgery.

  19. The Fragility of Statistically Significant Findings From Randomized Trials in Sports Surgery: A Systematic Survey.

    Science.gov (United States)

    Khan, Moin; Evaniew, Nathan; Gichuru, Mark; Habib, Anthony; Ayeni, Olufemi R; Bedi, Asheesh; Walsh, Michael; Devereaux, P J; Bhandari, Mohit

    2017-07-01

    High-quality, evidence-based orthopaedic care relies on the generation and translation of robust research evidence. The Fragility Index is a novel method for evaluating the robustness of statistically significant findings from randomized controlled trials (RCTs). It is defined as the minimum number of patients in 1 arm of a trial that would have to change status from a nonevent to an event to alter the results of the trial from statistically significant to nonsignificant. To calculate the Fragility Index of statistically significant results from clinical trials in sports medicine and arthroscopic surgery to characterize the robustness of the RCTs in these fields. A search was conducted in Medline, EMBASE, and PubMed for RCTs related to sports medicine and arthroscopic surgery from January 1, 2005, to October 30, 2015. Two reviewers independently assessed titles and abstracts for study eligibility, performed data extraction, and assessed risk of bias. The Fragility Index was calculated using the Fisher exact test for all statistically significant dichotomous outcomes from parallel-group RCTs. Bivariate correlation was performed to evaluate associations between the Fragility Index and trial characteristics. A total of 48 RCTs were included. The median sample size was 64 (interquartile range [IQR], 48.5-89.5), and the median total number of outcome events was 19 (IQR, 10-27). The median Fragility Index was 2 (IQR, 1-2.8), meaning that changing 2 patients from a nonevent to an event in the treatment arm changed the result to a statistically nonsignificant result, or P ≥ .05. Most statistically significant RCTs in sports medicine and arthroscopic surgery are not robust because their statistical significance can be reversed by changing the outcome status on only a few patients in 1 treatment group. Future work is required to determine whether routine reporting of the Fragility Index enhances clinicians' ability to detect trial results that should be viewed cautiously.

  20. Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

    Science.gov (United States)

    Probst, Pascal; Knebel, Phillip; Grummich, Kathrin; Tenckhoff, Solveig; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-07-01

    Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

  1. Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Björn Stessel, MD

    2014-12-01

    Conclusions: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

  2. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  3. Interventions in randomised controlled trials in surgery: issues to consider during trial design.

    Science.gov (United States)

    Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M

    2015-09-04

    Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

  4. Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial

    Directory of Open Access Journals (Sweden)

    Legemate Dink A

    2009-07-01

    Full Text Available Abstract Background Intravenous (IV fluid administration is an essential part of postoperative care. Some studies suggest that a restricted post-operative fluid regime reduces complications and postoperative hospital stay after surgery. We investigated the effects of postoperative fluid restriction in surgical patients undergoing major abdominal surgery. Methods In a blinded randomized trial, 62 patients (ASA I-III undergoing elective major abdominal surgical procedures in a university hospital were allocated either to a restricted (1.5 L/24 h or a standard postoperative IV fluid regime (2.5 L/24 h. Primary endpoint was length of postoperative hospital stay (PHS. Secondary endpoints included postoperative complications and time to restore gastric functions. Results After a 1-year inclusion period, an unplanned interim analysis was made because of many protocol violations due to patient deterioration. In the group with the restricted regime we found a significantly increased PHS (12.3 vs. 8.3 days; p = 0.049 and significantly more major complications: 12 in 30 (40% vs. 5 in 32 (16% patients (Absolute Risk Increase: 0.24 [95%CI: 0.03 to 0.46], i.e. a number needed to harm of 4 [95%CI: 2–33]. Therefore, the trial was stopped prematurely. Intention to treat analysis showed no differences in time to restore gastric functions between the groups. Conclusion Restricted postoperative IV fluid management, as performed in this trial, in patients undergoing major abdominal surgery appears harmful as it is accompanied by an increased risk of major postoperative complications and a prolonged postoperative hospital stay. Trial registration Current Controlled Trials ISRCTN16719551

  5. Persistent submacular fluid diagnosed with optical coherence tomography after successful scleral buckle surgery for macula-off retinal detachment.

    Science.gov (United States)

    Kovačević, Igor; Radosavljević, Aleksandra; Kalezić, Bojan; Potić, Jelena; Damjanović, Goran; Stefanović, Ivan

    2012-08-01

    Crataegus species have been widely used in herbal medicine, especially for the hearth diseases. In the present study, the effect of Crataegus aronia var. dentata Browicz extract on partially hepatectomized rats was investigated with biochemical and TUNEL apoptosis assays. The extracts of the plant at the concentrations of 0.5 and 1 ml/100 g body weight/day were administered orally to the two experimental groups including partially hepatectomized rats for 42 days. At the end of the experimental period, animals were sacrificed, blood was collected for the assessment of serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyltransferase (GGT), and the liver tissue was used for TUNEL assay. In biochemical assay, it was found a significant decrease in the levels of serum ALT and AST in the experimental groups. On the other hand, the plant extract did not cause any significant changes in the level of GGT in these groups. In apoptosis assay, TUNEL positive hepatocytes could not be detected in both experimental groups. The present findings can suggest that Crataegus aronia var. dentata Browicz extract can decrease the levels of serum ALT and AST and play a role in apoptosis of hepatocytes in the liver of partially hepatectomized rats. However, further studies are required to confirm the effects of the plant extract on hepatoprotection and apoptosis in the regenerating liver after partial hepatectomy in animal models.

  6. Minimally invasive surgery for spontaneous supratentorial intracerebral hemorrhage: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhou, Xinyu; Chen, Jianjun; Li, Qi; Ren, Gaoping; Yao, Guoen; Liu, Ming; Dong, Qiang; Guo, Jìng; Li, Leilei; Guo, Jing; Xie, Peng

    2012-11-01

    There has been a nonstandard surgical procedure and extensive international controversy in minimally invasive surgery (MIS) for the management of spontaneous supratentorial intracerebral hemorrhage. This meta-analysis assessed the effectiveness of MIS as compared with other treatment options, including conservative medical treatment and conventional craniotomy, in patients with supratentorial intracerebral hemorrhage. PubMed, Embase, Cochrane Controlled Trials Register (CCTR), Web of Science, European Association for Grey Literature Exploitation (EAGLE), National Technical Information Service (NTIS), Current Controlled Trials, Clinical Trials, International Clinical Trials Registry, Internet Stroke Center, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI) (last searched December 2011) were searched. Randomized controlled trials on MIS in patients with computed tomography-confirmed supratentorial intracerebral hemorrhage were included. We excluded low-quality randomized controlled trials. The death or dependence at the end of follow-up was defined as the primary outcome, and the death at the end of follow-up was defined as the secondary outcome. The 313 randomized controlled trials met the included criteria. We only analyzed 12 high-quality randomized controlled trials involving 1955 patients. The quality of the included trials was consistently high. OR of the primary outcome and secondary outcome of MIS both showed significant reductions (OR, 0.54, P<0.00001; OR, 0.53, P<0.00001). Patients with supratentorial intracerebral hemorrhage may benefit more from MIS than other treatment options. The most likely candidates to benefit from MIS are both sexes, age of 30 to 80 years with superficial hematoma, Glasgow Coma Scale score of ≥9, hematoma volume between 25 and 40 mL, and within 72 hours after onset of symptoms. Our study could help select appropriate patients for MIS and guide clinicians to optimize treatment

  7. Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Stessel, Björn; Boon, Michiel; Joosten, Elbert A; Ory, Jean-Paul; Evers, Stefan; van Kuijk, Sander M J; Dubois, Jasperina; Hoofwijk, Daisy; Jamaer, Luc; Buhre, Wolfgang F F A

    2016-09-26

    Postoperative pain and, in a more extended perspective, quality of recovery (QOR) should be considered the principal endpoints after day surgery. Non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are a cornerstone of pain treatment after painful day surgery. Nevertheless, NSAIDs are not always sufficiently effective, have numerous contraindications, and consequently are not suitable in up to 25 % of all patients. Metamizole is a non-opioid compound with a favourable gastrointestinal, cardiovascular and cerebrovascular profile compared to NSAIDs. The aim of this study is to assess if a combination of metamizole and paracetamol is non-inferior to a combination of ibuprofen and paracetamol in the treatment of acute postoperative pain at home after painful day case surgery. In addition, we aim to assess and compare quality of recovery (QOR) profiles of both groups. This is an investigator-initiated, double-blind, randomised controlled, non-inferiority trial. A total of 200 patients undergoing elective haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair in a day care setting will be randomised to receive either a combination of metamizole and paracetamol (MP) or a combination of ibuprofen and paracetamol (IP). Participants will take study medication orally for 4 days. Primary endpoints are average postoperative pain intensity measured by an 11-point Numeric Rating Scale at postoperative day 1 and QOR profile measured by the Functional Recovery Index (FRI), the 1-item Global Surgical Recovery (GSR) index and the EuroQol (EQ-5D) questionnaire at days 1, 2, 3, 4, 7, 14 and 28 postoperatively. Secondary outcomes include compliance with study medication, adverse effects of study medication, use of rescue medication and satisfaction with study medication, surgery and hospital care and telephone follow-up. This study will provide clinical evidence on the analgesic efficacy and safety of a combination of metamizole and

  8. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  9. Intrathecal Morphine in Spine Surgery: A Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Pendi, Arif; Acosta, Frank L; Tuchman, Alexander; Movahedi, Rana; Sivasundaram, Lakshmanan; Arif, Ibraheem; Gucev, Gligor

    2017-06-15

    Meta-analysis of randomized controlled trials (RCTs). The aim of this study was to evaluate the effectiveness of intrathecal morphine (ITM) in reducing postoperative pain and opioid analgesic consumption following spine surgery. The use of ITM following adult spine surgery is of particular interest because of the ease of access to the thecal sac and the potential to provide adequate analgesia at low doses. However, previous studies of ITM have been limited by small sample sizes and conflicting results. A comprehensive search of PubMed, Web of Science, Clinicaltrials.gov, and the Cochrane Central Register of Controlled Trials for prospective RCTs was performed by two independent reviewers. Postoperative opioid consumption, pain scores, and complications were documented from the identified studies. Standard mean differences (SMDs) were applied to continuous outcomes and odds ratios were determined for dichotomous outcomes. Eight RCTs involving 393 subjects met inclusion criteria and were included in this meta-analysis. Patients receiving ITM (ITM group) as an adjunct to postoperative opioid analgesic were compared to patients receiving postoperative opioids only (control group). Postoperative morphine equivalent consumption was significantly lower during the first 24 hours postoperative in the ITM group (P spine surgery in those who received ITM (P spine surgery, use of ITM significantly reduced opioid analgesic consumption and Visual Analogue Schores pain scores compared to controls within the first 24 hours postoperatively. High-quality, follow-up RCTs with large sample sizes are recommended to determine the potential of supplementary ITM in spine surgery and complete the side effects profile. 1.

  10. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial).

    Science.gov (United States)

    2017-04-18

    Objectives To determine whether preoperative dexamethasone reduces postoperative vomiting in patients undergoing elective bowel surgery and whether it is associated with other measurable benefits during recovery from surgery, including quicker return to oral diet and reduced length of stay.Design Pragmatic two arm parallel group randomised trial with blinded postoperative care and outcome assessment.Setting 45 UK hospitals.Participants 1350 patients aged 18 or over undergoing elective open or laparoscopic bowel surgery for malignant or benign pathology.Interventions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia compared with standard care.Main outcome measures Primary outcome: reported vomiting within 24 hours reported by patient or clinician. vomiting with 72 and 120 hours reported by patient or clinician; use of antiemetics and postoperative nausea and vomiting at 24, 72, and 120 hours rated by patient; fatigue and quality of life at 120 hours or discharge and at 30 days; time to return to fluid and food intake; length of hospital stay; adverse events.Results 1350 participants were recruited and randomly allocated to additional dexamethasone (n=674) or standard care (n=676) at induction of anaesthesia. Vomiting within 24 hours of surgery occurred in 172 (25.5%) participants in the dexamethasone arm and 223 (33.0%) allocated standard care (number needed to treat (NNT) 13, 95% confidence interval 5 to 22; P=0.003). Additional postoperative antiemetics were given (on demand) to 265 (39.3%) participants allocated dexamethasone and 351 (51.9%) allocated standard care (NNT 8, 5 to 11; Pdexamethasone at induction of anaesthesia significantly reduces both the incidence of postoperative nausea and vomiting at 24 hours and the need for rescue antiemetics for up to 72 hours in patients undergoing large and small bowel surgery, with no increase in adverse events.Trial registration EudraCT (2010-022894-32) and ISRCTN (ISRCTN

  11. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

    Directory of Open Access Journals (Sweden)

    McDonald AM

    2011-02-01

    Full Text Available Abstract Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons; plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists; three focus groups with anaesthetists (one national, two regional; 58 anaesthetists; two focus groups with members of the patient organisation Arthritis Care (7 participants; telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants; interviews with Chairs of UK ethics committees (6 individuals; postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists; two centre pilot (49 patients assessed. Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions proved easier than the method of anaesthesia (general anaesthesia. General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about

  12. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  13. Timing of surgery for sciatica: subgroup analysis alongside a randomized trial

    Science.gov (United States)

    Arts, Mark P.; Brand, Ronald; Koes, Bart W.

    2009-01-01

    Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while “sciatica provoked by sitting” showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7–3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8–2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent. PMID:19132412

  14. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II)

    DEFF Research Database (Denmark)

    Andersson, J; Abis, G; Gellerstedt, M

    2014-01-01

    BACKGROUND: This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer. METHODS: Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed...... the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaire before surgery, and after 4 weeks, 6, 12 and 24 months. Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning......, sexual enjoyment, male and female sexual problems, and micturition symptoms. RESULTS: Of 617 randomized patients, 385 completed this phase of the trial. Their mean age was 67·1 years. Surgery caused an anticipated reduction in genitourinary function after 4 weeks, with no significant differences between...

  15. Nutritional Risk in Major Abdominal Surgery: Protocol of a Prospective Observational Trial to Evaluate the Prognostic Value of Different Nutritional Scores in Pancreatic Surgery.

    Science.gov (United States)

    Probst, Pascal; Haller, Sebastian; Dörr-Harim, Colette; Bruckner, Thomas; Ulrich, Alexis; Hackert, Thilo; Diener, Markus K; Knebel, Phillip

    2015-11-16

    The influence of patients' preoperative nutritional status on their clinical outcome has already been proven. Therefore, patients with malnutrition are in need of additional therapeutic efforts. However, for pancreatic surgery, evidence suggesting the adequacy of existing nutritional assessment scores to estimate malnutrition associated with postoperative outcome is limited. The aim of the observational trial "Nutritional Risk in Major Abdominal Surgery (NURIMAS) Pancreas" is to prospectively assess and analyze different nutritional assessment scores for their prognostic value on postoperative complications in patients undergoing pancreatic surgery. All patients scheduled to receive elective pancreatic surgery at the University Hospital of Heidelberg will be screened for eligibility. Preoperatively, 12 nutritional assessment scores will be collected and patients will be assigned either at risk or not at risk for malnutrition. The postoperative course will be followed prospectively and complications according to the Clavien-Dindo classification will be recorded. The prognostic value for complications will be evaluated for every score in a univariable and multivariable analysis corrected for known risk factors in pancreatic surgery. Final data analysis is expected to be available during Spring 2016. The NURIMAS Pancreas trial is a monocentric, prospective, observational trial aiming to find the most predictive clinical nutritional assessment score for postoperative complications. Using the results of this protocol as a knowledge base, it is possible to conduct nutritional risk-guided intervention trials to prevent postoperative complications in the pancreatic surgical population. germanctr.de: DRKS00006340; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00006340 (Archived by WebCite at http://www.webcitation.org/6bzXWSRYZ).

  16. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial.

    Science.gov (United States)

    Manzano, Roberta Munhoz; Carvalho, Celso Ricardo Fernandes de; Saraiva-Romanholo, Beatriz Mangueira; Vieira, Joaquim Edson

    2008-09-01

    Abdominal surgical procedures increase pulmonary complication risks. The aim of this study was to evaluate the effectiveness of chest physiotherapy during the immediate postoperative period among patients undergoing elective upper abdominal surgery. This randomized clinical trial was performed in the post-anesthesia care unit of a public university hospital. Thirty-one adults were randomly assigned to control (n = 16) and chest physiotherapy (n = 15) groups. Spirometry, pulse oximetry and anamneses were performed preoperatively and on the second postoperative day. A visual pain scale was applied on the second postoperative day, before and after chest physiotherapy. The chest physiotherapy group received treatment at the post-anesthesia care unit, while the controls did not. Surgery duration, length of hospital stay and postoperative pulmonary complications were gathered from patients' medical records. The control and chest physiotherapy groups presented decreased spirometry values after surgery but without any difference between them (forced vital capacity from 83.5 +/- 17.1% to 62.7 +/- 16.9% and from 95.7 +/- 18.9% to 79.0 +/- 26.9%, respectively). In contrast, the chest physiotherapy group presented improved oxygen-hemoglobin saturation after chest physiotherapy during the immediate postoperative period (p postoperative day. The medical record data were similar between groups. Chest physiotherapy during the immediate postoperative period following upper abdominal surgery was effective for improving oxygen-hemoglobin saturation without increased abdominal pain. Breathing exercises could be adopted at post-anesthesia care units with benefits for patients.

  17. Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shantz Jesse A

    2012-06-01

    Full Text Available Abstract Background A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. Methods/Design A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle. A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. Discussion Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site

  18. Pharmacologic prophylaxis for postoperative atrial tachyarrhythmia in general thoracic surgery: evidence from randomized clinical trials.

    Science.gov (United States)

    Sedrakyan, Artyom; Treasure, Tom; Browne, John; Krumholz, Harlan; Sharpin, Carlos; van der Meulen, Jan

    2005-05-01

    Atrial tachyarrhythmia is the most common complication after general thoracic surgery and is associated with significant morbidity, longer hospital stay, and higher costs. We sought to determine whether the use of antiarrhythmic medications is associated with a reduced rate of postoperative atrial tachyarrhythmia. MEDLINE, EMBASE, Cochrane Database of clinical trials (1980-2003), and reference lists of relevant articles were searched for randomized controlled trials with placebo control, general thoracic patients, and noncombined and prophylactic use of the medications. Search, data abstraction, and analyses were performed and confirmed by at least 2 authors. A fixed-effects model was used to perform meta-analyses. There were 11 unique trials (total n = 1294) that met the inclusion criteria. Calcium-channel blockers and beta-blockers reduced the risk of atrial tachyarrhythmia in 4 and 2 trials, respectively (relative risk of 0.50 and 95% confidence interval of 0.34-0.73; relative risk of 0.40 and 95% confidence interval of 0.17-0.95, respectively). However, beta-blockers tended to increase the risk of pulmonary edema (relative risk, 2.15; 95% confidence interval, 0.74-6.23). Magnesium tested in one unblinded trial also reduced the risk of atrial tachyarrhythmia (relative risk, 0.4; 95% confidence interval, 0.21-0.78). On the other hand, digitalis preparations were found to be harmful because they increased the risk of atrial tachyarrhythmia in 3 trials (relative risk, 1.51; 95% confidence interval, 1.00-2.28). Finally, 2 other medications, flecainide and amiodarone, were each tested in a single small trial, and their effects were associated with great uncertainty. Calcium-channel blockers and beta-blockers are effective in reducing postoperative atrial tachyarrhythmia. The use of these medications should be individualized, and possible adverse events of beta-blockers should be taken into account. Randomized clinical trials do not support the use of digitalis in

  19. Surgery

    Science.gov (United States)

    ... Disease Lookup > COPD > Diagnosing and Treating COPD Surgery Chronic obstructive pulmonary disease (COPD) includes two separate lung problems, emphysema and chronic bronchitis. Some people with COPD have ...

  20. Physical conditioning and mental stress reduction - a randomised trial in patients undergoing cardiac surgery

    Directory of Open Access Journals (Sweden)

    van der Merwe Juliana

    2011-03-01

    Full Text Available Abstract Background Preoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL, rates of postoperative atrial fibrillation (AF and length of stay (LOS in hospital. Methods Elective patients scheduled for coronary artery bypass graft and/or valve surgery at a public hospital in Melbourne, Australia were enrolled. Patients were randomized to receive either holistic therapy (HT or usual care (UC. HT consisted of a series of light physical exercise sessions together with a mental stress reduction program administered in an outpatient setting for the first two weeks after placement on the waiting list for surgery. A self-administered SF-36 questionnaire was used to measure QOL and hospital records to collect data on LOS and rate of postoperative AF. Results The study population comprised 117 patients of whom 60 received HT and 57 received UC. Both programs were able to be delivered within the hospital setting but ongoing therapy beyond the two week duration of the program was not carried out due to long waiting periods and insufficient resources. HT, as delivered in this study, compared to UC did not result in significant changes in QOL, LOS or AF incidence. Conclusions Preoperative holistic therapy can be delivered in the hospital setting, although two weeks is insufficient to provide benefits beyond usual care on QOL, LOS or postoperative AF. Further research is now required to determine whether a similar program of longer duration, or targeted to high risk patients can provide measurable benefits. Trial registration This trial was conducted as part of a larger study and according to the principles contained in

  1. Enhanced Recovery After Surgery for Advanced Ovarian Cancer: A Systematic Review of Interventions Trialed.

    Science.gov (United States)

    Lindemann, Kristina; Kok, Peey-Sei; Stockler, Martin; Jaaback, Ken; Brand, Alison

    2017-07-01

    We sought to summarize the evidence for interventions aiming at enhanced recovery after surgery (ERAS) in ovarian cancer through a systematic review. We searched MEDLINE, EMBASE, and The Cochrane Library for studies testing ERAS interventions in patients undergoing surgery for ovarian cancer. Study selection and data extraction were done independently by 2 reviewers with disagreements resolved by discussion with a senior, third reviewer. We identified 25 studies including 1648 participants with ovarian cancer. Nine observational studies addressed ERAS protocols. Four of them were prospective, and 3 included historical controls. The other 16 studies reported single interventions, for example, early feeding, omission of pelvic drains, early orogastric tube removal, Doppler-guided fluid management, and patient-controlled epidural analgesia. Early feeding protocols were tested in 7 of the 12 randomized trials. Early feeding appeared to be safe and was associated with significantly faster recovery of bowel function. Few studies have specifically studied ERAS interventions in ovarian cancer. All studies on protocols including multiple interventions were susceptible to bias. Early feeding is the intervention that is best supported by randomized trials. Application of evidence for ERAS derived from nonovarian cancer is challenged by the differences not only in the scope of surgery but also in ovarian cancer patients' comorbidities. Postoperative morbidity is particularly high in these patients because of their poor nutritional status, perioperative fluids shifts, and long operating times. These patients may also show excessive response to surgical stress. Innovative, randomized trials are needed to reliably determine the feasibility, safety, and effectiveness of specific ERAS interventions in ovarian cancer.

  2. Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

    Science.gov (United States)

    2014-01-01

    Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

  3. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  4. Erythromycin for Gastric Emptying in Patients Undergoing General Anesthesia for Emergency Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Czarnetzki, Christoph; Elia, Nadia; Frossard, Jean-Louis; Giostra, Emiliano; Spahr, Laurent; Waeber, Jean-Luc; Pavlovic, Gordana; Lysakowski, Christopher; Tramèr, Martin R

    2015-08-01

    Patients undergoing emergency procedures under general anesthesia have impaired gastric emptying and are at high risk for aspiration of gastric contents. Erythromycin has strong gastric prokinetic properties. To evaluate the efficacy of erythromycin lactobionate in gastric emptying in patients undergoing emergency surgery. The Erythro-Emerge trial was a single-center, randomized, double-blinded, placebo-controlled clinical trial in patients undergoing emergency surgery under general anesthesia at Geneva University Hospitals. We included 132 patients from March 25, 2009, through April 10, 2013, and all patients completed the study. Randomization was stratified for trauma and nontrauma procedures. The randomization code was opened on April 23, 2013, and analyses were performed through July 26, 2013. We performed an intention-to-treat analysis. Patients were randomized to intravenous erythromycin lactobionate, 3 mg/kg, or placebo 15 minutes before tracheal intubation. Patients were followed up for 24 hours. The primary outcome was a clear stomach, defined as less than 40 mL of liquids and no solids and identified through endoscopy immediately after intubation. The secondary outcome was the pH level of residual gastric content. A clear stomach was diagnosed in 42 of 66 patients (64%) receiving placebo compared with 53 of 66 patients (80%) receiving erythromycin (risk ratio, 1.26 [95% CI, 1.01-1.57]). In the population undergoing surgery for nontrauma, the association between receipt of erythromycin and having a clear stomach (adjusted odds ratio [95% CI]) was statistically significant (13.4 [1.49-120]; P = .02); in the population undergoing surgery for trauma, it was not (1.81 [0.64-5.16]; P = .26). Median (interquartile range) pH of the residual gastric liquid was 2 (1-4) in 36 patients receiving placebo and 6 (3-7) in 16 receiving erythromycin (P = .002). Patients receiving erythromycin had nausea (20 [30%] vs 4 [6%]) and stomach cramps (15 [23%] vs 2 [3

  5. Thrombelastographic hypercoagulability and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial)

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Johansson, Pär I; Kofoed, Klaus F

    2017-01-01

    , and death compared to aspirin monotherapy in hypercoagulable patients undergoing coronary artery bypass surgery. A total of 1683 patients were screened for eligibility, among which 165 patients were randomized and 133 patients underwent multislice computed tomography scan to evaluate their grafts...... trial to test the hypothesis of intensified antiplatelet therapy in hypercoagulable patients. Due to the low enrollment and high loss to follow up, our results can only be viewed as hypothesis generating. We found a high rate of graft occlusions in this patient population. Our results were...

  6. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Heliövaara, Arja; Küseler, Annelise; Skaare, Pål

    2017-01-01

    BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised clinical trials were...... undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born...

  7. Psychological sequelae of surgery in a prospective cohort of patients from three intraoperative awareness prevention trials.

    Science.gov (United States)

    Whitlock, Elizabeth L; Rodebaugh, Thomas L; Hassett, Afton L; Shanks, Amy M; Kolarik, Ellen; Houghtby, Janet; West, Hannah M; Burnside, Beth A; Shumaker, Erik; Villafranca, Alex; Edwards, W Alex; Levinson, Cheri A; Langer, Julia K; Fernandez, Katya C; El-Gabalawy, Renee; Zhou, Elizabeth Y; Sareen, Jitender; Jacobsohn, Eric; Mashour, George A; Avidan, Michael S

    2015-01-01

    Elective surgery can have long-term psychological sequelae, especially for patients who experience intraoperative awareness. However, risk factors, other than awareness, for symptoms of posttraumatic stress disorder (PTSD) after surgery are poorly defined, and practical screening methods have not been applied to a broad population of surgical patients. The Psychological Sequelae of Surgery study was a prospective cohort study of patients previously enrolled in the United States and Canada in 3 trials for the prevention of intraoperative awareness. The 68 patients who experienced definite or possible awareness were matched with 418 patients who denied awareness based on age, sex, surgery type, and awareness risk. Participants completed the PTSD Checklist-Specific (PCL-S) and/or a modified Mini-International Neuropsychiatric Interview telephone assessment to identify symptoms of PTSD and symptom complexes consistent with a PTSD diagnosis. We then used structural equation modeling to produce a composite PTSD score and examined potential risk factors. One hundred forty patients were unreachable; of those contacted, 303 (88%) participated a median of 2 years postoperatively. Forty-four of the 219 patients (20.1%) who completed the PCL-S exceeded the civilian screening cutoff score for PTSD symptoms resulting from their surgery (15 of 35 [43%] with awareness and 29 of 184 [16%] without). Nineteen patients (8.7%; 5 of 35 [14%] with awareness and 14 of 184 [7.6%] without) both exceeded the cutoff and endorsed a breadth of symptoms consistent with the Diagnostic and Statistical Manual Fourth Edition diagnosis of PTSD attributable to their surgery. Factors independently associated with PTSD symptoms were poor social support, previous PTSD symptoms, previous mental health treatment, dissociation related to surgery, perceiving that one's life was threatened during surgery, and intraoperative awareness (all P ≤ 0.017). Perioperative dissociation was identified as a potential

  8. Effect of Preoperative Warm-up Exercise Before Laparoscopic Gynecological Surgery: A Randomized Trial.

    Science.gov (United States)

    Polterauer, Stephan; Husslein, Heinrich; Kranawetter, Marlene; Schwameis, Richard; Reinthaller, Alexander; Heinze, Georg; Grimm, Christoph

    2016-01-01

    Laparoscopic surgical procedures require a high level of cognitive and psychomotoric skills. Thus, effective training methods to acquire an adequate level of expertise are crucial. The aim of this study was to investigate the effect of preoperative warm up training on surgeon׳s performance during gynecologic laparoscopic surgery. In this randomized controlled trial, surgeons performed a preoperative warm up training using a virtual reality simulator before laparoscopic unilateral salpingo-oophorectomy. Serving as their own controls, each subject performed 2 pairs of laparoscopic cases, each pair consisting of 1 case with and 1 without warm up before surgery. Surgeries were videotaped and psychomotoric skills were rated using objective structured assessment of technical skills (OSATS) and the generic error rating tool by a masked observer. Perioperative complications were assessed. Statistical analysis was performed using a mixed model, and mean OSATS scores were compared between both the groups. In total, data of 10 surgeons and 17 surgeries were available for analysis. No differences between educational level and surgical experiences were observed between the groups. Mean standard error psychomotoric and task-specific OSATS scores of 19.8 (1.7) and 3.7 (0.2) were observed in the warm up group compared with 18.6 (1.7) and 3.8 (0.2) in the no warm up group, respectively (p = 0.51 and p = 0.29). Using generic error rating tool, the total number of errors was 8.75 (2.15) in the warm up group compared with 10.8 (2.18) in the no warm-up group (p = 0.53). Perioperative complications and operating time did not differ between both the groups. The present study suggests that warm-up before laparoscopic salpingo-oophorectomy does not increase psychomotoric skills during surgery. Moreover, it does not influence operating time and complication rates. (Medical University of Vienna-IRB approval number, 1072/2011, ClinicalTrials.gov number, NCT01712607). Copyright © 2016

  9. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  10. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

    Science.gov (United States)

    Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

    2013-01-01

    To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  11. Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial.

    Science.gov (United States)

    Shantz, Jesse A; Vernon, James; Leiter, Jeff; Morshed, Saam; Stranges, Gregory

    2012-06-06

    A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given

  12. Conservative surgery versus colorectal resection in deep endometriosis infiltrating the rectum: a randomized trial.

    Science.gov (United States)

    Roman, Horace; Bubenheim, Michael; Huet, Emmanuel; Bridoux, Valérie; Zacharopoulou, Chrysoula; Daraï, Emile; Collinet, Pierre; Tuech, Jean-Jacques

    2018-01-01

    Is there a difference in functional outcome between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 2 years postoperatively? No evidence was found that functional outcomes differed when conservative surgery was compared to radical rectal surgery for deeply invasive endometriosis involving the bowel. Adopting a conservative approach to the surgical management of deep endometriosis infiltrating the rectum, by employing shaving or disc excision, appears to yield improved digestive functional outcomes. However, previous comparative studies were not randomized, introducing a possible bias regarding the presumed superiority of conservative techniques due to the inclusion of patients with more severe deep endometriosis who underwent colorectal resection. From March 2011 to August 2013, we performed a 2-arm randomized trial, enroling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring more than 20 mm in length, involving at least the muscular layer in depth and up to 50% of rectal circumference. No women were lost to follow-up. Patients were enroled in three French university hospitals and had either conservative surgery, by shaving or disc excision, or radical rectal surgery, by segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of the results of randomization. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), defecation pain, anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were the values of the Visual Analog Scale (VAS), Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), the Gastrointestinal Quality of Life Index (GIQLI), the Wexner scale, the Urinary Symptom

  13. Lung volume reduction surgery since the National Emphysema Treatment Trial: study of Society of Thoracic Surgeons Database.

    Science.gov (United States)

    Decker, Marquita R; Leverson, Glen E; Jaoude, Wassim Abi; Maloney, James D

    2014-12-01

    The National Emphysema Treatment Trial demonstrated that lung volume reduction surgery is an effective treatment for emphysema in select patients. With chronic lower respiratory disease being the third leading cause of death in the United States, this study sought to assess practice patterns and outcomes for lung volume reduction surgery on a national level since the National Emphysema Treatment Trial. Aggregate statistics on lung volume reduction surgery reported in the Society of Thoracic Surgeons Database from January 2003 to June 2011 were analyzed to assess procedure volume, preoperative and operative characteristics, and outcomes. Comparisons with published data from the National Emphysema Treatment Trial were made using chi-square and 2-sided t tests. In 8.5 years, 538 patients underwent lung volume reduction surgery, with 20 to 118 cases reported in the Society of Thoracic Surgeons Database per year. When compared with subjects in the National Emphysema Treatment Trial, subjects in the Society of Thoracic Surgeons Database were younger (P volume in 1 second was 31% versus 28% of predicted (P lung volume reduction surgery. It underscores the need for dedicated centers to increasingly address the heavy burden of chronic lower respiratory disease in the United States in a multidisciplinary fashion, particularly for preoperative evaluation and postoperative management of emphysema. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  14. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kovacs, Francisco M; Urrútia, Gerard; Alarcón, José Domingo

    2011-09-15

    Systematic review. To compare the effectiveness of surgery versus conservative treatment on pain, disability, and loss of quality of life caused by symptomatic lumbar spinal stenosis (LSS). LSS is the most common reason for spine surgery in persons older than 65 years in the United States. Randomized controlled trials (RCTs) comparing any form of conservative and surgical treatment were searched in CENTRAL, MEDLINE, EMBASE, and TripDatabase databases until July 2009, with no language restrictions. Additional data were requested from the authors of the original studies. The methodological quality of each study was assessed independently by two reviewers, following the criteria recommended by the Cochrane Back Review Group. Only data from randomized cohorts were extracted. A total of 739 citations were reviewed. Eleven publications corresponding to five RCTs were included. All five scored as high quality despite concerns deriving from heterogeneity of treatment, lack of blinding, and potential differences in the size of the placebo effect across groups. They included a total of 918 patients in whom conservative treatments had failed for 3 to 6 months, and included orthosis, rehabilitation, physical therapy, exercise, heat and cold, transcutaneous electrical nerve stimulation, ultrasounds, analgesics, nonsteroidal anti-inflammatory drugs, and epidural steroids. Surgical treatments included the implantation of a specific type of interspinous device and decompressive surgery (with and without fusion, instrumented or not). In all the studies, surgery showed better results for pain, disability, and quality of life, although not for walking ability. Results of surgery were similar among patients with and without spondylolisthesis, and slightly better among those with neurogenic claudication than among those without it. The advantage of surgery was noticeable at 3 to 6 months and remained for up to 2 to 4 years, although at the end of that period differences tended to be

  15. Endoscopic surgery for the antenatal treatment of myelomeningocele: the CECAM trial.

    Science.gov (United States)

    Pedreira, Denise A L; Zanon, Nelci; Nishikuni, Koshiro; Moreira de Sá, Renato A; Acacio, Gregório L; Chmait, Ramen H; Kontopoulos, Eftichia V; Quintero, Rubén A

    2016-01-01

    A recent randomized clinical trial named Management of Myelomeningocele Study (MOMS trial) showed that prenatal correction of open spina bifida (OSB) via open fetal surgery was associated with improved infant neurological outcomes relative to postnatal repair, but at the expense of increased maternal morbidity. We sought to report the final results of our phase I trial (Cirurgia Endoscópica para Correção Antenatal da Meningomielocele [CECAM]) on the feasibility, safety, potential benefits, and side effects of the fetoscopic treatment of OSB using our unique surgical technique. Ten consecutive pregnancies with lumbosacral OSB were enrolled in the study. Surgeries were performed percutaneously under general anesthesia with 3 ports and partial carbon dioxide insufflation. After appropriate surgical positioning of the fetus, the neuroplacode was released with scissors and the skin was undermined to place a biocellulose patch over the lesion. The skin was closed over the patch using a single running stitch. Preoperative, postoperative, and postnatal magnetic resonance imaging were performed to assess hindbrain herniation. Neurodevelopmental evaluation was performed before discharge and at 3, 6, and 12 months. All cases were delivered by cesarean delivery, at which time the uterus was assessed for evidence of thinning or dehiscence. The median gestational age at the time of surgery was 27 weeks (range 25-28 weeks). Endoscopic repair was completed in 8 of 10 fetuses. Two cases were unsuccessful due to loss of uterine access. The mean gestational age at birth was 32.4 weeks with a mean latency of 5.6 weeks between surgery and delivery (range 2-8 weeks). There was 1 fetal and 1 neonatal demise, and 1 unsuccessful case underwent postnatal repair. Of the 7 infants available for analysis, complete reversal of hindbrain herniation occurred in 6 of 7 babies. Three babies required ventriculoperitoneal shunting or third ventriculostomy. Functional motor level was the same or

  16. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial.

    Science.gov (United States)

    Vachiramon, Vasanop; Sobanko, Joseph F; Rattanaumpawan, Pinyo; Miller, Christopher J

    2013-02-01

    Many patients undergoing Mohs micrographic surgery (MMS) experience anxiety and stress. Although music has been proven to reduce anxiety and promote relaxation in other fields of medicine, scant research investigates the effect of music on anxiety during MMS. To determine whether music can reduce anxiety in patients undergoing MMS. An open-labeled randomized controlled trial was conducted to assess anxiety before and after listening to music. Subjects undergoing MMS were randomly allocated to listen to self-selected music (n = 50) or to have surgery without music (n = 50). Anxiety was measured using the State-Trait Anxiety Inventory (STAI) and on a visual analog scale (VAS). Subjects in the music group experienced statistically significantly lower STAI and VAS scores than those in the control group. STAI and VAS scores were significantly lower in subjects who underwent MMS for the first time. Anxiety measures did not correlate with sex or type of skin cancer. Listening to self-selected music reduces anxiety in patients undergoing MMS, especially those who undergo MMS for the first time. Presenting patients the opportunity to listen to music is a simple strategy to minimize anxiety during MMS. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  17. Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Moyano, Jairo; García, Maria; Caicedo, Maria

    2016-01-01

    Background. Dexamethasone is sometimes used as a coanalgesic because of its anti-inflammatory properties. Objective. To evaluate opioid use, postoperative pain intensity, and side effects after a single dose of dexamethasone in patients undergoing arthroscopic knee surgery. Methods. In this randomized controlled study patients were randomized to receive either 10 mg of intravenous dexamethasone (DM group) or 0.9% normal saline (NS group) during the intraoperative period. Primary outcomes were pain intensity and total morphine and codeine use after surgery. Results. Seventy-eight patients were included in the study. The DM group showed statistically significant higher pain intensity at the fourth postoperative hour (DM: 3.96/10, standard deviation [SD] 0.54; NS: 2.46/10, SD 0.45; p = 0.036). No statistically significant difference in total opioid use (morphine plus codeine) was identified with 15.9 (SD 1.97) codeine tablets used in DM group and 20 (SD 2.14) in NS group (p = 0.25). Discussion. Pain intensity tended to decrease in both groups suggesting morphine as the main source of analgesia. Conclusions. Intravenous dexamethasone during the intraoperative period has no clinical impact on postoperative pain intensity during the first 48 h after arthroscopic knee surgery. This trial is registered with R000020892.

  18. Oral magnesium supplementation reduces the incidence of gastrointestinal complications following cardiac surgery: a randomized clinical trial.

    Science.gov (United States)

    Moradian, Seyed Tayeb; Ghiasi, Mohammad Saeid; Mohamadpour, Alireza; Siavash, Yadollah

    2017-02-01

    Gastrointestinal complications are common after coronary artery bypass graft surgery. These complications are ranged from nausea and vomiting to mesenteric ischemia and liver failure. It seems that nausea, vomiting, and constipation are related to magnesium deficiency. This study was designed to examine the effect of oral magnesium supplementation on the incidence of gastrointestinal complications in patients undergoing cardiac surgery. In a single blinded randomized clinical trial, 102 patients who were undergoing coronary artery bypass graft surgery were randomly allocated into two groups, 52 patients in the intervention and 50 patients in control group. Patients in the experimental group received 800 milligram magnesium oxide (2 tablets each of them containing 240 mg elemental magnesium) daily from the admission to discharge from hospital. The incidence of post-operative nausea and vomiting, constipation, and atrial fibrillation was compared between the groups. Our results showed that postoperative hypomagnesemia is present in 41.20 and 70.80 percent of the patients in the intervention and control group patients, respectively. The overall incidence of constipation was 62%. Patients who received magnesium supplementation experienced less atrial fibrillation, nausea, vomiting, and constipation. Our data showed that oral magnesium supplementation could reduce the postoperative complications. Despite the better status in the intervention group, the hypomagnesemia was present in many of intervention group patients. It seems that supplementation with higher doses is needed.

  19. Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jairo Moyano

    2016-01-01

    Full Text Available Background. Dexamethasone is sometimes used as a coanalgesic because of its anti-inflammatory properties. Objective. To evaluate opioid use, postoperative pain intensity, and side effects after a single dose of dexamethasone in patients undergoing arthroscopic knee surgery. Methods. In this randomized controlled study patients were randomized to receive either 10 mg of intravenous dexamethasone (DM group or 0.9% normal saline (NS group during the intraoperative period. Primary outcomes were pain intensity and total morphine and codeine use after surgery. Results. Seventy-eight patients were included in the study. The DM group showed statistically significant higher pain intensity at the fourth postoperative hour (DM: 3.96/10, standard deviation [SD] 0.54; NS: 2.46/10, SD 0.45; p=0.036. No statistically significant difference in total opioid use (morphine plus codeine was identified with 15.9 (SD 1.97 codeine tablets used in DM group and 20 (SD 2.14 in NS group (p=0.25. Discussion. Pain intensity tended to decrease in both groups suggesting morphine as the main source of analgesia. Conclusions. Intravenous dexamethasone during the intraoperative period has no clinical impact on postoperative pain intensity during the first 48 h after arthroscopic knee surgery. This trial is registered with R000020892.

  20. Surgery

    Science.gov (United States)

    ... and impairs lung function. People need to stop smoking several weeks before surgery so that the defense mechanisms of the respiratory system can recover. Doctors' evaluations The surgeon does a ...

  1. Ensuring Early Mobilization Within an Enhanced Recovery Program for Colorectal Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Fiore, Julio Flavio; Castelino, Tanya; Pecorelli, Nicolò; Niculiseanu, Petru; Balvardi, Saba; Hershorn, Olivia; Liberman, Sender; Charlebois, Patrick; Stein, Barry; Carli, Franco; Mayo, Nancy E; Feldman, Liane S

    2017-08-01

    To estimate the extent to which the addition of staff-directed facilitation of early mobilization to an Enhanced Recovery Program (ERP) impacts recovery after colorectal surgery, compared with usual care. Early mobilization is considered an important component of ERPs but, despite guidelines recommendations, adherence remains quite low. The value of dedicating specific resources (eg, staff time) to increase early mobilization is unknown. This randomized trial involved 99 colorectal surgery patients in an established ERP (median age 63, 57% male, 80% laparoscopic) randomized 1:1 to usual care (including preoperative education about early mobilization with postoperative daily targets) or facilitated mobilization [staff dedicated to assist transfers and walking from postoperative days (PODs) 0-3]. Primary outcome was the proportion of patients returning to preoperative functional walking capacity (6-min walk test) at 4 weeks after surgery. We also explored the association of the intervention with in-hospital mobilization, time to achieve discharge criteria, time to recover gastrointestinal function, 30-day comprehensive complication index, and patient-reported outcome measures. In the facilitated mobilization group, adherence to mobilization targets was greater on POD0 [OR 4.7 (95% CI 1.8-11.9)], POD1 [OR 6.5 (95% CI 2.3-18.3)], and POD2 [OR 3.7 (95% CI 1.2-11.3)]. Step count was at least 2-fold greater on POD1 [mean difference 843.3 steps (95% CI 219.5-1467.1)] and POD2 [mean difference 1099.4 steps (95% CI 282.7-1916.1)] There was no between-group difference in recovery of walking capacity at 4 weeks after surgery [OR 0.77 (95% CI 0.30-1.97)]. Other outcome measures were also not different between groups. In an ERP for colorectal surgery, staff-directed facilitation of early mobilization increased out-of-bed activities during hospital stay but did not improve outcomes. This study does not support the value of allocating additional resources to ensure early

  2. Effect of Topical Furosemide on Rhinosinusal Polyposis Relapse After Endoscopic Sinus Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Hashemian, Farnaz; Ghorbanian, Mohammad Ali; Hashemian, Farshad; Mortazavi, Seyed Alireza; Sheikhi, Mojgan; Jahanshahi, Javaneh; Poorolajal, Jalal

    2016-11-01

    Evidence from previous studies suggests that furosemide may be effective in reducing the recurrence of polyps after sinus surgery. However, the evidence is limited and insufficient, and further investigations are required. To assess the effect of topical furosemide on recurrence rate of rhinosinusal polyposis after endoscopic sinus surgery. Triple-blind randomized clinical trial of patients aged 18 to 60 years with chronic rhinosinusitis associated with polyposis who did not respond to medical treatment and were candidates for endoscopic sinus surgery at Besat Hospital, Hamadan University of Medical Sciences, from April 2014 to June 2015. Patients were randomly assigned to receive postoperative nasal spray, 2 puffs twice a day for 2 months, either 300 µg of furosemide per day or placebo. Six months after surgery, the patients were examined for nasal and paranasal sinus polyposis using Meltzer endoscopic grading, computed tomographic (CT) scan of paranasal sinuses (PNS) scoring, Sino-Nasal Outcome Test (SNOT-22) scoring, and visual analog scale (VAS). Of 110 patients enrolled, 84 patients remained for analysis (53 men and 31 women; mean age in the furosemide group, 37.02 years, range, 18-58 years; mean age in the placebo group, 36.30 years, range, 18-60 years). Six months after the intervention, the grade of polyposis decreased in both groups, but this reduction was substantial in the furosemide group vs the placebo group. The severity of polyposis was significantly lower in the furosemide group vs the placebo group based on SNOT-22 scoring (difference, 8.05; 95% CI, 3.24-12.85) and VAS (difference, 0.81; 95% CI, 0.22-1.39) but not significantly different based on CT scan of PNS scoring (difference, 2.52; 95% CI, -0.35 to 5.39). The incidence of adverse effects (nasal irritation, headache, and constipation) were not significantly different between the 2 groups. These findings indicate that topical furosemide is a safe drug, with no important adverse effects, that

  3. Randomized trial of antimicrobial-coated sutures to prevent surgical site infection after breast cancer surgery.

    Science.gov (United States)

    Williams, Nia; Sweetland, Helen; Goyal, Sumit; Ivins, Nicola; Leaper, David J

    2011-12-01

    Surgical site infection (SSI) is the fourth commonest healthcare-associated infection and complicates at least 5% of open operations. In a randomized clinical trial, antimicrobial-coated sutures were compared with their conventional counterparts, polyglactin and poliglecaprone, for skin closure after breast cancer surgery to assess their role in reducing the rate of SSI. Between November 2008 and February 2011, 150 female patients presenting with breast cancer to a single center were randomized to skin closure with antimicrobial-coated or plain sutures. Postoperatively, SSI was defined using the U.S. Centers for Disease Control and Prevention (CDC) definitions and scored using the ASEPSIS or Southampton systems by trained, blinded observers with close post-discharge surveillance and patient diaries. Surgeons and patients were blinded to the type of suture used. Using CDC criteria, the overall rate of SSI was 18.9% at six weeks. Six patients (4.7%) needed intervention or readmission for SSI. Skin closure with antimicrobial sutures showed a non-statistically significant reduction in the SSI rate, to 15.2%, compared with conventional sutures (22.9%). A uniform tendency for fewer SSIs in the antimicrobial-coated suture group was found using ASEPSIS and Southampton scores, but again, the difference was not statistically significant. The previously reported high rate of SSI related to breast surgery was confirmed. Using statistical modeling and earlier reports, the study was powered to show a difference using ASEPSIS scores, but the modification used in this trial failed to find a difference. Finding a statistically significant difference would have needed two to three times the number of patients recruited. Further evaluation of antimicrobial-coated sutures is merited, particularly if used as part of a care bundle to reduce SSI after breast cancer surgery.

  4. Fish oil and atrial fibrillation after cardiac surgery: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Wei Xin

    Full Text Available BACKGROUND: Influence of fish oil supplementation on postoperative atrial fibrillation (POAF was inconsistent according to published clinical trials. The aim of the meta-analysis was to evaluate the effects of perioperative fish oil supplementation on the incidence of POAF after cardiac surgery. METHODS: Pubmed, Embase and the Cochrane Library databases were searched. Randomized controlled trials (RCTs assessing perioperative fish oil supplementation for patients undergoing cardiac surgery were identified. Data concerning study design, patient characteristics, and outcomes were extracted. Risk ratio (RR and weighted mean differences (WMD were calculated using fixed or random effects models. RESULTS: Eight RCTs involving 2687 patients were included. Perioperative supplementation of fish oil did not significantly reduce the incidence of POAF (RR = 0.86, 95%CI 0.71 to 1.03, p = 0.11 or length of hospitalization after surgery (WMD = 0.10 days, 95% CI: 0.48 to 0.67 days, p = 0.75. Fish oil supplementation also did not affect the perioperative mortality, incidence of major bleeding or the length of stay in the intensive care unit. Meta-regression and subgroup analyses indicated mean DHA dose in the supplements may be a potential modifier for the effects of fish oil for POAF. For supplements with DHA >1 g/d, fish oil significantly reduced the incidence of POAF; while it did not for the supplements with a lower dose of DHA. CONCLUSIONS: Current evidence did not support a preventative role of fish oil for POAF. However, relative amounts of DHA and EPA in fish oil may be important for the prevention of POAF.

  5. Neuraxial anesthesia for orthopedic surgery: systematic review and meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Fabiano Timbó Barbosa

    Full Text Available CONTEXT AND OBJECTIVE: Taking the outcome of mortality into consideration, there is controversy about the beneficial effects of neuraxial anesthesia for orthopedic surgery. The aim of this study was to compare the effectiveness and safety of neuraxial anesthesia versus general anesthesia for orthopedic surgery. DESIGN AND SETTING: Systematic review at Universidade Federal de Alagoas. METHODS: We searched the Cochrane Central Register of Controlled Trials (Issue 10, 2012, PubMed (1966 to November 2012, Lilacs (1982 to November 2012, SciELO, EMBASE (1974 to November 2012 and reference lists of the studies included. Only randomized controlled trials were included. RESULTS: Out of 5,032 titles and abstracts, 17 studies were included. There were no statistically significant differences in mortality (risk difference, RD: -0.01; 95% confidence interval, CI: -0.04 to 0.01; n = 1903, stroke (RD: 0.02; 95% CI: -0.04 to 0.08; n = 259, myocardial infarction (RD: -0.01; 95% CI: -0.04 to 0.02; n = 291, length of hospitalization (mean difference, -0.05; 95% CI: -0.69 to 0.58; n = 870, postoperative cognitive dysfunction (RD: 0.00; 95% CI: -0.04 to 0.05; n = 479 or pneumonia (odds ratio, 0.61; 95% CI: 0.25 to 1.49; n = 167. CONCLUSION: So far, the evidence available from the studies included is insufficient to prove that neuraxial anesthesia is more effective and safer than general anesthesia for orthopedic surgery. However, this systematic review does not rule out clinically important differences with regard to mortality, stroke, myocardial infarction, length of hospitalization, postoperative cognitive dysfunction or pneumonia.

  6. Desmopressin after cardiac surgery in bleeding patients. A multicenter randomized trial.

    Science.gov (United States)

    Bignami, E; Cattaneo, M; Crescenzi, G; Ranucci, M; Guarracino, F; Cariello, C; Baldassarri, R; Isgrò, G; Baryshnikova, E; Fano, G; Franco, A; Gerli, C; Crivellari, M; Zangrillo, A; Landoni, G

    2016-08-01

    Previous studies showed that desmopressin decreases post-operative blood loss in patients undergoing cardiac surgery. These studies were small and never studied the effect of desmopressin in patients with active bleeding. Objective of the study was to determine whether desmopressin reduces red blood cells transfusion requirements in patients with active bleeding after cardiac surgery who had been pre-treated with tranexamic acid. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study randomized elective patients with bleeding after cardiac surgery despite pre-treatment with tranexamic acid, to receive placebo (saline solution) or a single administration of desmopressin (0.3 μg/kg in saline solution). The primary endpoint was the number of patients requiring red blood cells transfusion after randomization and during hospital stay. Secondary end points were: blood loss from chest tubes during the first 24 h after study drug administration, hours of mechanical ventilation, intensive care unit stay, and in-hospital mortality. The study was interrupted after inclusion of 67% of the planned patients for futility. The number of patients requiring red blood cells transfusion after randomization was 37/68 (54%) in desmopressin group and 33/67 (49%) in placebo group (P = 0.34) with no difference in blood loss: 575 (interquartile 422-770) ml in desmopressin group and 590 (476-1013) ml in placebo group (P = 0.42), mechanical ventilation, intensive care unit stay or mortality. This multicenter randomized trial demonstrated that, in patients pre-treated with tranexamic acid, desmopressin should not be expected to improve treatment of patients who experience bleeding after cardiac surgery. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  7. Use of clustering analysis in randomized controlled trials in orthopaedic surgery.

    Science.gov (United States)

    Oltean, Hanna; Gagnier, Joel J

    2015-03-08

    The effects of clustering in randomized controlled trials (RCTs) and the resulting potential violation of assumptions of independence are now well recognized. When patients in a single study are treated by several therapists, there is good reason to suspect that the variation in outcome will be smaller for patients treated in the same group than for patients treated in different groups. This potential correlation of outcomes results in a loss of independence of observations. The purpose of this study is to examine the current use of clustering analysis in RCTs published in the top five journals of orthopaedic surgery. RCTs published from 2006 to 2010 in the top five journals of orthopaedic surgery, as determined by 5-year impact factor, that included multiple therapists and/or centers were included. Identified articles were assessed for accounting for the effects of clustering of therapists and/or centers in randomization or analysis. Logistic regression used both univariate and multivariate models, with use of clustering analysis as the outcome. Multivariate models were constructed using stepwise deletion. An alpha level of 0.10 was considered significant. A total of 271 articles classified as RCTs were identified from the five journals included in the study. Thirty-two articles were excluded due to inclusion of nonhuman subjects. Of the remaining 239 articles, 186 were found to include multiple centers and/or therapists. The prevalence of use of clustering analysis was 21.5%. Fewer than half of the studies reported inclusion of a statistician, epidemiologist or clinical trials methodologist on the team. In multivariate modeling, adjusting for clustering was associated with a 6.7 times higher odds of inclusion of any type of specialist on the team (P = 0.08). Likewise, trials that accounted for clustering had 3.3 times the odds of including an epidemiologist/clinical trials methodologist than those that did not account for clustering (P = 0.04). Including

  8. Respiratory Muscle Training in Patients Recovering Recent Open Cardiothoracic Surgery: A Randomized-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ernesto Crisafulli

    2013-01-01

    Full Text Available Objectives. To evaluate the clinical efficacy and feasibility of an expiratory muscle training (EMT device (Respilift applied to patients recovering from recent open cardiothoracic surgery (CTS. Design. Prospective, double-blind, 14-day randomised-controlled trial. Participants and Setting. A total of 60 inpatients recovering from recent CTS and early admitted to a pulmonary rehabilitation program. Interventions. Chest physiotherapy plus EMT with a resistive load of 30 cm H2O for active group and chest physiotherapy plus EMT with a sham load for control group. Measures. Changes in maximal expiratory pressure (MEP were considered as primary outcome, while maximal inspiratory pressures (MIP, dynamic and static lung volumes, oxygenation, perceived symptoms of dyspnoea, thoracic pain, and well being (evaluated by visual analogic scale—VAS and general health status were considered secondary outcomes. Results. All outcomes recorded showed significant improvements in both groups; however, the change of MEP (+34.2 mmHg, and +26.1%, for absolute and % of predicted, resp. was significantly higher in active group. Also VAS dyspnoea improved faster and more significantly ( at day 12, and 14 in active group when compared with control. The drop-out rate was 6%, without differences between groups. Conclusions. In patients recovering from recent CTS, specific EMT by Respilift is feasible and effective. This trial is registered with ClinicalTrials.gov NCT01510275.

  9. Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site.

    Science.gov (United States)

    Mauri, Laura; Normand, Sharon-Lise T; Pencina, Michael; Cutlip, Donald E; Jeon, Cathy; Dreyer, Paul; Kuntz, Richard E; Baim, Donald S; Jacobs, Alice K

    2011-11-01

    Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI. The MASS COMM trial (ClinicalTrials.gov no. NCT01116882) is a randomized trial comparing the safety and effectiveness of nonemergency PCI at hospitals without surgery on-site (SOS) (non-SOS hospitals) and hospitals with SOS (SOS hospitals). A total of 3,690 subjects will be randomized in a 3:1 fashion to undergo PCI at non-SOS and SOS hospitals, with follow-up at hospital discharge, 30 days, and 12 months after PCI. The rate of major adverse cardiac events (all-cause mortality, myocardial infarction, repeat revascularization, and stroke) will serve as the primary safety end point at 30 days and the primary effectiveness end point at 12 months. The design is a 1-way randomized trial with a statistical hypothesis of noninferiority of nonemergency PCI at non-SOS hospitals for both safety and effectiveness end points. This multicenter, randomized trial will compare the relative safety and effectiveness of nonemergency PCI at sites with and without cardiac SOS. Copyright © 2011 Mosby, Inc. All rights reserved.

  10. PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol.

    Science.gov (United States)

    Lindbäck, Yvonne; Tropp, Hans; Enthoven, Paul; Abbott, Allan; Öberg, Birgitta

    2016-07-11

    Current guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes. This study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary

  11. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial.

    Science.gov (United States)

    Fernández-de-Las Peñas, César; Ortega-Santiago, Ricardo; de la Llave-Rincón, Ana I; Martínez-Perez, Almudena; Fahandezh-Saddi Díaz, Homid; Martínez-Martín, Javier; Pareja, Juan A; Cuadrado-Pérez, Maria L

    2015-11-01

    This randomized clinical trial investigated the effectiveness of surgery compared with physical therapy consisting of manual therapies including desensitization maneuvers in carpal tunnel syndrome (CTS). The setting was a public hospital and 2 physical therapy practices in Madrid, Spain. One hundred twenty women with CTS were enrolled between February 2013 and January 2014, with 1-year follow-up completed in January 2015. Interventions consisted of 3 sessions of manual therapies including desensitization maneuvers of the central nervous system (physical therapy group, n = 60) or decompression/release of the carpal tunnel (surgical group, n = 60). The primary outcome was pain intensity (mean pain and the worst pain), and secondary outcomes included functional status and symptoms severity subscales of the Boston Carpal Tunnel Questionnaire and the self-perceived improvement. They were assessed at baseline and 1, 3, 6, and 12 months by a blinded assessor. Analysis was by intention to treat. At 12 months, 111 (92%) women completed the follow-up (55/60 physical therapy, 56/60 surgery). Adjusted analyses showed an advantage (all, P physical therapy at 1 and 3 months in mean pain (Δ -2.0 [95% confidence interval (CI) -2.8 to -1.2]/-1.3 [95% CI -2.1 to -.6]), the worst pain (Δ -2.9 [-4.0 to -2.0]/-2.0 [-3.0 to -.9]), and function (Δ -.8 [-1.0 to -.6]/-.3 [-.5 to -.1]), respectively. Changes in pain and function were similar between the groups at 6 and 12 months. The 2 groups had similar improvements in the symptoms severity subscale of the Boston Carpal Tunnel Questionnaire at all follow-ups. In women with CTS, physical therapy may result in similar outcomes on pain and function to surgery. http://www.clinicaltrials.gov, ClinicalTrials.gov, NCT01789645. This study found that surgery and physical manual therapies including desensitization maneuvers of the central nervous system were similarly effective at medium-term and long-term follow-ups for improving pain and

  12. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Vale, Luke; Norrie, John; Kinsella, John; Cook, Jonathan; Brittenden, Julie; Grant, Adrian

    2010-04-16

    Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial registration number - ISRCTN32188676.

  13. Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Heger, Patrick; Zaschke, Steffen; Knebel, Phillip; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-03-24

    Blinding is a measure in randomized controlled trials (RCT) to reduce detection and performance bias. There is evidence that lack of blinding leads to overestimated treatment effects. Because of the physical component of interventions, blinding is not easily applicable in surgical trials. This is a protocol for a systematic review and empirical study about actual impact on outcomes and future potential of blinding in general and abdominal surgery RCT. A systematic literature search in CENTRAL, MEDLINE and Web of Science will be conducted to locate RCT between 1996 and 2015 with a surgical intervention. General study characteristics and information on blinding methods will be extracted. The risk of performance and detection bias will be rated as low, unclear or high according to the Cochrane Collaboration's tool for assessing risk of bias. The main outcome of interest will be the association of a high risk of performance or detection bias with significant trial results and will be tested at a level of significance of 5 %. Further, trials will be meta-analysed in a Mantel-Haenszel model comparing trials with high risk of bias to other trials at a level of significance of 5 %. Detection and performance bias distort treatment effects. The degree of such bias in general and abdominal surgery is unknown. Evidence on influence of missing blinding would improve critical appraisal and conduct of general and abdominal surgery RCT. PROSPERO 2015: CRD42015026837.

  14. Patient education videos for elective colorectal surgery: results of a randomized controlled trial.

    Science.gov (United States)

    Ihedioha, U; Vaughan, S; Mastermann, J; Singh, B; Chaudhri, S

    2013-11-01

    Recent advances in surgery have focused on peri-operative care and interventions to improve outcome following surgery. Psychological preparation has a positive impact on recovery and incorporates a range of strategies with dissemination of information as one of the key elements. Information can be given verbally, through printed information or through use of a video. Traditionally, reliance has been on the use of written material as an adjunct to patient education in clinic. The current study is a randomized trial on the use of video education in patients undergoing elective colorectal resection within an enhanced recovery programme. Sixty-five eligible patients undergoing elective colorectal surgery were identified and 61 were randomized between August 2010 and August 2011 to either video and information leaflets or information leaflets alone. A fast track protocol was established for all the patients. Clinicians in charge of postoperative recovery were blinded. Standard discharge criteria were employed for all patients. Of 61 patients randomized, one dropped out and outcomes on 60 were analysed. There was no difference in baseline characteristics between the groups (age, P = 0.964; body mass index, P = 0.829). Twenty-eight (91%) patients in the video group had left sided resections while two (6%) had right sided resections. Nineteen (66%) in the non-video group had left sided resections while nine (31%) had right sided resections. One (3%) patient in the non-video group and one (3%) in the video group had a total colectomy. Fourteen (45%) patients in the video group and 12 (41%) in the non-video group had surgery completed laparoscopically. There was no difference in the primary (median hospital stay 5 vs 5 days; P = 0.239) or the secondary outcome measures (pain score on movement, P = 0.338; pain score at rest, P = 0.989; nausea score, P = 0.74; epidural use, P = 0.984; paracetamol use, P = 0.44; voltarol use, P = 0.506) between the groups. Use of video

  15. Haloperidol prophylaxis decreases delirium incidence in elderly patients after noncardiac surgery: a randomized controlled trial*.

    Science.gov (United States)

    Wang, Wei; Li, Hong-Liang; Wang, Dong-Xin; Zhu, Xi; Li, Shuang-Ling; Yao, Gai-Qi; Chen, Kai-Sheng; Gu, Xiu-E; Zhu, Sai-Nan

    2012-03-01

    To evaluate the efficacy and safety of short-term low-dose intravenous haloperidol for delirium prevention in critically ill elderly patients after noncardiac surgery. Prospective, randomized, double-blind, and placebo-controlled trial in two centers. Intensive care units of two large tertiary teaching hospitals. Four hundred fifty-seven patients 65 yrs or older who were admitted to the intensive care unit after noncardiac surgery. Haloperidol (0.5 mg intravenous bolus injection followed by continuous infusion at a rate of 0.1 mg/h for 12 hrs; n = 229) or placebo (n = 228) was randomly administered from intensive care unit admission. The primary end point was the incidence of delirium within the first 7 days after surgery. Secondary end points included time to onset of delirium, number of delirium-free days, length of intensive care unit stay, all-cause 28-day mortality, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit. The incidence of delirium during the first 7 days after surgery was 15.3% (35/229) in the haloperidol group and 23.2% (53/228) in the control group (p = .031). The mean time to onset of delirium and the mean number of delirium-free days were significantly longer (6.2 days [95% confidence interval 5.9-6.4] vs. 5.7 days [95% confidence interval 5.4-6.0]; p = .021; and 6.8 ± 0.5 days vs. 6.7 ± 0.8 days; p = .027, respectively), whereas the median length of intensive care unit stay was significantly shorter (21.3 hrs [95% confidence interval 20.3-22.2] vs. 23.0 hrs [95% confidence interval 20.9-25.1]; p = .024) in the haloperidol group than in the control group. There was no significant difference with regard to all-cause 28-day mortality between the two groups (0.9% [2/229] vs. 2.6% [6/228]; p = .175). No drug-related side effects were documented. For elderly patients admitted to intensive care unit after noncardiac surgery, short-term prophylactic administration of low-dose intravenous

  16. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Gorecki, P; Rainsford, K D; Taneja, P; Bulsara, Y; Pearson, D; Saund, D; Ahmed, B; Dietrich, T

    2017-12-01

    indicate efficacy, safety, and relative tolerability of diclofenac HPβCD used locally as a submucosal injection prior to third molar surgery (ClinicalTrials.gov NCT01706588).

  17. Clinical trial of modified ankylos implants for extraoral use in cranio- and maxillofacial surgery.

    Science.gov (United States)

    Schlegel, Karl Andreas; Schultze-Mosgau, Stefan; Eitner, Stefan; Wiltfang, Joerg; Rupprecht, Stephan

    2004-01-01

    Epithetic solutions in the maxillofacial region are indicated if plastic surgery reconstruction is not a valid option for an extensive defect. The purpose of this study was to examine whether the extraoral implants used provided sufficient retention to be used as anchoring aids. Between November 1999 and September 2002, 33 identical modified Ankylos implants for extraoral anchorage were placed in 10 patients for the fixation of various epitheses in the midfacial (eye, nose) and ear regions in the course of a clinical trial. Over a follow-up period of 2 to 34 months, all implants remained osseointegrated (as confirmed radiographically), and the implants and epithetic restorations were clinically stable. The results demonstrated that the lasting retention of maxillofacial epitheses provided by implants assures patients that their epitheses are securely fixed. The demonstrated extraoral implant system not only achieved sufficient osseointegration but also showed good clinical handling and easy fixation possibilities for epithetic anchorage.

  18. Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial)

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Johansson, Pär I; Zacho, Mette

    2012-01-01

    , as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively. METHODS: This is a prospective randomized clinical trial, with an open......ABSTRACT: BACKGROUND: Hypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin......-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus...

  19. Conservative Care in Lumbar Spine Surgery Trials: A Descriptive Literature Review.

    Science.gov (United States)

    Yang, Aaron J; Coronado, Rogelio A; Hoffecker, Lilian; Gao, Chan; Saurwein, Kelly; Shoreman, Danielle; Hoffberg, Adam S; Akuthota, Venu

    2017-01-01

    To evaluate the degree to which conservative care and failure were specifically defined in studies comparing nonoperative treatment versus surgery for low back pain (LBP) conditions in adults. A comprehensive literature search was conducted by an experienced librarian using MEDLINE (PubMed), Embase, Google Scholar, and CENTRAL from January 2003 to June 2014. Endnote bibliographic management application was used to remove duplicates and organize the citations. Prospective, randomized, or cohort trials comparing surgery versus conservative intervention for patients with LBP conditions. Study selection was conducted by 2 independent reviewers. Three independent reviewers extracted data from each article using a structured data extraction form. Data extracted included type of study, participant characteristics, sample size, description, and duration of conservative care and whether failed conservative care criterion was defined. A total of 852 unique records were screened for eligibility; of those, 72 articles were identified for further full-text review. Thirty-four full texts were excluded based on the exclusion criteria, and 38 articles, representing 20 unique studies, were included for qualitative synthesis. Fifteen of the 20 studies defined the duration of conservative care. Only 3 studies defined the dosage of physical therapy sessions, including total number of visits and visit duration. Two studies described medication usage, including the duration and type. No studies specifically defined what constituted failed conservative therapy. This literature review suggests conservative care is poorly defined in randomized trials, which can lead to ambiguity of research procedures and unclear guidelines for clinicians. Future studies should increase transparency and explicitly define conservative care. Copyright © 2016 American Congress of Rehabilitation Medicine. All rights reserved.

  20. Surrendering control, or nothing to lose: Parents' preferences about participation in a randomised trial of childhood strabismus surgery.

    Science.gov (United States)

    Buck, Deborah; Hogan, Vanessa; Powell, Christine J; Sloper, John J; Speed, Chris; Taylor, Robert H; Tiffin, Peter; Clarke, Michael P

    2015-08-01

    Intermittent exotropia is the most common form of divergent strabismus (squint) in children. Evidence regarding its optimum management is limited. A pilot randomised controlled trial has recently been completed (Surgery versus Active Monitoring in Intermittent Exotropia trial) to determine the feasibility of a full randomised controlled trial. To identify drivers for and barriers against parents' participation in Surgery versus Active Monitoring in Intermittent Exotropia and to seek their views on information received, the need for randomisation, and enhancing acceptability. Multiple method qualitative study using semi-structured telephone interviews to explore parents' motivations and trial screening logs to provide an indication of common barriers. Exploratory thematic analysis identified key themes. A total of 48 interviews were conducted (14 participants; 34 non-participants). Barriers included no desire for surgery/preference to 'wait and see', wanting surgery immediately, feeling uncomfortable about 'surrendering control' over decision-making/being managed 'at random', lack of confidence in the effectiveness of surgery, believing the risks outweighed the benefits, and lack of trust. Drivers included desiring surgery, 'nothing to lose', benefits offsetting the risks, and being in a trial would result in better care. Some also mentioned 'doing their bit' for research. Suggestions for enhancing acceptability included allowing choice of treatment group, giving more time for decision-making, expanding on information given, and improving communication. Many felt the necessity of randomisation was adequately explained, but there was some indication that it was misunderstood. Information extracted from the screening logs of 80/89 eligible non-participants indicated the most prevalent barrier was not wanting surgery/preferring to observe (56%), followed by desiring surgery straightaway (15%). Opposition to randomisation/wanting to retain control was recorded in 9% of

  1. Perioperative steroids for lumbar disc surgery: A meta-analysis of randomized controlled trials

    Science.gov (United States)

    Waqas, Muhammad; Shallwani, Hussain; Shamim, Muhammad S.; Ahmad, Khabir

    2017-01-01

    Background: Our review question was “Does perioperative steroids administration, in comparison with other treatments or placebo, improve either postoperative pain control, length of hospital stay, or return to work in patients undergoing lumbar disc surgery?” Methods: We searched PubMed, CINAHL PLUS, and Cochrane databases for randomized control trials (RCTs) studying the role of steroids for lumbar disc surgery. Studies that compared perioperative steroids with other treatments or placebo were included. Study outcomes included postoperative back pain, leg pain, length of hospital stay, and return to work. Data was extracted through a proforma. Means and mean differences were calculated for continuous data, whereas odds ratios were calculated for dichotomous data. Data were analyzed with the help of Rev Man 5. Results: Twenty RCTs were included in the review. Quantitative analysis could be performed on 19 RCTs. Intraoperative steroids improve control of back pain at 24–48 hours. Although there was some benefit of steroid administration in controlling postoperative leg pain, it disappeared at 1 year and in the overall pooled analysis. The length of hospital stay was much shorter in the steroid group. The frequency of adverse events and complications also favored steroid administration. Conclusion: Intraoperative epidural steroid administration offers some benefit in pain control with a significant reduction in the length of hospital stay. However, there is insufficient evidence to support the routine use of oral and intravenous steroids in the perioperative period. PMID:28480104

  2. Randomized clinical trial of comprehensive geriatric assessment and optimization in vascular surgery.

    Science.gov (United States)

    Partridge, J S L; Harari, D; Martin, F C; Peacock, J L; Bell, R; Mohammed, A; Dhesi, J K

    2017-05-01

    Increasing numbers of older patients are undergoing vascular surgery. Inadequate preoperative assessment and optimization may contribute to increased postoperative morbidity and mortality. Patients aged at least 65 years scheduled for elective aortic aneurysm repair or lower-limb arterial surgery were enrolled in an RCT of standard preoperative assessment or preoperative comprehensive geriatric assessment and optimization. Randomization was stratified by sex and surgical site (aorta/lower limb). Primary outcome was length of hospital stay. Secondary outcome measures included new medical co-morbidities, postoperative medical or surgical complications, discharge to a higher level of dependency and 30-day readmission rate. A total of 176 patients were included in the final analysis (control 91, intervention 85). Geometric mean length of stay was 5·53 days in the control group and 3·32 days in the intervention group (ratio of geometric means 0·60, 95 per cent c.i. 0·46 to 0·79; P < 0·001). There was a lower incidence of delirium (11 versus 24 per cent; P = 0·018), cardiac complications (8 versus 27 per cent; P = 0·001) and bladder/bowel complications (33 versus 55 per cent; P = 0·003) in the intervention group compared with the control group. Patients in the intervention group were less likely to require discharge to a higher level of dependency (4 of 85 versus 12 of 91; P = 0·051). In this study of patients aged 65 years or older undergoing vascular surgery, preoperative comprehensive geriatric assessment was associated with a shorter length of hospital stay. Patients undergoing assessment and optimization had a lower incidence of complications and were less likely to be discharged to a higher level of dependency. Registration number: ISRCTN23142588 (http://www.controlled-trials.com). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  3. Shared medical appointments as a new model for carpal tunnel surgery consultation: A randomized clinical trial.

    Science.gov (United States)

    Wong, Alison L; Martin, Janet; Wong, Michael J; Bezuhly, Michael; Tang, David

    2016-01-01

    In chronic disease management, shared medical appointments have been shown to improve clinic access, productivity and patient education. However, adoption of this model in surgical consultation is limited, and its effect on surgical patients' satisfaction, comfort and surgical risk recall is unknown. To determine whether shared medical appointments could be applied to carpal tunnel surgery consultation while being equally effective as individual consultation for risk recall, patient comfort and satisfaction. A prospective randomized trial involving 80 patients referred for carpal tunnel release consultation, in which patients were assigned to an educational discussion individually or as part of a shared appointment, was conducted. In a blinded fashion, patients were contacted preoperatively to assess their risk recall and postoperatively to rate their overall satisfaction, comfort and satisfaction with the surgeon. Patient demographics were equal. Surgical risk recall was equivalent between shared and individual consults (2.06±1.15 versus 1.64±1.04; P=0.11). More participants in the shared appointments condition remembered the specific risks of infection (61.1% versus 33.3%; P=0.020) and bleeding (30.6% versus 10.3%; P=0.028). There was no difference in overall satisfaction (8.70 versus 8.88; P=0.75), satisfaction with the surgeon (8.05 versus 8.13; P=0.92) or overall comfort (8.80 versus 8.31; P=0.46). Shared medical appointments for carpal tunnel surgery consultation were equivalent to individual consultation in terms of surgical risk recall, patient satisfaction and comfort. These results support the use of shared appointments for large-volume, low-variation surgery.

  4. Preoperative enoxaparin versus postoperative semuloparin thromboprophylaxis in major abdominal surgery: a randomized controlled trial.

    Science.gov (United States)

    Kakkar, Ajay K; Agnelli, Giancarlo; Fisher, William; George, Daniel; Lassen, Michael R; Mismetti, Patrick; Mouret, Patrick; Murphy, Judith; Lawson, Francesca; Turpie, Alexander G G

    2014-06-01

    To compare efficacy and safety of thromboprophylaxis with semuloparin started postoperatively versus enoxaparin started preoperatively in major abdominal surgery. Venous thromboembolism is an important complication following major abdominal surgery. Semuloparin is a novel ultra-low-molecular-weight heparin with high antifactor Xa and minimal antifactor IIa activity. In this double-blind noninferiority trial, adult patients undergoing major abdominal or pelvic operation under general anesthesia lasting more than 45 minutes were assigned to either daily enoxaparin 40 mg commenced preoperatively or daily semuloparin 20 mg commenced postoperatively, for 7 to 10 days. Patients underwent bilateral leg venography between 7 and 11 days postsurgery. The primary efficacy end point was the composite of any deep vein thrombosis, nonfatal pulmonary embolism, or all-cause death. The primary safety outcome was bleeding. Both were independently adjudicated. In total, 4413 patients were randomized; 3030 (1499 in the enoxaparin and 1531 in the semuloparin groups) were evaluable for the primary efficacy end point, which occurred in 97 patients (6.3%) in the semuloparin group and 82 patients (5.5%) in the enoxaparin group [odds ratio (OR) = 1.16, 95% confidence interval (CI): 0.84-1.59]. On the basis of a noninferiority margin of 1.25, postoperative semuloparin did not demonstrate noninferiority to preoperative enoxaparin. Major bleeding occurred in 63 of 2175 patients (2.9%) in the semuloparin group and 98 of 2177 patients (4.5%) in the enoxaparin group (OR = 0.63, 95% CI: 0.46-0.87). Semuloparin commenced postoperatively did not demonstrate noninferiority to enoxaparin initiated preoperatively for thromboprophylaxis after major abdominal surgery. Study registered with clinicaltrials.gov: NCT00679588.

  5. The effect of music intervention in stress response to cardiac surgery in a randomized clinical trial.

    Science.gov (United States)

    Nilsson, Ulrica

    2009-01-01

    To evaluate the effect of bed rest with music on the first postoperative day to decrease stress for patients who have undergone heart surgery. A repeated-measures randomized controlled trial was used. The study took place in a cardiothoracic intermediary unit of a university hospital in Sweden. Fifty-eight patients who had undergone open coronary artery bypass grafting or aortic valve replacement surgery were included. Stress response was assessed by determining the serum cortisol, heart rate, respiratory rate, mean arterial pressure, arterial oxygen tension, arterial oxygen saturation, and subjective pain and anxiety levels. At 12:00 noon on postoperative day 1, patients were allocated to receive 30 minutes of uninterrupted bed rest with music and then 30 minutes of bed rest or alternatively 60 minutes of uninterrupted bed rest. The music was soft and relaxing, included different melodies in new-age style, played with a volume at 50 to 60 dB, and distributed through a music pillow connected to an MP3 player. After 30 minutes of bed rest, there was a significant difference in s-cortisol levels between the groups; 484. 4 mmol/L in the music group versus 618.8 mmol/L in the control group (P difference in s-cortisol levels was not found 30 minutes later (ie, after a total of 60 minutes). There was no difference in heart rate, respiratory rate, mean arterial pressure, arterial oxygen tension, arterial oxygen saturation, and subjective pain and anxiety levels between the groups. There is sufficient practical evidence of stress reduction to suggest that a proposed regimen of listening to music while resting in bed after open heart surgery be put into clinical use.

  6. A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

    Science.gov (United States)

    Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradic, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Likhvantsev, Valery; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, Bruno; Monaco, Fabrizio; De Vuono, Giovanni; Corcione, Antonio; Galdieri, Nicola; Cariello, Claudia; Bove, Tiziana; Fominskiy, Evgeny; Auriemma, Stefano; Baiocchi, Massimo; Bianchi, Alessandro; Frontini, Mario; Paternoster, Gianluca; Sangalli, Fabio; Wang, Chew-Yin; Zucchetti, Maria Chiara; Biondi-Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J; Lomivorotov, Vladimir V; Landoni, Giovanni

    2016-07-01

    Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Effect of gum chewing on ameliorating ileus following colorectal surgery: A meta-analysis of 18 randomized controlled trials.

    Science.gov (United States)

    Liu, Qing; Jiang, Honglei; Xu, Dong; Jin, Junzhe

    2017-11-01

    Chewing gum, as an alternative to sham feeding, had been shown to hasten the recovery of gut function following abdominal surgery. However, conclusions remained contradictory. We sought to conduct an updated meta-analysis to evaluate the efficacy of gum chewing in alleviating ileus following colorectal surgery. We searched PubMed, EMBASE, and Cochrane Library Databases through February 2017 to identify randomized controlled trials (RCTs) evaluating the efficacy of the additional use of chewing gum following colorectal surgery. After screening for inclusion, data extraction, and quality assessment, meta-analysis was conducted by the Review Manager 5.3 software. The outcomes of interest were the time to first flatus, time to first bowel movement, length of hospital stay, and some clinically relevant parameters. We also performed subgroup analyses according to the type of surgical approaches or on trials that adopted enhanced recovery after surgery (ERAS) protocol or sugared gum. A total of 18 RCTs, involving 1736 patients, were included. Compared with standardized postoperative care, Chewing gum resulted in a shorter passage to first flatus [WMD = -8.81, 95%CI: (-13.45, -4.17), P = 0.0002], earlier recovery of bowel movement [WMD = -16.43, 95%CI: (-22.68, -10.19), P safe and effective method to ameliorate ileus following colorectal surgery. However, tightly controlled, randomized and considerably larger multicenter trials are warranted to further validate our findings. Copyright © 2017. Published by Elsevier Ltd.

  8. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

    DEFF Research Database (Denmark)

    Andersson, J; Angenete, E; Gellerstedt, M

    2013-01-01

    Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....

  9. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...

  10. Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial).

    Science.gov (United States)

    Steffens, Daniel; Young, Jane; Beckenkamp, Paula R; Ratcliffe, James; Rubie, Freya; Ansari, Nabila; Pillinger, Neil; Solomon, Michael

    2018-02-17

    There is a need for evidence of the effectiveness of pre-operative exercise for patients undergoing major cancer surgery; however, recruitment to such trials can be challenging. The PrE-operative Physical Activity (PEPA) Trial will establish the feasibility and acceptability of a pre-operative exercise programme aimed to improve patient outcomes after cytoreductive surgery and pelvic exenteration. The secondary aim is to obtain pilot data on the likely difference in key outcomes (post-operative complications, length of hospital stay, post-operative functional capacity and quality of life) to inform the sample size calculation for the substantive randomised clinical trial. Twenty patients undergoing cytoreductive surgery and pelvic exenteration at the Royal Prince Alfred Hospital, Sydney will be recruited and randomly allocated (1:1 ratio) to either 2 to 6 weeks' pre-operative exercise programme (intervention group) or usual care (control group). Those randomised to the intervention group will receive up to six individualised, 1-h physiotherapy sessions (including aerobic and endurance exercises, respiratory muscle exercises, stretching and flexibility exercises), home exercises (instruction and recommendations on how to progress the exercises at home) and encouragement to be more active by using an activity tracker to measure the number of steps walked daily. Patients allocated to the control group will not receive any specific advice about exercise training. Feasibility will be assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the exercise programme. Acceptability of the exercise programme will be assessed with a semi-structured questionnaire. The following measures of the effectiveness of the intervention will be collected at baseline (2 to 6 weeks pre-operative), a week before surgery, during hospital stay and pre hospital discharge: post-operative complication rates (Clavien-Dindo), post

  11. Clinical trials and graft patency data in coronary artery surgery--a 30-year perspective.

    Science.gov (United States)

    Buxton, Brian F; Fuller, John

    2004-01-01

    The treatment of coronary artery disease, initially by medical and surgical and subsequently using percutaneous interventions, has evolved rapidly over the last 50 years. Randomized controlled clinical trials and observational studies of large cohorts have been instrumental in the evolution of the current practice of coronary artery revascularisation. This paper traces some of the historic trials of medical versus surgical therapy, surgical versus percutaneous intervention and graft patency studies. Medical therapy and percutaneous intervention are now the primary therapeutic modalities. However, there was an early recurrence rate with percutaneous intervention which has decreased with the use of drug-eluting stents. Coronary artery bypass surgery remains a major option for treating advanced coronary artery disease. Furthermore, it remains the treatment of first choice in most patients with left main coronary artery disease and those with extensive three-vessel proximal coronary artery disease, especially when associated with poor left ventricular function. The choice of a coronary artery bypass conduit is of major importance in developing a single long-term strategy for the surgical treatment of coronary artery disease. Bilateral internal thoracic artery grafting is now accepted as the treatment of choice, although not universally practiced. The role of other arterial conduits is being defined.

  12. Squeeze bottle versus saline spray after endoscopic sinus surgery for chronic rhinosinusitis: a pilot multicentre trial.

    Science.gov (United States)

    Macdonald, K I; Wright, E D; Sowerby, L J; Rotenberg, B W; Chin, C J; Rudmik, L; Sommer, D D; Nayan, S; DesRosiers, M; Tewfik, M A; Valdes, C J; Massoud, E; Thomas, D; Kilty, S J; Vescan, A; Mechor, B; Lavigne, F; Fandino, M; Javer, A R; Witterick, I J

    2015-01-01

    There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population. Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22 (SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores. Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8 versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9-32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2-16.1), and NSS 8.2 versus 5.0, treatment effect 3.1 (95% CI, 1.4-4.9) pre- and postoperatively, respectively (all p spray showed significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential difference between the two treatment groups.

  13. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration Current Controlled Trials ISRCTN46462267.

  14. Randomized Controlled Trial of Antiseptic Hand Hygiene Methods in an Outpatient Surgery Clinic.

    Science.gov (United States)

    Therattil, Paul J; Yueh, Janet H; Kordahi, Anthony M; Cherla, Deepa V; Lee, Edward S; Granick, Mark S

    2015-12-01

    Outpatient wound care plays an integral part in any plastic surgery practice. However, compliance with hand hygiene measures has shown to be low, due to skin irritation and lack of time. The objective of this trial was to determine whether single-use, long-acting antiseptics can be as effective as standard multiple-use hand hygiene methods in an outpatient surgical setting. A prospective, randomized controlled trial was performed in the authors' outpatient plastic surgery clinic at Rutgers New Jersey Medical School, Newark, NJ to compare the efficacy of an ethyl alcohol-based sanitizer (Avagard D Instant Hand Aniseptic, 3M Health Care, St. Paul, MN), a benzalkonium chloride-based sanitizer (Soft & Shield, Bioderm Technologies, Inc, Trenton, NJ, distributed by NAPP Technologies, Hackensack, NJ ), and soap and- water handwashing. Subjects included clinic personnel, who were followed throughout the course of a 3-hour clinic session with hourly hand bacterial counts taken. During the course of the trial, 95 subjects completed the clinic session utilizing 1 of the hand hygiene methods (36 ethyl alcohol-based sanitizer, 38 benzalkonium chloride-based sanitizer, and 21 soap-and-water handwashing). There was no difference between hand bacterial counts using the different methods at 4 hourly time points (P greater than 0.05). Hand bacterial counts increased significantly over the 3-hour clinic session with the ethyl alcohol-based sanitizer (9.24 to 21.90 CFU, P less than 0.05), benzalkonium chloride-based sanitizer (6.69 to 21.59 CFU, P less than 0.05), and soap-and-water handwashing (8.43 to 22.75 CFU, P less than 0.05). There does not appear to be any difference in efficacy between single-use, long-acting sanitizer, and standard multiple-use hand hygiene methods. Hand bacterial counts increased significantly over the course of the 3-hour clinic session regardless of the hand hygiene measure used. Hand condition of subjects was improved with the ethyl alcohol

  15. Fetal surgery for myelomeningocele: history, research, clinical trials, and future directions.

    Science.gov (United States)

    Keller, B A; Farmer, D L

    2015-08-01

    Myelomeningocele, more commonly known as spina bifida, is the most common neural tube defect worldwide. In the United States, it is the primary cause of lifelong childhood paralysis with approximately four children born daily with this devastating disease. To minimize damage to the exposed spinal cord and prevent ascending central nervous system infections, postnatal closure of the spinal defect has been the standard of care for decades. Research into the mechanism of spinal cord injury in those with spina bifida revealed that damage continues to accrue during the gestational period. Prenatal defect closure via in utero surgery was proposed to prevent this early deterioration of the spinal cord, and early animal research demonstrated that prenatal repair was feasible and promising. This paved the way for the first human prenatal repairs in the mid-to-late 1990s. Following the promising outcomes observed during the first human cases, a randomized controlled trial, the Management of Myelomeningocele Study (MOMS), was conducted comparing postnatal repair of spina bifida to prenatal repair. The MOMS trial demonstrated that to those undergoing prenatal repair of spina bifida had a decreased need for ventriculoperitoneal shunting and improved lower extremity motor function. With the success of the MOMS trial, in utero repair is now considered the standard of care in those who meet the criteria for prenatal repair. This review will provide an overview of spina bifida and its impact, highlight the historical changes in care, describe the early research and theory that made prenatal repair an option, discuss the clinical experiences with human fetal repair and briefly touch on future research directions for those with myelomeningocele.

  16. Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Boshuisen, Kim; Lamberink, Herm J; van Schooneveld, Monique Mj; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg; Geleijns, Karin; Uiterwaal, Cuno Spm; Braun, Kees Pj

    2015-10-26

    The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at the cost of long-term seizure outcome. Moreover, AED withdrawal seemed to improve cognitive outcome. A randomized trial is needed to confirm these findings. We hypothesized that early AED withdrawal in children is not only safe, but also beneficial with respect to cognitive functioning. This is a multi-center pragmatic randomized clinical trial to investigate whether early AED withdrawal improves cognitive function, in terms of attention, executive function and intelligence, quality of life and behavior, and to confirm safety in terms of eventual seizure freedom, seizure recurrences and "seizure and AED freedom." Patients will be randomly allocated in parallel groups (1:1) to either early or late AED withdrawal. Randomization will be concealed and stratified for preoperative IQ and medical center. In the early withdrawal arm reduction of AEDs will start 4 months after surgery, while in the late withdrawal arm reduction starts 12 months after surgery, with intended complete cessation of drugs after 12 and 20 months respectively. Cognitive outcome measurements will be performed preoperatively, and at 1 and 2 years following surgery, and consist of assessment of attention and executive functioning using the EpiTrack Junior test and intelligence expressed as IQ (Wechsler Intelligence Scales). Seizure outcomes will be assessed at 24 months after surgery, and at 20 months following start of AED reduction. We aim to randomize 180 patients who underwent anticipated curative epilepsy surgery below 16 years of age, were able to perform the EpiTrack Junior test preoperatively, and have no predictors of poor postoperative seizure prognosis (multifocal magnetic resonance imaging (MRI

  17. Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation

    Directory of Open Access Journals (Sweden)

    Teddy Oosterhuis

    2017-07-01

    Trial registration: Netherlands Trial Register NTR3156. [Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017 Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation. Journal of Physiotherapy 63: 144–153

  18. Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial.

    Science.gov (United States)

    Kim, Stephen J; Lo, Wayne R; Hubbard, G Baker; Srivastava, Sunil K; Denny, John P; Martin, Daniel F; Yan, Jiong; Bergstrom, Chris S; Cribbs, Blaine E; Schwent, Bryan J; Aaberg, Thomas M

    2008-09-01

    To evaluate the effects of topical ketorolac in patients undergoing vitreoretinal surgery. One hundred nine patients undergoing vitrectomies were randomized to receive either topical ketorolac tromethamine, 0.4%, or placebo. Patients were instructed to begin taking the study medication 3 days preoperatively (4 times daily) and to continue taking it 4 weeks postoperatively. Intraoperative pupil diameter, postoperative day 1 pain and inflammation, 1-month postoperative retinal thickness, and preoperative and 1-month postoperative best-corrected visual acuities. The difference in mean pupil diameters between patients using ketorolac and those taking placebo was 0.06 mm (P = .39). Patients taking ketorolac and those taking placebo had mean pain scores (scale, 1-10) of 0.24 (SD, 0.6) and 1.06 (SD, 2) (P = .03) and mean inflammation grades (grade, 0-4) of 0.59 (SD, 0.7) and 1.16 (SD, 0.9) (P < .001), respectively. Ketorolac reduced central subfield thickness by 8%, but this was not statistically significant. At 1 month, mean visual acuities improved to 0.40 logMAR units (mean Snellen, 20/50; SD, 0.28 logMAR units) in the ketorolac group from 0.83 logMAR units (20/150(+2); SD, 0.60 logMAR units) at baseline and to 0.67 logMAR units (20/100(+1); SD, 0.46 logMAR units) in the placebo group from 0.92 logMAR units (20/150(-2); SD, 0.62 logMAR units) at baseline (P = .001). Topical ketorolac was well tolerated and safe, reduced postoperative pain and inflammation, and improved visual recovery in this prospective, double-masked trial. Topical ketorolac may benefit patients undergoing vitreoretinal surgery. clinicaltrials.gov Identifier: NCT00576329.

  19. A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery.

    Science.gov (United States)

    Koch, Colleen G; Sessler, Daniel I; Mascha, Edward J; Sabik, Joseph F; Li, Liang; Duncan, Andra I; Zimmerman, Nicole M; Blackstone, Eugene H

    2017-10-01

    Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use. From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model. At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%). Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  20. High-intensity training following lung cancer surgery: a randomised controlled trial.

    Science.gov (United States)

    Edvardsen, E; Skjønsberg, O H; Holme, I; Nordsletten, L; Borchsenius, F; Anderssen, S A

    2015-03-01

    Many patients with lung cancer are deconditioned with poor physical fitness. Lung resection reduces physical fitness further, impairing the patient's ability to function in daily life. We conducted a single-blind randomised controlled trial of high-intensity endurance and strength training (60 min, three times a week, 20 weeks), starting 5-7 weeks after surgery. The control group received standard postoperative care. The primary outcome was the change in peak oxygen uptake measured directly during walking until exhaustion. Other outcomes included changes in pulmonary function, muscular strength by one-repetition maximum (1RM), total muscle mass measured by dual energy X-ray absorptiometry, daily physical functioning and quality of life (QoL). The intention-to-treat analysis of the 61 randomised patients showed that the exercise group had a greater increase in peak oxygen uptake (3.4 mL/kg/min between-group difference, p=0.002), carbon monoxide transfer factor (Tlco) (5.2% predicted, p=0.007), 1RM leg press (29.5 kg, pmental component summary score was 55.5±5.3 and 46.6±14.0 (p=0.015) in the exercise and control groups, respectively. In patients recently operated for lung cancer, high-intensity endurance and strength training was well tolerated and induced clinically significant improvements in peak oxygen uptake, Tlco, muscular strength, total muscle mass, functional fitness and QoL. This study may provide a basis for exercise therapy after lung cancer surgery. NCT01748981. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  1. AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery

    DEFF Research Database (Denmark)

    Sort, Rune; Brorson, Stig; Gögenur, Ismail

    2017-01-01

    INTRODUCTION: Ankle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following.......METHODS AND ANALYSIS: AnAnkle Trial is a randomised, dual-centre, open-label, blinded analysis trial of 150 adult patients undergoing primary internal fixation of an ankle fracture. Main exclusion criteria are habitual opioid use, impaired pain sensation, other painful injuries or cognitive impairment...

  2. A Meta-analysis of Randomized Trials Comparing Surgery versus Endovascular Therapy for Thrombosed Arteriovenous Fistulas and Grafts in Hemodialysis

    Energy Technology Data Exchange (ETDEWEB)

    Kuhan, G., E-mail: gkuhan@nhs.net; Antoniou, G. A. [Central Manchester University Hospital Foundation Trust, Regional Vascular and Endovascular Unit (United Kingdom); Nikam, M.; Mitra, S. [Central Manchester University Hospital Foundation Trust, Department of Renal Medicine (United Kingdom); Farquharson, F. [Central Manchester University Hospital Foundation Trust, Department of Radiology (United Kingdom); Brittenden, J. [University of Aberdeen (United Kingdom); Chalmers, N. [Central Manchester University Hospital Foundation Trust, Department of Radiology (United Kingdom)

    2013-06-15

    Purpose. To carry out a systematic review of randomized trials comparing surgery vs. endovascular therapy for occluded fistulas and grafts. Methods. All randomized trials which compared surgery and endovascular therapy for occluded fistulas and grafts were retrieved from 1990 onwards. The following search terms were used: 'haemodialysis,' 'thrombosis,' 'arteriovenous fistula,' 'arteriovenous shunt,' 'end stage renal failure' on Medline and PubMed. The results of the pooled data were analysed by a fixed-effect model. Results. There were no randomized trials comparing surgery vs. endovascular therapy for native fistulas and vein grafts. Six randomized studies reporting on 573 occluded grafts were identified. Technical success, need for access line and primary patency at 30 days were similar between the two groups (odds ratio [OR] 1.40, 95 % confidence interval [CI] 0.91-2.14; OR 0.77, 95 % CI 0.44-1.34; and OR 1.15, 95 % CI 0.79-1.68, respectively). There was no significant difference in morbidity at 30 days between groups (OR 1.12, 95 % CI 0.67-1.86). There were no statistical difference between the two groups for 1 year primary patency (OR 2.08, 95 % CI 0.97-4.45). Primary assisted patency at 1 year was better with surgery (OR 3.03, 95 % CI 1.12-8.18) in a single study. Conclusion. Comparable results to surgery have been achieved with endovascular techniques for occluded prosthetic grafts for dialysis access. Long-term data comparing the two groups were lacking. Further trials designed to encompass variation in methods are warranted in order to obtain the best available evidence particularly for native fistulas.

  3. Controlled trial for long-term low-dose erythromycin after sinus surgery for chronic rhinosinusitis.

    Science.gov (United States)

    Haxel, Boris R; Clemens, Meike; Karaiskaki, Niki; Dippold, Uta; Kettern, Lisanne; Mann, Wolf J

    2015-05-01

    The efficacy of macrolides in chronic rhinosinusitis (CRS) is still under controversy. To date, only two double-blind, placebo-controlled studies have been published with differing results. None of these studies investigated the possible benefit of macrolides in the postoperative period. We conducted an investigator-initiated clinical trial using 250-mg erythromycin once a day over a period of 3 months, beginning the administration of either erythromycin or placebo 2 weeks after a surgical intervention for CRS. Randomized double-blind, placebo-controlled trial. The concentrations of eosinophilic cationic protein (ECP) and myeloperoxidase in nasal secretion were chosen as primary outcome measures. Additionally, as a secondary outcome measure, changes in the Sino-Nasal Outcome Test-20 score, olfaction, saccharin transit time, nasal endoscopy score, and self-rating of nasal health using a visual analogue scale were evaluated. Sixty-seven patients after surgery for CRS with or without nasal polyps were screened, and 58 patients were randomized to the study groups. For the primary outcomes, the concentrations of ECP changed from 176.4 µl/l ± 79.0 to 226.1 µl/l ± 200.6 in the erythromycin group and from 186.9 µl/l ± 36.0 to 192.9 µl/l ± 189.2 in the placebo group; no statistical differences were found. Of the secondary outcomes, only the nasal endoscopy score showed a statistically significant improvement in the erythromycin group (from 2.6 ± 1.4 to 1.9 ± 1.5 points) compared to the placebo group (from 2.5 ± 1.3 to 2.6 ± 1.5 points). The subgroup of patients without nasal polyps in the erythromycin group showed a tendency to improvement in some secondary outcome criteria. A general recommendation for long-term, low-dose erythromycin treatment after surgery for CRS cannot be given. In patients with CRS without nasal polyps, a tendency to improved parameters was detected. Ib. © 2014 The American Laryngological, Rhinological and

  4. Early percutaneous tracheotomy versus prolonged intubation of mechanically ventilated patients after cardiac surgery: a randomized trial.

    Science.gov (United States)

    Trouillet, Jean-Louis; Luyt, Charles-Edouard; Guiguet, Marguerite; Ouattara, Alexandre; Vaissier, Elisabeth; Makri, Ralouka; Nieszkowska, Ania; Leprince, Pascal; Pavie, Alain; Chastre, Jean; Combes, Alain

    2011-03-15

    Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial. To compare the outcomes of severely ill patients who require prolonged mechanical ventilation randomly assigned to early percutaneous tracheotomy or prolonged intubation. Prospective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321). Academic center. 216 adults requiring mechanical ventilation 4 or more days after cardiac surgery. Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization. The primary end point was the number of ventilator-free days during the first 60 days after randomization. Secondary outcomes included 28-, 60-, or 90-day mortality rates; durations of mechanical ventilation, intensive care unit stay, and hospitalization; sedative, analgesic, and neuroleptic use; ventilator-associated pneumonia rate; unscheduled extubations; comfort and ease of care; and long-term health-related quality of life (HRQoL) and psychosocial evaluations. There was no difference in ventilator-free days during the first 60 days after randomization between early percutaneous tracheotomy and prolonged intubation groups (mean, 30.4 days [SD, 22.4] vs. 28.3 days [SD, 23.7], respectively; absolute difference, 2.1 days [95% CI, -4.1 to 8.3 days]) nor in 28-, 60-, or 90-day mortality rates (16% vs. 21%, 26% vs. 28%, and 30% vs. 30%, respectively). The durations of mechanical ventilation and hospitalization, as well as frequencies of ventilator-associated pneumonia and other severe infections, were also similar. However, early percutaneous tracheotomy was associated with less intravenous sedation; less time of heavy sedation; less haloperidol use for agitation, delirium, or both; fewer unscheduled extubations; better comfort and ease of care; and earlier resumption of oral nutrition. After a median

  5. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Staehr Anne K

    2012-07-01

    Full Text Available Abstract Background A high perioperative inspiratory oxygen fraction (FiO2 may reduce the frequency of surgical site infection. Perioperative atelectasis is caused by absorption, compression and reduced function of surfactant. It is well accepted, that ventilation with 100% oxygen for only a few minutes is associated with significant formation of atelectasis. However, it is still not clear if a longer period of 80% oxygen results in more atelectasis compared to a low FiO2. Our aim was to assess if a high FiO2 is associated with impaired oxygenation and decreased pulmonary functional residual capacity (FRC. Methods Thirty-five patients scheduled for laparotomy for ovarian cancer were randomized to receive either 30% oxygen (n = 15 or 80% oxygen (n = 20 during and for 2 h after surgery. The oxygenation index (PaO2/FiO2 was measured every 30 min during anesthesia and 90 min after extubation. FRC was measured the day before surgery and 2 h after extubation by a rebreathing method using the inert gas SF6. Results Five min after intubation, the median PaO2/FiO2 was 69 kPa [53-71] in the 30%-group vs. 60 kPa [47-69] in the 80%-group (P = 0.25. At the end of anesthesia, the PaO2/FiO2 was 58 kPa [40-70] vs. 57 kPa [46-67] in the 30%- and 80%-group, respectively (P = 0.10. The median FRC was 1993 mL [1610-2240] vs. 1875 mL [1545-2048] at baseline and 1615 mL [1375-2318] vs. 1633 mL [1343-1948] postoperatively in the 30%- and 80%-group, respectively (P = 0.70. Conclusion We found no significant difference in oxygenation index or functional residual capacity between patients given 80% and 30% oxygen for a period of approximately 5 hours. Trial registration ClinicalTrials.gov Identifier: NCT00637936.

  6. Exogenous Fibrinogen Pertains Beneficial Effects in Managing Post-Cardiac Surgery Bleeding: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Esmaeelzadeh

    2016-09-01

    Full Text Available Introduction: Post cardiac surgery hemorrhagic syndromes, potentialized by implementing   cardiopulmonary bypass, leads to increased hazards of blood products transfusion and          pertains serious impacts on immediate patients outcome. The objective of this clinical trial was to investigate the efficiency of exogenous fibrinogen to control hemorrhagic syndromes following cardiac surgery in the intensive care unit. Materials and Methods: Eighty patients undergoing open heart surgery at Imam Reza Hospital, Mashhad, Iran with blood drainage more than 200 ml per hour were randomly divided to receive either fibrinogen 2 grams or placebo. The patients were investigated for amount of blood drainage, units of required blood product, length of stay in intensive care unit (ICU, and mortality. Results:  The first early 3-hours drainage (443.97±169.98 vs 606.66±235.93ml; p value =0.001 and total first 24 hours drainage (1025.30 ml and 1377.60 ml; p value: 0.041 showed significant difference in favor of fibrinogen receiving group. The fibrinogen group required significantly lesser units of red blood cells, and fresh frozen plasma (FFP (1.62 and 2.55 compared to placebo group (2.74 and 3.21 (p values: 0.010 and 0.032. Platelets units requirement did not reach significant difference between the groups.   ICU length of stay was shorter in fibrinogen group (2.82 days versus 4.02 days; p value 0.045, while mechanical ventilation time did not significantly differ among the two groups. In addition, there was a trend towards decreased  early mortality in fibrinogen receiving group (7.5% versus 17.5 % ; p value = 0.02. Conclusion: Administration of low dose of fibrinogen in patients with postoperative bleeding can reduce ongoing and total blood drainage, transfusion of blood products, ICU length and early mortality.

  7. A randomized trial of urodynamic testing before stress-incontinence surgery.

    Science.gov (United States)

    Nager, Charles W; Brubaker, Linda; Litman, Heather J; Zyczynski, Halina M; Varner, R Edward; Amundsen, Cindy; Sirls, Larry T; Norton, Peggy A; Arisco, Amy M; Chai, Toby C; Zimmern, Philippe; Barber, Matthew D; Dandreo, Kimberly J; Menefee, Shawn A; Kenton, Kimberly; Lowder, Jerry; Richter, Holly E; Khandwala, Salil; Nygaard, Ingrid; Kraus, Stephen R; Johnson, Harry W; Lemack, Gary E; Mihova, Marina; Albo, Michael E; Mueller, Elizabeth; Sutkin, Gary; Wilson, Tracey S; Hsu, Yvonne; Rozanski, Thomas A; Rickey, Leslie M; Rahn, David; Tennstedt, Sharon; Kusek, John W; Gormley, E Ann

    2012-05-24

    Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

  8. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Min Jung; Park, Sung Chan; Park, Ji Won; Chang, Hee Jin; Kim, Dae Yong; Nam, Byung-Ho; Sohn, Dae Kyung; Oh, Jae Hwan

    2018-02-01

    The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer. The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet. Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life. A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03). Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

  9. Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial.

    Science.gov (United States)

    Kjeken, Ingvild; Eide, Ruth Else Mehl; Klokkeide, Åse; Matre, Karin Hoegh; Olsen, Monika; Mowinckel, Petter; Andreassen, Øyvor; Darre, Siri; Nossum, Randi

    2016-11-15

    In the absence of disease-modifying interventions for hand osteoarthritis (OA), occupational therapy (OT) comprising patient education, hand exercises, assistive devices and orthoses are considered as core treatments, whereas surgery are recommended for those with severe carpometacarpal (CMC1) OA. However, even though CMC1 surgery may reduce pain and improve function, the risk of adverse effects is high, and randomized controlled trials comparing surgery with non-surgical interventions are warranted. This multicentre randomized controlled trial aims to address the following questions: Does OT in the period before surgical consultation reduce the need for surgery in CMC1-OA? What are patients' motivation and reasons for wanting CMC1-surgery? Are there differences between departments of rheumatology concerning the degree of CMC1-OA, pain and functional limitations in patients who are referred for surgical consultation for CMC1 surgery? Is the Measure of Activity Performance of the Hand a reliable measure in patients with CMC1-OA? Do patients with CMC1-OA with and without affection of the distal and proximal interphalangeal finger joints differ with regard to symptoms and function? Do the degree of CMC1-OA, symptoms and functional limitations significantly predict improvement after 2 years following OT or CMC1-surgery? Is OT more cost-effective than surgery in the management of CMC1-OA? All persons referred for surgical consultation due to their CMC1-OA at one of three Norwegian departments of rheumatology are invited to participate. Those who agree attend a clinical assessment and report their symptoms, function and motivation for surgery in validated outcome measures, before they are randomly selected to receive OT in the period before surgical consultation (estimated n = 180). The primary outcome will be the number of participants in each group who have received surgical treatment after 2 years. Secondary and tertiary outcomes are pain, function and

  10. Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol.

    Science.gov (United States)

    Day, Alexander C; Burr, Jennifer M; Bunce, Catey; Doré, Caroline J; Sylvestre, Yvonne; Wormald, Richard P L; Round, Jeff; McCudden, Victoria; Rubin, Gary; Wilkins, Mark R

    2015-11-27

    Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual outcomes through greater precision and reproducibility, and improved safety. FACT is a randomised single masked non-inferiority trial to establish whether laser-assisted cataract surgery is as good as or better than standard manual phacoemulsification. 808 patients aged 18 years and over with visually significant cataract will be randomised to manual phacoemulsification cataract surgery (standard care) or laser-assisted cataract surgery (intervention arm). Outcomes will be measured at 3 and 12 months after surgery. The primary clinical outcome is uncorrected distance visual acuity (UDVA, logMAR) at 3 months in the study eye recorded by an observer masked to the trial group. Secondary outcomes include UDVA at 12 months, corrected distance visual acuity at 3 and 12 months, complications, endothelial cell loss, patient-reported outcome measures and a health economic analysis conforming to National Institute for Health and Care Excellence standards. Research Ethics Committee Approval was obtained on 6 February 2015, ref: 14/LO/1937. Current protocol: v2.0 (08/04/2015). Study findings will be published in peer-reviewed journals. 77602616. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. Assessment of patient-specific surgery effect based on weighted estimation and propensity scoring in the re-analysis of the sciatica trial.

    Directory of Open Access Journals (Sweden)

    Bart J A Mertens

    Full Text Available We consider a re-analysis of the wait-and-see (control arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery.

  12. Assessment of Patient-Specific Surgery Effect Based on Weighted Estimation and Propensity Scoring in the Re-Analysis of the Sciatica Trial

    Science.gov (United States)

    Mertens, Bart J. A.; Jacobs, Wilco C. H.; Brand, Ronald; Peul, Wilco C.

    2014-01-01

    We consider a re-analysis of the wait-and-see (control) arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery. PMID:25353633

  13. General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial.

    Science.gov (United States)

    Purwar, B; Ismail, K M; Turner, N; Farrell, A; Verzune, M; Annappa, M; Smith, I; El-Gizawy, Zeiad; Cooper, J C

    2015-08-01

    Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes. Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient's subjective perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire. Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS. This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery.

  14. [Learning success of students in surgery with a multimedia-based manual. A prospective randomized trial].

    Science.gov (United States)

    Pape-Köhler, C; Chmelik, C; Heiss, M M; Lefering, R

    2013-10-01

    Teaching surgery to students means covering two main learning fields: theoretical knowledge and practical skills. The objective of this study was to compare a multimedia-based surgical procedure manual to a text-based one in a student population. This randomized controlled trial in a pre-post-retention test design was conducted online with the participation of 101 medical students. Subjects studied the performance of a laparoscopic cholecystectomy either in a multimedia-based (MMG) or text-based (TG) presentation. The post-test surveyed the knowledge gain and 3 months later a retention test assessed the sustainability of that knowledge. The study showed a significant knowledge gain in the intragroup comparison. Regarding the procedural knowledge, the MMG scored significantly higher in Δpost-test with 3.84 (MMG) vs 2.98 (TG) correct answers (p = 0.040). This finding was confirmed in the retention test. The MMG (7.17) scored overall significantly higher than the TG (6.41) with correct answers (p = 0.028). Multimedia-based learning can be regarded as an alternative to text-based learning. Students learn factual knowledge equally well with both devices but the MMG scored higher in procedural and more complex knowledge.

  15. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial

    DEFF Research Database (Denmark)

    Meyhoff, Christian Sylvest; Wetterslev, Jørn; Jorgensen, Lars N

    2008-01-01

    A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk of surg...... complications, such as atelectasis, pneumonia and respiratory failure. The aim of our trial is to assess the potential benefits and harms of a high perioperative oxygen fraction in patients undergoing abdominal surgery....... of surgical site infections after elective colorectal surgery, but a third trial was stopped early because the frequency of surgical site infections was more than doubled in the group receiving FiO(2) = 0.80. It has not been settled if a high inspiratory oxygen fraction increases the risk of pulmonary......A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk...

  16. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial

    Science.gov (United States)

    Mendelow, A David; Gregson, Barbara A; Rowan, Elise N; Murray, Gordon D; Gholkar, Anil; Mitchell, Patrick M

    2013-01-01

    Summary Background The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10–100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients. Methods In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967. Findings 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI −4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367). Interpretation The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage. Funding UK Medical Research Council. PMID:23726393

  17. Effects of a prehabilitation program on patients? recovery following spinal stenosis surgery: study protocol for a randomized controlled trial

    OpenAIRE

    Marchand, Andr?e-Anne; Suitner, Margaux; O?Shaughnessy, Julie; Ch?tillon, Claude-?douard; Cantin, Vincent; Descarreaux, Martin

    2015-01-01

    Background Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention progr...

  18. A Randomized Controlled Trial Comparing Outcomes of Cataract Surgery in Nanophthalmos With and Without Prophylactic Sclerostomy.

    Science.gov (United States)

    Rajendrababu, Sharmila; Babu, Naresh; Sinha, Sapna; Balakrishnan, Vijayakumar; Vardhan, Ashok; Puthuran, George Varghese; Ramulu, Pradeep Y

    2017-11-01

    To prospectively evaluate visual outcomes and complications during and after cataract surgery with or without prophylactic sclerostomy in nanophthalmic eyes with visually significant cataract. Randomized controlled trial. Sixty nanophthalmic eyes of 60 patients with visually significant cataract were randomly assigned to cataract surgery alone (control group, n = 31) or cataract surgery with concomitant prophylactic sclerostomy (sclerostomy group, n = 29). Surgery was performed using phacoemulsification or manual small-incision cataract surgery (SICS) based on the LOCS III grading score. Group differences in intraoperative and postoperative complications were analyzed and risk factors assessed. Fewer complications were noted in eyes receiving sclerostomy (5/29, 17.2%) as compared to control group eyes (12/31, 38.7%), though differences were marginally significant (P = .065). Four control group, but no sclerostomy group, eyes developed postoperative uveal effusions (P = .04). In multivariable models, sclerostomy decreased the odds of an intraoperative or postoperative complication by 80% (odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.04-0.92, P = .039); SICS was associated with a significantly higher risk of complications as compared to phacoemulsification (OR = 5.95, 95% CI = 1.49-23.73, P = .012), while high preoperative intraocular pressure (OR = 4.54, 95% CI = 0.99-20.9, P = .052) and greater lens thickness (OR = 3.38, 95% CI = 0.88-12.91, P = .075) demonstrated a marginally significant association. Cataract surgery in eyes with nanophthalmos is associated with a high risk for vision-threatening complications. Performing a simultaneous prophylactic sclerostomy with cataract surgery reduces complication rates, particularly uveal effusions. Cataract surgery at earlier stages by phacoemulsification may be more beneficial than undergoing manual SICS. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. The Effect of Cataract Surgery on Circadian Photoentrainment: A Randomized Trial of Blue-Blocking versus Neutral Intraocular Lenses.

    Science.gov (United States)

    Brøndsted, Adam Elias; Sander, Birgit; Haargaard, Birgitte; Lund-Andersen, Henrik; Jennum, Poul; Gammeltoft, Steen; Kessel, Line

    2015-10-01

    Cataract decreases blue light transmission. Because of the selective blue light sensitivity of the retinal ganglion cells governing circadian photoentrainment, cataract may interfere with normal sleep-wake regulation and cause sleep disturbances. The purpose was to investigate the effect of cataract surgery on circadian photoentrainment and to determine any difference between blue-blocking and neutral intraocular lenses (IOLs). The study was a single-center, investigator-driven, double-masked, block-randomized clinical trial. One eye in 76 patients with bilateral age-related cataract eligible for cataract surgery was included. Intervention was cataract surgery by phacoemulsification. Patients were randomized to receive a blue-blocking or neutral IOL. Primary outcome was activation of intrinsic photosensitive ganglion cells using post-illumination pupil response (PIPR) to blue light from 10 to 30 seconds after light exposure as a surrogate measure. Secondary outcomes were circadian rhythm analysis using actigraphy and 24-hour salivary melatonin measurements. Finally, objective and subjective sleep quality were determined by actigraphy and the Pittsburgh Sleep Quality Index. The blue light PIPR increased 2 days (17%) and 3 weeks (24%) after surgery (P blue-blocking and neutral IOLs, whereas low preoperative blue light transmission was inversely associated with an increase in PIPR (P = 0.021) and sleep efficiency (P = 0.048). Cataract surgery increases photoreception by the photosensitive retinal ganglion cells. Because of inconsistency between the significant findings and the many parameters that were unchanged, we can conclude that cataract surgery does not adversely affect the circadian rhythm or sleep. Longer follow-up time and fellow eye surgery may reveal the significance of the subtle changes observed. We found no difference between blue-blocking and neutral IOLs, and, because of the minor effect of surgery in itself, an effect of IOL type seems highly unlikely

  20. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefore...... to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation....

  1. Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial).

    Science.gov (United States)

    Rogers, Chris A; Pike, Katie; Campbell, Helen; Reeves, Barnaby C; Angelini, Gianni D; Gray, Alastair; Altman, Doug G; Miller, Helen; Wells, Sian; Taggart, David P

    2014-07-01

    Coronary artery bypass grafting (CABG) is the treatment of choice for patients with multivessel coronary artery disease (CAD). Evidence from randomised controlled trials (RCTs) in low-risk populations shows that 'off-pump' CABG is at least as safe as 'on-pump' CABG, but high-quality trial data in high-risk populations are lacking. To test the hypothesis that, in high-risk patients, off-pump coronary artery bypass grafting (OPCABG) reduces mortality and morbidity without causing a higher risk of reintervention compared with on-pump coronary artery bypass grafting (ONCABG). Open parallel-group RCT with a 1 : 1 allocation ratio and expertise-based randomisation. Eight specialist cardiac surgery centres in the UK and one specialist centre in Kolkata, India. Patients with an additive European system for cardiac operative risk evaluation score (EuroSCORE) of ≥ 5, undergoing non-emergency isolated CABG via a median sternotomy. CABG without cardiopulmonary bypass (CPB), i.e. OPCABG on the beating heart, or CABG with CPB, i.e. ONCABG on a chemically arrested heart. Primary outcome - a composite of death or serious morbidity [all-cause mortality, myocardial infarction (MI), stroke, prolonged initial ventilation, sternal wound dehiscence] within 30 days of surgery. Secondary outcomes - quality of life (QoL) [Rose Angina Questionnaire, Canadian Cardiovascular Society (CCS) angina class, European QoL-5 Dimensions (EQ-5D), Coronary Revascularisation Outcome Questionnaire (CROQ)] and resource utilisation. The organisation of a tertiary cardiac surgery service in the UK presented several barriers to recruitment. Referral information was often inadequate to confirm eligibility. Limited surgeon participation at a centre, the need to meet referral-to-treatment performance targets and complex referral pathways did not support an expertise-based allocation. Urgent patients waiting for surgery in local 'feeder' hospitals were often not transferred until late the night before

  2. The quality of randomised controlled trials involving surgery from the hand to the elbow: a critical analysis of the literature.

    Science.gov (United States)

    Kim, J M; Zimmerman, R M; Jones, C M; Muhit, A Al; Higgins, J P; Means, K R

    2017-01-01

    Our purpose was to determine the quality of current randomised controlled trials (RCTs) in hand surgery using standardised metrics. Based on five-year mean impact factors, we selected the six journals that routinely publish studies of upper extremity surgery. Using a journal-specific search query, 62 RCTs met our inclusion criteria. Then three blinded reviewers used the Jadad and revised Coleman Methodology Score (RCMS) to assess the quality of the manuscripts. Based on the Jadad scale, 28 studies were of high quality and 34 were of low quality. Methodological deficiencies in poorly scoring trials included the absence of rate of enrolment, no power analysis, no description of withdrawal or dropout, and a failure to use validated outcomes assessments with an independent investigator. A large number of RCTs in hand, wrist, and elbow surgery were of suboptimal quality when judged against the RCMS and Jadad scales. Even with a high level of evidence, study design and execution of RCTs should be critically assessed. Methodological deficiencies may introduce bias and lead to statistically underpowered studies. Cite this article: Bone Joint J 2017;99-B:94-9. ©2017 The British Editorial Society of Bone & Joint Surgery.

  3. Meta-analysis of randomized trials comparing fusion surgery to non-surgical treatment for discogenic chronic low back pain.

    Science.gov (United States)

    Wang, Xin; Wanyan, Pingping; Tian, Jin Hui; Hu, Long

    2015-01-01

    Chronic low back pain causes socioeconomic burdens. Whether lumbar fusion is more effective than nonsurgical treatment of discogenic low back pain (DLBP) is controversial. Several randomized controlled trials that compared conservative treatment and fusion surgery had conflicting conclusions. To compare between the effectiveness of lumbar fusion and nonsurgical intervention in patients with chronic low back pain caused by disc degeneration. PubMed, the Cochrane Library, EMBASE, the Science Citation Index, Chinese Biomedical Literature Database, and references of relevant papers published from 1990 to 2013 were searched. Related data matching standards established for this research were extracted and statistically analyzed by using the RevMan (5.2) software. Meta-analysis of 6 randomized controlled trials with a total of 889 patients revealed no difference in Oswestry Disability Index (ODI) score for DLBP between the fusion surgery and nonsurgical groups (mean difference, 1.94; 95% confidence interval [CI], -6.02 to 2.14). Postsurgical complication rate significantly differed between the 2 groups (risk ratio, 22.11; 95% CI, 55.99-81.60). Fusion surgery was not superior to nonsurgical treatment in terms of changes in ODI scores for DLBP. Fusion surgery resulted in surgical complications. Longer follow-up observation is necessary regarding condition-specific disability, pain, and life satisfaction.

  4. Prophylactic nimodipine treatment for cochlear and facial nerve preservation after vestibular schwannoma surgery: a randomized multicenter Phase III trial.

    Science.gov (United States)

    Scheller, Christian; Wienke, Andreas; Tatagiba, Marcos; Gharabaghi, Alireza; Ramina, Kristofer F; Ganslandt, Oliver; Bischoff, Barbara; Zenk, Johannes; Engelhorn, Tobias; Matthies, Cordula; Westermaier, Thomas; Antoniadis, Gregor; Pedro, Maria Teresa; Rohde, Veit; von Eckardstein, Kajetan; Kretschmer, Thomas; Kornhuber, Malte; Steighardt, Jörg; Richter, Michael; Barker, Fred G; Strauss, Christian

    2016-03-01

    A pilot study of prophylactic nimodipine and hydroxyethyl starch treatment showed a beneficial effect on facial and cochlear nerve preservation following vestibular schwannoma (VS) surgery. A prospective Phase III trial was undertaken to confirm these results. An open-label, 2-arm, randomized parallel group and multicenter Phase III trial with blinded expert review was performed and included 112 patients who underwent VS surgery between January 2010 and February 2013 at 7 departments of neurosurgery to investigate the efficacy and safety of the prophylaxis. The surgery was performed after the patients were randomly assigned to one of 2 groups using online randomization. The treatment group (n = 56) received parenteral nimodipine (1-2 mg/hr) and hydroxyethyl starch (hematocrit 30%-35%) from the day before surgery until the 7th postoperative day. The control group (n = 56) was not treated prophylactically. Intent-to-treat analysis showed no statistically significant effects of the treatment on either preservation of facial nerve function (35 [67.3%] of 52 [treatment group] compared with 34 [72.3%] of 47 [control group]) (p = 0.745) or hearing preservation (11 [23.4%] of 47 [treatment group] compared with 15 [31.2%] of 48 [control group]) (p = 0.530) 12 months after surgery. Since tumor sizes were significantly larger in the treatment group than in the control group, logistic regression analysis was required. The risk for deterioration of facial nerve function was adjusted nearly the same in both groups (OR 1.07 [95% CI 0.34-3.43], p = 0.91). In contrast, the risk for postoperative hearing loss was adjusted 2 times lower in the treatment group compared with the control group (OR 0.49 [95% CI 0.18-1.30], p = 0.15). Apart from dose-dependent hypotension (p nimodipine can be recommended in VS surgery.

  5. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial.

    Science.gov (United States)

    Al Tmimi, L; Van Hemelrijck, J; Van de Velde, M; Sergeant, P; Meyns, B; Missant, C; Jochmans, I; Poesen, K; Coburn, M; Rex, S

    2015-10-01

    Off-pump coronary artery bypass (OPCAB) surgery carries a high risk for haemodynamic instability and perioperative organ injury. Favourable haemodynamic effects and organ-protective properties could render xenon an attractive anaesthetic for OPCAB surgery. The primary aim of this study was to assess whether xenon anaesthesia for OPCAB surgery is non-inferior to sevoflurane anaesthesia with regard to intraoperative vasopressor requirements. Forty-two patients undergoing elective OPCAB surgery were enrolled in this prospective, single-blind, randomized controlled pilot trial. Patients were randomized to either xenon (50-60 vol%) or sevoflurane (1.1-1.4 vol%) anaesthesia. Primary outcome was intraoperative noradrenaline requirements necessary to achieve predefined haemodynamic goals. Secondary outcomes included safety variables such as the occurrence of adverse events (intraoperatively and during a 6-month follow-up after surgery) and the perioperative cardiorespiratory and inflammatory profile. Baseline and intraoperative data did not differ between groups. Xenon was non-inferior to sevoflurane, as xenon patients required significantly less noradrenaline intraoperatively to achieve the predefined haemodynamic goals {geometric mean 428 [95% confidence interval (CI) 312, 588] vs 1702 [1267, 2285] µg, Pxenon anaesthesia allows a significant reduction in vasopressor administration in OPCAB surgery. Moreover, xenon anaesthesia was associated with a lower risk for POD, a finding that has to be confirmed in larger studies. ClinicalTrials.gov (NCT01757106) and EudraCT (2012-002316-12). © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Spieth, Peter M; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

    2014-05-02

    General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary function and reduces systemic inflammatory response. However, it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation. The PROtective VARiable ventilation trial ('PROVAR') is a single center, randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3 hours. PROVAR compares conventional (non-variable) lung protective ventilation (CV) with variable lung protective ventilation (VV) regarding pulmonary function and inflammatory response. The primary endpoint of the study is the forced vital capacity on the first postoperative day. Secondary endpoints include further lung function tests, plasma cytokine levels, spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications. We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3 hours. PROVAR is the first randomized controlled trial aiming at intra- and postoperative effects of VV on lung function. This study may help to define the role of VV during general anesthesia requiring mechanical ventilation. Clinicaltrials.gov NCT01683578 (registered on September 3 3012).

  7. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

    DEFF Research Database (Denmark)

    Skou, Søren Thorgaard; Lind, Martin; Hölmich, Per

    2017-01-01

    adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. METHODS AND ANALYSIS......INTRODUCTION: Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger...... will be randomly allocated to one of two groups (1:1 ratio). Participants randomised to surgery will undergo either arthroscopic partial meniscectomy or meniscal repair followed by standard postsurgical care, while participants allocated to exercise and education will undergo a 12-week individualised, supervised...

  8. Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

    Directory of Open Access Journals (Sweden)

    Wollermann C

    2006-09-01

    Full Text Available Abstract Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

  9. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

    2015-07-30

    Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary

  10. Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral : a randomised trial and economic evaluation

    NARCIS (Netherlands)

    Oosterhuis, Teddy; Ostelo, Raymond W; van Dongen, Johanna M; Peul, Wilco C.; de Boer, Michiel R; Bosmans, Judith E; Vleggeert-Lankamp, Carmen L; Arts, Mark P.; van Tulder, Maurits W

    2017-01-01

    QUESTION: Is referral for early rehabilitation after lumbar disc surgery effective and cost-effective compared to no referral? DESIGN: Multicentre, randomised, controlled trial, and economic evaluation with concealed allocation and intention-to-treat-analysis. PARTICIPANTS: Adults who underwent

  11. A randomised controlled trial comparing Rapid Rhino Mannheim and Netcell series 5000 packs following routine nasal surgery.

    Science.gov (United States)

    McDonald, S E; Slater, J; Powell, R; Khalil, H S; Garth, R J N

    2009-03-01

    To determine whether there is a difference in discomfort between Netcell Series 5000 and Rapid Rhino Mannheim 8.0 cm (Cat. No. 800) packs used after routine nasal surgery, whilst in situ and during removal. This was tested in a single blind, randomised controlled trial at the ENT Department, Royal Devon & Exeter Hospital. Adults aged 16-65 undergoing nasal septal surgery and trimming of inferior turbinates. Patients were excluded if they were undergoing revision surgery, taking anticoagulants, or had a history of sino-nasal disease or trauma. Thirty nine entered and 32 completed the study. The intervention was a different nasal pack in each side of the nose, removed the morning after surgery. Pain experienced by patients while packs are in situ and on removal as recorded on a standard unmarked 100 mm visual analogue scale. There was no difference in the pain scores whilst in situ. Rapid Rhino Mannheim was more painful on removal (difference = 10.6 mm, p Mannheim packs do not confer a benefit over Netcell Series 5000 packs after routine nasal surgery.

  12. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marcelo Soares Privado

    Full Text Available CONTEXT AND OBJECTIVE: Controversy exists regarding the site of action of fentanyl after epidural injection. The objective of this investigation was to compare the efficacy of epidural and intravenous fentanyl for orthopedic surgery. DESIGN AND SETTING: A randomized double-blind study was performed in Hospital São Paulo. METHODS: During the postoperative period, in the presence of pain, 29 patients were divided into two groups: group 1 (n = 14 received 100 µg of fentanyl epidurally and 2 ml of saline intravenously; group 2 (n = 15 received 5 ml of saline epidurally and 100 µg of fentanyl intravenously. The analgesic supplementation consisted of 40 mg of tenoxicam intravenously and, if necessary, 5 ml of 0.25% bupivacaine epidurally. Pain intensity was evaluated on a numerical scale and plasma concentrations of fentanyl were measured simultaneously. RESULTS: The percentage of patients who required supplementary analgesia with tenoxicam was lower in group 1 (71.4% than in group 2 (100%: 95% confidence interval (CI = 0.001-0.4360 (P = 0.001, Fisher's exact test; relative risk, RR = 0.07. Epidural bupivacaine supplementation was also lower in group 1 (14.3% than in group 2 (53.3%: 95% CI = 0.06-1.05 (P = 0.03, Fisher's exact test; RR = 0.26. There was no difference in pain intensity on the numerical scale. Mean fentanyl plasma concentrations were similar in the two groups. CONCLUSION: Intravenous and epidural fentanyl appear to have similar efficacy for reducing pain according to the numerical scale, but supplementary analgesia was needed less frequently when epidural fentanyl was used. CLINICAL TRIAL REGISTRATION NUMBER: NCT00635986

  13. Immunoenhanced enteral nutrition formulas in head and neck cancer surgery: a prospective, randomized clinical trial.

    Science.gov (United States)

    Casas-Rodera, P; Gómez-Candela, C; Benítez, S; Mateo, R; Armero, M; Castillo, R; Culebras, J M

    2008-01-01

    Significant malnutrition exists in a high percentage of patients with head and neck cancer. Malnutrition is associated with defects in immune function that may impair the host response to malignancy. Malnutrition and immunosupression make patients highly susceptible to postoperative infections and complications. Compare two immunoenhanced enteral nutritions with a control diet, and evaluate the effect in postoperative infections, length of stay and inflammatory markers. A population of 44 patients with oral and laryngeal cancer was enrolled in a randomized trial. At surgery, patients were randomly allocated to three groups: (group I); patients receiving an arginine-enhanced formula (group II); patients receiving a standard polymeric formula, and (group III) patients receiving an arginine, RNA and omega-3 fatty acids enhanced formula, in an isonitrogenous way. The duration of enteral nutrition in the three groups was similar with an average duration of 14,5 +/- 8 days. The length of postoperative stay was similar, with an average of 19,8 +/- 8,5 days. Wound infections and general infections were more frequent in the control group. Fistula rates were not improved in the enhanced diet groups. No significant intergroup differences in the trend of the two plasma proteins (albumin, transferrin), lymphocytes, weight, IL-6, CPR and TNFalpha were detected. The control group showed the highest levels of TNFalpha at the fourteenth postoperative day. Gastrointestinal tolerance and diarrhoea rate were similar in all the patients. Immunoenhanced enteral nutrition formulas improved the infection rate in the postoperative of head and neck cancer patients. In the fistula rates, we observed that technical problems and nutritional status might have played an equally important role, and therefore the positive effect of immunonutrition in this parameter might have been overestimated.

  14. Fibrin sealant improves hemostasis in peripheral vascular surgery: a randomized prospective trial.

    Science.gov (United States)

    Schenk, Worthington G; Burks, Sandra G; Gagne, Paul J; Kagan, Steven A; Lawson, Jeffrey H; Spotnitz, William D

    2003-06-01

    To evaluate the efficacy and safety of an investigational fibrin sealant (FS) in a randomized prospective, partially blinded, controlled, multicenter trial. Upper extremity vascular access surgery using polytetrafluorethylene (PTFE) graft placement for dialysis was chosen as a reproducible, clinically relevant model for evaluating the usefulness of FS. The FS consisted of pooled human fibrinogen (60 mg/mL) and thrombin (500 NIH U/mL). Time to hemostasis was measured, and adverse events were monitored. Consenting adult patients (n = 48) undergoing placement of a standard PTFE graft were randomized in a 2:1:1 ratio to the treatment group using FS (ZLB Bioplasma AG, Bern, Switzerland), oxidized regenerated cellulose (Surgicel, Johnson & Johnson, New Brunswick, NJ), or pressure. Patients received heparin (3,000 IU IVP) before placement of vascular clamps. If the treatment was FS, clamps were left in place for 120 seconds after the application of study material to permit polymerization. If treatment was Surgicel, clamps were left in place until the agent had been applied according to manufacturer's instructions. If the treatment was pressure, clamps were released as soon as the investigator was ready to apply compression. Immediately after release of the last clamp, the arterial and venous suture lines were evaluated for bleeding. The time to hemostasis at both the venous and arterial sites was recorded. Significant (P < or =.005) reduction in time to hemostasis was achieved in the FS group. Thirteen (54.2%) patients randomized to FS experienced immediate hemostasis at both suture lines following clamp removal compared to no patients using Surgicel or pressure. Only one patient (7.1%) in the Surgicel group and no patients in the pressure group experienced hemostasis at 120 seconds from clamp removal, compared to 13 (54.2%) patients for FS. Adverse events were comparable in all groups. There were no seroconversions. FS achieved more rapid hemostasis than traditional

  15. Prevention of Bleeding in Orthognathic Surgery--A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    DEFF Research Database (Denmark)

    Olsen, Jesper J; Skov, Jane; Ingerslev, Janne

    2016-01-01

    PURPOSE: The objective of the present study was to evaluate the efficacy of hemostatic adjuncts on intraoperative blood loss (IOB) in orthognathic surgery (OS) detected by randomized controlled trials (RCTs) of the highest quality. MATERIALS AND METHODS: A search of the Medline, Cochrane, Embase...... and operating time. This review is registered at PROSPERO (CRD42014014840). RESULTS: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid...... of whether it was given intravenously (IV) or applied topically. Additional RCTs are needed to confirm the effect of topical TXA in OS, and larger studies of intravenous administration are needed before any routine recommendations. No hemostatic effect of hypotensive anesthesia was found, mainly owing...

  16. Timing and approaches in congenital cataract surgery: a four-year, two-layer randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jin-Chao Liu

    2017-12-01

    Full Text Available "AIM: To compare visual prognoses and postoperative adverse events of congenital cataract surgery performed at different times and using different surgical approaches. METHODS: In this prospective, randomized controlled trial, we recruited congenital cataract patients aged 3mo or younger before cataract surgery. Sixty-one eligible patients were randomly assigned to two groups according to surgical timing: a 3-month-old group and a 6-month-old group. Each eye underwent one of three randomly assigned surgical procedures, as follows: surgery A, lens aspiration (I/A; surgery B, lens aspiration with posterior continuous curvilinear capsulorhexis (I/A+PCCC; and surgery C, lens aspiration with posterior continuous curvilinear capsulorhexis and anterior vitrectomy (I/A+PCCC+A-Vit. The long-term best-corrected visual acuity (BCVA and the incidence of complications in the different groups were compared and analyzed. RESULTS: A total of 57 participants (114 eyes with a mean follow-up period of 48.7mo were included in the final analysis. The overall logMAR BCVA in the 6-month-old group was better than that in the 3-month-old group (0.81±0.28 vs 0.96±0.30; P=0.02. The overall logMAR BCVA scores in the surgery B group were lower than the scores in the A and C groups (A: 0.80±0.29, B: 1.02±0.28, and C: 0.84±0.28; P=0.007. A multivariate linear regression revealed no significant relationships between the incidence of complications and long-term BCVA. CONCLUSION: It might be safer and more beneficial for bilateral total congenital cataract patients to undergo surgery at 6mo of age than 3mo. Moreover, with rigorous follow-up and timely intervention, the postoperative complications in these patients are treatable and do not compromise visual outcomes."

  17. The effect of listening to Vaghe\\'a Surah and its translation on the state and trait anxiety before general surgeries: a Randomized Controlled Clinical Trial

    OpenAIRE

    Seyed Alireza Mirsane; Davood Kheirkhah; Shima Shafagh; Neda Mirbagher Ajorpaz; Javad Aminpour

    2016-01-01

    Background and Objectives: Patients experience moderate to high level of anxiety before general surgery. There are differences in studies on the effect of listening Quran to decrease anxiety in general surgery patients. The purpose of this study was to evaluate the effects of Vaghe'a Surah and its translation on the state - trait anxiety before general surgeries. Methods: In this randomized controlled trial study, 60 patients who met the inclusion criteria were randomly allocated to the ex...

  18. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver

    Directory of Open Access Journals (Sweden)

    Biffi Roberto

    2012-05-01

    Full Text Available Abstract Background An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Methods Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel® Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel® Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. Results A total of 112 patients (58 in the experimental arm and 54 in the control group qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5% than in controls (14.3% center 1, 24.2% center 2, overall 20.4%, but the observed difference was not statistically significant (P = 0.451, even with respect to surgical-site infection grade 1 (superficial versus grades 2 and 3, or grade 1 and 2 versus grade 3. Conclusions This randomized trial did not confirm a statistically significant superiority of Aquacel® Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Trial registration Clinicaltrials.gov: NCT00981110

  19. Progressive resistance training and stretching following surgery for breast cancer: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ward Leigh C

    2006-12-01

    Full Text Available Abstract Background Currently 1 in 11 women over the age of 60 in Australia are diagnosed with breast cancer. Following treatment, most breast cancer patients are left with shoulder and arm impairments which can impact significantly on quality of life and interfere substantially with activities of daily living. The primary aim of the proposed study is to determine whether upper limb impairments can be prevented by undertaking an exercise program of prolonged stretching and resistance training, commencing soon after surgery. Methods/design We will recruit 180 women who have had surgery for early stage breast cancer to a multicenter single-blind randomized controlled trial. At 4 weeks post surgery, women will be randomly assigned to either an exercise group or a usual care (control group. Women allocated to the exercise group will perform exercises daily, and will be supervised once a week for 8 weeks. At the end of the 8 weeks, women will be given a home-based training program to continue indefinitely. Women in the usual care group will receive the same care as is now typically provided, i.e. a visit by the physiotherapist and occupational therapist while an inpatient, and receipt of pamphlets. All subjects will be assessed at baseline, 8 weeks, and 6 months later. The primary measure is arm symptoms, derived from a breast cancer specific questionnaire (BR23. In addition, range of motion, strength, swelling, pain and quality of life will be assessed. Discussion This study will determine whether exercise commencing soon after surgery can prevent secondary problems associated with treatment of breast cancer, and will thus provide the basis for successful rehabilitation and reduction in ongoing problems and health care use. Additionally, it will identify whether strengthening exercises reduce the incidence of arm swelling. Trial Registration The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRN012606000050550.

  20. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Li-Ang Lee

    on most measures of subjective and objective snoring. Multi-stage radiofrequency surgery was not tested. TRIAL REGISTRATION: ClinicalTrials.gov NCT01955083.

  1. Assessment of risk of bias in randomized clinical trials in surgery

    DEFF Research Database (Denmark)

    Gurusamy, K S; Gluud, C; Nikolova, D

    2009-01-01

    BACKGROUND: Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. METHODS: The causes of bias...... in surgical trials as described by The Cochrane Collaboration, and the methods that can be used to avoid them, are reviewed. RESULTS: Blinding is difficult in many surgical trials but careful trial design can reduce the bias risk due to lack of blinding. It is possible to conduct surgical trials with low risk...... of bias by using appropriate trial design. CONCLUSION: The risk of providing a treatment based on a biased effect estimate must be balanced against the difficulty of conducting trials with very low risk of bias. Better understanding of the risk of bias may result in improved trials with a closer estimate...

  2. Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial

    Science.gov (United States)

    Baos, Sarah; Sheehan, Karen; Culliford, Lucy; Pike, Katie; Ellis, Lucy; Parry, Andrew J; Stoica, Serban; Ghorbel, Mohamed T; Caputo, Massimo

    2015-01-01

    Background During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. Objective The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. Methods This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of

  3. Low-level laser therapy for treatment of neurosensory disorders after orthognathic surgery: A systematic review of randomized clinical trials.

    Science.gov (United States)

    Bittencourt, M-A-V; Paranhos, L-R; Martins-Filho, P-R-S

    2017-11-01

    Low-level laser has been widely used in Dentistry and many studies have focused on its application in oral surgeries. This study was conducted with the aim of searching for scientific evidence concerning the effectiveness of laser to reduce pain or paresthesia related to orthognathic surgery. An electronic search was performed in PubMed, Scopus, Science Direct, LILACS, SciELO, CENTRAL, Google Scholar, OpenGrey, and ClinicalTrials.gov, up to November 2016, with no restrictions on language or year of publication. Additionally, a hand search of the reference list of the selected studies was carried out. The PICOS strategy was used to define the eligibility criteria and only randomized clinical trials were selected. Out of 1,257 identified citations, three papers fulfilled the criteria and were included in the systematic review. The risk of bias was assessed according to the Cochrane Guidelines for Clinical Trials and results were exposed based on a descriptive analysis. One study showed that laser therapy was effective to reduce postoperative pain 24 hours (P=0.007) and 72 hours (P=0.007) after surgery. Other study revealed the positive effect of laser to improve neurosensory recovery 60 days after surgery, evaluated also by the two-point discrimination (P=0.005) and sensory (P=0.008) tests. The third study reported an improvement for general sensibility of 68.75% for laser group, compared with 21.43% for placebo (P=0.0095), six months after surgery. Individual studies suggested a positive effect of low-level laser therapy on reduction of postoperative pain and acceleration of improvement of paresthesia related to orthognathic surgery. However, due to the insufficient number and heterogeneity of studies, a meta-analysis evaluating the outcomes of interest was not performed, and a pragmatic recommendation about the use of laser therapy is not possible. This systematic review was conducted according to the statements of PRISMA and was registered at PROSPERO under the

  4. Impact of secondary cytoreductive surgery on survival in patients with platinum sensitive recurrent ovarian cancer: analysis of the CALYPSO trial.

    Science.gov (United States)

    Lee, Chee Khoon; Lord, Sarah; Grunewald, Tami; Gebski, Val; Hardy-Bessard, Anne-Claire; Sehouli, Jalid; Woie, Kathrine; Heywood, Mark; Schauer, Christian; Vergote, Ignace; Scambia, Giovanni; Ferrero, Annamaria; Harter, Philipp; Pujade-Lauraine, Eric; Friedlander, Michael

    2015-01-01

    The role of secondary cytoreductive surgery (SCR) in platinum-sensitive recurrent ovarian cancer (ROC) remains controversial. The overall survival (OS) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis. Using data from the CALYPSO trial, OS of patients who had SCR was compared to those treated with chemotherapy alone. Multivariate analyses were performed to adjust for prognostic factors. We also tested for an interaction between baseline prognostic groupings and the benefit of surgery. Of the 975 patients randomised in CALYPSO, 19% had SCR and 80% had chemotherapy alone. OS was longer for the SCR group than for chemotherapy alone (median, 49.9 vs. 29.7 months; adjusted hazard ratio (HR), 0.68; P = 0.004). For patients with SCR, the 3-year OS was 72% for those with no measurable disease, and 28% if residual tumour was larger than 5 cm. Patients with good prognostic features benefited the most from SCR (HR 0.43; P < 0.001). The benefit of SCR was less in patients with poorer prognostic features (test of trend P < 0.001). SCR was associated with improved OS in platinum-sensitive ROC, particularly in patients with favourable prognostic characteristics. However, these findings may be due to selection bias, and hence randomised trials are still essential. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Timing of surgery for sciatica: Subgroup analysis alongside a randomized trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); M.P. Arts (Mark); R. Brand (René); B.W. Koes (Bart)

    2009-01-01

    textabstractSurgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies,

  6. Effects of Dexamethasone on Cognitive Decline after Cardiac Surgery A Randomized Clinical Trial

    NARCIS (Netherlands)

    Ottens, Thomas H.; Dieleman, Jan M.; Sauër, Anne-Mette C.; Peelen, Linda M.; Nierich, Arno P.; de Groot, Welmer J.; Nathoe, Hendrik M.; Buijsrogge, Marc P.; Kalkman, Cor J.; van Dijk, Diederik; Bredée, Jaap J.; Buhre, Wolfgang F.; van Herwerden, Lex A.; van Klarenbosch, Jan; Moons, Karel G.; Numan, Sandra C.; Roes, Kit C.; Sauer, Anne-Mette C.; Slooter, Arjen J.; Ennema, Jacob J.; Rosseel, Peter M.; van der Meer, Nardo J.; van der Maaten, Joost M.; Cernak, Vlado; Hofland, Jan; van Thiel, Robert J.; Diephuis, Jan C.; Schepp, Ronald M.; Haenen, Jo; de Lange, Fellery; Boer, Christa; de Jong, Jan R.; Tijssen, Jan G.

    2014-01-01

    Background: Cardiac surgery can be complicated by postoperative cognitive decline (POCD), which is characterized by impaired memory function and intellectual ability. The systemic inflammatory response that is induced by major surgery and cardiopulmonary bypass may play an important role in the

  7. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study.

    Science.gov (United States)

    Gueli Alletti, Salvatore; Bottoni, Carolina; Fanfani, Francesco; Gallotta, Valerio; Chiantera, Vito; Costantini, Barbara; Cosentino, Francesco; Ercoli, Alfredo; Scambia, Giovanni; Fagotti, Anna

    2016-04-01

    Laparoscopy has acquired an increasing role in the management of ovarian cancer. Laparoscopic cytoreduction could represent a new frontier for selected patients after neoadjuvant chemotherapy (NACT). We sought to assess feasibility and early complication rate of minimally invasive (MI) interval debulking surgery (IDS) in stage III-IV epithelial ovarian cancer (EOC) patients after NACT. This is a phase II multicentric study in advanced EOC cases with clinical complete response after NACT, according to Gynecologic Cancer Intergroup and Response Evaluation Criteria In Solid Tumors criteria. Institutional review board approval was obtained and all patients signed written informed consent to be included in the protocol. The study was registered in clinicaltrials.gov (NCT02324595) and was named "MISSION" trial. For patients meeting inclusion criteria, surgical procedures started with diagnostic laparoscopy to confirm preoperative findings and assess surgical complexity. MI-IDS included hysterectomy, bilateral salpingo-oophorectomy, appendectomy, omentectomy, peritonectomy, and bowel resection. Pelvic and/or aortic lymphadenectomy was not considered as standard procedure in these cases. Intraoperative and postoperative outcomes, time to restart chemotherapy, survival rate, and quality of life data were registered. From December 2013 through February 2015, of 184 advanced EOC patients considered eligible for IDS, 52 (28.2%) met inclusion criteria and were enrolled in the study. For 22 (12%) of them, standard laparotomic approach was preferred because of intraoperative surgeon evaluation. Thirty (16.3%) patients received the planned treatment of MI-IDS. Median age was 61 (range 39-81) years and median body mass index was 24 (range 20-31) kg/m(2). Median numbers of NACT cycles was 4 (range 3-7). Median operative time was 285 (range 124-418) minutes and median estimated blood loss was 100 (range 50-200) mL. Surgical procedures included 28 (93.3%) hysterectomy and bilateral

  8. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  9. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    Science.gov (United States)

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  10. Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2011-10-01

    Full Text Available Abstract Background The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP surgeries. Methods/design Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm, or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire, as well as secondary end points: patient satisfaction, safety and health economics. Discussion The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key

  11. Effectiveness of audiovisual interventions on stress responses in adolescents with ENT surgery in hospital: randomized controlled trial protocol.

    Science.gov (United States)

    Liu, Cai Yun; Xu, Lei; Zang, Yu Li

    2014-06-01

    To investigate the circadian pattern of cortisol secretion and other stress indictors in association with audiovisual stimuli in adolescents having otorhinolaryngological surgery in hospital. Hospitalization for surgery is a major stressful life event for adolescents causing negative consequences, including anxiety. Recent studies suggest that entertaining and educational interventions might be effective at reducing such adversities, but little is known about the pattern of these responses and effects. Randomized controlled trial. Adolescents with otorhinolaryngological surgery in hospital without any contraindictions for salivary cortisol enzyme immunoassays will be recruited and randomly allocated to experimental, placebo and control. Stress indicators will be collected regularly for 5 days. Standard audiovisual interventions will be displayed for experimental and placebo groups including a simultaneous video-recording of facial and behavioural changes on the second afternoon postadmission and stress indicators will be collected pre- and three times with 20-minute interval postintervention. Follow-up will be conducted to evaluate the longer term effects at 2 weeks, 1-month and 3 months postadmission, respectively. Descriptive and comparative analyses of stress indicators will be performed to examine group differences. Competitive funding was obtained from the Independent Innovation Foundation of Shandong University for interdisciplinary research in 2012. This study will help identify timeslots for interventions for integrating strength-building into stress response reduction in adolescents hospitalized for surgery. © 2013 John Wiley & Sons Ltd.

  12. Effects of a leukocyte depleting arterial line filter on perioperative morbidity in patients undergoing cardiac surgery: a controlled randomized trial.

    Science.gov (United States)

    Leal-Noval, Santiago R; Amaya, Rosario; Herruzo, Angel; Hernández, Ana; Ordóñez, Antonio; Marín-Niebla, Ana; Camacho, Pedro

    2005-10-01

    Activated leukocytes may increase morbidity in cardiac surgery. The objective of this study is to investigate the influence on morbidity of leukocyte-depleting blood filters placed into the arterial line of cardiopulmonary bypass circuits. Simple, blind, prospective, randomized and controlled clinical trial carried out in a cardiac surgery ICU at a university center. We included 159 consecutive low-risk patients (ie, Parsonnet score < 10) undergoing cardiac surgery who were initially stratified in three risk levels according to the Parsonnet score at admission into the hospital (ie, low, < 4; middle, 4 to 7; and high, 8 to 10). Once stratified, all patients were randomized to undergo cardiopulmonary bypass either with a conventional blood filter or with a leukocyte filter (randomization ratio, 2:1). The outcome variable was morbidity. Patients were considered to have a high morbidity if any of the following clinical situations were present (ie, pulmonary dysfunction, cardiac dysfunction, perioperative infections, postoperative hyperthermia, and hyperdynamic states). The leukocyte filter was used in 52 patients and the conventional filter in 107 patients. The morbidity rate was similar in both groups, but patients with leukocyte filter had a lower incidence of perioperative infections, fever, and hyperdynamic states as compared with patients with the conventional filter. Leukocyte filtration in patients undergoing cardiac surgery with extracorporeal perfusion showed no measurable effects on postoperative morbidity. However, although not statistically significant, a decrease was observed in the rates of perioperative infection, fever, and hyperdynamic states.

  13. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection

    Directory of Open Access Journals (Sweden)

    Vigneau Axelle

    2011-11-01

    Full Text Available Abstract Background The effect of local infiltration after breast surgery is controversial. This prospective double blind randomized study sought to document the analgesic effect of local anaesthetic infiltration after breast cancer surgery. Methods Patients scheduled for mastectomy or tumorectomy and axillary nodes dissection had immediate postoperative infiltration of the surgical wound with 20 ml of ropivacaine 7.5 mg.ml-1 or isotonic saline. Pain was assessed on a visual analogue scale at H2, H4, H6, H12, H24, H72, and at 2 month, at rest and on mobilization of the arm. Patient'comfort was evaluated with numerical 0-3 scales for fatigue, quality of sleep, state of mood, social function and activity. Results Twenty-two and 24 patients were included in the ropivacaine and saline groups respectively. Postoperative pain was lower at rest and on mobilization at 2, 4 and 6 hour after surgery in the ropivacaine group. No other difference in pain intensity and patient 'comfort scoring was documented during the first 3 postoperative days. Patients did not differ at 2 month for pain and comfort scores. Conclusion Single shot infiltration with ropivacaine transiently improves postoperative pain control after breast cancer surgery. Trial registration number NCT01404377

  14. Effect of tranexamic acid irrigation on perioperative blood loss during orthognathic surgery: a double-blind, randomized controlled clinical trial.

    Science.gov (United States)

    Eftekharian, Hamidreza; Vahedi, Ruhollah; Karagah, Tuba; Tabrizi, Reza

    2015-01-01

    Perioperative hemorrhage is an important concern during orthognathic surgery. The purpose of this study was to assess the effect of tranexamic acid (TXA) irrigation on perioperative hemorrhage during orthognathic surgery. In this double-blind, randomized controlled clinical trial, 56 participants who underwent orthognathic surgery were divided into 2 groups. The patients in the first group received TXA irrigation with normal saline (1 mg/mL), and the patients in the second group had normal saline for irrigation during orthognathic surgery. Age, gender, operation duration, the amount of irrigation solution used, and preoperative hemoglobin, hematocrit, and weight were the variables that were studied. The use of TXA solution for irrigation was the predictive factor of the study. Each group consisted of 28 patients. Group 1 consisted of 15 male patients (53.6%) and 13 female patients (46.4%) and group 2 consisted of 14 male patients (50%) and 14 female patients (50%). There was no difference in the distributions of the variables between the 2 groups, except for the duration of the operation. The mean duration of the operation was 3.94 ± 0.61 hours in group 1 and 4.17 ± 0.98 hours in group 2, and the difference in this respect between the 2 groups was statistically significant (P .05). TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  15. Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

    NARCIS (Netherlands)

    Krekel, N.M.A.; Zonderhuis, B.M.; Schreurs, H.W.H.; Cardozo, A.M.F.L.; Rijna, H.; van der Veen, H.; Muller, S.; Poortman, P.; Widt, L.; de Roos, W.K.; Bosch, A.M.; Taets van amerongen, A.H.M.; Bergers, E.; van der Linden, M.H.M.; de Klerk, E.S.M.; Winters, H.A.H.; Meijer, S.; van den Tol, M.P.

    2011-01-01

    Background: Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local

  16. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix for pelvic reconstructive surgery

    Directory of Open Access Journals (Sweden)

    Aguirre Oscar A

    2010-12-01

    Full Text Available Abstract Background A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA during vaginal reconstructive surgery. Methods Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20, sexual function (PISQ-12, and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. Results The majority of the subjects had cystocele (98% and/or rectocele (84% defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p ®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. Conclusion This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. Trial Registration ClinicalTrials.gov NCT01244165

  17. Xenon for the prevention of postoperative delirium in cardiac surgery: study protocol for a randomized controlled clinical trial.

    Science.gov (United States)

    Al Tmimi, Layth; Van de Velde, Marc; Herijgers, Paul; Meyns, Bart; Meyfroidt, Geert; Milisen, Koen; Fieuws, Steffen; Coburn, Mark; Poesen, Koen; Rex, Steffen

    2015-10-09

    Postoperative delirium (POD) is a manifestation of acute postoperative brain dysfunction that is frequently observed after cardiac surgery. POD is associated with short-term complications such as an increase in mortality, morbidity, costs and length of stay, but can also have long-term sequelae, including persistent cognitive deficits, loss of independence, and increased mortality for up to 2 years. The noble gas xenon has been demonstrated in various models of neuronal injury to exhibit remarkable neuroprotective properties. We therefore hypothesize that xenon anesthesia reduces the incidence of POD in elderly patients undergoing cardiac surgery with the use of cardiopulmonary bypass. One hundred and ninety patients, older than 65 years, and scheduled for elective cardiac surgery, will be enrolled in this prospective, randomized, controlled trial. Patients will be randomized to receive general anesthesia with either xenon or sevoflurane. Primary outcome parameter will be the incidence of POD in the first 5 postoperative days. The occurrence of POD will be assessed by trained research personnel, blinded to study group, with the validated 3-minute Diagnostic Confusion Assessment Method (3D-CAM) (on the intensive care unit in its version specifically adapted for the ICU), in addition to chart review and the results of delirium screening tools that will be performed by the bedside nurses). Secondary outcome parameters include duration and severity of POD, and postoperative cognitive function as assessed with the Mini-Mental State Examination. Older patients undergoing cardiac surgery are at particular risk to develop POD. Xenon provides remarkable hemodynamic stability and has been suggested in preclinical studies to exhibit neuroprotective properties. The present trial will assess whether the promising profile of xenon can be translated into a better outcome in the geriatric population. EudraCT Identifier: 2014-005370-11 (13 May 2015).

  18. Effects of a prehabilitation program on patients' recovery following spinal stenosis surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Marchand, Andrée-Anne; Suitner, Margaux; O'Shaughnessy, Julie; Châtillon, Claude-Édouard; Cantin, Vincent; Descarreaux, Martin

    2015-10-27

    Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention program on the improvement of clinical parameters and functional physical capacity in patients undergoing surgery for lumbar spinal stenosis. Forty patients will be recruited and randomly allocated to one of the 2 treatment arms: 6 weeks supervised preoperative rehabilitation program (experimental group) or hospital standard preoperative management (control group). The intervention group will be trained three times per week, with each session aiming to improve strength, muscular endurance, spinal stabilization and cardiovascular fitness. Intensity and complexity of exercises will be gradually increased throughout the sessions, depending on each participant's individual progress. Primary outcomes are level of low back disability and level of pain. Secondary outcomes include the use of pain medication, quality of life, patient's global impression of change, lumbar extensor muscles endurance, maximum voluntary contraction of lumbar flexor and extensor muscles, maximum voluntary contraction of knee extensors, active lumbar ranges of motion, walking abilities, and cardiovascular capacity. Both the primary and secondary outcomes will be measured at baseline, at the end of the training program (6 weeks after baseline evaluation for control participants), and at 6 weeks, 3 and 6 months postoperatively. This study will inform the design of a future large-scale trial. Improvements of physical performances before undergoing lumbar surgery may limit functional limitations occurring after a surgical

  19. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial.

    Science.gov (United States)

    Ickmans, Kelly; Moens, Maarten; Putman, Koen; Buyl, Ronald; Goudman, Lisa; Huysmans, Eva; Diener, Ina; Logghe, Tine; Louw, Adriaan; Nijs, Jo

    2016-07-01

    Despite scientific progress with regard to pain neuroscience, perioperative education tends to stick to the biomedical model. This may involve, for example, explaining the surgical procedure or 'back school' (education that focuses on biomechanics of the lumbar spine and ergonomics). Current perioperative education strategies that are based on the biomedical model are not only ineffective, they can even increase anxiety and fear in patients undergoing spinal surgery. Therefore, perioperative pain neuroscience education is proposed as a dramatic shift in educating patients prior to and following surgery for lumbar radiculopathy. Rather than focusing on the surgical procedure, ergonomics or lumbar biomechanics, perioperative pain neuroscience education teaches people about the underlying mechanisms of pain, including the pain they will feel following surgery. The primary objective of the study is to examine whether perioperative pain neuroscience education ('brain school') is more effective than classic back school in reducing pain and improving pain inhibition in patients undergoing surgery for spinal radiculopathy. A secondary objective is to examine whether perioperative pain neuroscience education is more effective than classic back school in: reducing postoperative healthcare expenditure, improving functioning in daily life, increasing return to work, and improving surgical experience (ie, being better prepared for surgery, reducing incongruence between the expected and actual experience) in patients undergoing surgery for spinal radiculopathy. A multi-centre, two-arm (1:1) randomised, controlled trial with 2-year follow-up. People undergoing surgery for lumbar radiculopathy (n=86) in two Flemish hospitals (one tertiary care, university-based hospital and one regional, secondary care hospital) will be recruited for the study. All participants will receive usual preoperative and postoperative care related to the surgery for lumbar radiculopathy. The experimental

  20. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Karsten, Agneta; Marcusson, Agneta; Hurmerinta, Kirsti

    2017-01-01

    controlled trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, and D) were tested against a common procedure (Arm A) in the total......- and intra-examiner reliability was good-to-excellent (0.61-0.94; 0.66-1.0, respectively). The mean total scores (+2 to -18) varied from -5.56 (Trial 2C) to -7.21 (Trial 3D). The mean anterior scores (+2 to -6) varied from -1.66 (Trial 2C) to -2.56 (Trial 3A). The mean posterior cleft-side scores (0 to -6......) varied from -3.24 (Trial 3A) to -3.82 (Trial 3D) and the mean non-cleft-side scores (0 to -6) varied from -0.60 (Trial 2C) to -1.30 (Trial 3A); however, no significant differences were found within the trials. CONCLUSION: There was no statistical evidence of a difference in occlusion between the two...

  1. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial

    Directory of Open Access Journals (Sweden)

    Russell Stuart J

    2012-02-01

    Full Text Available Abstract Background Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints. Method/design A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease. After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing for 48 hours. The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be

  2. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Xue Li

    Full Text Available Delirium is a frequent complication after cardiac surgery and its occurrence is associated with poor outcomes. The purpose of this study was to investigate the impact of perioperative dexmedetomidine administration on the incidence of delirium in elderly patients after cardiac surgery.This randomized, double-blinded, and placebo-controlled trial was conducted in two tertiary hospitals in Beijing between December 1, 2014 and July 19, 2015. Eligible patients were randomized into two groups. Dexmedetomidine (DEX was administered during anesthesia and early postoperative period for patients in the DEX group, whereas normal saline was administered in the same rate for the same duration for patients in the control (CTRL group. The primary endpoint was the incidence of delirium during the first five days after surgery. Secondary endpoints included the cognitive function assessed on postoperative days 6 and 30, the overall incidence of non-delirium complications within 30 days after surgery, and the all-cause 30-day mortality.Two hundred eighty-five patients were enrolled and randomized. Dexmedetomidine did not decrease the incidence of delirium (4.9% [7/142] in the DEX group vs 7.7% [11/143] in the CTRL group; OR 0.62, 95% CI 0.23 to 1.65, p = 0.341. Secondary endpoints were similar between the two groups; however, the incidence of pulmonary complications was slightly decreased (OR 0.51, 95% CI 0.26 to 1.00, p = 0.050 and the percentage of early extubation was significantly increased (OR 3.32, 95% CI 1.36 to 8.08, p = 0.008 in the DEX group. Dexmedetomidine decreased the required treatment for intraoperative tachycardia (21.1% [30/142] in the DEX group vs 33.6% [48/143] in the CTRL group, p = 0.019, but increased the required treatment for postoperative hypotension (84.5% [120/142] in the DEX group vs 69.9% [100/143] in the CTRL group, p = 0.003.Dexmedetomidine administered during anesthesia and early postoperative period did not decrease the incidence

  3. Enhanced recovery programs in lung cancer surgery: systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Li S

    2017-11-01

    Full Text Available Shuangjiang Li,1 Kun Zhou,1 Guowei Che,1 Mei Yang,1 Jianhua Su,2 Cheng Shen,1 Pengming Yu2 1Department of Thoracic Surgery, 2Department of Rehabilitation, Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, China Background: Enhanced recovery after surgery (ERAS program is an effective evidence-based multidisciplinary protocol of perioperative care, but its roles in thoracic surgery remain unclear. This systematic review of randomized controlled trials (RCTs aims to investigate the efficacy and safety of the ERAS programs for lung cancer surgery. Materials and methods: We searched the PubMed and EMBASE databases to identify the RCTs that implemented an ERAS program encompassing more than four care elements within at least two phases of perioperative care in lung cancer surgery. The heterogeneity levels between studies were estimated by the Cochrane Collaborations. A qualitative review was performed if considerable heterogeneity was revealed. Relative risk (RR and weighted mean difference served as the summarized statistics for the meta-analyses. Additional analyses were also performed to perceive potential bias risks. Results: A total of seven RCTs enrolling 486 patients were included. The meta-analysis indicated that the ERAS group patients had significantly lower morbidity rates (RR=0.64; p<0.001, especially the rates of pulmonary (RR=0.43; p<0.001 and surgical complications (RR=0.46; p=0.010, than those of control group patients. No significant reduction was found in the in-hospital mortality (RR=0.70; p=0.58 or cardiovascular complications (RR=1.46; p=0.25. In the qualitative review, most of the evidence reported significantly shortened length of hospital and intensive care unit stay and decreased hospitalization costs in the ERAS-treated patients. No significant publication bias was detected in the meta-analyses. Conclusion: Our review demonstrates that the implementation of an ERAS program for lung cancer

  4. The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial).

    Science.gov (United States)

    Clout, Madeleine; Harris, Tracy; Rogers, Chris; Culliford, Lucy; Taylor, Jodi; Angelini, Gianni; Narayan, Pradeep; Reeves, Barnaby; Hillier, James; Ashton, Kate; Sarkar, Kunal; Ascione, Raimondo

    2017-06-19

    Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to "fit for discharge", incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann's solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were "fit for discharge", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol

  5. Comparable three months' outcome of total arterial revascularization versus conventional coronary surgery: Copenhagen Arterial Revascularization Randomized Patency and Outcome trial

    DEFF Research Database (Denmark)

    Damgaard, S.; Lund, J.T.; Lilleor, N.B.

    2008-01-01

    OBJECTIVE: The in-hospital safety of total arterial revascularization for coronary artery bypass surgery seems to be comparable to conventional revascularization, but randomized trials evaluating this are few and data on complications in the postoperative months are sparse. METHODS: In a randomized...... single-center trial, 331 patients underwent total arterial revascularization using single or bilateral internal thoracic and radial arteries versus conventional revascularization using the left internal thoracic artery and saphenous vein grafts. We report the results from 3 months' follow-up. RESULTS...... complications requiring hospitalization: 3 (1.9%) versus 6 (3.5%) (P = .50), respectively. CONCLUSION: These results confirm previous reports that total arterial revascularization can be performed with low in-hospital morbidity and mortality. Further, in the 3 postoperative months, total arterial...

  6. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.

    Science.gov (United States)

    Hofmeijer, Jeannette; Amelink, G Johan; Algra, Ale; van Gijn, Jan; Macleod, Malcolm R; Kappelle, L Jaap; van der Worp, H Bart

    2006-09-11

    Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

  7. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Brunner, Thomas B. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany); Witzigmann, Helmut [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Marti, Lukas [Hospital of Kanton St. Gallen, General Surgery, St. Gallen (Switzerland); Bechstein, Wolf-Otto [University Hospital Frankfurt, Department of Surgery, Frankfurt/Main (Germany); Bruns, Christiane [University Hospital Munich, Department of Surgery - Hospital Campus Grosshadern, Munich (Germany); University Hospital Magdeburg, Department of Surgery, Magdeburg (Germany); Jungnickel, Henry [Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Schreiber, Stefan [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Grabenbauer, Gerhard G. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Hospital Coburg, Department of Radiation Oncology, Coburg (Germany); Meyer, Thomas [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Hospital Ansbach, General Surgery, Ansbach (Germany); Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2014-09-25

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [German] Mehrere nichtrandomisierte Studien zeigten, dass eine neoadjuvante Therapie das Ueberleben bei Patienten mit Pankreaskarzinom verlaengert. Beim lokal fortgeschrittenen Rektumkarzinom gehoert die

  8. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    National Research Council Canada - National Science Library

    Oswal, Sheetal; Ravindra, Shivamurthy; Sinha, Aditya; Manjunath, Shaurya

    2014-01-01

    (1) To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2...

  9. Effectiveness of the Surgery Core Clerkship Flipped Classroom: a prospective cohort trial.

    Science.gov (United States)

    Liebert, Cara A; Lin, Dana T; Mazer, Laura M; Bereknyei, Sylvia; Lau, James N

    2016-02-01

    The flipped classroom has been proposed as an alternative curricular approach to traditional didactic lectures but has not been previously applied to a surgery clerkship. A 1-year prospective cohort of students (n = 89) enrolled in the surgery clerkship was taught using a flipped classroom approach. A historical cohort of students (n = 92) taught with a traditional lecture curriculum was used for comparison. Pretest and post-test performance, end-of-clerkship surveys, and National Board of Medical Examiners (NBME) scores were analyzed to assess effectiveness. Mean pretest and post-test scores increased across all modules (P flipped classroom contributed to this increase. Implementation of a flipped classroom in the surgery clerkship is feasible and results in high learner satisfaction, effective knowledge acquisition, and increased career interest in surgery with noninferior NBME performance. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. The efficacy of a smoking cessation programme in patients undergoing elective surgery - a randomised clinical trial

    DEFF Research Database (Denmark)

    Azodi, O. Sadr; Lindstrom, D.; Adami, J.

    2009-01-01

    It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective...... orthopaedic and general surgery, to smoking cessation intervention and control group. The intervention group underwent a programme initiated, on average, 4 weeks prior to surgery with weekly meetings or telephone counselling and were provided with free nicotine replacement therapy (NRT). The control group...... received standard care. As a result, 20/55 (36%) patients the intervention group vs 1/62 (2%) in the control group became completely abstinent throughout the peri-operative period (p intervention group was most likely to be abstinent (18/55 (33%) vs 9/62 (15...

  11. Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

    Science.gov (United States)

    Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

    2017-03-01

    Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Randomized clinical trial of comprehensive geriatric assessment and optimization in vascular surgery

    OpenAIRE

    Partridge, J S L; Harari, D; Martin, Finbarr; Peacock, J L; Bell, R; Mohammed, A.; Dhesi, J K

    2017-01-01

    BACKGROUND: Increasing numbers of older patients are undergoing vascular surgery. Inadequate preoperative assessment and optimization may contribute to increased postoperative morbidity and mortality.METHODS: Patients aged at least 65 years scheduled for elective aortic aneurysm repair or lower-limb arterial surgery were enrolled in an RCT of standard preoperative assessment or preoperative comprehensive geriatric assessment and optimization. Randomization was stratified by sex and surgical s...

  13. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    OpenAIRE

    Sheetal Oswal; Shivamurthy Ravindra; Aditya Sinha; Shaurya Manjunath

    2014-01-01

    Aims and Objectives: (1) To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2) To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-y...

  14. Factors affecting patient participation in orthopaedic trials comparing surgery to non-surgical interventions

    Directory of Open Access Journals (Sweden)

    Rajat Mittal

    2016-08-01

    Conclusion: Patient non-participation in an RCT comparing surgery to no surgery is related to concern about receiving a treatment through chance and the presence of a strong preference for a particular treatment, particularly a non-surgical one. To avoid protracted recruitment periods, investigators can increase the number of study sites and ensure personnel involved have equipoise and are trained to provide a balanced view of both treatment arms.

  15. Soothing music can increase oxytocin levels during bed rest after open-heart surgery: a randomised control trial.

    Science.gov (United States)

    Nilsson, Ulrica

    2009-08-01

    To evaluate the effect of bed rest with music on relaxation for patients who have undergone heart surgery on postoperative day one. Music intervention has been evaluated as an appropriate nursing intervention to reduce patients 'pain, stress and anxiety levels in several clinical settings, but its effectiveness in increasing patients' subjective and objective relaxation levels has not been examined. A randomised controlled trial. Forty patients undergoing open coronary artery bypass grafting and/or aortic valve replacement surgery were randomly allocated to either music listening during bed rest (n = 20) or bed rest only (n = 20). Relaxation was assessed during bed rest the day after surgery by determining the plasma oxytocin, heart rate, mean arterial blood pressure, PaO2 SaO2 and subjective relaxation levels. In the music group, levels of oxytocin increased significantly in contrast to the control group for which the trend over time was negative i.e., decreasing values. Subjective relaxation levels increased significantly more and there were also a significant higher levels of PaO2 in the music group compared to the control group. There was no difference in mean arterial blood pressure, heart rate and SaO2 between the groups. Listening to music during bed rest after open-heart surgery has some effects on the relaxation system as regards s-oxytocin and subjective relaxations levels. This effect seems to have a causal relation from the psychological (music makes patients relaxed) to the physical (oxytocin release). Music intervention should be offered as an integral part of the multimodal regime administered to the patients that have undergone cardiovascular surgery. It is a supportive source that increases relaxation.

  16. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery.

    Science.gov (United States)

    Hudson, B F; Ogden, J; Whiteley, M S

    2015-11-01

    High levels of anxiety during surgery are associated with poorer post-surgical outcomes. This prospective, non-blinded randomized controlled trial aimed to compare the effectiveness of four intraoperative distraction interventions for anxiety and pain management during minimally invasive venous surgery under local anaesthetic. 407 patients presenting with varicose veins at a private clinic, were randomized to one of four intraoperative distraction interventions or treatment as usual. All participants received endovenous thermoablation and/or phlebectomies of varicose veins. After losses to follow-up, 398 participants were entered into the analysis. Participants were randomly allocated to one of the following intraoperative distraction techniques: patient selected music (n = 85), patient selected DVD (n = 85), interaction with nurses (n = 81), touch (stress balls) (n = 80) or treatment as usual (TAU, n = 76). The state scale of the STAI, the Short-form McGill pain questionnaire and numeric rating scales were used to assess intraoperative pain and anxiety. Intraoperative anxiety ratings were significantly lower when participants interacted with nurses, used stress balls or watched a DVD during surgery compared to treatment as usual. Intraoperative pain ratings were significantly lower than treatment as usual when participants interacted with nurses or used stress balls during surgery. Patients' satisfaction was not significantly impacted by intraoperative distractions. The use of simple intraoperative distraction techniques, particularly interacting with nurses, using stress balls or watching a DVD during surgery conducted under local anaesthetic can significantly improve patients' experiences. © 2015 European Pain Federation - EFIC®

  17. Ten-year risk of stroke in patients with previous cerebral infarction and the impact of carotid surgery in the Asymptomatic Carotid Surgery Trial.

    Science.gov (United States)

    Streifler, Jonathan Y; den Hartog, Anne G; Pan, Samuel; Pan, Hongchao; Bulbulia, Richard; Thomas, Dafydd J; Brown, Martin M; Halliday, Alison

    2016-12-01

    Silent brain infarcts are common in patients at increased risk of stroke and are associated with a poor prognosis. In patients with asymptomatic carotid stenosis, similar adverse associations were claimed, but the impact of previous infarction or symptoms on the beneficial effects of carotid endarterectomy is not clear. Our aim was to evaluate the impact of prior cerebral infarction in patients enrolled in the Asymptomatic Carotid Surgery Trial, a large trial with 10-year follow-up in which participants whose carotid stenosis had not caused symptoms for at least six months were randomly allocated either immediate or deferred carotid endarterectomy. The first Asymptomatic Carotid Surgery Trial included 3120 patients. Of these, 2333 patients with baseline brain imaging were identified and divided into two groups irrespective of treatment assignment, 1331 with evidence of previous cerebral infarction, defined as a history of ischemic stroke or transient ischemic attack > 6 months prior to randomization or radiological evidence of an asymptomatic infarct (group 1) and 1002 with normal imaging and no prior stroke or transient ischemic attack (group 2). Stroke and vascular deaths were compared during follow-up, and the impact of carotid endarterectomy was observed in both groups. Baseline characteristics of patients with and without baseline brain imaging were broadly similar. Of those included in the present report, male gender and hypertension were more common in group 1, while mean ipsilateral stenosis was slightly greater in group 2. At 10 years follow-up, stroke was more common among participants with cerebral infarction before randomization (absolute risk increase 5.8% (1.8-9.8), p = 0.004), and the risk of stroke and vascular death was also higher in this group (absolute risk increase 6.9% (1.9-12.0), p = 0.007). On multivariate analysis, prior cerebral infarction was associated with a greater risk of stroke (hazard ratio = 1.51, 95% confidence

  18. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Majid Eshghpour

    2014-10-01

    Full Text Available Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery.   Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P  Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group.   Conclusion:  The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient.

  19. Reduction of Endogenous Angiogenesis Inhibitors in Bruch’s Membrane of the Submacular Region in Eyes With Age-Related Macular Degeneration

    Science.gov (United States)

    Bhutto, Imran A.; Uno, Koichi; Merges, Carol; Zhang, Lei; McLeod, D. Scott; Lutty, Gerard A.

    2016-01-01

    Objectives To determine the relative levels of 3 potent inhibitors of angiogenesis (endostatin, pigment epithelium–derived factor, and thrombospondin 1) in the retinal pigment epithelium–Bruch’s membrane–choriocapillaris complex in the submacular region in aged control eyes and eyes with age-related macular degeneration (AMD). Methods Immunohistochemical analysis with antibodies against endostatin, pigment epithelium–derived factor, and thrombospondin 1 was performed on the macular region of aged control donor eyes (n=8; mean age, 79.8 years) and eyes with AMD (n=12; mean age, 83.9 years). Three independent masked observers scored the reaction product (scored from 0–7). Mean scores from the control eyes and the eyes with AMD were analyzed using 1-way analysis of variance and unpaired t test. Results In control eyes, strong immunoreactivity of all 3 inhibitors was observed in the retinal pigment epithelium–Bruch’s membrane–choriocapillaris complex. Immunoreactivity for endostatin, pigment epithelium–derived factor, and thrombospondin 1 in Bruch’s membrane was significantly lower in eyes with AMD compared with aged control eyes (analysis of variance, P=.003, P = .009, and P< .001, respectively). In the choriocapillaris, a significant reduction was observed in endostatin (analysis of variance, P=.02) and thrombospondin 1 (analysis of variance, P=.005) in eyes with AMD. Conclusions These findings suggest that endogenous angiogenesis inhibitors in the retinal pigment epithelium–Bruch’s membrane–choriocapillaris complex may provide a biochemical barrier for choroidal neovascular invasion. Clinical Relevance Decreased levels of angiogenic inhibitors at the retinal pigment epithelium–Bruch’s membrane–choriocapillaris complex in eyes with AMD make Bruch’s membrane vulnerable to choroidal neovascularization. PMID:18474778

  20. The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

    Directory of Open Access Journals (Sweden)

    Armstrong Sarah J

    2010-04-01

    Full Text Available Abstract Background Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed. This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment. Methods/Design Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i clinical success at 1, 2 and 5 years, ii time to first recurrence, iii cosmetic appearance of lesion site after treatment, iv level of pain, and v cost-effectiveness. Safety and tolerability data will also be reported. Discussion This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010. Trial registration Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

  1. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials

    Science.gov (United States)

    Briel, Matthias; Bhatt, Deepak L; Kashyap, Sangeeta R; Schauer, Philip R; Mingrone, Geltrude; Bucher, Heiner C; Nordmann, Alain J

    2013-01-01

    Objective To quantify the overall effects of bariatric surgery compared with non-surgical treatment for obesity. Design Systematic review and meta-analysis based on a random effects model. Data sources Searches of Medline, Embase, and the Cochrane Library from their inception to December 2012 regardless of language or publication status. Eligibility criteria Eligible studies were randomised controlled trials with ≥6 months of follow-up that included individuals with a body mass index ≥30, compared current bariatric surgery techniques with non-surgical treatment, and reported on body weight, cardiovascular risk factors, quality of life, or adverse events. Results The meta-analysis included 11 studies with 796 individuals (range of mean body mass index at baseline 30-52). Individuals allocated to bariatric surgery lost more body weight (mean difference −26 kg (95% confidence interval −31 to −21)) compared with non-surgical treatment, had a higher remission rate of type 2 diabetes (relative risk 22.1 (3.2 to 154.3) in a complete case analysis; 5.3 (1.8 to 15.8) in a conservative analysis assuming diabetes remission in all non-surgically treated individuals with missing data) and metabolic syndrome (relative risk 2.4 (1.6 to 3.6) in complete case analysis; 1.5 (0.9 to 2.3) in conservative analysis), greater improvements in quality of life and reductions in medicine use (no pooled data). Plasma triglyceride concentrations decreased more (mean difference −0.7 mmol/L (−1.0 to −0.4) and high density lipoprotein cholesterol concentrations increased more (mean difference 0.21 mmol/L (0.1 to 0.3)). Changes in blood pressure and total or low density lipoprotein cholesterol concentrations were not significantly different. There were no cardiovascular events or deaths reported after bariatric surgery. The most common adverse events after bariatric surgery were iron deficiency anaemia (15% of individuals undergoing malabsorptive bariatric surgery) and reoperations

  2. Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial

    National Research Council Canada - National Science Library

    Mailhot, Tanya; Cossette, Sylvie; Bourbonnais, Anne; Côté, José; Denault, André; Côté, Marie-Claude; Lamarche, Yoan; Guertin, Marie-Claude

    2014-01-01

    .... Therefore, this randomized pilot trial examines the acceptability, feasibility, and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery...

  3. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial.

    Science.gov (United States)

    Oswal, Sheetal; Ravindra, Shivamurthy; Sinha, Aditya; Manjunath, Shaurya

    2014-09-01

    (1) To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2) To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic), Group B (therapeutic), and Group C (no antibiotics). Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection.

  4. Randomized clinical trial examining the effect of music therapy in stress response to day surgery.

    Science.gov (United States)

    Leardi, S; Pietroletti, R; Angeloni, G; Necozione, S; Ranalletta, G; Del Gusto, B

    2007-08-01

    Music therapy could reduce stress and the stress response. The aim of this study was to investigate the role of music therapy in alleviating stress during day surgery. Sixty patients undergoing day surgery were randomized to one of three groups, each containing 20 patients. Before and during surgery, patients in group 1 listened to new age music and those in group 2 listened to a choice of music from one of four styles. Patients in group 3 (control group) heard the normal sounds of the operating theatre. Plasma levels of cortisol and subpopulations of lymphocytes were evaluated before, during and after operation. Plasma cortisol levels decreased during operation in both groups of patients who listened to music, but increased in the control group. Postoperative cortisol levels were significantly higher in group 1 than in group 2 (mean(s.d.) 14.21(6.96) versus 8.63(2.72) ng/dl respectively; P music therapy changed the neurohormonal and immune stress response to day surgery, especially when the type of music was selected by the patient. Copyright (c) 2007 British Journal of Surgery Society Ltd.

  5. Randomized clinical trial examining psychosocial and quality of life benefits of bilateral breast reduction surgery.

    Science.gov (United States)

    Iwuagwu, O C; Walker, L G; Stanley, P W; Hart, N B; Platt, A J; Drew, P J

    2006-03-01

    The aim was to determine the effects of bilateral reduction mammaplasty on quality of life and psychosocial functioning in women with mammary hypertrophy. Seventy-three women who were referred to either the Hull Breast Unit or Hull Plastic and Reconstructive Surgery Unit were randomized to early or delayed surgery. Both groups had quality of life and psychosocial assessment. Each group underwent two sets of tests. Women who had early bilateral breast reduction were tested before and at 4 months after surgery, whereas those in the control group were tested at the time of randomization and 4 months later, before undergoing surgery. All 73 women completed the study. Mean age was 39 years, and the two groups were well matched for age, body mass index and breast dimension. There were highly significant differences between groups in scores measured on the Functional Assessment of Non-Life Threatening Conditions version 4, EuroQoL, and both mental and physical scales of Short Form 36 (P emotional stability in the early treatment group. Reduction mammaplasty significantly improved quality of life, and increased extroversion and emotional stability. Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  6. The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial.

    Science.gov (United States)

    Sunitha Suresh, B S; De Oliveira, Gildasio S; Suresh, Santhanam

    2015-02-01

    To evaluate the analgesic effect of music and audiobooks in children undergoing major surgical procedures when compared to a control (silence) group. The study was a prospective and randomized trial. Children undergoing major surgeries were randomized to one of the three groups: music, audiobook or control (silence). The primary outcome was the pain burden reduction by two treatments within 48 h postoperatively. Pain burden was measured using the area under the pain scale versus the 30 min interval for each treatment. 60 patients were recruited and 56 completed the study. Pain burden was reduced in the music and audiobook groups compared to control, median (IQR) of -60 (-90 to 0), -45 (-90 to 0) and 0 (-30 to 90) (min × pain score), respectively, P = 0.04. A linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment, slope of regression line -56.8 ± 24 goodness of fit r (2) = 0.25 and slope significantly different from 0 (P = 0.02). Audio therapy is an efficacious adjunct method to decrease post-surgical pain in children undergoing major surgeries. Audio therapy should be considered as an important strategy to minimize pain in children undergoing major surgery.

  7. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial.

    Science.gov (United States)

    Barberan-Garcia, Anael; Ubré, Marta; Roca, Josep; Lacy, Antonio M; Burgos, Felip; Risco, Raquel; Momblán, Dulce; Balust, Jaume; Blanco, Isabel; Martínez-Pallí, Graciela

    2018-01-01

    The aim of this study was to assess the impact of personalized prehabilitation on postoperative complications in high-risk patients undergoing elective major abdominal surgery. Prehabilitation, including endurance exercise training and promotion of physical activity, in patients undergoing major abdominal surgery has been postulated as an effective preventive intervention to reduce postoperative complications. However, the existing studies provide controversial results and show a clear bias toward low-risk patients. This was a randomized blinded controlled trial. Eligible candidates accepting to participate were blindly randomized (1:1 ratio) to control (standard care) or intervention (standard care + prehabilitation) groups. Inclusion criteria were: i) age >70 years; and/or, ii) American Society of Anesthesiologists score III/IV. Prehabilitation covered 3 actions: i) motivational interview; ii) high-intensity endurance training; and promotion of physical activity. The main study outcome was the proportion of patients suffering postoperative complications. Secondary outcomes included the endurance time (ET) during cycle-ergometer exercise. We randomized 71 patients to the control arm and 73 to intervention. After excluding 19 patients because of changes in the surgical plan, 63 controls and 62 intervention patients were included in the intention-to-treat analysis. The intervention group enhanced aerobic capacity [ΔET 135 (218) %; P high-risk candidates for elective major abdominal surgery, which can be explained by the increased aerobic capacity.

  8. Prolapse surgery with or without stress incontinence surgery for pelvic organ prolapse: a systematic review and meta-analysis of randomised trials

    NARCIS (Netherlands)

    van der Ploeg, J. M.; van der Steen, A.; Oude Rengerink, K.; van der Vaart, C. H.; Roovers, J. P.

    2014-01-01

    The combination of prolapse surgery with an incontinence procedure can reduce the incidence of stress urinary incontinence (SUI) after surgery, but may increase adverse events. We compared the effectiveness and safety of prolapse surgery versus combined prolapse and incontinence surgery in women

  9. Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial.

    Science.gov (United States)

    Amanullah, Muhammad M; Hamid, Mohammad; Hanif, Hashim M; Muzaffar, Marium; Siddiqui, Maria T; Adhi, Fatima; Ahmad, Khabir; Khan, Shahjahan; Hasan, Zahra

    2016-03-01

    Cardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters. To assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery. A randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010-2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines - Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha - were measured. Clinical parameters were also assessed. Blood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups. Dexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

  10. Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial.

    Science.gov (United States)

    Kaufmann, K B; Stein, L; Bogatyreva, L; Ulbrich, F; Kaifi, J T; Hauschke, D; Loop, T; Goebel, U

    2017-06-01

    Postoperative pulmonary and renal complications are frequent in patients undergoing lung surgery. Hyper- and hypovolaemia may contribute to these complications. We hypothesized that goal-directed haemodynamic management based on oesophageal Doppler monitoring would reduce postoperative pulmonary complications in a randomized clinical parallel-arm trial. One hundred patients scheduled for thoracic surgery were randomly assigned to either standard haemodynamic management (control group) or goal-directed therapy (GDT group) guided by an oesophageal Doppler monitoring-based algorithm. The primary endpoint was postoperative pulmonary complications, including spirometry. Secondary endpoints included haemodynamic variables, renal, cardiac, and neurological complications, and length of hospital stay. The investigator assessing outcomes was blinded to group assignment. Forty-eight subjects of each group were analysed. Compared to the control group, fewer subjects in the GDT group developed postoperative pulmonary complications (6 vs. 15 patients; P  = 0.047), while spirometry did not differ between groups. Compared to the control group, patients of the GDT group showed higher cardiac index (2.9 vs. 2.1 [l min - 1 m  - 2 ]; P  < 0.001) and stroke volume index (43 vs. 34 [ml m 2 ]; P  < 0.001) during surgery. Renal, cardiac and neurological complications did not differ between groups. Length of hospital stay was shorter in the GDT compared to the control group (9 vs. 11 days; P  = 0.005). Compared to standard haemodynamic management, oesophageal Doppler monitor-guided GDT was associated with fewer postoperative pulmonary complications and a shorter hospital stay. The study was registered in the German Clinical Trials Register (DRKS 00006961). https://drks-neu.uniklinik-freiburg.de/drks_web/.

  11. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial.

    Science.gov (United States)

    Hemmes, Sabrine N T; Gama de Abreu, Marcelo; Pelosi, Paolo; Schultz, Marcus J

    2014-08-09

    The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery. In this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer-generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574. From February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12-12) in the higher PEEP group and 2 cm H2O (0-2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher

  12. Randomized clinical trial of expressive writing on wound healing following bariatric surgery.

    Science.gov (United States)

    Koschwanez, Heidi; Robinson, Hayley; Beban, Grant; MacCormick, Andrew; Hill, Andrew; Windsor, John; Booth, Roger; Jüllig, Mia; Broadbent, Elizabeth

    2017-07-01

    Writing emotionally about upsetting life events (expressive writing) has been shown to speed healing of punch-biopsy wounds compared to writing objectively about daily activities. We aimed to investigate whether a presurgical expressive writing intervention could improve surgical wound healing. Seventy-six patients undergoing elective laparoscopic bariatric surgery were randomized either to write emotionally about traumatic life events (expressive writing) or to write objectively about how they spent their time (daily activities writing) for 20 min a day for 3 consecutive days beginning 2 weeks prior to surgery. A wound drain was inserted into a laparoscopic port site and wound fluid analyzed for proinflammatory cytokines collected over 24 hr postoperatively. Expanded polytetrafluoroethylene tubes were inserted into separate laparoscopic port sites during surgery and removed after 14 days. Tubes were analyzed for hydroxyproline deposition (the primary outcome), a major component of collagen and marker of healing. Fifty-four patients completed the study. Patients who wrote about daily activities had significantly more hydroxyproline than did expressive writing patients, t(34) = -2.43, p = .020, 95% confidence interval [-4.61, -0.41], and higher tumor necrosis factor-alpha, t(29) = -2.42, p = .022, 95% confidence interval [-0.42, -0.04]. Perceived stress significantly reduced in both groups after surgery. Expressive writing prior to bariatric surgery was not effective at increasing hydroxyproline at the wound site 14 days after surgery. However, writing about daily activities did predict such an increase. Future research needs to replicate these findings and investigate generalizability to other surgical groups. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  13. Analgesia with interfascial continuous wound infiltration after laparoscopic colon surgery: A randomized clinical trial.

    Science.gov (United States)

    Telletxea, S; Gonzalez, J; Portugal, V; Alvarez, R; Aguirre, U; Anton, A; Arizaga, A

    2016-04-01

    For major laparoscopic surgery, as with open surgery, a multimodal analgesia plan can help to control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects. We conducted a prospective, randomized, study of patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital from January 2012 to January 2013. Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for pain at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale scores and amount of intravenous morphine used via patient controlled infusion. 92 patients were included in the study, 43 had a wound catheter implanted and 49 did not. Statistically significant differences in morphine consumption were observed between groups throughout the course of the treatment period. The mean total morphine consumption at the end of the study was 5.63±5.02mg among wound catheter patients and 21. 86±17.88mg among control patients (P=.0001). Wound catheter patients had lower pain scale scores than control patients throughout the observation period. No adverse effects associated with the wound catheter technique were observed. The wound catheter group showed lower hospital stays with statistically significant difference (P=.02). In patients undergoing laparoscopic colon surgery, continuous infusion of local anaesthetics through interfascial wound catheters during the first 48h aftersurgery reduced the level of perceived pain and also reduced parenteral morphine consumption with no associated adverse effects and lower hospital stays. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

  14. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial.

    Science.gov (United States)

    Chu, Edward W; Chernoguz, Artur; Divino, Celia M

    2016-06-01

    The perioperative safety profile of clopidogrel, a potent antiplatelet agent used in the management of cardiovascular disease, is unknown, and there are no evidence-based guidelines recommending for either its interruption or continuation at this time. The aim of this study was to determine whether patients who are maintained on clopidogrel before general surgical procedures are at increased risk of perioperative bleeding complications. Patients receiving clopidogrel at the time of elective general surgery were randomized to either discontinue clopidogrel 1 week before surgery (group A) or continue clopidogrel into surgery (group B). All other antiplatelet and anticoagulant agents were discontinued before surgery. The primary end points were perioperative bleeding requiring intraoperative or postoperative transfusion of blood or blood components and bleeding-related readmission, reoperation, or mortality within 90 days of surgery. The secondary end points were perioperative myocardial infarction or cerebrovascular accidents within 90 days of surgery. Thirty-nine patients were enrolled and underwent 43 general surgical operations. Twenty-one procedures were randomized to group A and 22 to group B. The most commonly performed individual procedures were open inguinal hernia repair (23%), laparoscopic cholecystectomy (21%), open ventral hernia repair (15%), laparoscopic ventral hernia repair (11%), and laparoscopic inguinal hernia repair (9%). No perioperative mortalities, bleeding events requiring blood transfusion, or reoperations occurred. One readmission for intra-abdominal hematoma requiring percutaneous drainage occurred in each group (group A: 4.8% vs group B: 4.5%; P = 1.0). No myocardial infarctions or cerebrovascular accidents were observed or reported. The outcomes from this prospective study suggest that, patients undergoing commonly performed elective general surgical procedures can be safely maintained on clopidogrel without increased perioperative

  15. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...... anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome...... with serious adverse events was 2.4% (- 0.8% to 5.6%). Conclusions Perioperative metoprolol did not significantly affect mortality and cardiac morbidity in these patients with diabetes. Confidence intervals, however, were wide, and the issue needs reassessment. Trial registration Current Controlled Trials...

  16. A randomised controlled trial comparing abdominal and vaginal prolapse surgery: effects on urogenital function

    NARCIS (Netherlands)

    Roovers, Jan-Paul W. R.; van der Vaart, C. Huub; van der Bom, Johanna G.; van Leeuwen, Jules H. Schagen; Scholten, Piet C.; Heintz, A. Peter M.

    2004-01-01

    OBJECTIVE: To compare the effects of vaginal hysterectomy (combined with anterior and/or posterior colporraphy) and abdominal sacro-colpopexy (with preservation of the uterus) on urogenital function. DESIGN: Randomised trial. SETTING: Three teaching hospitals in The Netherlands. POPULATION:

  17. Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial

    OpenAIRE

    Emmert, Maximilian Y.; Puippe, Gilbert; Baumüller, Stephan; Alkadhi, Hatem; Landmesser, Ulf; Plass, Andre; Bettex, Dominique; Scherman, Jacques; Grünenfelder, Jürg; Genoni, Michele; Falk, Volkmar; Salzberg, Sacha P.

    2017-01-01

    OBJECTIVES Atrial fibrillation (AF) is a significant risk factor for embolic stroke originating from the left atrial appendage (LAA). This is the first report of long-term safety and efficacy data on LAA closure using a novel epicardial LAA clip device in patients undergoing cardiac surgery. METHODS Forty patients with AF were enrolled in this prospective ‘first-in-man' trial. The inclusion criterion was elective cardiac surgery in adult patients with AF for which a concomitant ablation proce...

  18. Both lavender fleur oil and unscented oil aromatherapy reduce preoperative anxiety in breast surgery patients: a randomized trial.

    Science.gov (United States)

    Franco, Lola; Blanck, Thomas J J; Dugan, Kimberly; Kline, Richard; Shanmugam, Geetha; Galotti, Angela; von Bergen Granell, Annelise; Wajda, Michael

    2016-09-01

    The objective of this study was to determine whether lavender fleur oil (LFO) aromatherapy would reduce anxiety when administered to women before undergoing breast surgery. This was a single-site, randomized study comparing the effect of LFO to unscented oil (UO). The study was conducted in the preoperative holding area of the ambulatory surgery department of NYU Langone Medical Center. Ninety three women, 18 years and older, scheduled for breast surgery. Women meeting inclusion/exclusion criteria were randomized to either LFO or UO aromatherapy and were blind to their assigned treatment. Subjects completed a Speilberger State Anxiety Inventory for Adults (STAI) before and after aromatherapy. Vital signs were recorded before and after aromatherapy. STAI-State questions were divided into positive and negative emotions for analysis. Before aromatherapy, there was no significant difference between groups by individual questions or overall average answer of either positive or negative questions. The use of both LFO and UO increased the positive STAI score totals, with the LFO group having a slightly, but statistically significant, greater increase. Both resulted in a statistically significant decrease in the negative score totals after treatment. There were no differences in vital signs between groups for either treatment. Following the conclusion of the trial LFO was analyzed and found to contain a very low content of the 2 major Lavandula angustifolia constituents. Both LFO and UO aromatherapy treatments lowered anxiety before surgery despite no significant changes in vital signs. LFO treatment generated a slight but statistically significant increase in positive feelings compared with UO treatment. It is probable that the beneficial effect observed was due to both aromatherapy with LFO and a placebo effect related to the added attention given to the patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery.

    Science.gov (United States)

    Goldstein, Howard B; Maccarone, Joseph; Naughton, Martin J; Aguirre, Oscar A; Patel, Rakesh C

    2010-12-13

    A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. ClinicalTrials.gov NCT01244165.

  20. Voice Quality After Treatment of Early Vocal Cord Cancer: A Randomized Trial Comparing Laser Surgery With Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Aaltonen, Leena-Maija, E-mail: leena-maija.aaltonen@hus.fi [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Rautiainen, Noora; Sellman, Jaana [Institute of Behavioural Sciences, University of Helsinki, Helsinki (Finland); Saarilahti, Kauko [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Mäkitie, Antti; Rihkanen, Heikki [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Laranne, Jussi; Kleemola, Leenamaija [Department of Otorhinolaryngology–Head and Neck Surgery, Tampere University Hospital, and University of Tampere, Tampere (Finland); Wigren, Tuija [Department of Oncology, Tampere University Hospital, and University of Tampere, Tampere (Finland); Sala, Eeva [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Lindholm, Paula [Department of Oncology, Turku University Hospital, and University of Turku, Turku (Finland); Grenman, Reidar [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Joensuu, Heikki [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland)

    2014-10-01

    Objective: Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy. The quality of voice achieved with these treatments has not been compared in a randomized trial. Methods and Materials: Male patients with carcinoma limited to 1 mobile vocal cord (T1aN0M0) were randomly assigned to receive either laser surgery (n=32) or external beam radiation therapy (n=28). Surgery consisted of tumor excision with a CO{sub 2} laser with the patient under general anaesthesia. External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks. Voice quality was assessed at baseline and 6 and 24 months after treatment. The main outcome measures were expert-rated voice quality on a grade, roughness, breathiness, asthenia, and strain (GRBAS) scale, videolaryngostroboscopic findings, and the patients' self-rated voice quality and its impact on activities of daily living. Results: Overall voice quality between the groups was rated similar, but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy. Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment. Three patients in each group had local cancer recurrence within 2 years from randomization. Conclusions: Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding. Overall voice quality was similar in both treatment groups, however, indicating a need for careful consideration of patient-related factors in the choice of a treatment option.

  1. Follow-up assessment of problem-based learning in dental alveolar surgery education: a pilot trial.

    Science.gov (United States)

    Bai, Xiaofeng; Zhang, Xia; Wang, Xukai; Lu, Li; Liu, Qiang; Zhou, Qing

    2017-06-01

    Limited information exists on the effects of an oral and maxillofacial surgery integrated problem-based learning (PBL) course for dental undergraduates and the performance of these students after graduation. Therefore, we designed a PBL-implemented course with integrated dental alveolar surgery to evaluate its effects on the preparedness of graduates for clinical practice, their lifelong learning habits and their ability to collaborate, compared with the results of traditional courses. A randomised controlled trial was performed with 90 undergraduate students. The undergraduates were asked to perform a theoretical examination and to complete a clinical case analysis at the end of the course. Three years later, a follow-up survey was administered via a telephone interview and a questionnaire that measured self-perceived and supervisor-rated preparedness for clinical practice related to professional knowledge of dental alveolar surgery, lifelong learning habits, attitude and collaboration ability. All results were analysed using one-way analysis of variance (ANOVA) and a t-test. At the 3-year post-graduation time point, both PBL graduates and their supervisors rated their preparation for clinical practice as higher than those who received traditional lecture-based courses. In addition, the respondents in the PBL group believed that they were more likely than their counterparts in the traditional group to consult with professionals and other health-care staff members. No significant between-group differences were observed in the graduates' habits or lifelong learning attitudes. The PBL mode of teaching integrated dental alveolar surgery may improve preparedness for clinical practice and help undergraduates to develop the desire to collaborate. © 2017 FDI World Dental Federation.

  2. The effect of milrinone on induced hypotension in elderly patients during spinal surgery: a randomized controlled trial.

    Science.gov (United States)

    Hwang, Wonjung; Kim, Eunsung

    2014-08-01

    Induced hypotension is widely used intraoperatively to reduce blood loss and to improve the surgical field during spinal surgery. To determine the effect of milrinone on induced hypotension during spinal surgery in elderly patients. Prospective randomized clinical trial. Forty patients, 60 to 70 years old, ASA I-II, who underwent elective lumbar fusion surgery. Intraoperative hemodynamics, blood loss, hourly urine output, and grade of surgical field. All patients were randomized to group M or N. The study drug was infused after perivertebral muscle retraction until complete interbody fusion. In group M, 50 μg/kg/min of milrinone was infused over 10 minutes as a loading dose followed by 0.6 μg/kg/min of milrinone as a continuous dose. In group N, an identical volume of normal saline was infused in the same fashion. This study was not funded by commercial or other sponsorship and the authors confirm no conflicts of interest, financial or otherwise. During infusion of the study drug, the systolic and mean blood pressures were maintained within adequate limits of induced hypotension in group M. Intraoperative blood loss was 445.0±226.5 mL in group M and 765.0±339.2 mL in group N (p=.001). Hourly urine output was 1.4±0.6 mL in group M and 0.8±0.2 mL in group N (phypotension in elderly patients during spinal surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Archer, Kristin R; Devin, Clinton J; Vanston, Susan W; Koyama, Tatsuki; Phillips, Sharon E; George, Steven Z; McGirt, Matthew J; Spengler, Dan M; Aaronson, Oran S; Cheng, Joseph S; Wegener, Stephen T

    2016-01-01

    The purpose of this study was to determine the efficacy of a cognitive-behavioral-based physical therapy (CBPT) program for improving outcomes in patients after lumbar spine surgery. A randomized controlled trial was conducted on 86 adults undergoing a laminectomy with or without arthrodesis for a lumbar degenerative condition. Patients were screened preoperatively for high fear of movement using the Tampa Scale for Kinesiophobia. Randomization to either CBPT or an education program occurred at 6 weeks after surgery. Assessments were completed pretreatment, posttreatment and at 3-month follow-up. The primary outcomes were pain and disability measured by the Brief Pain Inventory and Oswestry Disability Index. Secondary outcomes included general health (SF-12) and performance-based tests (5-Chair Stand, Timed Up and Go, 10-Meter Walk). Multivariable linear regression analyses found that CBPT participants had significantly greater decreases in pain and disability and increases in general health and physical performance compared with the education group at the 3-month follow-up. Results suggest a targeted CBPT program may result in significant and clinically meaningful improvement in postoperative outcomes. CBPT has the potential to be an evidence-based program that clinicians can recommend for patients at risk for poor recovery after spine surgery. This study investigated a targeted cognitive-behavioral-based physical therapy program for patients after lumbar spine surgery. Findings lend support to the hypothesis that incorporating cognitive-behavioral strategies into postoperative physical therapy may address psychosocial risk factors and improve pain, disability, general health, and physical performance outcomes. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  4. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial.

    Science.gov (United States)

    Güngördük, Kemal; Özdemir, İsa Aykut; Güngördük, Özgü; Gülseren, Varol; Gokçü, Mehmet; Sancı, Muzaffer

    2017-02-01

    Paralytic ileus that develops after elective surgery is a common and uncomfortable complication and is considered inevitable after an intraperitoneal operation. The purpose of this study was to investigate whether coffee consumption accelerates the recovery of bowel function after complete staging surgery of gynecologic cancers. In this randomized controlled trial, 114 patients were allocated preoperatively to either postoperative coffee consumption with 3 times daily (n=58) or routine postoperative care without coffee consumption (n=56). Total abdominal hysterectomy and bilateral salpingo-oophorectomy with systematic pelvic and paraaortic lymphadenectomy were performed on all patients as part of complete staging surgery for endometrial, ovarian, cervical, or tubal cancer. The primary outcome measure was the time to the first passage of flatus after surgery. Secondary outcomes were the time to first defecation, time to first bowel movement, and time to tolerance of a solid diet. The mean time to flatus (30.2±8.0 vs 40.2±12.1 hours; Pcoffee compared with control subjects. Mild ileus symptoms were observed in 17 patients (30.4%) in the control group compared with 6 patients (10.3%) in the coffee group (P=.01). Coffee consumption was well-tolerated and well-accepted by patients, and no intervention-related side-effects were observed. Coffee consumption after total abdominal hysterectomy and systematic paraaortic lymphadenectomy expedites the time to bowel motility and the ability to tolerate food. This simple, cheap, and well-tolerated treatment should be added as an adjunct to the postoperative care of gynecologic oncology patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Renal water conservation determines the increase in body weight after surgery: A randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Robert G Hahn

    2017-01-01

    Conclusion: How strongly the kidneys excrete or retain fluid, which can be assessed by urine sampling, was the strongest indicator of the increase in body weight during the day of surgery. The amount of fluid alone did not correlate with the gain in body weight.

  6. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Steinbrüchel, Daniel Andreas; Wanscher, Michael Jaeger

    2014-01-01

    BACKGROUND: To evaluate if an opiate sparing multimodal regimen of dexamethasone, gabapentin, ibuprofen and paracetamol had better analgesic effect, less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery. METHODS: Open-label, prospective...

  7. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery

    Directory of Open Access Journals (Sweden)

    Mostafa Sadeghi

    2014-07-01

    Full Text Available BACKGROUND AND OBJECTIVES: Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding. METHODS: A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1 g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients. RESULTS: There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0 ± 1.4 in fibrinogen group, and 1.3 ± 1.1 in control group. Less postoperative bleeding was observed in the fibrinogen group (477 ± 143 versus 703 ± 179, p = 0.0001. Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p = 0.094. No thrombotic event was observed through 72 h after surgery. CONCLUSION: Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft.

  8. Effect of smoking cessation intervention on results of acute fracture surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Nåsell, Hans; Adami, Johanna; Samnegård, Eva

    2010-01-01

    Tobacco smoking is a major health and economic concern and is also known to have a significant negative effect on surgical outcomes. The benefits of a smoking cessation intervention prior to elective orthopaedic surgery have been evaluated previously. Our aim was to assess whether a smoking...

  9. One-year results of total arterial revascularization vs. conventional coronary surgery: CARRPO trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Wetterslev, Jørn; Lund, Jens T

    2009-01-01

    AIMS: To investigate clinical and angiographic outcomes after coronary surgery using total arterial revascularization (TAR). METHODS AND RESULTS: We randomized 331 patients with multivessel or isolated left main disease to TAR [internal thoracic (ITA) and radial arteries] vs. conventional...... revascularization (CR) using left ITA and vein grafts. The primary angiographic outcome was the patency index: number of patent grafts (

  10. QUALITY ASSURANCE OF 4D-CT SCAN TECHNIQUES IN MULTICENTER PHASE III TRIAL OF SURGERY VERSUS STEREOTACTIC RADIOTHERAPY (RADIOSURGERY OR SURGERY FOR OPERABLE EARLY STAGE (STAGE 1A) NON-SMALL-CELL LUNG CANCER [ROSEL] STUDY)

    NARCIS (Netherlands)

    Hurkmans, Coen W.; van Lieshout, Maarten; Schuring, Danny; van Heumen, Marielle J. T.; Cuijpers, Johan P.; Lagerwaard, Frank J.; Widder, Joachim; van der Heide, Uulke A.; Senan, Suresh

    2011-01-01

    Purpose: To determine the accuracy of four-dimensional computed tomography (4D-CT) scanning techniques in institutions participating in a Phase III trial of surgery vs. stereotactic radiotherapy (SBRT) for lung cancer. Methods and Materials: All 9 centers performed a 4D-CT scan of a motion phantom

  11. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    Directory of Open Access Journals (Sweden)

    Sheetal Oswal

    2014-01-01

    Full Text Available Aims and Objectives: (1 To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2 To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic, Group B (therapeutic, and Group C (no antibiotics. Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P < 0.05 was considered as statistically significant. Results: No infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. Summary and Conclusion: There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is <1% and this low risk does not justify the routine use of systemic antimicrobials just to prevent infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection.

  12. Effects of dexamethasone on early cognitive decline after cardiac surgery: A randomised controlled trial.

    Science.gov (United States)

    Glumac, Sandro; Kardum, Goran; Sodic, Lidija; Supe-Domic, Daniela; Karanovic, Nenad

    2017-11-01

    Postoperative cognitive decline (POCD), a very common complication after cardiac surgery, is characterised by impairment of both memory function and intellectual ability as well as being associated with increased use of healthcare resources. The investigators focused on the role of the inflammatory response to a surgical procedure as a potential factor involved in the pathogenesis of POCD. The use of prophylactic dexamethasone to attenuate the inflammatory response was hypothesised to reduce the risk of POCD. Randomised controlled study. Single university teaching hospital, from March 2015 to January 2016. A total of 169 patients scheduled for elective cardiac surgery were enrolled, and 161 patients were included in the analyses. Patients were randomised to receive a single intravenous bolus of 0.1 mg kg dexamethasone (n = 85) or placebo (n = 84) 10 h before the surgery. The primary outcome measure in both groups was the incidence of POCD on the 6th day after surgery. The investigators also evaluated the effect of dexamethasone on the incidence of systemic inflammatory response syndrome, postoperative C-reactive protein levels and postoperative serum S100β protein levels. Compared to the placebo group, the dexamethasone group showed statistically significant reductions in the incidence of POCD (relative risk, 0.43; 95% confidence interval, 0.21 to 0.89; P = 0.02), the incidence of systemic inflammatory response syndrome (30.0 versus 58.0%, P < 0.001) and postoperative C-reactive protein levels (P < 0.001). Postoperative S100β levels were insignificantly lower (P = 0.56) in the dexamethasone group. Preoperative administration of dexamethasone reduced the inflammatory response and thereby decreased the risk of early POCD after cardiac surgery. Clinicaltrials.gov identifier: NCT02767713.

  13. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial.

    Science.gov (United States)

    Martorella, Géraldine; Côté, José; Racine, Mélanie; Choinière, Manon

    2012-12-14

    Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7

  14. Evaluation of Postoperative Povidone-Iodine in Adjustable Suture Strabismus Surgery to Reduce Suture Colonization: A Randomized Clinical Trial.

    Science.gov (United States)

    Rossetto, Julia D; Suwannaraj, Sirinya; Cavuoto, Kara M; Spierer, Oriel; Miller, Darlene; McKeown, Craig A; Capo, Hilda

    2016-10-01

    Although the association between suture colonization and postoperative infections remains hypothetical, measures to reduce perioperative suture colonization may minimize postoperative infections. The suture colonization rate in adjustable suture strabismus surgery is not well defined, and the effect of povidone-iodine use on suture colonization is unknown. To assess whether povidone-iodine application at the end of adjustable suture strabismus surgery decreases the suture colonization rate. In this randomized clinical trial designed in 2015 and performed from June 1 through October 31, 2015, a total of 65 adjustable and 43 control suture specimens from 65 demographically similar adults undergoing adjustable suture strabismus surgery were studied. A random sampling assigned participants into group 1 (with povidone-iodine) or group 2 (without povidone-iodine) at the end of surgery. A control suture specimen was obtained if ipsilateral nonadjustable surgery was performed. Both groups received antibiotic ointment at the end of the procedure. No patients refused participation or withdrew. Data analysis was performed from October 1 to December 31, 2015. Observers were unaware of patient grouping. One drop of 5% povidone-iodine directly over the sliding noose of the adjustable suture at the end of surgery. The suture colonization rate after adjustment in group 1, group 2, and the control group. Of 65 adults undergoing surgery, there were 17 men (49%) and 18 women (51%) in group 1 and 10 men (33%) and 20 women (67%) in group 2, as well as 20 men (47%) and 23 women (53%) in the control group. The mean (SD) age of the patients was 48.5 (16.8) years in group 1, 46.6 (18.1) years in group 2, and 47.7 (17.0) years in the control group. There was no difference in the colonization rate between group 1 (57%) and group 2 (47%) (relative risk [RR], 1.1; 95% CI, 0.6-1.7; P = .80), group 1 and the control group (44%) (RR, 1.0; 95% CI, 0.5-1.8; P > .99), or group 2 and

  15. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial

    Directory of Open Access Journals (Sweden)

    Buggeskov Katrine B

    2013-01-01

    Full Text Available Abstract Background Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB creates a whole body systemic inflammatory response syndrome (SIRS that could impair pulmonary function. Impaired pulmonary function can, however, be attenuated by pulmonary perfusion with oxygenated blood or custodiol HTK (histidine-tryptophan-ketoglutarate solution. Methods/Design The Pulmonary Protection Trial (PP-Trial randomizes 90 patients undergoing CPB-dependent cardiac surgery to evaluate whether pulmonary perfusion with oxygenated blood or custodiol HTK solution reduces postoperative pulmonary dysfunction in COPD patients. Further, we aim for a non-randomized evaluation of postoperative pulmonary function after transcatheter aortic-valve implantation (TAVI. The primary outcome measure is the oxygenation index measured from anesthesia induction to the end of surgery and until 24 hours after anesthesia induction for a total of six evaluations. Discussion Patients with COPD may be impaired by hypoxemia and SIRS. Thus, prolonged recovery and even postoperative complications and death may be reflected by the degree of hypoxemia and SIRS. The limited sample size does not aim for confirmatory conclusions on mortality, cardiovascular complications or risk of pneumonia and sepsis, but the PP-Trial is considered an important feasibility trial paving the road for a multicenter confirmatory trial. Trial registration ClinicalTrials.gov: NCT01614951.

  16. The benefit of adjuvant radiotherapy after breast conserving surgery in older patients with low risk breast cancer- a meta-analysis of randomized trials

    OpenAIRE

    Matuschek, Christiane; B?lke, Edwin; Haussmann, Jan; Mohrmann, Svjetlana; Nestle-Kr?mling, Carolin; Gerber, Peter Arne; Corradini, Stefanie; Orth, Klaus; Kammers, Kai; Budach, Wilfried

    2017-01-01

    Purpose/Objective(s) It is currently unclear whether patients with low risk breast cancer receiving adjuvant endocrine therapy need adjuvant radiation therapy after breast conserving surgery. The data of randomized trials are available. Materials/Methods In a database search 5 randomized trials including in total 3766 mostly elderly patients with early stage breast cancer tr?eated either with adjuvant endocrine therapy or with endocrine therapy and additional whole breast radiation after brea...

  17. Long Term Survival Results of Surgery Alone versus Surgery plus 5-Fluorouracil and Leucovorin for Stage II and Stage III Colon Cancer: Pooled Analysis of NSABP C-01 through C-05 Baseline from Which to Compare Modern Adjuvant Trials

    Science.gov (United States)

    Wilkinson, Neal W.; Yothers, Greg; Lopa, Samia; Costantino, Joseph P.; Petrelli, Nicholas J.; Wolmark, Norman

    2010-01-01

    Background The objective of this study is to conduct a pooled analysis of National Surgical Adjuvant Breast and Bowel Project (NSABP) colon trials involving surgery and surgery plus 5-fluorouracil and leucovorin (5-FU/LV) to compare survival and establish a baseline from which to evaluate future studies. Methods All patients enrolled in NSABP adjuvant trials C-01 through C-05 with stage II and III disease who were treated with surgery or with surgery plus 5-FU/LV were examined for overall survival (OS), disease free survival (DFS), and recurrence free interval (RFI). Time-to-event by treatment group was examined using adjusted Kaplan-Meier estimates and multivariable Cox regression analysis. Results There were 2,966 eligible patients: 693 (23%) surgery and 2,273 (77%) surgery plus 5-FU/LV; 1,255 (42%) stage II and 1,711 (58%) stage III. Age ≥ 60 years {hazard ratio (HR)=1.36, P<0.000], male gender (HR=1.20, P=0.0012), and more nodes positive or fewer nodes examined (P< 0.0001) were associated with worse survival. At 5 years, the adjusted OS was 0.62 [confidence interval (CI)= 0.60-0.63] in the surgery group and 0.76 (CI= 0.74- 0.78) in the surgery plus 5-FU/LV group. Treatment with 5-FU/LV was associated with improved outcome compared with surgery: OS (HR=0.62, P<0.0001), DFS (HR=0.66, P<0.0001) and RFI (HR=0.64, P<0.0001). Improved OS with adjuvant treatment was seen in both stage II (HR=0.58, 95% CI=0.48-0.71) and stage III disease (HR=0.65, 95% CI=0.55-0.75). Conclusions This analysis demonstrates that treatment of colon cancer patients with 5-FU/LV following surgery provides benefit over surgery alone and can provide anticipated survival outcomes from which to compare modern adjuvant trials. PMID:20082144

  18. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform? Matrix) for pelvic reconstructive surgery

    OpenAIRE

    Aguirre Oscar A; Naughton Martin J; Maccarone Joseph; Goldstein Howard B; Patel Rakesh C

    2010-01-01

    Abstract Background A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Methods Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks...

  19. Prospective trial of a short hospital stay protocol after endoscopic endonasal pituitary adenoma surgery.

    Science.gov (United States)

    Thomas, Jonathan G; Gadgil, Nisha; Samson, Susan L; Takashima, Masayoshi; Yoshor, Daniel

    2014-01-01

    Patients typically remain hospitalized for several days after transsphenoidal surgery for pituitary adenoma resection for reasons including pain control, serial neurological assessments, surveillance for cerebrospinal fluid leak, and management of endocrine issues. We sought to determine whether an evidence-based perioperative care protocol combined with an endoscopic approach could lead to routine and safe discharge on postoperative day 1. Our multidisciplinary pituitary group prospectively implemented a perioperative care protocol that emphasizes patient education, early mobilization, and scheduled inpatient and outpatient endocrine assessments on 50 consecutive patients who underwent surgical resection of a pituitary adenoma (82% macroadenomas, 2.1 ± 0.8 cm, maximum 4.5 cm, 18% microadenomas). Endoscopic endonasal surgery characterized by aggressive tumor resection and avoidance of nasal packing and lumbar drains was used in all cases. Lengths of stay, readmissions, and postoperative outcomes were analyzed. Using the short-stay protocol, 92% (46 of 50) of patients were successfully discharged on postoperative day 1. The average length of stay for all patients was 1.16 ± 0.55 days (range 1 to 4). Postoperative diabetes insipidus occurred in 16% of patients (8 of 50), was effectively managed on an outpatient basis, and did not delay discharge. Readmission was required in 2 patients, in both cases for delayed presentation of a cerebrospinal fluid leak. A short-stay protocol allows for an overnight hospital stay for patients after pituitary surgery, with a low rate of complications or readmission. This study offers evidence-based guidelines that may be used to avoid complications and facilitate early discharge after transsphenoidal surgery. Published by Elsevier Inc.

  20. Effect of smoking cessation intervention on results of acute fracture surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Nåsell, Hans; Adami, Johanna; Samnegård, Eva

    2010-01-01

    Tobacco smoking is a major health and economic concern and is also known to have a significant negative effect on surgical outcomes. The benefits of a smoking cessation intervention prior to elective orthopaedic surgery have been evaluated previously. Our aim was to assess whether a smoking cessa...... cessation program, initiated during the acute hospitalization period and carried out for six weeks, could reduce the number of complications following emergency surgical treatment of fractures....

  1. The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Onerup, Aron; Angenete, Eva; Bock, David; Börjesson, Mats; Fagevik Olsén, Monika; Grybäck Gillheimer, Elin; Skullman, Stefan; Thörn, Sven-Egron; Haglind, Eva; Nilsson, Hanna

    2017-05-08

    Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer. We are conducting a randomised, controlled, parallel-group, open-label, multi-centre trial with physical recovery within 4 weeks after cancer surgery as the primary endpoint. Some 640 patients planned for surgery for colorectal cancer will be enrolled. The intervention consists of pre- and post-operative physical activity with increased daily aerobic activity of moderate intensity as well as IMT. In the control group, patients will be advised to continue their normal daily exercise routine. The primary outcome is patient-reported physical recovery 4 weeks post-operatively. Secondary outcomes are length of sick leave, complication rate and severity, length of hospital stay, re-admittances, re-operations, post-operative mental recovery, quality of life and mortality, as well as changes in insulin-like growth factor 1 and insulin-like growth factor-binding protein 3, perception of pain and a health economic analysis. An increase in moderate-intensity aerobic physical activity is a safe, cheap and feasible intervention that would be possible to implement in standard care for patients with colorectal cancer. If shown to be effective, this lifestyle intervention could be a clinical parallel to pre-operative smoke cessation that has already been implemented with good clinical results. ClinicalTrials.gov identifier: NCT

  2. Renal water conservation determines the increase in body weight after surgery: A randomized, controlled trial.

    Science.gov (United States)

    Hahn, Robert G

    2017-01-01

    The present study was undertaken to identify factors that correlate with the gain in body weight after surgery. Twenty-one patients (median age of 49 years) were randomized to receive either Ringer × s acetate or 6% dextran 70 as their first infusion fluid during cholecystectomy or hysterectomy. Each patient's body weight was measured before the surgery and on the first postoperative morning. Blood and urine samples were analyzed for signs of stress, inflammation, and kidney injury. The fluid retention index (FRI), which reflects how strongly the kidneys excrete or retain fluid, was also calculated. The body weight increased by a median of 0.4 kg in the crystalloid fluid group and by 1.0 kg in the colloid fluid group (maximum 2.5 kg, P weight did not correlate with the infused fluid volume, the plasma concentrations of C-reactive protein or cortisol, or the urinary excretion of albumin, cortisol, or neutrophil gelatinase-associated lipocalin. However, the body weight increased with the postoperative FRI score (r = 0.64; P weight during the day of surgery. The amount of fluid alone did not correlate with the gain in body weight.

  3. Prophylaxis of complications after pancreatic surgery: results of a multicenter trial in Italy. Italian Study Group.

    Science.gov (United States)

    Bassi, C; Falconi, M; Lombardi, D; Briani, G; Vesentini, S; Camboni, M G; Pederzoli, P

    1994-01-01

    An Italian prospective multicentre study evaluated the efficacy of octreotide, a synthetic somatostatin analogue, in preventing the complications of elective pancreatic surgery. 303 patients with tumours of the pancreas or the ampullary region, in whom ultrasonography and computed tomography scan had shown a resectable lesion, or with chronic pancreatitis, were randomized in a double-blind fashion to treatment with octreotide 100 micrograms t.i.d. s.c. starting at least 1 h before surgery and continued till the 7th postsurgical day, or with matching placebo. Unresectable lesions were found at laparatomy in 31 patients (15% of those with tumours). In 14 others, procedures not anticipated in the study protocol had to be performed, and in 6 additional cases there were other protocol violations so that these 20 patients were excluded from the study analysis. Considering the 252 evaluable patients, the complication rate was significantly higher in the 130 placebo-treated patients than in the 122 who received octreotide (29.2 vs. 15.6%; p = 0.01). We therefore suggest that octreotide may substantially reduce the risk of complications after elective pancreatic surgery.

  4. Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial.

    Science.gov (United States)

    Lockwood, Geoff G; Cabreros, Leilani; Banach, Dorota; Punjabi, Prakash P

    2017-10-01

    Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg(-1).hr(-1)) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l(-1). There were no adverse events as a consequence of the study. Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. ISRCTN13424423 ( https://www.isrctn.com ).

  5. The One-stop trial: Does electronic referral and booking by the general practitioner (GPs to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Vonen Barthold

    2008-08-01

    Full Text Available Abstract Background Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery. Materials and Methods In a randomised controlled trial, selected patients (inguinal hernia, gallstone disease and pilonidal sinus referred to the university hospital are either randomised to direct electronic referral and booking for outpatient surgery (one stop, or to the traditional patient pathway where all patients are seen at the outpatient clinic several weeks ahead of surgery. Consultants in gastrointestinal surgery designed standardised referral forms and guidelines. New software has been designed making it possible to implement referral forms, guidelines and patient information in the GP's electronic health record. For "one-stop" referral, GPs must provide mandatory information about the specific condition. Referrals were linked to a booking system, enabling the GPs to book the hospital, day and time for outpatient surgery. The primary endpoints are waiting time and costs. The sample size calculation was based on waiting time. A reduction in waiting time of 60 days (effect size, 25%, is significant, resulting in a sample size of 120 patients in total. Discussion Poor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it

  6. Non-opioid analgesics in adults after major surgery: systematic review with network meta-analysis of randomized trials.

    Science.gov (United States)

    Martinez, V; Beloeil, H; Marret, E; Fletcher, D; Ravaud, P; Trinquart, L

    2017-01-01

    Morphine, and analgesics other than morphine (AOM), are commonly used to treat postoperative pain after major surgery. However, which AOM provides the best efficacy-safety profile remains unclear. Randomized trials of any AOM alone or any combination of AOM compared with placebo or another AOM in adults undergoing major surgery and receiving morphine patient-controlled analgesia were included in a network meta-analysis. The outcomes were morphine consumption, pain, incidence of nausea, vomiting at 24 h and severe adverse effects. 135 trials (13,287 patients) assessing 14 AOM alone or in combination were included. For all outcomes, comparisons with placebo were over-represented. Few trials assessed combinations of two AOM and none the combination of three or more. Network meta-analysis found morphine consumption reduction was greatest with the combination of two AOM (acetaminophen + nefopam, acetaminophen + NSAID, and tramadol + metamizol): -23.9 (95% CI -40;-7.7), -22.8 (-31.5;-14) and -19.8 (35.4;-4.2) mg per 24 h, respectively. For AOM used alone, morphine consumption reduction was greatest with α-2 agonists, NSAIDs, and COX-2 inhibitors. When considering the risk of nausea, NSAIDs, corticosteroids and α-2 agonists used alone were the most efficacious (OR 0.7 [95% CI: 0.6-0.8], 0.36 [0.18-0.79], 0.41 [0.15-.64], respectively). The paucity of severe adverse effects data did not allow assessment of efficacy-safety balance. A combination of aetaminophen with either an NSAID or nefopam was superior to most AOM used alone, in reducing morphine consumption. Efficacy was best with three AOM used alone (α-2 agonists, NSAIDs and COX-2 inhibitors) and least with tramadol and acetaminophen. There is insufficient trial data reporting adverse events. PROSPERO: CRD42013003912. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Pantel, Haddon; Hwang, John; Brams, David; Schnelldorfer, Thomas; Nepomnayshy, Dmitry

    2017-05-01

    The combination of obesity and foregut surgery puts patients undergoing bariatric surgery at high risk for postoperative pulmonary complications. Postoperative incentive spirometry (IS) is a ubiquitous practice; however, little evidence exists on its effectiveness. To determine the effect of postoperative IS on hypoxemia, arterial oxygen saturation (Sao2) level, and pulmonary complications after bariatric surgery. A randomized noninferiority clinical trial enrolled patients undergoing bariatric surgery from May 1, 2015, to June 30, 2016. Patients were randomized to postoperative IS (control group) or clinical observation (test group) at a single-center tertiary referral teaching hospital. Analysis was based on the evaluable population. The controls received the standard of care with IS use 10 times every hour while awake. The test group did not receive an IS device or these orders. The primary outcome was frequency of hypoxemia, defined as an Sao2 level of less than 92% without supplementation at 6, 12, and 24 postoperative hours. Secondary outcomes were Sao2 levels at these times and the rate of 30-day postoperative pulmonary complications. A total of 224 patients (50 men [22.3%] and 174 women [77.7%]; mean [SD] age, 45.6 [11.8] years) were enrolled, and 112 were randomized for each group. Baseline characteristics of the groups were similar. No significant differences in frequency of postoperative hypoxemia between the control and test groups were found at 6 (11.9% vs 10.4%; P = .72), 12 (5.4% vs 8.2%; P = .40), or 24 (3.7% vs 4.6%; P = .73) postoperative hours. No significant differences were observed in mean (SD) Sao2 level between the control and test groups at 6 (94.9% [3.2%] vs 94.9% [2.9%]; P = .99), 12 (95.4% [2.2%] vs 95.1% [2.5%]; P = .40), or 24 (95.7% [2.4%] vs 95.6% [2.4%]; P = .69) postoperative hours. Rates of 30-day postoperative pulmonary complications did not differ between groups (8 patients [7.1%] in the control group vs

  8. Fracture Surgery of the extremities with the intra-operative use of 3D-RX: A randomized multicenter trial (EF3X-trial

    Directory of Open Access Journals (Sweden)

    Marmor Meir

    2011-07-01

    Full Text Available Abstract Background Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed. Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated. The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1 the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2 The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. Methods/design In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years with a traumatic intra-articular fracture of the

  9. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Hudson, Jemma; Wood, Jessica; Kilonzo, Mary; Brown, Steven R; McDonald, Alison; Norrie, John; Bruhn, Hanne; Cook, Jonathan A

    2016-11-12

    Two commonly performed surgical interventions are available for severe (grade II-IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II-IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference -0·073 (95% CI -0·140 to -0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life

  10. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  11. Effectiveness of radiation therapy without surgery in metastatic spinal cord compression: Final results from a prospective trial

    Energy Technology Data Exchange (ETDEWEB)

    Maranzano, E.; Latini, P. [Univ. School of Medicine, Perugia (Italy)

    1995-07-15

    In assessing effectiveness of radiation therapy (RT) in metastatic spinal cord compression (MSCC), we performed a prospective trial in which patients with this complication were generally treated with RT plus steroids, and surgery was reserved for selected cases. Of the 209 evaluable cases, 110 were females and 99 males, and median age was 62 years. Median follow-up was 49 months (range, 13 to 88) and treatment consisted of 30 Gy RT (using two different schedules) together with steroids (standard or high doses, depending on motor deficit severity). Back pain total response rate was 82% (complete or partial response or stable pain, 54, 17, or 11%, respectively). About three-fourths of the patients (76%) achieved full recovery or preservation of walking ability and 44% with sphincter dysfunction improved. Early diagnosis was the most important response predictor so that a large majority of patients able to walk and with good bladder function maintained these capacities. Duration of response was also influenced by histology. Median survival time was 6 months, with a 28% probability of survival for 1 year. Survival time was longer for patients able to walk before and/or after RT, those with favourable histologies, and females. There was agreement between patient survival and duration of response, systemic relapse of disease being generally the cause of death. Early diagnosis of MSCC was a powerful predictor of outcome. Primary tumor histology had weight only when patients were nonwalking, paraplegic, or had bladder dysfunction. The effectiveness of RT plus steroids in MSCC emerged in our trial. The most important factors positively conditioning our results were: the high rate of early diagnoses (52%) and the number of tumors with favorable histologies (124 out of 209, 63%) recruited, and the choice of best treatment based on appropriate patient selection for surgery and RT or RT alone. 30 refs., 5 figs., 7 tabs.

  12. A randomized trial of outcomes of anesthetic management directed to very early extubation after cardiac surgery in children.

    Science.gov (United States)

    Preisman, Sergey; Lembersky, Henrietta; Yusim, Yakov; Raviv-Zilka, Lisa; Perel, Azriel; Keidan, Ilan; Mishaly, David

    2009-06-01

    Intraoperative management directed to early extubation of children undergoing cardiac surgery has been suggested as a viable alternative to prolonged postoperative mechanical ventilation. The authors evaluated the safety and efficacy of this approach in a randomized prospective trial. A prospective randomized observational study. A single university-affiliated hospital. One hundred consecutive pediatric patients (age 1 month-15 years, weight 3.0-51 kg) requiring cardiac surgery. Patients younger than 1 month of age and those requiring mechanical ventilation before the operation were considered ineligible for the study. Patients were randomly allocated to a group with anesthetic management and extubation in the operating room (early group [EG]) and a group with elective prolonged mechanical ventilation (control group [CG]). A difference in outcome as reflected by the pediatric intensive care unit (PICU) and hospital lengths of stay and postoperative morbidity and mortality was analyzed. A separate analysis was performed in children younger than 3 years old. The extubation time in the CG was 25.0 +/- 26.9 hours. No differences in mortality, the need for re-exploration for bleeding, the need for reintubation, the incidence of abnormal chest radiographic findings, or cardiac and septic complications between groups were found. PICU and postoperative hospital lengths of stay were significantly shorter in patients in the EG (3.3 +/- 1.9 days in the EG v 5.8 +/- 4.1 in the CG, p management with early cessation of mechanical ventilation appears to be safe and decreases hospital and PICU length of stay. However, because the size of the study did not allow for the detection of possible differences in perioperative mortality, only a large multicenter study may provide a definite answer to this question. The present study may be treated as a pilot for such a trial.

  13. Effects of low intraperitoneal pressure and a warmed, humidified carbon dioxide gas in laparoscopic surgery: a randomized clinical trial.

    Science.gov (United States)

    Matsuzaki, Sachiko; Vernis, Lise; Bonnin, Martine; Houlle, Celine; Fournet-Fayard, Aurelie; Rosano, Giuseppe; Lafaye, Anne Laure; Chartier, Christian; Barriere, Agnes; Storme, Brigitte; Bazin, Jean-Etienne; Canis, Michel; Botchorishvili, Revaz

    2017-09-12

    Laparoscopic surgery technology continues to advance. However, much less attention has been focused on how alteration of the laparoscopic surgical environment might improve clinical outcomes. We conducted a randomized, 2 × 2 factorial trial to evaluate whether low intraperitoneal pressure (IPP) (8 mmHg) and/or warmed, humidified CO2 (WH) gas are better for minimizing the adverse impact of a CO2 pneumoperitoneum on the peritoneal environment during laparoscopic surgery and for improving clinical outcomes compared to the standard IPP (12 mmHg) and/or cool and dry CO2 (CD) gas. Herein we show that low IPP and WH gas may decrease inflammation in the laparoscopic surgical environment, resulting in better clinical outcomes. Low IPP and/or WH gas significantly lowered expression of inflammation-related genes in peritoneal tissues compared to the standard IPP and/or CD gas. The odds ratios of a visual analogue scale (VAS) pain score >30 in the ward was 0.18 (95% CI: 0.06, 0.52) at 12 hours and 0.06 (95% CI: 0.01, 0.26) at 24 hours in the low IPP group versus the standard IPP group, and 0.16 (95% CI: 0.05, 0.49) at 0 hours and 0.29 (95% CI: 0.10, 0.79) at 12 hours in the WH gas group versus the CD gas group.

  14. Effectiveness of a cognitive behavioral therapy for dysfunctional eating among patients admitted for bariatric surgery: a randomized controlled trial.

    Science.gov (United States)

    Gade, Hege; Hjelmesæth, Jøran; Rosenvinge, Jan H; Friborg, Oddgeir

    2014-01-01

    To examine whether cognitive behavioral therapy (CBT) alleviates dysfunctional eating (DE) patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. A total of 98 (68 females) patients with a mean (SD) age of 43 (10) years and BMI 43.5 (4.9) kg/m(2) were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education). The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g = -.92, P ≤ .001; DE-uncontrolled eating, g = -.90, P ≤ .001), moderate (HADS-depression, g = -.73, P ≤ .001; DE-emotional eating, g = -.67, P ≤ .001; HADS-anxiety, g = -.62, P = .003), and low (BMI, g = -.24, P = .004). This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.

  15. Intermittent Versus Continuous and Intermittent Medications for Pain and Sedation After Pediatric Cardiothoracic Surgery; A Randomized Controlled Trial.

    Science.gov (United States)

    Penk, Jamie S; Lefaiver, Cheryl A; Brady, Colleen M; Steffensen, Christine M; Wittmayer, Kimberly

    2017-10-12

    Compare continuous infusions of morphine and midazolam in addition to intermittent doses with an intermittent only strategy for pain and sedation after pediatric cardiac surgery. Randomized controlled trial. Advocate Children's Hospital, Oak Lawn, IL. Sixty patients 3 months to 4 years old with early extubation after pediatric cardiac surgery. Patients received a continuous infusion of morphine and midazolam or placebo for 24 hours. Both groups received intermittent morphine and midazolam doses as needed. Gender, age, bypass time, and surgical complexity were not different between groups. Scheduled ketorolac and acetaminophen were used in both groups and were not associated with adverse events. The mean, median, and maximum Faces, Legs, Activity, Cry, And Consolability score were not different between groups. There was no significant difference in number of intermittent doses received between groups. The total morphine dose was higher in the continuous/intermittent group (0.90 vs 0.23 mg/kg; p intermittent group (0.90 vs 0.18 mg/kg; p intermittent group (8.4 vs 4.9 d; p = 0.04). Pain was not better controlled with the addition of continuous infusions of morphine and midazolam when compared with intermittent dosing only. Use of continuous infusions resulted in a significantly higher total dosage of these medications and a longer length of stay.

  16. Comparative study of hemodynamic changes caused by diazepam and midazolam during third molar surgery: a randomized controlled trial.

    Science.gov (United States)

    de Morais, Hécio Henrique Araújo; Barbalho, Jimmy Charles Melo; de Holanda Vasconcellos, Ricardo José; Landim, Fabricio Souza; da Costa Araújo, Fábio Andrey; de Souza Dias, Tasiana Guedes

    2015-09-01

    The aim of the present study was to compare hemodynamic changes using midazolam 7.5 mg and diazepam 10.0 mg during the surgical removal of symmetrically positioned third molars. A prospective, randomized, double-blind, clinical trial was carried out involving 120 patients divided into three groups: Group 1 (diazepam and placebo), Group 2 (midazolam and placebo), and Group 3 (diazepam and midazolam). Each subject underwent two surgeries on separate occasions under local anesthesia. The following parameters were assessed at five different times (T0, T1, T2, T3, and T4): systolic, diastolic, and mean blood pressure (SBP, DBP, and MBP, respectively); heart rate (HR); oxygen saturation (SpO(2)); rate pressure product (RPP); and pressure rate quotient (PRQ). Statistically significant differences were found regarding heart rate at T2 and T3 (p diazepam administration, whereas a higher heart rate occurred at T3 with midazolam. Midazolam 7.5 mg and diazepam 10.0 mg exert an influence on some hemodynamic parameters without perceptible clinical changes in healthy patients undergoing lower third molar surgery.

  17. Effectiveness of a Cognitive Behavioral Therapy for Dysfunctional Eating among Patients Admitted for Bariatric Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hege Gade

    2014-01-01

    Full Text Available Objective. To examine whether cognitive behavioral therapy (CBT alleviates dysfunctional eating (DE patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. Design and Methods. A total of 98 (68 females patients with a mean (SD age of 43 (10 years and BMI 43.5 (4.9 kg/m2 were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education. The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Results. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g=-.92, P≤.001; DE-uncontrolled eating, g=-.90, P≤.001, moderate (HADS-depression, g=-.73, P≤.001; DE-emotional eating, g=-.67, P≤.001; HADS-anxiety, g=-.62, P=.003, and low (BMI, g=-.24, P=.004. Conclusion. This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.

  18. Intraoperative monitoring of stroke volume variation versus central venous pressure in laparoscopic liver surgery: a randomized prospective comparative trial.

    Science.gov (United States)

    Ratti, Francesca; Cipriani, Federica; Reineke, Raffaella; Catena, Marco; Paganelli, Michele; Comotti, Laura; Beretta, Luigi; Aldrighetti, Luca

    2016-02-01

    Central venous pressure (CVP) is used as a marker of cardiac preload to control intraoperative blood loss in open hepatectomies, while its reliability in laparoscopy is less certain. The aim of this randomized prospective trial was to evaluate the outcome of laparoscopic resections performed with stroke volume variation (SVV) or CVP monitoring. All candidates for laparoscopic liver resection were assigned randomly to SVV or to CVP groups. Outcome was evaluated included conversion rate, cause of conversion, intraoperative blood loss, need for transfusions, length of surgery and postoperative results. Ninety consecutive patients were enrolled: both SVV and CVP groups included 45 patients each and were comparable in terms of patient and disease characteristics. A reduced rate of conversion was recorded in the SVV compared to the CVP group (6.7% and 17.8% respectively, p = 0.02). Blood loss was lower in the SVV group (150 mL), compared to the CVP group (300 mL, p = 0.04). Morbidity, mortality, length of stay and functional recovery were comparable. On multivariate analysis, lesion location, extent of hepatectomy and type of cardiac preload monitoring were associated significantly to risk of conversion. SVV monitoring in laparoscopic liver surgery improves intraoperative outcome, thus enhancing the benefits of the minimally-invasive approach and fast-track protocols. Copyright © 2015 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

  19. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Marianne J E van der Heijden

    Full Text Available Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery.We searched 25 electronic databases from their first available date until October 2014.Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music.4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators.Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated, the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale.Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07 and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16.This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  20. A prospective randomized controlled trial to compare single-port endo-laparoscopic surgery versus conventional TEP inguinal hernia repair.

    Science.gov (United States)

    Wijerathne, Sujith; Agarwal, Narendra; Ramzy, Ahmad; Lomanto, Davide

    2014-11-01

    The success of laparoscopic surgery is due to the less surgical trauma, including less operative pain, complications and better cosmetics. Objective of our study was to compare in two blind randomized groups of patients, the surgical outcome of total extra-peritoneal (TEP) inguinal hernia repair using either single-port or conventional surgical technique. We will report our interim results in the first group of 50 patients. Our study is a prospective, randomized, controlled clinical trial conducted from August 2011 to June 2013. Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups: conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair. Clinical data on patient demographics, surgical technique and findings, postoperative complications and pain scores were collected. Primary endpoint is the postoperative pain while secondary endpoints are recurrence, chronic pain, postoperative hospital stay and complications. Out of the 50 patients, 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization. Mean operative time was 51.7 (±13.4) min in the multiport group and 59.3 (±14.9) min in the single-port group, respectively (P = 0.064). Mean hospital stay was 19.7 (±4.8) h in the conventional group and 22.1 (±4.5) h in the single-port group (P = 0.079). No statistically significant differences were observed between the two groups for postoperative complications, and no recurrence reported at 11 months follow-up. There was no significant difference in the pain scores (visual analog scale) between the two groups at regular intervals post surgery. The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique.

  1. Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional hernia in colorectal surgery.

    Science.gov (United States)

    García-Ureña, Miguel Ángel; López-Monclús, Javier; Hernando, Luis Alberto Blázquez; Montes, Daniel Melero; Valle de Lersundi, Alvaro Robín; Pavón, Camilo Castellón; Ceinos, Carmen Jiménez; Quindós, Patricia López

    2015-05-01

    To reduce the incidence of incisional hernia (IH) in colorectal surgery by implanting a mesh on the overlay position. The incidence of IH in colorectal surgery may be as high as 40%. IH causes severe health and cosmetic problems, and its repair increases health care costs. Randomized, controlled, prospective trial. Patients undergoing any colorectal procedure (both elective and emergency) through a midline laparotomy were divided into 2 groups. The abdomen was closed with an identical technique in both groups, except for the implantation of an overlay large-pore polypropylene mesh in the study group. Patients were followed up clinically and radiologically for 24 months. A total of 107 patients were included: 53 in the study group and 54 in the control group. Both groups were homogeneous, except for a higher incidence of diabetes in the mesh group. There were 20 emergency procedures in the study group and 17 in the control group. There were no statistical differences in surgical site infections, seromas, or mortality between the groups (33.3%, 13.8%, and 3.7% in the control group and 18.9%, 13.2%, and 3.8% in the study group). No mesh rejection was reported. The incidence of IH was 17 of 54 (31.5%) in the control group and 6 of 53 (11.3%) in the study group (P = 0.011). The incidence of IH is high in patients undergoing elective or emergency surgery for colorectal diseases. The addition of a prophylactic large-pore polypropylene mesh on the overlay position decreases the incidence of IH without adding morbidity.

  2. Combining interscalene brachial plexus block with intravenous-inhalation combined anesthesia for upper extremity fractures surgery: a randomized controlled trial.

    Science.gov (United States)

    Yuan, Lan; Tang, Wei; Fu, Guo-qiang; Wang, Jian; Guo, Jun; Chen, Wen-ting

    2014-12-01

    A parallel-group randomized controlled trial (RCT) was conducted to evaluate the effect of combining the interscalene brachial plexus block (IBPB) with Intravenous-inhalation combined anesthesia to isolated Intravenous-inhalation anesthesia in the upper extremity fractures surgery of elderly patients. One hundred elderly patients who underwent upper extremity surgery were randomly assigned to received isolated Intravenous-inhalation combined anesthesia (group CI, n = 50) and IBPB associated with Intravenous-inhalation combined anesthesia (group NB, n = 50). Associated side effects, recovery time after operation, as well as the dose of intraoperative vasoactive agents and auxiliary drugs were noted. The two groups were not significantly different in gender (P = 0.539), ages (P = 0.683) and weight (P = 0.212). Five patients (10%) in the group NB and 17 patients (34%) in the group CI suffered from preoperative hypotension (P = 0.004). Besides, lower incidence of other adverse effects such as mental stress, incision pain and hypertension were also found in the group NB; however, the differences were not statistically significant (P > 0.05). The consumption of general anesthetics in the group NB was significantly less than that of the group CI (propofol, P = 0.004; lsoflurane, P < 0.001), and the recovery time of the group NB was significantly shorter than that of the group CI (P = 0.020). Combining IBPB with Intravenous-inhalation combined anesthesia in elderly patients hold a greater potential for upper extremity fractures surgery due to its improved clinical effectiveness and fewer side effects. Copyright © 2014. Published by Elsevier Ltd.

  3. Whey Protein Supplementation Enhances Body Fat and Weight Loss in Women Long After Bariatric Surgery: a Randomized Controlled Trial.

    Science.gov (United States)

    Lopes Gomes, Daniela; Moehlecke, Milene; Lopes da Silva, Fernanda Bassan; Dutra, Eliane Said; D'Agord Schaan, Beatriz; Baiocchi de Carvalho, Kenia Mara

    2017-02-01

    The ideal nutritional approach for weight regain after bariatric surgery remains unclear. The objective of this study is to assess the effect of whey protein supplementation on weight loss and body composition of women who regained weight 24 or more months after bariatric surgery. This is a 16-week open-label, parallel-group, randomized controlled trial of women who regained at least 5 % of their lowest postoperative weight after a Roux-en-Y gastric bypass (RYGB). A total of 34 participants were treated with hypocaloric diet and randomized (1:1) to receive or not supplementation with whey protein, 0.5 g/kg of the ideal body weight. The primary outcomes were changes in body weight, fat free mass (FFM), and fat mass (FM), evaluated by tetrapolar bioelectrical impedance analysis (BIA). Secondary outcomes included resting energy expenditure, blood glucose, lipids, adiponectin, interleukin 6 (IL-6), and cholecystokinin levels. Statistical analyses included generalized estimating equations adjusted for age and physical activity. Fifteen patients in each group were evaluated: mean age was 45 ± 11 years, body mass index (BMI) was 35.7 ± 5.2 kg/m2, and time since surgery was 69 ± 23 months. Protein intake during follow-up increased by approximately 75 % in the intervention group (p = 0.01). The intervention group presented more body weight loss (1.86 kg, p = 0.017), accounted for FM loss (2.78, p = 0.021) and no change in FFM, as compared to controls (gain of 0.42 kg of body weight and 0.6 kg of FM). No differences in secondary outcomes were observed between groups. Whey protein supplementation promoted body weight and FM loss in women with long-term weight regain following RYGB.

  4. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  5. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica.

  6. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two year results of a randomised controlled trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); W.B. van den Hout (Wilbert); R. Brand (René); R.T.W.M. Thomeer (Raph); B.W. Koes (Bart)

    2008-01-01

    textabstractObjectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica.

  7. Endoscopic surgery versus conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage (ECMOH: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zan Xin

    2012-06-01

    Full Text Available Abstract Background Spontaneous intracerebral hemorrhage is a disease with high morbidity, high disability rate, high mortality, and high economic burden. Whether patients can benefit from surgical evacuation of hematomas is still controversial, especially for those with moderate-volume hematomas in the basal ganglia. This study is designed to compare the efficacy of endoscopic surgery and conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage. Methods Patients meet the criteria will be randomized into the endoscopic surgery group (endoscopic surgery for hematoma evacuation and the best medical treatment or the conservative treatment group (the best medical treatment. Patients will be followed up at 1, 3, and 6 months after initial treatment. The primary outcomes include the Extended Glasgow Outcome Scale and the Modified Rankin Scale. The secondary outcomes consist of the National Institutes of Health Stroke Scale and the mortality. The Barthel Index(BI will also be evaluated. The sample size is 100 patients. Discussion The ECMOH trial is a randomized controlled trial designed to evaluate if endoscopic surgery is better than conservative treatment for patients with moderate-volume hematomas in the basal ganglia. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-11001614 (http://www.chictr.org/en/proj/show.aspx?proj=1618

  8. Comparably improved health-related quality of life after total arterial revascularization versus conventional coronary surgery--Copenhagen arterial revascularization randomized patency and outcome trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Lund, Jens T; Lilleør, Nikolaj B

    2011-01-01

    OBJECTIVE: We compared health-related quality of life up to 11 months after coronary artery bypass grafting using total arterial revascularization versus conventional coronary surgery. METHODS: In this randomized single-center trial, 161 patients underwent total arterial revascularization using s...

  9. Protection of xenon against postoperative oxygen impairment in adults undergoing Stanford Type-A acute aortic dissection surgery: Study protocol for a prospective, randomized controlled clinical trial.

    Science.gov (United States)

    Jin, Mu; Cheng, Yi; Yang, Yanwei; Pan, Xudong; Lu, Jiakai; Cheng, Weiping

    2017-08-01

    The available evidence shows that hypoxemia after Stanford Type-A acute aortic dissection (AAD) surgery is a frequent cause of several adverse consequences. The pathogenesis of postoperative hypoxemia after AAD surgery is complex, and ischemia/reperfusion and inflammation are likely to be underlying risk factors. Xenon, recognized as an ideal anesthetic and anti-inflammatory treatment, might be a possible treatment for these adverse effects. The trial is a prospective, double-blind, 4-group, parallel, randomized controlled, a signal-center clinical trial. We will recruit 160 adult patients undergoing Stanford type-A AAD surgery. Patients will be allocated a study number and will be randomized on a 1:1:1:1 basis to receive 1 of the 3 treatment options (pulmonary inflated with 50% xenon, 75% xenon, or 100% xenon) or no treatment (control group, pulmonary inflated with 50% nitrogen). The aims of this study are to clarify the lung protection capability of xenon and its possible mechanisms in patients undergoing the Stanford type-A AAD surgery. This trial uses an innovative design to account for the xenon effects of postoperative oxygen impairment, and it also delineates the mechanism for any benefit from xenon. The investigational xenon group is considered a treatment intervention, as it includes 3 groups of pulmonary static inflation with 50%, 75%, and 100% xenon. It is suggested that future trials might define an appropriate concentration of xenon for the best practice intervention.

  10. What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata.

    Science.gov (United States)

    Durand, Marie-Anne; Yen, Renata West; O'Malley, A James; Politi, Mary C; Dhage, Shubhada; Rosenkranz, Kari; Weichman, Katie; Margenthaler, Julie; Tosteson, Anna N A; Crayton, Eloise; Jackson, Sherrill; Bradley, Ann; Volk, Robert J; Sepucha, Karen; Ozanne, Elissa; Percac-Lima, Sanja; Song, Julia; Acosta, Jocelyn; Mir, Nageen; Elwyn, Glyn

    2018-02-13

    Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata. We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions' sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially

  11. Can we increase the chance of sphincter saving surgery in rectal cancer with neoadjuvant treatments: lessons from a systematic review of recent randomized trials.

    Science.gov (United States)

    Gerard, Jean-Pierre; Rostom, Yousri; Gal, Jocelyn; Benchimol, Daniel; Ortholan, Cécile; Aschele, Carlo; Levi, Jean-Michel Hannoun

    2012-01-01

    A common hypothesis is that neo-adjuvant treatment in rectal cancer, is able to increase sphincter saving surgery. This review studies data relevant to this question. A total of 17 randomized trials were analysed. Since 1976, the rate of sphincter saving surgery increased from 20% to 75%. In none of the 17 trials it was possible to demonstrate a significant benefit of the neo-adjuvant regimens on the rate of sphincter saving surgery. There was a reduction in the risk of 5-year local recurrence partly due to these neo-adjuvant treatments. These neo-adjuvant regimens had no significant impact on the overall 5-year survival. None of the neo-adjuvant treatments tested was able to demonstrate an increase in the rate of sphincter saving surgery. The improvement in conservative surgery is mainly due to technical changes in surgery. Organ preservation after complete clinical response appears as an interesting hypothesis to test. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  12. Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

    Science.gov (United States)

    Bridoux, Valérie; Moutel, Grégoire; Schwarz, Lilian; Michot, Francis; Herve, Christian; Tuech, Jean-Jacques

    2014-10-01

    Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p journal being ICMJE-affiliated (49.3 vs 40 %; p journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001). Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

  13. Long-term results of surgery for lumbar spinal stenosis: a randomised controlled trial.

    Science.gov (United States)

    Slätis, Pär; Malmivaara, Antti; Heliövaara, Markku; Sainio, Päivi; Herno, Arto; Kankare, Jyrki; Seitsalo, Seppo; Tallroth, Kaj; Turunen, Veli; Knekt, Paul; Hurri, Heikki

    2011-07-01

    We randomised a total of 94 patients with long-standing moderate lumbar spinal stenosis (LSS) into a surgical group and a non-operative group, with 50 and 44 patients, respectively. The operative treatment comprised undercutting laminectomy of stenotic segments, augmented with transpedicular-instrumented fusion in suspected lumbar instability. The primary outcome was the Oswestry disability index (ODI), and the other main outcomes included assessments of leg and back pain and self-reported walking ability, all based on questionnaire data from 85 patients at the 6-year follow-up. At the 6-year follow-up, the mean difference in ODI in favour of surgery was 9.5 (95% confidence interval 0.9-18.1, P-value for global difference 0.006), whereas the intensity of leg or back pain did not differ between the two treatment groups any longer. Walking ability did not differ between the treatment groups at any time. Decompressive surgery of LSS provided modest but consistent improvement in functional ability, surpassing that obtained after non-operative measures.

  14. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial

    Directory of Open Access Journals (Sweden)

    Shiv Akshat

    2014-01-01

    Full Text Available Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated with many side effects including respiratory depression, sedation, postoperative nausea vomiting, and pruritus. Nalbuphine, on the other hand, is known to cause less respiratory depression. Thus this study was undertaken to compare the intraoperative and postoperative analgesic efficacy and side effect profile of the two drugs. Methodology. 60 patients undergoing open gynaecological surgery were randomized to receive either morphine (Group M or nalbuphine (Group N in the intraoperative and postoperative period. Intraoperative analgesic efficacy (measured by need for rescue analgesics, postoperative pain by visual analogue scale, and side effects like postoperative nausea, vomiting, sedation, respiratory depression, and pruritus were compared in both groups. Intraoperative and postoperative heart rate and blood pressure were also compared between the groups. Results. Need for intraoperative analgesia was significantly more in Group N (P=0.023. Postoperative VAS scores were significantly different between the groups at various time points; however, none of the patients required any rescue analgesia. The incidence of various side effects was not significantly different between the groups. The haemodynamic profile of patients was comparable between the groups in both intraoperative and postoperative period. Conclusion. Nalbuphine provides less effective intraoperative analgesia than morphine in patients undergoing open gynaecological surgery under general anaesthesia. Both drugs, however, provided similar postoperative analgesia and had similar haemodynamic and side effect profile.

  15. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  16. Fracture surgery of the extremities with the intra-operative use of 3D-RX: a randomized multicenter trial (EF3X-trial).

    Science.gov (United States)

    Beerekamp, M Suzan H; Ubbink, Dirk Th; Maas, Mario; Luitse, Jan Sk; Kloen, Peter; Blokhuis, Taco Jm; Segers, Michiel Jm; Marmor, Meir; Schep, Niels Wl; Dijkgraaf, Marcel Gw; Goslings, J Carel

    2011-07-06

    Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed.Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated.The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1) the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2) The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years) with a traumatic intra-articular fracture of the wrist, ankle or calcaneus eligible for surgery will be

  17. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vonk Noordegraaf Antonie

    2012-02-01

    Full Text Available Abstract Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR: NTR2087

  18. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Tyler, Matthew A; Lam, Kent; Ashoori, Faramarz; Cai, Chunyan; Kain, Joshua J; Fakhri, Samer; Citardi, Martin J; Cattano, Davide; Luong, Amber

    2017-08-01

    Intravenous acetaminophen is a commonly prescribed analgesic for the prevention and treatment of postsurgical pain. Its efficacy in the context of endoscopic sinus surgery (ESS) has yielded mixed results. To compare the efficacy of perioperative intravenous acetaminophen (IVAPAP) with that of placebo in improving early postoperative pain after endoscopic sinus surgery (ESS). A prospective, randomized clinical trial including 62 patients undergoing ESS for chronic rhinosinusitis in a single tertiary referral hospital. Participants were randomized to receive 1 g of IVAPAP or 100 mL of placebo consisting of saline infusions immediately before the start of surgery and 4 hours after the initial dose. The primary outcome was postoperative pain measured by visual analog scale (VAS) scores up to 24 hours after surgery by blinded observers. Secondary endpoints included postoperative opioid (intravenous and oral) use and adverse events in the 24-hour postoperative period. Of the 62 enrolled adult participants, 60 were randomized (31 to IVAPAP intervention and 29 to placebo). The mean (SD) age of participants was 53.7 (14.7) years and 35 (58%) of the participants were men and 25 (42%) were women. Within the first hour, mean pain scores were reduced in the IVAPAP group compared with the control group, reaching a maximum difference of 7.7 mm on a VAS scale favoring the treatment group with a true difference possibly as high as 22 mm, and the data are compatible with a clinically meaningful difference. At 12- and 24-hours, average pain scores were less in the placebo group and the data are compatible with a clinically meaningful difference of 5.8 (-5.2 to 16.8) and 8.2 (-1.9 to 18.4), respectively, favoring the placebo group. However, at all time points the CIs included the null value and were wide, thus preventing definitive conclusions. Inspection of the secondary outcomes favored IVAPAP, but the wide range of the CIs and inclusion of the null value prevent definitive

  19. Preoperative use of pregabalin for acute pain in spine surgery: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jiang, Hai-Liang; Huang, Shuang; Song, Jiang; Wang, Xiang; Cao, Zhong-Shu

    2017-03-01

    We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of pregabalin for pain management following spine surgery. In September 2016, a systematic computer-based search was conducted in PubMed, EMBASE, Web of Science, and Cochrane Database of Systematic Reviews. RCTs of patients prepared for spine surgery that compared pregabalin with placebo were retrieved. The primary endpoint was the VAS score with rest or mobilization at 12 hours, 24 hours, and 48 hours and cumulative morphine consumption at 24 hours and 48 hours. The secondary outcomes were complications of nausea, sedation, dizziness, headache, and visual disturbances. After testing for publication bias and heterogeneity between studies, data were aggregated for random-effects models when necessary. Ten clinical studies with 535 patients (pregabalin group = 294, control group = 241) were included in the meta-analysis. Pregabalin was associated with reduced pain scores at 12 hours, 24 hours, and 48 hours, corresponding to a reduction of 1.91 points (95% CI, -4.07 to 0.24 point) at 12 hours, 2.66 points (95% CI, -4.51 to -0.81 point) at 24 hours, and 4.33 points (95% confidence interval, -6.38 to -2.99 point) at 48 hours on a 100-point numeric rating scale. There was no significant difference between VAS scores with mobilization at 12 hours, 24 hours, or 48 hours. Similarly, pregabalin was associated with a reduction in cumulative morphine consumption at 24 hours (-7.07, 95% CI -9.84, -4.30) and 48 hours (-6.52, 95% CI -7.78, -5.25, P = 0.000). Furthermore, pregabalin can reduce the occurrence of nausea (RR 0.57, 95% CI 0.41, 0.79, P = 0.001, number needed to treat = 8.4). There were no significant differences in the occurrence of sedation, dizziness, headache, or visual disturbances. Preoperative use of pregabalin was efficacious in reduction of postoperative pain, total morphine

  20. Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery

    DEFF Research Database (Denmark)

    Vedel, Anne G.; Holmgaard, Frederik; Rasmussen, Lars Simon

    2016-01-01

    Background: Debilitating brain injury occurs in 1.6–5 % of patients undergoing cardiac surgery with cardiopulmonary bypass. Diffusion-weighted magnetic resonance imaging studies have reported stroke-like lesions in up to 51 % of patients after cardiac surgery. The majority of the lesions seem...... to be caused by emboli, but inadequate blood flow caused by other mechanisms may increase ischaemia in the penumbra or cause watershed infarcts. During cardiopulmonary bypass, blood pressure can be below the lower limit of cerebral autoregulation. Although much debated, the constant blood flow provided...... by the cardiopulmonary bypass system is still considered by many as appropriate to avoid cerebral ischaemia despite the low blood pressure. Methods/design: The Perfusion Pressure Cerebral Infarct trial is a single-centre superiority trial with a blinded outcome assessment. The trial is randomising 210 patients...

  1. Shortening cardioplegic arrest time in patients undergoing combined coronary and valve surgery: results from a multicentre randomized controlled trial: the SCAT trial.

    Science.gov (United States)

    Rogers, Chris A; Capoun, Radek; Scott, Lauren J; Taylor, Jodi; Jain, Anil; Angelini, Gianni D; Narayan, Pradeep; Suleiman, M-Saadeh; Sarkar, Kunal; Ascione, Raimondo

    2017-08-01

    Combined coronary artery bypass grafting and valve surgery requires a prolonged period of cardioplegic arrest (CA) predisposing to myocardial injury and postoperative cardiac-specific complications. The aim of this trial was to reduce the CA time in patients undergoing combined coronary artery bypass grafting and valve surgery and assess if this was associated with less myocardial injury and related complications. Participants were randomized to (i) coronary artery bypass grafting performed on the beating heart with cardiopulmonary bypass support followed by CA for the valve procedure (hybrid) or (ii) both procedures under CA (conventional). To assess complications related to myocardial injury, we used the composite of death, myocardial infarction, arrhythmia, need for pacing or inotropes for >12 h. To assess myocardial injury, we used serial plasma troponin T and markers of metabolic stress in myocardial biopsies. Hundred and sixty patients (80 hybrid and 80 conventional) were randomized. Mean age was 66.5 years and 74% were male. Valve procedures included aortic (61.8%) and mitral (33.1%) alone or in combination (5.1%). CA time was 16% lower in the hybrid group [median 98 vs 89 min, geometric mean ratio (GMR) 0.84, 95% confidence interval (CI) 0.77-0.93, P  = 0.0004]. Complications related to myocardial injury occurred in 131/160 patients (64/80 conventional, 67/80 hybrid), odds ratio 1.24, 95% CI 0.54-2.86, P  = 0.61. Release of troponin T was similar between groups (GMR 1.04, 95% CI 0.87-1.24, P  = 0.68). Adenosine monophosphate was 28% lower in the hybrid group (GMR 0.72, 95% CI 0.51-1.02, P  = 0.056). The hybrid procedure reduced the CA time but myocardial injury outcomes were not superior to conventional approach. ISRCTN65770930.

  2. Osteopathic Manipulative Treatment Improves Heart Surgery Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Racca, Vittorio; Bordoni, Bruno; Castiglioni, Paolo; Modica, Maddalena; Ferratini, Maurizio

    2017-07-01

    Controlling sternal pain after heart surgery is important to reduce the risk of postoperative complications, but pain is often undertreated because of contraindications and side effects of analgesic drugs. Recently, osteopathic manipulative treatment (OMT) was demonstrated to reduce pain in different clinical contexts, suggesting its potential utility after cardiac surgery. The aim of this open-label, controlled study is to assess whether OMT contributes to sternal pain relief and improves postoperative outcomes. Eighty post-sternotomy adult inpatients were randomly allocated one to one to receive a standardized cardiorespiratory rehabilitation program alone (control group) or combined with OMT. Pain intensity and respiratory functional capacity were quantified by the Visual Analogue Scale score and by a standardized breathing test, at the start and end of rehabilitation. At the start of rehabilitation, the control group and the OMT group had similar Visual Analogue Scale median scores (controls 4, interquartile range [IQR]: 2 to 5; OMT 4, IQR: 3 to 5; p = not significant) and mean inspiratory volumes (controls 825 ± 381 mL; OMT 744 ± 291 mL; p = not significant). At the end of rehabilitation, the OMT group had a lower Visual Analogue Scale median score (controls 3, IQR: 2 to 4; OMT 1, IQR: 1 to 2; p < 0.01) and higher mean inspiratory volume (controls 1,400 ± 588 mL; OMT 1,781 ± 633 mL; p < 0.01). The analgesic drug intake was similar in the two groups. The hospitalization was shorter in the OMT group than in the control group (19.1 ± 4.8 versus 21.7 ± 6.3 days; p < 0.05). The combination of standard care with OMT is effective in inducing pain relief and functional recovery, and significantly improves the management of patients after heart surgery with sternotomy. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  3. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

    DEFF Research Database (Denmark)

    Skou, Søren Thorgaard; Lind, Martin; Hölmich, Per

    2017-01-01

    adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. METHODS AND ANALYSIS......: This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18-40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon...... will be randomly allocated to one of two groups (1:1 ratio). Participants randomised to surgery will undergo either arthroscopic partial meniscectomy or meniscal repair followed by standard postsurgical care, while participants allocated to exercise and education will undergo a 12-week individualised, supervised...

  4. Cardioprotection of Electroacupuncture for Enhanced Recovery after Surgery on Patients Undergoing Heart Valve Replacement with Cardiopulmonary Bypass: A Randomized Control Clinical Trial

    Directory of Open Access Journals (Sweden)

    Fangxiang Zhang

    2017-01-01

    Full Text Available We attempted to investigate cardioprotection of electroacupuncture (EA for enhanced recovery after surgery on patients undergoing heart valve replacement with cardiopulmonary bypass. Forty-four patients with acquired heart valve replacement were randomly allocated to the EA group or the control group. Patients in the EA group received EA stimulus at bilateral Neiguan (PC6, Ximen (PC4, Shenting (GV24, and Baihui (GV20 acupoints twenty minutes before anesthesia induction to the end of surgery. The primary end point was cardioprotection effect of electroacupuncture postoperatively and the secondary endpoints were quality of recovery and cognitive functioning postoperatively. The present study demonstrated that electroacupuncture reduced the occurrence of complications and played a role of cardioprotective effect on patients after heart valve replacement surgery with cardiopulmonary bypass, and it benefits patients more comfortable and contributes to recovery after surgery. This trial is registered with ChiCTR-IOC-16009123.

  5. Immunostimulation to reduce recurrence after surgery for anal condyloma acuminata: a prospective randomized controlled trial.

    Science.gov (United States)

    Mistrangelo, M; Cornaglia, S; Pizzio, M; Rimonda, R; Gavello, G; Dal Conte, I; Mussa, A

    2010-08-01

    Human papillomavirus is the most common cause of sexually transmitted disease. It is associated with immunosuppression and shows a marked tendency to recur. We investigated a natural immunostimulant aimed to reduce recurrence. A randomized controlled study was carried out including 261 patients allocated to surgical excision alone (control group; n = 122) and surgical excision plus postoperative immunostimulation for 30 days with a natural product (STET; study group; n = 139). Patients with HIV positivity were excluded. All patients gave fully informed consent. The patients were followed for 6 months after surgery. Recurrence occurred in 7.2% (10/139) in the study group and in 27.1% (33/122) in the control group (P sexual orientation, number of lesions, time to diagnosis and treatment or localization of lesions in the two groups. Immunostimulation using a natural product significantly reduced the incidence of recurrence of anal condylomata in patients undergoing surgical excision.

  6. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial

    DEFF Research Database (Denmark)

    Larsen, Christian R; Soerensen, Jette L; Grantcharov, Teodor P

    2009-01-01

    -14 minutes) and in the control group was 24 (20-29) minutes (Pincreased in a clinically relevant manner using proficiency based virtual reality simulator training. The performance level of novices......OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising...... in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee...

  7. Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I and in patients with genital prolapse and occult stress incontinence (CUPIDO II

    Directory of Open Access Journals (Sweden)

    van der Vaart Huub

    2010-05-01

    Full Text Available Abstract Background About 40% of all patients with genital prolapse report stress-incontinence. In about half of the 60% patients that do not report stress-incontinence, occult urinary stress-incontinence can be detected. In these patients stress-incontinence is masked due to kinking or compression of the urethra by the prolapse. In case surgical correction is indicated there are two strategies to manage patients with combined prolapse and (occult stress incontinence. This strategy is either (i a combination of prolapse surgery and stress-incontinence surgery or (ii to correct the prolapse first and evaluate afterwards whether additional stress-incontinence surgery is indicated. The advantage of combining prolapse and stress-incontinence surgery is that only few patients report stress-incontinence following such combination. However, this combination has been associated with an increased risk on complications, of which the development of obstructive micturition symptoms, overactive bladder symptoms and bladder retention are the most important ones. Furthermore, combining two procedures may be unnecessary as performing only prolapse surgery may cure stress-incontinence In the randomized CUPIDO trials both strategies are compared in patients with prolapse and evident stress incontinence (CUPIDO I trial and in patients with prolapse and occult stress incontinence (CUPIDO II trial. Methods/Design The CUPIDO trials are two multicenter randomized controlled trials in which women with stress urinary incontinence (SUI or occult stress urinary incontinence (OSUI are randomized to prolapse surgery combined with anti incontinence surgery (concomitant surgery or to prolapse surgery only. Patients with at least stage 2 POP are eligible, women with evident SUI are randomized in CUPIDO I. Patients without SUI are eligible for CUPIDO II and will have urodynamic evaluation or a standardized redression test. Women with OSUI are randomized, women without OSUI are

  8. The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trial controlled trial

    Directory of Open Access Journals (Sweden)

    Tharanon C

    2016-08-01

    Full Text Available Chantip Tharanon, Kovit Khampitak Department of Obstetrics and Gynecology, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand Objectives: To compare the effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery and the amount of postoperative analgesic dosage.Methods: The trial included 45 females who had undergone operations during the period December 2014 to October 2015. The patients were block randomized based on operating time (<2 and ≥2 hours. The intervention group (n=23 was treated with postoperative intraperitoneal gas drain and the control group (n=22 was not. The mean difference in scores for shoulder, epigastric, suprapubic, and overall pain at 6, 24, 48 hours postoperatively were statistically evaluated using mixed-effect restricted maximum likelihood regression. The differences in the analgesic drug usage between the groups were also analyzed using a Student’s t-test. The data were divided and analyzed to two subgroups based on operating time (<2 hours, n=20; and ≥2 hours, n=25.Results: The intervention had significantly lower overall pain than the control group, with a mean difference and 95% confidence interval at 6, 24, and 48 hours of 2.59 (1.49–3.69, 2.23 (1.13–3.34, and 1.48 (0.3–2.58, respectively. Correspondingly, analgesic drug dosage was significantly lower in the intervention group (3.52±1.47 mg vs 5.72±2.43 mg, P<0.001. The three largest mean differences in patients with operating times of ≥2 hours were in overall pain, suprapubic pain at 6 hours, and shoulder pain at 24 hours at 3.27 (1.14–5.39, 3.20 (1.11–5.26, and 3.13 (1.00–5.24, respectively. These were greater than the three largest mean differences in the group with operating times of <2 hours, which were 2.81 (1.31–4.29, 2.63 (0.51–4.73, and 2.02 (0.68–3.36. The greatest analgesic drug requirement was in the control group with a longer operative time.Conclusion: The use of

  9. [Macula analysis by spectral domain OCT in rhegmatogenous retinal detachment surgery].

    Science.gov (United States)

    Zghal, I; Zgolli, H; Fekih, O; Chebbi, A; Bouguila, H; Nacef, L

    2015-03-01

    Despite surgical reattachment of retinal layers, postoperative functional outcomes after rhegmatogenous retinal detachment (RRD) may be limited. This can be explained by microstructural changes in the macula inherent to the pathology itself as well as the surgery. To evaluate the various changes in the macula by OCT pre- and postoperatively, and correlate them with functional and clinical outcomes in patients with RRD. To establish pre- and postoperative prognostic factors. This was a prospective study of 50 eyes of 50 patients operated for RDD. Each patient underwent a complete clinical examination and macular OCT using the Heidelberg Spectralis; preoperatively and then successively at 7 days, 1 month, 3 months and 6 months after RRD surgery. Preoperative tomographic results revealed an average height of submacular fluid of 742 ± 345 μm. Ninety-six percent of patients exhibited thickening of photoreceptor outer segments (PROS), 62% an outer layer undulation, 60% cystic cavities in the outer and/or inner nuclear layers (ONL, INL), 36% disruptions of the external limiting membrane (ELM) and 64% disruption of the IS/OS junction. Postoperatively, 24% of patients had persistent submacular fluid. The average thickness of the central fovea, the ONL, the IS/OS junction and the PROS were 172 ± 51.3 μm, 88.4 ± 30.9 μm, 11.36 ± 5.4 μm and 19.54 ± 13.1 μm respectively. Postoperative disruptions of the ELM, the IS/OS junction and Verhoeff's membrane (VM) were present in 24%, 60% and 82% of patients respectively. The preoperative tomographic risk factors for poor visual outcome were: submacular fluid height > 800 μm (P<0.001), disruptions of the MLE and/or IS/OS junction (P<0.001), as well as cystic cavities in the ENL and/or INL (P=0.002). Postoperative risk factors were: thinning of the fovea (≤ 250 μm), central fovea (≤ 160 μm), ONL (≤ 90 μm), IS/OS junction (≤ 10 μm) and PROS (≤ 18 μm) layers (P<0.001), as well as a discontinuous or absent

  10. Evaluation of computer-assisted mandibular reconstruction with vascularized iliac crest bone graft compared to conventional surgery: a randomized prospective clinical trial

    Science.gov (United States)

    2014-01-01

    Background Computer-assisted surgery plays an increasingly important role in mandibular reconstruction, ensuring the best possible masticatory function and aesthetic outcome. Methods Twenty patients were randomly assigned to computer-assisted or conventional mandibular reconstruction with vascularized iliac crest bone graft in a prospective study design. Virtual surgical planning was based on preoperative CT-data using specific surgical planning software. A rapid prototyping guide transferred the virtual surgery plan to the operation site. During surgery the transplant ischemic time, reconstruction time, time for shaping the transplant and amount of bone removed were measured. Additionally, the difference in the intercondylar distance before and after surgery was calculated. Results Computer-assisted surgery shortened the time of transplant ischemia (P < 0.005) and defect reconstruction (P < 0.001) compared to conventional surgery. The time to saw and shape the transplant at the donor site was shorter using conventional surgery (P < 0.005); therefore, the overall time for surgery didn’t change (P = 0.527). In the computer-assisted group, the amount of bone harvested equaled the defect size, whereas the transplant size in the conventional group exceeded the defect site by 16.8 ± 5.6 mm (P < 0.001) on average. The intercondylar distance before compared to after surgery was less affected in the computer-assisted than in the conventional group (P < 0.001). Conclusions The presented study shows that computer-assisted surgery can help reduce the time for mandibular defect reconstruction and consequently the transplant ischemic time. In the computer-assisted group, the iliac crest donor site defect was downsized and the postoperative condyle position was less altered, reducing possible risks of postoperative complications and donor site morbidity. Trial Registration DRKS00005181. PMID:24716651

  11. Surgery is more cost-effective than splinting for carpal tunnel syndrome in the Netherlands: results of an economic evaluation alongside a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adèr Herman J

    2006-11-01

    Full Text Available Abstract Background Carpal tunnel syndrome (CTS is a common disorder, often treated with surgery or wrist splinting. The objective of this economic evaluation alongside a randomized trial was to evaluate the cost-effectiveness of splinting and surgery for patients with CTS. Methods Patients at 13 neurological outpatient clinics with clinically and electrophysiologically confirmed idiopathic CTS were randomly allocated to splinting (n = 89 or surgery (n = 87. Clinical outcome measures included number of nights waking up due to symptoms, general improvement, severity of the main complaint, paraesthesia at night and during the day, and utility. The economic evaluation was performed from a societal perspective and involved all relevant costs. Results There were no differences in costs. The mean total costs per patient were in the surgery group EURO 2,126 compared to EURO 2,111 in the splint group. After 12 months, the success rate in the surgery group (92% was significantly higher than in the splint group (72%. The acceptability curve showed that at a relatively low ceiling ratio of EURO 2,500 per patient there is a 90% probability that surgery is cost-effective. Conclusion In the Netherlands, surgery is more cost-effective compared with splinting, and recommended as the preferred method of treatment for patients with CTS.

  12. The Prevention of Respiratory Insufficiency after Surgical Management (PRISM) Trial. Report of the protocol for a pragmatic randomized controlled trial of CPAP to prevent respiratory complications and improve survival following major abdominal surgery.

    Science.gov (United States)

    Pearse, Rupert M; Abbott, Tom E; Haslop, Richard; Ahmad, Tahania; Kahan, Brennan C; Filipini, Claudia; Rhodes, Andrew; Ranieri, Marco

    2017-02-01

    Over 300 million patients undergo surgery worldwide each year. Postoperative morbidity - particularly respiratory complications - are most frequent and severe among high-risk patients undergoing major abdominal surgery. However, standard treatments, like physiotherapy or supplemental oxygen, often fail to prevent these. Preliminary research suggests that prophylactic continuous positive airways pressure (CPAP) can reduce the risk of postoperative respiratory complications. However, without evidence from a large clinical effectiveness trial, CPAP has not become routine care. This trial aims to determine whether early postoperative CPAP reduces the incidence of respiratory complications and improves one-year survival following major intra-peritoneal surgery. This is an international multicenter randomized controlled trial with open study group allocation. The participants are aged 50 years and over undergoing major elective intra-peritoneal surgery. The intervention is CPAP for at least four hours, started within four hours of the end of surgery. The primary outcome is a composite of pneumonia, re-intubation, or death within 30 days of randomization. All participants with a recorded outcome will be analyzed on an intention-to-treat basis. The primary analysis will use a mixed-effects logistic regression model, which includes center as a random-intercept, and will be adjusted for the minimization factors and other pre-specified covariates. Trial Registration: ISRCTN 56012545. This is the first proposed clinical effectiveness trial of postoperative CPAP to prevent respiratory complications of which we are aware. The large sample size and multicenter international design will make the result generalizable to a variety of healthcare settings.

  13. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kaulhausen Thomas

    2011-10-01

    Full Text Available Abstract Background Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD. To date, there is no convincing evidence that these devices provide any patient benefits. Methods/Design The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off". Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually. Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI. In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration, postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided. Discussion New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these

  14. Trial of everolimus-eluting stents or bypass surgery for coronary disease.

    Science.gov (United States)

    Park, Seung-Jung; Ahn, Jung-Min; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Choo, Suk Jung; Chung, Cheol Hyun; Lee, Jae Won; Cohen, David J; Yeung, Alan C; Hur, Seung Ho; Seung, Ki Bae; Ahn, Tae Hoon; Kwon, Hyuck Moon; Lim, Do-Sun; Rha, Seung-Woon; Jeong, Myung-Ho; Lee, Bong-Ki; Tresukosol, Damras; Fu, Guo Sheng; Ong, Tiong Kiam

    2015-03-26

    Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

  15. Epilepsy surgery and meaningful improvements in quality of life: results from a randomized controlled trial.

    Science.gov (United States)

    Fiest, Kirsten M; Sajobi, Tolulope T; Wiebe, Samuel

    2014-06-01

    We examine improvement and worsening in quality of life (QOL) in terms of proportions achieving minimum clinically important change (MCID), and factors related to MCID, in patients with temporal lobe epilepsy randomized to medical or surgical treatment. Eighty patients with temporal lobe epilepsy randomized to surgical (n(1) = 40) or medical (n(2) = 40) therapy were followed for 12 months, reporting QOL at baseline, and at 6 and 12 months. Previously established thresholds for MCID across various general and epilepsy-specific QOL instruments were used to determine meaningful improvement (positive MCID) or worsening (negative MCID). Generalized linear mixed-effects models were used to compare MCID in both groups. At 6 months, 56.0% of patients in the surgical group achieved positive MCID on the Quality of Life in Epilepsy (QOLIE)-89, as compared to 11.0% of those in the medical group (p MCID (p < 0.001). Substantially more medically treated patients exhibited clinically significant worsening in QOL, as compared with those surgically treated. The respective medical versus surgical proportions with worsening were 36.67% versus 13.8% in QOLIE31, 20% versus 15% in Health Utility Index-III (HUI-III), and 30% versus 19% in Short Form-36 (SF-36) Mental Composite Score (MCS). The number of patients who need to undergo surgery for one additional person to have a meaningful improvement in the QOLIE-31 is two (number needed to treat = 2). The results also favored surgery using the generic HUI-III instrument, but not with the mental of physical function subscales of the SF-36. Significantly more patients in the surgical group achieved meaningful improvement in epilepsy-specific measures of QOL at 6 and 12 months compared to those in the medical group. Substantially more patients in the medical therapy group exhibited clinically significant worsening in their QOL assessed with epilepsy-specific and generic instruments. A PowerPoint slide summarizing this article is available for

  16. A RANDOMIZED CLINICAL TRIAL ON THE ANTI - INFLAMATORY EFFECT OF INTRACAMERAL LOW MOLECULAR WE HEPARIN (ENOXAPAIN IN DIABETIC CATARACT SURGERY

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    Shivanand

    2015-08-01

    Full Text Available AIM: To study the effect intracameral low molecular weight on postoperative inflammation after cataract surgery in diabetic patients. SETTING: Department of Ophtha lmology J. N. Medical College. Belgaum. DESIGN: Randomized control trial . MATERIAL AND METHODS: Forty patients with diabetes undergoing small incision cataract surgery with posterior chamber intraocular lens (IOL implantation were randomly assigned to two groups, group A and group B. All patients in g roup A received low molecular weight heparin (enoxaparin in the concentration of 40 IU in 500ml in the irrigating solution and patients in group B received irrigating solution without low molecular weight heparin. In all patients polymethyl methacrylate ( PMMA IOLs were implanted. The patients were examined postoperatively on day 1, day 7, day 30 and day 60 for anterior chamber cells and flare and iris pigments on cell by slit lamp biomicroscopy. RESULTS: A statistically significant reduction in postoperat ive cells, flare and intraocular lens surface pigments was noted in group with addition of low molecular weight heparin (enoxaparin at day 1(p0.001 and 1 week (p<0.001. At 4 weeks and 8 weeks no statistically significant reduction in post - operative cell s and flare was seen between the two groups but there was a significant reduction in the intraocular lens pigments in the group with addition of low molecular weight heparin (enoxaparin. CONCLUSION: Intraoperative use of low molecular weight heparin (enox aparin reduced disturbance in the blood - aq ueous barrier in the early post - operative period evidenced by lower postoperative anterior chamber cells and flare, and also reduced iris pigments on the intraocular lens. At 8 weeks cells and flare in both the gr oups did not show significant difference.

  17. Distal rectus femoris transfer as part of multilevel surgery in children with spastic diplegia--a randomized clinical trial.

    Science.gov (United States)

    Dreher, Thomas; Götze, Marco; Wolf, Sebastian I; Hagmann, Sebastién; Heitzmann, Daniel; Gantz, Simone; Braatz, Frank

    2012-06-01

    The evidence in support of distal rectus femoris transfer (DRFT) as part of single-event multilevel surgery (SEMLS) is limited due to inconsistent outcome reports and a lack of randomized studies. The purpose of this prospective randomized trial was to establish whether the results of SEMLS without DRFT are similar to those of a conventional approach that includes DRFT in the SEMLS. In all, 32 children with spastic diplegia (GMFCS I-III) and an indication for DRFT were recruited and randomized into a DRFT (15 children) and a NON-DRFT group (17 children) using a minimization method. During SEMLS, bilateral DRFT was performed only in the DRFT group. Three-dimensional gait analysis and clinical examination were performed before and 1 year after surgery. In both groups a significant increase in range of motion during swing and knee flexion velocity were found, which was significantly higher in the DRFT group. While peak knee flexion in swing (pKFSw) was preserved in the DRFT group and significantly decreased in the NON-DRFT group, pKFSw timing was significantly earlier in both groups. The clinical relevance of the higher overall benefits in the DRFT group is limited, considering that 33% of patients in this group did not benefit from the procedure. Furthermore, 53% of the NON-DRFT patients did not undergo what proved to be an unnecessary DRFT. Subgroup analysis showed benefits for patients with decreased pKFSw, while those with severe flexed-knee gait (normal or increased pKFSw) did not profit from DRFT. This may explain the inconsistent overall results, and DRFT is therefore not recommended as a "prophylactic" procedure in patients with severe flexed-knee gait. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Protocol for enhanced recovery after surgery improves short-term outcomes for patients with gastric cancer: a randomized clinical trial.

    Science.gov (United States)

    Tanaka, Ryo; Lee, Sang-Woong; Kawai, Masaru; Tashiro, Keitaro; Kawashima, Satoshi; Kagota, Syuji; Honda, Kotaro; Uchiyama, Kazuhisa

    2017-09-01

    The feasibility of the use of the enhanced recovery after surgery (ERAS) protocol in patients with gastric cancer remains unclear. This study was a single-center, prospective randomized trial involving patients with gastric cancer undergoing curative gastrectomy. The primary end point was the length of postoperative hospital stay. Secondary end points were the postoperative complication rate, admission costs, weight loss, and amount of physical activity. From July 2013 to June 2015, we randomized 148 patients into an ERAS protocol group (n = 73) and a conventional protocol group (n = 69); six patients withdrew from the study. The hospital stay was significantly shorter in the ERAS protocol group than in the conventional protocol group (9 days vs 10 days; P = 0.037). The ERAS protocol group had a significantly lower rate of postoperative complications of grade III or higher (4.1% vs 15.4%; P = 0.042) and reduced costs of hospitalization (JPY 1,462,766 vs JPY 1,493,930; P = 0.045). The ratio of body weight to preoperative weight at 1 week and 1 month after the operation was higher in the ERAS protocol group (0.962 vs 0.957, P = 0.020, and 0.951 vs 0.937, P = 0.021, respectively). The ERAS protocol group recorded more physical activity in the first week after surgery. The ERAS protocol is safe and efficient, and seems to improve the postoperative course of patients with gastric cancer.

  19. Hypotonic versus isotonic maintenance fluids after surgery for children: a randomized controlled trial.

    Science.gov (United States)

    Choong, Karen; Arora, Steve; Cheng, Ji; Farrokhyar, Forough; Reddy, Desigen; Thabane, Lehana; Walton, J Mark

    2011-11-01

    The objective of this randomized controlled trial was to evaluate the risk of hyponatremia following administration of a isotonic (0.9% saline) compared to a hypotonic (0.45% saline) parenteral maintenance solution (PMS) for 48 hours to postoperative pediatric patients. Surgical patients 6 months to 16 years of age with an expected postoperative stay of >24 hours were eligible. Patients with an uncorrected baseline plasma sodium level abnormality, hemodynamic instability, chronic diuretic use, previous enrollment, and those for whom either hypotonic PMS or isotonic PMS was considered contraindicated or necessary, were excluded. A fully blinded randomized controlled trial was performed. The primary outcome was acute hyponatremia. Secondary outcomes included severe hyponatremia, hypernatremia, adverse events attributable to acute plasma sodium level changes, and antidiuretic hormone levels. A total of 258 patients were enrolled and assigned randomly to receive hypotonic PMS (N = 130) or isotonic PMS (N = 128). Baseline characteristics were similar for the 2 groups. Hypotonic PMS significantly increased the risk of hyponatremia, compared with isotonic PMS (40.8% vs 22.7%; relative risk: 1.82 [95% confidence interval: 1.21-2.74]; P = .004). Admission to the pediatric critical care unit was not an independent risk factor for the development of hyponatremia. Isotonic PMS did not increase the risk of hypernatremia (relative risk: 1.30 [95% confidence interval: 0.30-5.59]; P = .722). Antidiuretic hormone levels and adverse events were not significantly different between the groups. Isotonic PMS is significantly safer than hypotonic PMS in protecting against acute postoperative hyponatremia in children.

  20. Association Between Flexible Duty Hour Policies and General Surgery Resident Examination Performance: A Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Analysis.

    Science.gov (United States)

    Blay, Eddie; Hewitt, D Brock; Chung, Jeanette W; Biester, Thomas; Fiore, James F; Dahlke, Allison R; Quinn, Christopher M; Lewis, Frank R; Bilimoria, Karl Y

    2017-02-01

    Concerns persist about the effect of current duty hour reforms on resident educational outcomes. We investigated whether a flexible, less-restrictive duty hour policy (Flexible Policy) was associated with differential general surgery examination performance compared with current ACGME duty hour policy (Standard Policy). We obtained examination scores on the American Board of Surgery In-Training Examination, Qualifying Examination (written boards), and Certifying Examination (oral boards) for residents in 117 general surgery residency programs that participated in the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Using bivariate analyses and regression models, we compared resident examination performance across study arms (Flexible Policy vs Standard Policy) for 2015 and 2016, and 1 year of the Qualifying Examination and Certifying Examination. Adjusted analyses accounted for program-level factors, including the stratification variable for randomization. In 2016, FIRST trial participants were 4,363 general surgery residents. Mean American Board of Surgery In-Training Examination scores for residents were not significantly different between study groups (Flexible Policy vs Standard Policy) overall (Flexible Policy: mean [SD] 502.6 [100.9] vs Standard Policy: 502.7 [98.6]; p = 0.98) or for any individual postgraduate year level. There was no difference in pass rates between study arms for either the Qualifying Examination (Flexible Policy: 90.4% vs Standard Policy: 90.5%; p = 0.99) or Certifying Examination (Flexible Policy: 86.3% vs Standard Policy: 88.6%; p = 0.24). Results from adjusted analyses were consistent with these findings. Flexible, less-restrictive duty hour policies were not associated with differences in general surgery resident performance on examinations during the FIRST Trial. However, more years under flexible duty hour policies might be needed to observe an effect. Copyright © 2016 American College of Surgeons

  1. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial.

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    Sonia Gaucher

    Full Text Available To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial.Multicenter, two-arm, parallel-group, open-label randomized controlled trial.11 university hospital ambulatory surgery units in Paris, France.Patients scheduled for ambulatory surgery and able to be reached by telephone.A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults, was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Rate of cancellation on the day of surgery or the day before.The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6% vs. 113 (5.8%, adjusted odds ratio [95% confidence interval] = 0.91 [0.65-1.29], (p = 0.57. Checklist administration revealed that 355 patients (28.0% had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0% still had questions concerning the fasting state.A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.ClinicalTrials.gov NCT01732159.

  2. Sleep study, respiratory mechanics, chemosensitive response and quality of life in morbidly obese patients undergoing bariatric surgery: a prospective, randomized, controlled trial

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    Leitao Filho Fernando SS

    2011-10-01

    Full Text Available Abstract Background Obesity is a major public health problem in both developed and developing countries alike and leads to a series of changes in respiratory physiology. There is a strong correlation between obesity and cardiopulmonary sleep disorders. Weight loss among such patients leads to a reduction in these alterations in respiratory physiology, but clinical treatment is not effective for a long period of time. Thus, bariatric surgery is a viable option. Methods/Design The present study involves patients with morbid obesity (BMI of 40 kg/m2 or 35 kg/m2 to 39.9 kg/m2 with comorbidities, candidates for bariatric surgery, screened at the Santa Casa de Misericórdia Hospital in the city of Sao Paulo (Brazil. The inclusion criteria are grade III morbid obesity, an indication for bariatric surgery, agreement to participate in the study and a signed term of informed consent. The exclusion criteria are BMI above 55 kg/m2, clinically significant or unstable mental health concerns, an unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment. Bariatric surgery candidates who meet the inclusion criteria will be referred to Santa Casa de Misericórdia Hospital and will be reviewed again 30, 90 and 360 days following surgery. Data collection will involve patient records, personal data collection, objective assessment of HR, BP, neck circumference, chest and abdomen, collection and analysis of clinical preoperative findings, polysomnography, pulmonary function test and a questionnaire on sleepiness. Discussion This paper describes a randomised controlled trial of morbidly obese patients. Polysomnography, respiratory mechanics, chemosensitive response and quality of life will be assessed in patients undergoing or not undergoing bariatric surgery. Trial Registration The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-9k9hhv.

  3. Intrathecal sufentanil versus fentanyl for lower limb surgeries - A randomized controlled trial

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    Poonam Motiani

    2011-01-01

    Full Text Available Background:To compare the efficacy and safety of intrathecal sufentanil or fentanyl as adjuvants to hyperbaric bupivacaine in patients undergoing major orthopaedic lower limb surgeries in terms of onset and duration of sensory block, motor block and post-operative pain relief. Patients & Methods: Ninety patients were recruited in this Prospective, randomized double blind study to receive either intrathecal sufentanil 5 μg (Group S, fentanyl 25 μg (Group F or normal saline 0.5 ml (Group C as adjuvants to 15 mg of 0.5% hyperbaric bupivacaine. The onset and duration of sensory and motor block were assessed intraoperatively. The pain scores were assessed postoperatively. Duration of complete and effective analgesia was recorded. The incidence of side effects such as nausea, vomiting, pruritus, shivering and PDPH was recorded. Results: The Demographic data, hemodynamic and respiratory parameters were comparable in the three groups. There was a significantly earlier onset and prolonged duration of sensory block in the sufentanil and fentanyl groups. The duration of complete and effective analgesia were also significantly prolonged in the fentanyl and sufentanil groups. Pruritus was noticed in the study groups (Groups S&F. Conclusions: Intrathecal sufentanil (5 μg and fentanyl (25 μg, as adjuvants lead to an earlier onset and prolonged duration of sensory block. The duration of effective analgesia with intrathecal sufentanil and fentanyl as adjuvants to hyperbaric bupivacaine is longer than that of bupivacaine alone.

  4. Bupivacaine as an Adjunct to Lidocaine in Mohs Micrographic Surgery: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Peggy; Smith, Harvey; Vinciullo, Carl

    2017-11-14

    In Mohs micrographic surgery (MMS), the standard local anesthetic agent used is lignocaine with adrenaline. However, MMS can be prolonged; thus reinjections of local anesthetics are often required. Is 0.5% bupivacaine with 1:200,000 epinephrine a useful adjunctive treatment when compared with the use of 1% lidocaine with 1:100,000 epinephrine in MMS for the nose? Participants undergoing MMS received 2.5 mL of 1% lidocaine with 1:100,000 epinephrine before commencement of Stage 1. At the end of Stage 1, participants were randomized sequentially to either 2.5 mL 0.5% bupivacaine with 1:200,000 epinephrine (Group A) or 2.5 mL of 1% lidocaine with 1:100,000 epinephrine (Group B). Effectiveness of anesthesia was assessed using 30 G needle to 5 points of the wound before further stage or repair. Fifty-one patients were randomized, 26 to Group A, and 25 to Group B. No differences between the 2 groups in size of defect and time lapse between time of injection and time of testing were observed. Seven of 25 were tested positive in Group B. Zero of 26 tested positive in Group A (p = .003, 95% confidence interval: 10%-46%). Adjunctive use of 0.5% bupivacaine with 1:200,000 epinephrine is effective in prolonging anesthesia in MMS.

  5. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Directory of Open Access Journals (Sweden)

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  6. Single-incision surgery trocar-site hernia: an updated systematic review meta-analysis with trial sequential analysis by the Minimally Invasive Surgery Synthesis of Interventions Outcomes Network (MISSION).

    Science.gov (United States)

    Antoniou, Stavros A; García-Alamino, Josep M; Hajibandeh, Shahab; Hajibandeh, Shahin; Weitzendorfer, Michael; Muysoms, Filip E; Granderath, Frank A; Chalkiadakis, George E; Emmanuel, Klaus; Antoniou, George A; Gioumidou, Meropi; Iliopoulou-Kosmadaki, Styliani; Mathioudaki, Maria; Souliotis, Kyriakos

    2017-07-19

    Single-incision laparoscopic surgery (SILS) is a new technique that aims to minimize abdominal wall trauma and improve cosmesis. Concerns have been raised about the risk of trocar-site hernia following SILS. This study aims to assess the risk of trocar-site hernia following SILS compared to conventional laparoscopic surgery, and investigate whether current evidence is conclusive. We performed a systematic search of MEDLINE, AMED, CINAHL, CENTRAL, and OpenGrey. We considered randomized clinical trials comparing the risk of trocar-site hernia with SILS and conventional laparoscopic surgery. Pooled odds ratios with 95% confidence intervals (CI) were calculated using the Mantel-Haenszel method. Trial sequential analysis using the Land and DeMets method was performed to assess the possibility of type I error and compute the information size. Twenty-three articles reporting a total of 2471 patients were included. SILS was associated with higher odds of trocar-site hernia compared to conventional laparoscopic surgery (odds ratio 2.37, 95% CI 1.25-4.50, p = 0.008). There was no evidence of between-study heterogeneity or small-study effects. The information size was calculated at 1687 patients and the Z-curve crossed the O'Brien-Fleming α-spending boundaries at 1137 patients, suggesting that the evidence of higher risk of trocar-site hernia with SILS compared to conventional laparoscopic surgery can be considered conclusive. Single-incision laparoscopic procedures through the umbilicus are associated with a higher risk of trocar-site hernia compared to conventional laparoscopic surgery.

  7. A randomized, blinded, multicenter trial of a gentamicin vancomycin gel (DFA-02) in patients undergoing abdominal surgery.

    Science.gov (United States)

    Bennett-Guerrero, Elliott; Berry, Scott M; Bergese, Sergio D; Fleshner, Phillip R; Minkowitz, Harold S; Segura-Vasi, Alvaro M; Itani, Kamal M F; Henderson, Karen W; Rackowski, Felicia P; Aberle, Laura H; Stryjewski, Martin E; Corey, G Ralph; Allenby, Kent S

    2017-06-01

    SI is a significant medical problem. DFA-02 is an investigational bioresorbable modified release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL). A Phase 2a study, where the drug was applied during surgical incision closure, suggested safety and tolerability but was not designed to assess its efficacy. In a Phase 2b randomized, blinded trial patients undergoing abdominal, primarily colorectal, surgery were randomized (4:1:1) to one of three study arms: DFA-02, matching placebo gel, or standard of care (SOC) involving irrigation of the wound with normal saline. The DFA-02 and placebo gel groups received up to 20 mL of study drug inserted above the fascia during wound closure, and were treated in a double-blind manner; the SOC group was treated in a single-blind manner. The primary endpoint was SSI (adjudicated centrally by a blinded committee) through postoperative day 30. Overall, 445 subjects (intention-to-treat) were randomized at 35 centers with 425 subjects completing the study and being evaluable. There were 67 SSIs (15.8%): 64.2% superficial, 7.5% deep, and 28.4% organ space. The incidence of SSI was not statistically significantly different between the DFA-02 and the placebo gel/SOC arms combined, 42/287 = 14.6% vs 25/138 = 18.1% (p = 0.36), respectively. Rehospitalization within 30 days was also similar between study groups (DFA-02 28.6%, placebo gel 21.4%, SOC 27.3%). In this multicenter, blinded, randomized trial with central adjudication, the gentamicin/vancomycin gel was not associated with a significant reduction in SSI. Patients undergoing abdominal surgery were randomized to one of three study arms: DFA-02 gel consisting of both gentamicin and vancomycin, matching placebo gel, or standard of care (SOC). Of 425 patients completing the study at 35 sites the gentamicin/vancomycin gel was not associated with a significant reduction in SSI. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nguyen, Lee S; Merzoug, Messaouda; Estagnasie, Philippe; Brusset, Alain; Law Koune, Jean-Dominique; Aubert, Stephane; Waldmann, Thierry; Grinda, Jean-Michel; Gibert, Hadrien; Squara, Pierre

    2017-12-02

    Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery. The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen ventilation, mechanical ventilation or high-flow oxygen) at 2 days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during

  9. Shikani Optical Stylet versus Macintosh Laryngoscope for Intubation in Patients Undergoing Surgery for Cervical Spondylosis: A Randomized Controlled Trial.

    Science.gov (United States)

    Xu, Mao; Li, Xiao-Xi; Guo, Xiang-Yang; Wang, Jun

    2017-02-05

    Airway management is critical in patients with cervical spondylosis, a population with a high incidence of difficult airway. Intubation with Shikani Optical Stylet (SOS) has become increasingly popular in difficult airway. We compared the effects of intubation with SOS versus Macintosh laryngoscope (MLS) in patients undergoing surgery for cervical spondylosis. A total of 270 patients scheduled for elective surgery for cervical spondylosis of spinal cord and nerve root type from August 2012 to January 2016 were enrolled and randomly allocated to the MLS or SOS group by random numbers. Patients were evaluated for difficult airway preoperatively, and Cormack-Lehane laryngoscopy classification was determined during anesthesia induction. Difficult airway was defined as Cormack-Lehane Grades III-IV. Patients were intubated with the randomly assigned intubation device. The success rate, intubation time, required assistance, immediate complications, and postoperative complaints were recorded. Categorical variables were analyzed by Chi-square test, and continuous variables were analyzed by independent samples t-test or rank sum test. The success rate of intubation among normal airways was 100% in both groups. In patients with difficult airway, the success rates in the MLS and SOS groups were 84.2% and 94.1%, respectively (P = 0.605). Intubation with SOS took longer compared with MLS (normal airway: 25.1 ± 5.8 s vs. 24.5 ± 5.7 s, P = 0.426; difficult airway: 38.5 ± 8.5 s vs. 36.1 ± 8.2 s, P = 0.389). Intubation with SOS required less assistance in patients with difficult airway (5.9% vs. 100%, P< 0.001). The frequency of postoperative sore throat was lower in SOS group versus MLS group in patients with normal airway (22.0% vs. 34.5%, P = 0.034). SOS is a safe and effective airway management device in patients undergoing surgery for cervical spondylosis. Compared with MLS, SOS appears clinically beneficial for intubation, especially in patients with difficult airway

  10. Esmolol before cardioplegia and as cardioplegia adjuvant reduces cardiac troponin release after cardiac surgery. A randomized trial.

    Science.gov (United States)

    Bignami, Elena; Guarnieri, Marcello; Franco, Annalisa; Gerli, Chiara; De Luca, Monica; Monaco, Fabrizio; Landoni, Giovanni; Zangrillo, Alberto

    2017-05-01

    Cardioplegic solutions are the standard in myocardial protection during cardiac surgery, since they interrupt the electro-mechanical activity of the heart and protect it from ischemia during aortic cross-clamping. Nevertheless, myocardial damage has a strong clinical impact. We tested the hypothesis that the short-acting beta-blocker esmolol, given immediately before cardiopulmonary bypass and as a cardioplegia additive, would provide an extra protection to myocardial tissue during cardiopulmonary bypass by virtually reducing myocardial activity and, therefore, oxygen consumption to zero. This was a single-centre, double-blind, placebo-controlled, parallel-group phase IV trial. Adult patients undergoing elective valvular and non-valvular cardiac surgery with end diastolic diameter >60 mm and ejection fraction <50% were enrolled. Patients were randomly assigned to receive either esmolol, 1 mg/kg before aortic cross-clamping and 2 mg/kg with Custodiol® crystalloid cardioplegia or equivolume placebo. The primary end-point was peak postoperative troponin T concentration. Troponin was measured at Intensive Care Unit arrival and at 4, 24 and 48 hours. Secondary endpoints included ventricular fibrillation after cardioplegic arrest, need for inotropic support and intensive care unit and hospital stay. We found a reduction in peak postoperative troponin T, from 1195 ng/l (690-2730) in the placebo group to 640 ng/l (544-1174) in the esmolol group (p=0.029) with no differences in Intensive Care Unit stay [3 days (1-6) in the placebo group and 3 days (2-5) in the esmolol group] and hospital stay [7 days (6-10) in the placebo group and 7 days (6-12) in the esmolol group]. Troponin peak occurred at 24 hours for 12 patients (26%) and at 4 hours for the others (74%). There were no differences in other secondary end-points. Adding esmolol to the cardioplegia in high-risk patients undergoing elective cardiac surgery reduces peak postoperative troponin levels. Further investigation

  11. The effect of using an abdominal binder on postoperative gastrointestinal function, mobilization, pulmonary function, and pain in patients undergoing major abdominal surgery: A randomized controlled trial.

    Science.gov (United States)

    Arici, Emine; Tastan, Sevinc; Can, Mehmet Fatih

    2016-10-01

    Evidence on the effectiveness of using a binder following abdominal surgery and its effect on gastrointestinal function, mobilization, pulmonary function, and pain is currently unclear. The purpose of this study is to determine the effect of abdominal binder usage on gastrointestinal function, mobilization, pulmonary function, and postoperative pain in patients undergoing major abdominal surgery. This research was conducted as a randomized controlled trial. The study was conducted at the Department of General Surgery at a military education and research hospital in Ankara, Turkey, between September 2013 and April 2014. 104 patients were assessed for eligibility. The study was conducted on 84 eligible patients. The study sample consisted of 84 patients who underwent effective major abdominal surgery. The patients were randomized into two groups, the intervention group, which used an abdominal binder and the control group, which did not. Gastrointestinal function, mobilization, pulmonary function, and the pain status of both groups were evaluated on the first, fourth, and seventh days before and after surgery, and the intergroup results were compared. No significant difference was found between the two groups in terms of gastrointestinal and pulmonary function on the first, fourth, and seventh days following surgery (p>0.05). A comparative assessment of mobility by walking distance showed that patients in the intervention group were able to walk further on the fourth [mean (SD); 221.19 (69.08) m] and seventh [227.85 (60.02) m] days after surgery (p=0.003, pbinder does not have any effect on postoperative gastrointestinal and pulmonary function. However, an abdominal binder increases patient mobility soon after surgery. There was also a measurable effect on pain, with lower scores reported by patients who used an abdominal binder after any exercise or activity. These results indicate that the use of a routine abdominal binder is helpful for patients undergoing major

  12. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

    Science.gov (United States)

    Vonk Noordegraaf, Antonie; Huirne, Judith A F; Brölmann, Hans A M; Emanuel, Mark H; van Kesteren, Paul J M; Kleiverda, Gunilla; Lips, Jos P; Mozes, Alexander; Thurkow, Andreas L; van Mechelen, Willem; Anema, Johannes R

    2012-02-01

    Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Netherlands Trial Register (NTR): NTR2087.

  13. Randomized trial of stents versus bypass surgery for left main coronary artery disease.

    Science.gov (United States)

    Park, Seung-Jung; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Ahn, Jung-Min; Song, Hae Geun; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Chung, Cheol-Hyun; Lee, Jae-Won; Lim, Do-Sun; Rha, Seung-Woon; Lee, Sang-Gon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo; Chae, In-Ho; Jang, Yangsoo; Jeong, Myung-Ho; Tahk, Seung-Jea; Seung, Ki Bae

    2011-05-05

    Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02). In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered

  14. CORE STABILIZATION EXERCISES AFTER ACL RECONSTRUCTION SURGERY PROVIDES BETTER OUTCOMES: A RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Dilpreet Kaur

    2015-12-01

    Full Text Available Background: Decreased core stability displaces center of gravity away from base of support reducing activity participation of athlete. Present study was conducted to study the effect of core stabilization exercises after reconstruction surgery of ACL on functional outcomes. Methods: 30 subjects following 5 months of ACL reconstruction were randomly assigned to either group that performed (study group or did not performed (control group additional core stabilization exercises in conjugation with standard rehabilitation protocol. Outcome measures were: activity level using Tegnar activity level scale and functional performance using triple hop test. Outcome measures were compared at day 1 and day 42 of the treatment. Result: Significant improvement was seen in the study group for Tegnar score with mean difference changing from 4.5 to 1.5 from day 1 to day 42 of treatment (p=0.039 while the control group showed improvement in mean difference changing from 3.8 to 1.4 (p=.045 from day 1 to day 42 of treatment. Highly significant improvement was seen in the study group for triple hop test with mean difference changing from 25 to 6.7 (p<.001 compared to the control group with mean difference changing from 15.2 to 9.7(p=.005 from day 1 to day 42 of treatment. Conclusions: Both the groups showed improvement for activity level and functional performance but highly significant improvement was seen in the study group for functional performance. Core stabilization exercises in conjugation with the standard ACL rehabilitation protocol results better improvement in the triple hop test.

  15. Probiotics improve outcomes after Roux-en-Y gastric bypass surgery: a prospective randomized trial.

    Science.gov (United States)

    Woodard, Gavitt A; Encarnacion, Betsy; Downey, John R; Peraza, Joseph; Chong, Karen; Hernandez-Boussard, Tina; Morton, John M

    2009-07-01

    Roux-en-Y gastric bypass (RNYGB) surgery offers an effective and enduring treatment for morbid obesity. Gastric bypass may alter gastrointestinal (GI) flora possibly resulting in bacterial overgrowth and dysmotility. Our hypothesis was that daily use of probiotics would improve GI outcomes after RNYGB. Forty-four patients undergoing RNYGB were randomized to either a probiotic or control group; 2.4 billion colonies of Lactobacillus were administered daily postoperatively to the probiotic group. The outcomes of H(2) levels indicative of bacterial overgrowth, GI-related quality of life (GIQoL), serologies, and weight loss were measured preoperatively and at 3 and 6 months postoperatively. Categorical variables were analyzed by chi(2) test and continuous variables were analyzed by t test with a p probiotic group with a preoperative to postoperative change of sum H(2) part per million (probiotics = -32.13, controls = 0.80). Surprisingly, the probiotic group attained significantly greater percent excess weight loss than that of control group at 6 weeks (controls = 25.5%, probiotic = 29.9%) and 3 months (38.55%, 47.68%). This trend also continued but was not significant at 6 months (60.78%, 67.15%). The probiotic group had significantly higher postoperative vitamin B12 levels than the control group. Both probiotic and control groups significantly improved their GIQoL. In this novel study, probiotic administration improves bacterial overgrowth, vitamin B12 availability, and weight loss after RNYGB. These data may provide further evidence that altering the GI microbiota can influence weight loss.

  16. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: a randomized controlled trial.

    Science.gov (United States)

    Kiely, Daniel J; Gotlieb, Walter H; Lau, Susie; Zeng, Xing; Samouelian, Vanessa; Ramanakumar, Agnihotram V; Zakrzewski, Helena; Brin, Sonya; Fraser, Shannon A; Korsieporn, Pira; Drudi, Laura; Press, Joshua Z

    2015-09-01

    The objective of this randomized, controlled trial was to assess whether voluntary participation in a proctored, proficiency-based, virtual reality robotic suturing curriculum using the da Vinci(®) Skills Simulator™ improves robotic suturing performance. Residents and attending surgeons were randomized to participation or non-participation during a 5 week training curriculum. Robotic suturing skills were evaluated before and after training using an inanimate vaginal cuff model, which participants sutured for 10 min using the da Vinci(®) Surgical System. Performances were videotaped, anonymized, and subsequently graded independently by three robotic surgeons. 27 participants were randomized. 23 of the 27 completed both the pre- and post-test, 13 in the training group and 10 in the control group. Mean training time in the intervention group was 238 ± 136 min (SD) over the 5 weeks. The primary outcome (improvement in GOALS+ score) and the secondary outcomes (improvement in GEARS, total knots, satisfactory knots, and the virtual reality suture sponge 1 task) were significantly greater in the training group than the control group in unadjusted analysis. After adjusting for lower baseline scores in the training group, improvement in the suture sponge 1 task remained significantly greater in the training group and a trend was demonstrated to greater improvement in the training group for the GOALS+ score, GEARS score, total knots, and satisfactory knots.

  17. Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

    Science.gov (United States)

    Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

    2018-02-17

    Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism."

  18. Efficacy of Nalbuphine with Flurbiprofen on Multimodal Analgesia with Transverse Abdominis Plane Block in Elderly Patients Undergoing Open Gastrointestinal Surgery: A Randomized, Controlled, Double-Blinded Trial

    Directory of Open Access Journals (Sweden)

    Yu Mao

    2018-01-01

    Full Text Available Objective. To assess different doses of nalbuphine with flurbiprofen compared to sufentanil with flurbiprofen in multimodal analgesia efficacy for elderly patients undergoing gastrointestinal surgery with a transverse abdominis plane block (TAPB. Methods. 158 elderly patients scheduling for elective open gastrointestinal surgery under general anesthesia and TAPB were randomly assigned to four groups according to different doses of nalbuphine with flurbiprofen in postoperative intravenous analgesia (PCIA. Postoperative pain intensity, effective pressing numbers of PCIA, and adverse effects were recorded at 6, 12, 24, and 48 hours after surgery. Results. Postoperative pain intensity, effective pressing numbers, and the incidence of postoperative nausea and vomiting (PONV were similar among the four groups after surgery, while the severity of PONV was decreased in Group L compared with Group S at 6, 12, and 48 h after surgery. No individual experienced pruritus, respiratory depression, or hypotension. Conclusions. Low dose of nalbuphine (15 μg·kg−1·ml−1 combined with flurbiprofen is superior for elderly patients undergoing elective open gastrointestinal surgery with TAPB in terms of the efficient postoperative analgesia and decreased severity of PONV. This trial is registered with NCT02984865.

  19. Effects of a peer education on cardiac self-efficacy and readmissions in patients undergoing coronary artery bypass graft surgery: a randomized-controlled trial.

    Science.gov (United States)

    Varaei, Shokoh; Shamsizadeh, Morteza; Cheraghi, Mohammad A; Talebi, Mitra; Dehghani, Ali; Abbasi, Ali

    2017-01-01

    This study aimed to investigate the effects of a peer education on cardiac self-efficacy (CSE) and readmission of the patients undergoing bypass surgery. Self-efficacy is an antecedent vital factor in both initiating and maintaining healthy behaviours. It significantly improves after effects of heart attacks, anxiety and diminishes the possibility of readmission. This study is a randomized-controlled trial. Sixty patients undergoing bypass surgery were chosen and assigned equally into the control and intervention groups. While routine education was presented to the patients in the control group, intervention group were taught using the peer education in two sessions. CSE of all the selected patients was assessed orderly in 5 days, 4 weeks and 8 months after surgery. Moreover, their readmission was investigated after 8 months from surgery. Data was collected using demographic and the CSE scale. Data were also analysed by using χ2 , Kolmogorov-Smirnov and repeated measures analysis of variance tests. The mean score of CSE in the intervention group was significantly different from the corresponding number in the control group in all three stages of data collecting (p peer education has positive effects on CSE in patients who have bypass surgery and reduces their hospital readmission. It can be beneficial to apply this method as an educative-supportive approach in cardiac surgery fields. Implementation of peer education has positive effects on CSE in these patients and reduces their hospital readmission. © 2014 British Association of Critical Care Nurses.

  20. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial.

    Science.gov (United States)

    Rotenberg, Brian W; Zhang, Irene; Arra, Ian; Payton, Keith B

    2011-12-01

    Evidence is lacking to guide the postoperative management of Samter's triad patients with chronic rhinosinusitis with polyposis (CRSwP) undergoing endoscopic sinus surgery (ESS). The purpose of this study was to compare three different standardized medication regimens prescribed to these patients after ESS. Three-arm, randomized, double-blinded, controlled trial. Patients with Samter's triad undergoing ESS were postoperatively randomized into three medication regimens, those being saline irrigation alone (control group A), saline irrigation plus separate budesonide nasal spray (group B), and saline irrigation mixed with budesonide nasal spray (group C). Outcome measures were Sino-Nasal Outcome Test scores, Lund-Mackay computed tomography scores, and Lund-Kennedy endoscopic scores taken at preoperative baseline, and then at 6 months and 1 year postoperatively. Side effect profiles were also measured (adrenocorticotropic hormone blood level ranges and intraocular pressure at the same interval points). Analysis of variance and χ(2) analyses were conducted using a Bonferroni correction method and routine descriptive statistics. Inter- and intragroup comparisons were made. Sixty subjects were recruited. All groups were equivalent at baseline in all outcomes. All intragroup analyses showed statistically and clinically significant improvement in disease status as compared to baseline (P .05). There was no treatment effect noted. In this study, nasal steroids did not confer any additional benefit over saline alone as post-ESS care for the Samter's triad CRSwP patient population. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

  1. Submucosal injection of dexamethasone and methylprednisolone for the control of postoperative sequelae after third molar surgery: randomized controlled trial.

    Science.gov (United States)

    Chugh, A; Singh, S; Mittal, Y; Chugh, V

    2018-02-01

    Pain, swelling, and trismus are known sequelae of third molar surgery that can significantly affect the individual's quality of life (QOL). These should be minimized to improve QOL. The purpose of this study was to compare the effects of the preoperative submucosal administration of equivalent doses of two commonly used steroids on these postoperative sequelae. A randomized controlled clinical trial was conducted involving 60 subjects requiring the removal of impacted mandibular third molars. Extraction cases with a similar difficulty index were included. The participants were allocated randomly to three groups: the placebo group received normal saline injection (control), while the 8mg dexamethasone group and 40mg methylprednisolone group received submucosal injections of these steroids preoperatively. Each participant was assessed for postoperative pain, swelling, and trismus, along with a subjective assessment of QOL through a structured questionnaire. The participants administered dexamethasone showed significant reductions in pain and trismus compared to the control group (P<0.05). Submucosal injection of dexamethasone was found to be superior to methylprednisolone only in terms of the reduction in swelling. QOL was minimally affected in patients administered dexamethasone as compared to methylprednisolone and control subjects. The preoperative submucosal use of steroids can be considered an effective, safe, and simple therapeutic strategy to reduce swelling, pain, and trismus after the surgical removal of impacted mandibular third molars. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  2. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial.

    Science.gov (United States)

    Siewe, Jan; Otto, Christina; Knoell, Peter; Koriller, Marco; Stein, Gregor; Kaulhausen, Thomas; Eysel, Peer; Zarghooni, Kourosh; Franklin, Jeremy; Sobottke, Rolf

    2011-10-18

    Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits. The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided. New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the

  3. [A prospective randomized control trial of arthroscopic surgery for stable ramp lesion of the medial meniscus].

    Science.gov (United States)

    Liu, X; Feng, H; Hong, L; Zhang, H

    2017-03-01

    Objective: To evaluate the necessity of arthroscopic suture repair for the stable ramp lesion. Methods: From August 2008 to April 2012, 91 patients of consecutive cases were diagnosed as anterior cruciate ligament (ACL) injury associated with stable ramp lesion in Department of Sports Medicine Service of Beijing Jishuitan Hospital. All of the diagnosis was confirmed during arthroscopic surgeries. The patients were randomized into suture repair group and control group. The ACL was reconstructed using auto grafts of hamstring. MRI was used for evaluation of the healing of the ramp lesion during the follow-up period. The stability of the knee joint was evaluated using KT-1000 device. The clinical functional outcomes were analyzed with Lysholm and International Knee Documentation Committee(IKDC) score. t test and χ(2) test were used to analyze the data, respectively. Results: There were 73 patients (80%) were available for final follow-up. The follow-up period was 24 to 72 months (mean (38.9±16.1) months). The suture repair group included 40 patients, while the control group included 33 patients. There were no statistically difference in age(t=0.458, P>0.05), gender(χ(2)=0.222, P>0.05), time interval from injury(t=0.643, P>0.05) and associated injuries(χ(2)=0.658, P>0.05). At the final follow-up, the healing rate of ramp lesion in suture repair group was 97.5% (95% of complete healed, 2.5% of partial healed, and 2.5% of non-healed), in control group the healing rate was 93.9% (87.8% of complete healed, 6.1% of partial healed, and 6.1% of non healed), there were no significant differences between the two groups (χ(2)=0.446, P>0.05). There was no statistically significant difference of postoperative knee stability (t=-0.510, P>0.05). The healing status of ramp area from MRI evaluation had statistically significant correlation with the ACL stability (χ(2)=11.919, P0.05; t=0.032, P>0.05). Conclusions: Stable ramp lesion could be well healed after arthroscopic

  4. An Equivalence Trial Comparing Labetalol and Diltiazem in Controlling Emergence Hypertension after Supratentorial Tumor Surgery.

    Science.gov (United States)

    Sirivanasandha, Busara; Sakaew, Arerat; Sutthivaiyakit, Kulwadee; Raksamani, Kasana; Waitayawinyu, Pichaya; Rushatamukayanunt, Pranee; Punkla, Walaiporn

    2015-11-01

    Hypertension and tachycardia during emergence from anesthesia for craniotomy could increase risks of cerebral complications. Several anesthetic, sedative, and antihypertensive drugs have been suggested that may be successful at suppressing these unwanted hemodynamic consequences. To study the equivalent efficacy and side effects of two antihypertensive drugs, diltiazem and labetalol. A block randomized control trial was performed in 184 patients who developed emergence hypertensive response after craniotomyfor supratentorial tumor removal. Systolic blood pressure (SBP) of each patient was suppressed by 2.5 mg of study drugs and repeated with fix dosage of 2.5 mg every two to three minutes to maintain SBP lower than 140 mmHg with a cumulative dose within 20 mg. Data regarding demographic, successful rate in controlling hypertension, drug dosage, and incidence of side effects were analyzed. The success rate of treatment of labetalol was equivalent to diltiazem (87.1% and 80.2% respectively) [p = 0.003, 95% CI = 6.88 (-2.06 to 15.8)]. There was no statistical significant difference on dosage of drugs used or incidence ofside effect (hypotension, bradycardia, heart block, and bronchospasm). Median (minimum-maximum) dosage of labetalol and diltiazem were 10 mg (2.5-20 mg) and 10 mg (2.5-20 mg) respectively. The expense for labetalol was 1/6 of diltiazem. Labetalol has equivalent efficacy to diltiazem. Both drugs used low median dosage giving low incidence of side-effects. Labetalol is a good alternative drug to control hypertensive response during emergence from anesthesia for post-craniotomy.

  5. Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial.

    Science.gov (United States)

    Jeong, Seung-Yong; Park, Ji Won; Nam, Byung Ho; Kim, Sohee; Kang, Sung-Bum; Lim, Seok-Byung; Choi, Hyo Seong; Kim, Duck-Woo; Chang, Hee Jin; Kim, Dae Yong; Jung, Kyung Hae; Kim, Tae-You; Kang, Gyeong Hoon; Chie, Eui Kyu; Kim, Sun Young; Sohn, Dae Kyung; Kim, Dae-Hyun; Kim, Jae-Sung; Lee, Hye Seung; Kim, Jee Hyun; Oh, Jae Hwan

    2014-06-01

    Compared with open resection, laparoscopic resection of rectal cancers is associated with improved short-term outcomes, but high-level evidence showing similar long-term outcomes is scarce. We aimed to compare survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer. The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was an open-label, non-inferiority, randomised controlled trial done between April 4, 2006, and Aug 26, 2009, at three centres in Korea. Patients (aged 18-80 years) with cT3N0-2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned (1:1) to receive either open or laparoscopic surgery. Randomisation was stratified by sex and preoperative chemotherapy regimen. Investigators were masked to the randomisation sequence; patients and clinicians were not masked to the treatment assignments. The primary endpoint was 3 year disease-free survival, with a non-inferiority margin of 15%. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT0040951. We randomly assigned 340 patients to receive either open surgery (n=170) or laparoscopic surgery (n=170). 3 year disease-free survival was 72·5% (95% CI 65·0-78·6) for the open surgery group and 79·2% (72·3-84·6) for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin (-6·7%, 95% CI -15·8 to 2·4; p<0·0001). 25 (15%) patients died in the open group and 20 (12%) died in the laparoscopic group. No deaths were treatment related. Our results show that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection, thus justifying its use. National Cancer Center, South Korea. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Thromboprophylaxis With Apixaban in Patients Undergoing Major Orthopedic Surgery: Meta-Analysis and Trial-Sequential Analysis.

    Science.gov (United States)

    Caldeira, Daniel; Rodrigues, Filipe B; Pinto, Fausto J; Ferreira, Joaquim J; Costa, João

    2017-01-01

    Venous thromboembolism (VTE) is a potentially fatal complication of orthopedic surgery, and until recently, few antithrombotic compounds were available for postoperative thromboprophylaxis. The introduction of the non-vitamin K antagonists oral anticoagulants (NOAC), including apixaban, has extended the therapeutic armamentarium in this field. Therefore, estimation of NOAC net clinical benefit in comparison with the established treatment is needed to inform clinical decision making. Systematic review to assess the efficacy and safety of apixaban 2.5 mg twice a day versus low-molecular-weight heparins (LMWH) for thromboprophylaxis in patients undergoing knee or hip replacement. MEDLINE, Embase, and CENTRAL were searched from inception to September 2016, other systematic reviews, reference lists, and experts were consulted. All major orthopedic surgery randomized controlled trials comparing apixaban 2.5 mg twice daily with LMWH, reporting thrombotic and bleeding events. Two independent reviewers, using a predetermined form. The Cochrane tool to assess risk bias was used by two independent authors. RevMan software was used to estimate pooled risk ratio (RR) and 95% confidence intervals (95% CI) using random-effects meta-analysis. Trial sequential analysis (TSA) was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. Overall confidence in cumulative evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group methodology. Four studies comparing apixaban 2.5 mg twice daily with LMWH were included, with a total of 11.828 patients (55% undergoing knee and 45% hip replacement). The overall risk of bias across studies was low. In comparison with LMWH (all regimens), apixaban showed a significantly lower risk of VTE events and overall mortality combined (RR: 0.63, 95% CI: 0.42-0.95, I2 = 84%, n = 8346), but not of major VTE events (RR: 0.62, 95

  7. Thromboprophylaxis With Apixaban in Patients Undergoing Major Orthopedic Surgery: Meta-Analysis and Trial-Sequential Analysis

    Directory of Open Access Journals (Sweden)

    Daniel Caldeira

    2017-05-01

    Full Text Available Background: Venous thromboembolism (VTE is a potentially fatal complication of orthopedic surgery, and until recently, few antithrombotic compounds were available for postoperative thromboprophylaxis. The introduction of the non–vitamin K antagonists oral anticoagulants (NOAC, including apixaban, has extended the therapeutic armamentarium in this field. Therefore, estimation of NOAC net clinical benefit in comparison with the established treatment is needed to inform clinical decision making. Objectives: Systematic review to assess the efficacy and safety of apixaban 2.5 mg twice a day versus low-molecular-weight heparins (LMWH for thromboprophylaxis in patients undergoing knee or hip replacement. Data sources: MEDLINE, Embase, and CENTRAL were searched from inception to September 2016, other systematic reviews, reference lists, and experts were consulted. Study eligibility criteria, participants, and intervention: All major orthopedic surgery randomized controlled trials comparing apixaban 2.5 mg twice daily with LMWH, reporting thrombotic and bleeding events. Data extraction: Two independent reviewers, using a predetermined form. Study appraisal and synthesis methods: The Cochrane tool to assess risk bias was used by two independent authors. RevMan software was used to estimate pooled risk ratio (RR and 95% confidence intervals (95% CI using random-effects meta-analysis. Trial sequential analysis (TSA was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. Overall confidence in cumulative evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE Working Group methodology. Results: Four studies comparing apixaban 2.5 mg twice daily with LMWH were included, with a total of 11.828 patients (55% undergoing knee and 45% hip replacement. The overall risk of bias across studies was low. In comparison with LMWH (all regimens

  8. The Hip Fracture Surgery in Elderly Patients (HIPELD study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

    Directory of Open Access Journals (Sweden)

    Coburn Mark

    2012-09-01

    Full Text Available Abstract Background Strategies to protect the brain from postoperative delirium (POD after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABAA receptor and (ii through beneficial anesthetic and organ-protective effects. Methods and design An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM, in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane

  9. Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Ulrich, Alexis; Büchler, Markus W; Knebel, Phillip; Diener, Markus K

    2014-11-27

    Industry sponsorship has been identified as a factor correlating with positive research findings in several fields of medical science. To date, the influence of industry sponsorship in general and abdominal surgery has not been fully studied. This protocol describes the rationale and planned conduct of a systematic review to determine the association between industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery. A literature search in the Cochrane Library, MEDLINE and EMBASE and additional hand searches in relevant citations will be conducted. In order to cover all relevant areas of general and abdominal surgery, a new literature search strategy called multi-PICO search strategy (MPSS) has been developed. No language restriction will be applied. The search will be limited to publications between January 1985 and July 2014. Information on funding source, outcome, study characteristics and methodological quality will be extracted.The association between industry sponsorship and positive outcome will be tested by a chi-squared test. A multivariate logistic regression analysis will be performed to control for possible confounders, such as number of study centres, multinational trials, methodological quality, journal impact factor and sample size. This study was designed to clarify whether industry-sponsored trials report more positive outcomes than non-industry trials. It will be the first study to evaluate this topic in general and abdominal surgery. The findings of this study will enable surgical societies, in particular, to give advice about cooperation with the industry and disclosure of funding source based on empirical evidence. PROSPERO CRD42014010802.

  10. Efficiency and Safety Effects of Applying ERAS Protocols to Bariatric Surgery: a Systematic Review with Meta-Analysis and Trial Sequential Analysis of Evidence.

    Science.gov (United States)

    Singh, Preet Mohinder; Panwar, Rajesh; Borle, Anuradha; Goudra, Basavana; Trikha, Anjan; van Wagensveld, Bart A; Sinha, Ashish

    2017-02-01

    Application of the enhanced recovery after surgery (ERAS) to the bariatric surgical procedures is at its early stages with little consolidated evidence. This meta-analysis evaluates present literature and indicates pathways for development of evidence-based standardized ERAS protocols for bariatric surgery. Comparative trials between ERAS and conventional bariatric surgery published till June 2016 were searched in the medical database. Comparisons were made for length of stay (LOS), readmission, complications (major/minor), and reoperation rates. Trial sequential analysis (TSA) for the strength of meta-analysis was performed for the primary outcome LOS. Five subgroups with a total of 394 and 471 patients in ERAS and conventional group respectively were included. LOS was shorter in ERAS group by 1.56 ± 0.18 days (random-effects, p bariatric procedures allow faster return to home for patients. The present bariatric ERAS protocols have high heterogeneity and would benefit from standardization. Minor complication rates increase with implementation of ERAS, however without any significant effect on overall patient morbidity. Further randomized trials comparing ERAS with conventional care are required to consolidate these findings.

  11. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.

    Science.gov (United States)

    Hemmes, Sabrine N T; Severgnini, Paolo; Jaber, Samir; Canet, Jaume; Wrigge, Hermann; Hiesmayr, Michael; Tschernko, Edda M; Hollmann, Markus W; Binnekade, Jan M; Hedenstierna, Göran; Putensen, Christian; de Abreu, Marcelo Gama; Pelosi, Paolo; Schultz, Marcus J

    2011-05-06

    Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication. The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. ISRCTN: ISRCTN70332574.

  12. Perioperative elafin for ischaemia-reperfusion injury during coronary artery bypass graft surgery: a randomised-controlled trial.

    Science.gov (United States)

    Alam, S R; Lewis, S C; Zamvar, V; Pessotto, R; Dweck, M R; Krishan, A; Goodman, K; Oatey, K; Harkess, R; Milne, L; Thomas, S; Mills, N M; Moore, C; Semple, S; Wiedow, O; Stirrat, C; Mirsadraee, S; Newby, D E; Henriksen, P A

    2015-10-01

    Elafin is a potent endogenous neutrophil elastase inhibitor that protects against myocardial inflammation and injury in preclinical models of ischaemic-reperfusion injury. We investigated whether elafin could inhibit myocardial ischaemia-reperfusion injury induced during coronary artery bypass graft (CABG) surgery. In a randomised double-blind placebo-controlled parallel group clinical trial, 87 patients undergoing CABG surgery were randomised 1:1 to intravenous elafin 200 mg or saline placebo administered after induction of anaesthesia and prior to sternotomy. Myocardial injury was measured as cardiac troponin I release over 48 h (area under the curve (AUC)) and myocardial infarction identified with MRI. Postischaemic inflammation was measured by plasma markers including AUC high-sensitive C reactive protein (hs-CRP) and myeloperoxidase (MPO). Elafin infusion was safe and resulted in >3000-fold increase in plasma elafin concentrations and >50% inhibition of elastase activity in the first 24 h. This did not reduce myocardial injury over 48 h (ratio of geometric means (elafin/placebo) of AUC troponin I 0.74 (95% CI 0.47 to 1.15, p=0.18)) although post hoc analysis of the high-sensitive assay revealed lower troponin I concentrations at 6 h in elafin-treated patients (median 2.4 vs 4.1 μg/L, p=0.035). Elafin had no effect on myocardial infarction (elafin, 7/34 vs placebo, 5/35 patients) or on markers of inflammation: mean differences for AUC hs-CRP of 499 mg/L/48 h (95% CI -207 to 1205, p=0.16), and AUC MPO of 238 ng/mL/48 h (95% CI -235 to 711, p=0.320). There was no strong evidence that neutrophil elastase inhibition with a single-dose elafin treatment reduced myocardial injury and inflammation following CABG-induced ischaemia-reperfusion injury. (EudraCT 2010-019527-58, ISRCTN82061264). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  13. A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study

    National Research Council Canada - National Science Library

    Hilton, Paul; Armstrong, Natalie; Brennand, Catherine; Howel, Denise; Shen, Jing; Bryant, Andrew; Tincello, Douglas G; Lucas, Malcolm G; Buckley, Brian S; Chapple, Christopher R; Homer, Tara; Vale, Luke; McColl, Elaine

    2015-01-01

    .... The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women...

  14. Effects of tolvaptan in the early postoperative stage after heart valve surgery: results of the STAR (Study of Tolvaptan for fluid retention AfteR valve surgery) trial.

    Science.gov (United States)

    Nishi, Hiroyuki; Toda, Koichi; Miyagawa, Shigeru; Yoshikawa, Yasushi; Fukushima, Satsuki; Kawamura, Masashi; Yoshioka, Daisuke; Saito, Tetsuya; Ueno, Takayoshi; Kuratani, Toru; Sawa, Yoshiki

    2015-12-01

    The purpose of this study was to assess the efficacy of tolvaptan, a vasopressin V2 receptor antagonist, for the management of postoperative surgical fluid retention after heart valve surgery. This was a prospective observational study of 64 patients with heart valve disease who underwent valve surgery between 2013 and 2014. Those in the tolvaptan group received tolvaptan in addition to conventional diuretic therapy. The results were compared to the results of 55 patients who underwent heart valve surgery between 2007 and 2010 and received conventional postoperative diuretics alone. The time to return to the preoperative BW was significantly shorter in the patients who received tolvaptan (6.1 ± 3.8 vs. 8.7 ± 6.7 days, p tolvaptan group. The response to tolvaptan was related to the postoperative degree of BW increase and the preoperative creatinine level. Tolvaptan was effective in treating fluid retention during the early postoperative stage in cardiac surgery patients, without increased renal failure or abnormal electrolyte levels. This new type of diuretic therapy may be a suitable option for postoperative fluid management in patients undergoing cardiac surgery.

  15. The impact of cataract surgery on visual functioning, vision-related disability and psychological distress: a randomized controlled trial.

    Science.gov (United States)

    Walker, Janine G; Anstey, Kaarin J; Hennessy, Michael P; Lord, Stephen R; von Sanden, Chwee

    2006-11-01

    Determine whether there are changes in visual functioning, vision-related disability, health status and mood after cataract surgery. 45 adults (mean age = 73.7 years) with bilateral cataract needing surgery for the first eye were recruited from public ophthalmology clinics. The Visual Functioning-14 survey assessed visual disability. Minimal angle of resolution tested visual acuity, and the Melbourne Edge Test examined contrast sensitivity. Demographic, psychological, health and medication use variables were examined. Participants were randomized to either an intervention or control arm. Controls were assessed on two occasions at a 3-month interval before having surgery. The intervention group was assessed 1-2 weeks before surgery and then reassessed 3 months after surgery. Visual functioning improved for those who had cataract surgery with better visual acuity in the better (P = 0.010) and worse (P = 0.028) eye compared with controls. The intervention group reported fewer difficulties with overall vision-related disability (P = 0.0001), reading (P = 0.004) and instrumental activities of daily living (P = 0.010) post-surgery compared with controls. People with improved depression scores (P = 0.048) after surgery had less difficulty with reading compared with those with unchanged or worsened depression scores. Cataract surgery did not improve health status. First eye cataract surgery is effective in improving outcomes in visual functioning and disability. Improved mood after surgery was related to less vision-related disability compared with unchanged or worse depression.

  16. Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial: assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rafiq Sulman

    2012-04-01

    Full Text Available Abstract Background Hypercoagulability, assessed by the thrombelastography (TEG assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG patients and reduce their risk for thromboembolic complications and death postoperatively. Methods/Design This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT at three months after surgery. Conclusions The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy. Trial registration Clinicaltrials.gov Identifier NCT01046942

  17. Peritoneal Dialysis vs Furosemide for Prevention of Fluid Overload in Infants After Cardiac Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Kwiatkowski, David M; Goldstein, Stuart L; Cooper, David S; Nelson, David P; Morales, David L S; Krawczeski, Catherine D

    2017-04-01

    Fluid overload after congenital heart surgery is frequent and a major cause of morbidity and mortality among infants. Many programs have adopted the use of peritoneal dialysis (PD) for fluid management; however, its benefits compared with those of traditional diuretic administration are unknown. To determine whether infants randomized to PD vs furosemide for the treatment of oliguria have a higher incidence of negative fluid balance on postoperative day 1, as well as avoidance of 10% fluid overload; shorter duration of mechanical ventilation, intensive care unit stay, and inotrope use; and fewer electrolyte abnormalities. This single-center, unblinded, randomized clinical trial compared methods of fluid removal after cardiac surgery from October 1, 2011, through March 13, 2015, in a large tertiary pediatric hospital in Ohio. The parents or guardians of all eligible infants (aged furosemide (1 mg/kg every 6 hours) or a standardized PD regimen. The primary end point was incidence of negative fluid balance on postoperative day 1. Secondary end points included incidence of fluid overload, duration of mechanical ventilation and intensive care unit stay, electrolyte abnormalities and repletion doses, duration of inotropic administration, and mortality. Seventy-three patients (47 boys [64%] and 26 girls [35%]; median age, 8 [interquartile range (IQR), 6-14] days) received treatment and completed the trial. No difference was found between the PD and furosemide groups in the incidence of negative fluid balance on the first postoperative day. The furosemide group was 3 times more likely to have 10% fluid overload (odds ratio [OR], 3.0; 95% CI, 1.3-6.9), was more likely to have prolonged ventilator use (OR, 3.1; 95% CI, 1.2-8.2), and had a longer duration of inotrope use (median, 5.5 [IQR, 4-8] vs 4.0 [IQR, 3-6] days) and higher electrolyte abnormality scores (median, 6 [IQR, 4-7] vs 3 [IQR, 2-5]) compared with the PD group. No statistically significant differences in

  18. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial.

    Science.gov (United States)

    Williams, Hywel C; Bath-Hextall, Fiona; Ozolins, Mara; Armstrong, Sarah J; Colver, Graham B; Perkins, William; Miller, Paul S J

    2017-03-01

    We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma at low-risk sites in our noninferiority randomized controlled SINS trial. Here we report 5-year data. Participants were randomized to imiquimod 5% cream once daily (superficial basal cell carcinoma, 6 weeks; nodular basal cell carcinoma, 12 weeks) or excisional surgery (4-mm margin). The primary outcome was clinical absence of initial failure or signs of recurrence at the 3-year dermatology review. Five-year success was defined as 3-year success plus absence of recurrences identified through hospital, histopathology, and general practitioner records. Of 501 participants randomized, 401 contributed to the modified intention-to-treat analyses at year 3 (primary outcome), 383 (96%) of whom had data at year 5. Five-year success rates for imiquimod were 82.5% (170/206) compared with 97.7% (173/177) for surgery (relative risk of imiquimod success = 0.84, 95% confidence interval = 0.77-0.91, P < 0.001). These were comparable to year 3 success rates of 83.6% (178/213) and 98.4% (185/188) for imiquimod and surgery, respectively. Most imiquimod treatment failures occurred in year 1. Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Effects of coenzyme Q10 supplementation on antioxidant capacity and inflammation in hepatocellular carcinoma patients after surgery: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Liu, Hsiao-Tien; Huang, Yi-Chia; Cheng, Shao-Bin; Huang, Yin-Tzu; Lin, Ping-Ting

    2016-10-06

    It has been reported that higher levels of oxidative stress and inflammation play a key role in the progression of hepatocellular carcinoma (HCC) after surgery. Coenzyme Q10 is an endogenous lipid-soluble antioxidant. To date, no intervention study has investigated coenzyme Q10 supplementation in HCC patients after surgery. The purpose of this study was to investigate oxidative stress, antioxidant enzymes activity, and inflammation levels in HCC patients after surgery following administration of coenzyme Q10 (300 mg/day). This study was designed as a single-blinded, randomized, parallel, placebo-controlled study. Patients who were diagnosed with primary HCC (n = 41) and were randomly assign to a placebo (n = 20) or coenzyme Q10 (300 mg/day, n = 21) group after surgery. The intervention lasted for 12 weeks. Plasma coenzyme Q10, vitamin E, oxidative stress antioxidant enzymes activity and inflammatory markers levels were measured. The oxidative stress (p = 0.04) and inflammatory markers (hs-CRP and IL-6, p coenzyme Q10 supplementation. In addition, the coenzyme Q10 level was significantly negatively correlated with the oxidative stress (p = 0.01), and positively correlated with antioxidant enzymes activity (SOD, p = 0.01; CAT, p coenzyme Q10 supplementation significantly increased the antioxidant capacity and reduced the oxidative stress and inflammation levels in HCC patients after surgery. Clinical Trials.gov Identifier: NCT01964001.

  20. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Georgopoulou Stavroula

    2010-02-01

    Full Text Available Abstract Background Cardiac surgery is a major consumer of blood products, and hemodilution increases transfusion requirements during cardiac surgery under CPB. As intraoperative parenteral fluids contribute to hemodilution, we evaluated the hypothesis that intraoperative fluid restriction reduces packed red-cell (PRC use, especially in transfusion-prone adults undergoing elective cardiac surgery. Methods 192 patients were randomly assigned to restrictive (group A, 100 pts, or liberal (group B, 92 pts intraoperative intravenous fluid administration. All operations were conducted by the same team (same surgeon and perfusionist. After anesthesia induction, intravenous fluids were turned off in Group A (fluid restriction patients, who only received fluids if directed by protocol. In contrast, intravenous fluid administration was unrestricted in group B. Transfusion decisions were made by the attending anesthesiologist, based on identical transfusion guidelines for both groups. Results 137 of 192 patients received 289 PRC units in total. Age, sex, weight, height, BMI, BSA, LVEF, CPB duration and surgery duration did not differ between groups. Fluid balance was less positive in Group A. Fewer group A patients (62/100 required transfusion compared to group B (75/92, p Conclusions Our data suggest that fluid restriction reduces intraoperative PRC transfusions without significantly increasing postoperative transfusions in cardiac surgery; this effect is more pronounced in transfusion-prone patients. Trial registration NCT00600704, at the United States National Institutes of Health.

  1. Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial.

    Science.gov (United States)

    Maglio, Cristina; Peltonen, Markku; Neovius, Martin; Jacobson, Peter; Jacobsson, Lennart; Rudin, Anna; Carlsson, Lena M S

    2017-04-01

    To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires. Median follow-up for the incidence of gout was about 19 years for both groups. Moreover, the incidence of hyperuricaemia over up to 20 years was examined in a subgroup of participants having baseline uric acid levels gout compared with usual care (adjusted HR 0.60, 95% CI 0.48 to 0.75, pgout event was 32 (95% CI 22 to 59). The effect of bariatric surgery on gout incidence was not influenced by baseline risk factors, including body mass index. During follow-up, the surgery group had a lower incidence of hyperuricaemia (adjusted HR 0.47, 95% CI 0.39 to 0.58, pgout and hyperuricaemia in obese subjects. NCT01479452; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial.

    Science.gov (United States)

    Shariff, U; Kullar, N; Haray, P N; Dorudi, S; Balasubramanian, S P

    2015-05-01

    Conventional teaching in surgical training programmes is constrained by time and cost, and has room for improvement. This study aimed to determine the effectiveness of a multimedia educational tool developed for an index colorectal surgical procedure (anterior resection) in teaching and assessment of cognitive skills and to evaluate its acceptability amongst general surgical trainees. Multimedia educational tools in open and laparoscopic anterior resection were developed by filming multiple operations which were edited into procedural steps and substeps and then integrated onto interactive navigational platforms using Adobe® Flash® Professional CS5 10.1. A randomized controlled trial was conducted on general surgical trainees to evaluate the effectiveness of online multimedia in comparison with conventional 'study day' teaching for the acquisition of cognitive skills. All trainees were assessed before and after the study period. Trainees in the multimedia group evaluated the tools by completing a survey. Fifty-nine trainees were randomized but 27% dropped out, leaving 43 trainees randomized to the multimedia group (n = 25) and study day group (n = 18) who were available for analysis. Posttest scores improved significantly in both groups (P multimedia group was not significantly different from the study day group (6.02 ± 5.12 and 5.31 ± 3.42, respectively; P = 0.61). Twenty-five trainees completed the evaluation survey and experienced an improvement in their decision making (67%) and in factual and anatomical knowledge (88%); 96% agreed that the multimedia tool was a useful additional educational resource. Multimedia tools are effective for the acquisition of cognitive skills in colorectal surgery and are well accepted as an educational resource. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  3. Choosing surgery

    DEFF Research Database (Denmark)

    Thorstensson, Carina; Lohmander, L; Frobell, Richard

    2009-01-01

    ABSTRACT: BACKGROUND: The objective was to understand patients' views of treatment after acute anterior cruciate ligament (ACL) injury, and their reasons for deciding to request surgery despite consenting to participate in a randomised controlled trial (to 'cross-over'). METHODS: Thirty-four in...

  4. [Study of the factors motivating refusal of women to participate to a randomized clinical trial in gynecological surgery. Retrospective observational bicentric study].

    Science.gov (United States)

    Nguyen-Xuan, H-T; Thiollier, G; Ruault, O; Fauconnier, A; Lucot, J-P; Bader, G

    2016-11-01

    Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close

  5. Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract : the FACT trial protocol

    NARCIS (Netherlands)

    Day, Alexander C; Burr, Jennifer M; Bunce, Catey; Doré, Caroline J; Sylvestre, Yvonne; Wormald, Richard P L; Round, Jeff; McCudden, Victoria; Rubin, Gary; Wilkins, Mark R; Schilder, Anne

    2015-01-01

    INTRODUCTION: Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual

  6. Patients' experiences of postoperative intermediate care and standard surgical ward care after emergency abdominal surgery: a qualitative sub-study of the Incare trial.

    Science.gov (United States)

    Thomsen, Thordis; Vester-Andersen, Morten; Nielsen, Martin Vedel; Waldau, Tina; Møller, Ann Merete; Rosenberg, Jacob; Møller, Morten Hylander; Nystrup, Kristin Brønnum; Esbensen, Bente Appel

    2015-05-01

    To elicit knowledge of patient experiences of postoperative intermediate care in an intensive care unit and standard postoperative care in a surgical ward after emergency abdominal surgery. Emergency abdominal surgery is common, but little is known about how patients experience postoperative care. The patient population is generally older with multiple comorbidities, and the short-term postoperative mortality rate is 15-20%. Thus, vigilant surgeon and nursing attention is essential. The present study is a qualitative sub-study of a randomised trial evaluating postoperative intermediate care after emergency abdominal surgery, the InCare trial. A qualitative study with individual semi-structured interviews. We analysed interviews using Systematic Text Condensation. Eighteen patients (nine intervention/nine controls) were strategically sampled from the InCare trial. Data analysis resulted in three distinct descriptions of intermediate care; two of standard surgical ward care. Intermediate care was described as 'luxury service' or 'a life saver.' The latter description was prevalent among patients with a perceived complicated disease course. Intermediate care patients felt constrained by continuous monitoring of vital signs as they recovered from surgery. Standard surgical ward care was described as either 'ok - no more, no less' or 'suboptimal'. Experiencing suboptimal care was related to patient perceptions of heavy staff workloads, lack of staff availability and subsequent concerns about the quality of care. Postoperative intermediate care enhanced perceptions of quality of care, specifically in patients with a perceived complicated disease course. Patients were eager to contribute actively to their recovery; however, intermediate care patients felt hindered in doing so by continuous monitoring of vital signs. Intermediate care may increase patient perceptions of quality and safety of care. © 2014 John Wiley & Sons Ltd.

  7. Shoulder function and work disability after decompression surgery for subacromial impingement syndrome: a randomised controlled trial of physiotherapy exercises and occupational medical assistance.

    Science.gov (United States)

    Svendsen, Susanne W; Christiansen, David H; Haahr, Jens Peder; Andrea, Linda C; Frost, Poul

    2014-06-21

    Surgery for subacromial impingement syndrome is often performed in working age and postoperative physiotherapy exercises are widely used to help restore function. A recent Danish study showed that 10% of a nationwide cohort of patients retired prematurely within two years after surgery. Few studies have compared effects of different postoperative exercise programmes on shoulder function, and no studies have evaluated workplace-oriented interventions to reduce postoperative work disability. This study aims to evaluate the effectiveness of physiotherapy exercises and occupational medical assistance compared with usual care in improving shoulder function and reducing postoperative work disability after arthroscopic subacromial decompression. The study is a mainly pragmatic multicentre randomised controlled trial. The trial is embedded in a cohort study of shoulder patients referred to public departments of orthopaedic surgery in Central Denmark Region. Patients aged ≥18-≤63 years, who still have shoulder symptoms 8-12 weeks after surgery, constitute the study population. Around 130 participants are allocated to: 1) physiotherapy exercises, 2) occupational medical assistance, 3) physiotherapy exercises and occupational medical assistance, and 4) usual care. Intervention manuals allow individual tailoring. Primary outcome measures include Oxford Shoulder Score and sickness absence due to symptoms from the operated shoulder. Randomisation is computerised with allocation concealment by randomly permuted block sizes. Statistical analyses will primarily be performed according to the intention-to-treat principle. The paper presents the rationale, design, methods, and operational aspects of the Shoulder Intervention Project (SIP). SIP evaluates a new rehabilitation approach, where physiotherapy and occupational interventions are provided in continuity of surgical episodes of care. If successful, the project may serve as a model for rehabilitation of surgical shoulder

  8. The effect of an educational intervention on coronary artery bypass graft surgery patients' participation rate in cardiac rehabilitation programs: a controlled health care trial

    Directory of Open Access Journals (Sweden)

    Novikov Ilia

    2011-10-01

    Full Text Available Abstract Background Cardiac rehabilitation has a beneficial effect on the prognosis and quality of life of cardiac patients, and has been found to be cost-effective. This report describes a comprehensive and low cost educational intervention designed to increase the attendance at cardiac rehabilitation programs of patients who have undergone coronary artery bypass graft surgery. Methods/Design A controlled prospective intervention trial. The control arm comprised 520 patients who underwent coronary artery bypass graft surgery between January 2004 and May 2005 in five medical centers across Israel. This group received no additional treatment beyond usual care. The intervention arm comprised 504 patients recruited from the same cardiothoracic departments between June 2005 and November 2006. This group received oral and written explanations about the advantages of participating in cardiac rehabilitation programs and a telephone call two weeks after hospital discharge intended to further encourage their enrollment. The medical staff attended a one-hour seminar on cardiac rehabilitation. In addition, it was recommended that referral to cardiac rehabilitation be added to the letter of discharge from the hospital. Both study groups were interviewed before surgery and one-year post surgery. A one-year post-operative interview assessed factors affecting patient attendance at cardiac rehabilitation programs, as well as the structure and content of the cardiac rehabilitation programs attended. Anthropometric parameters were measured at pre- and post-operative interviews;- and medical information was obtained from patient medical records. The effect of cardiac rehabilitation on one- and three-year mortality was assessed. Discussion We report a low cost yet comprehensive intervention designed to increase cardiac rehabilitation participation by raising both patient and medical staff awareness to the potential benefits of cardiac rehabilitation. Trial

  9. Metabolic Surgery

    DEFF Research Database (Denmark)

    Pareek, Manan; Schauer, Philip R; Kaplan, Lee M

    2018-01-01

    The alarming rise in the worldwide prevalence of obesity is paralleled by an increasing burden of type 2 diabetes mellitus. Metabolic surgery is the most effective means of obtaining substantial and durable weight loss in individuals with obesity. Randomized trials have recently shown the superio......The alarming rise in the worldwide prevalence of obesity is paralleled by an increasing burden of type 2 diabetes mellitus. Metabolic surgery is the most effective means of obtaining substantial and durable weight loss in individuals with obesity. Randomized trials have recently shown...... the superiority of surgery over medical treatment alone in achieving improved glycemic control, as well as a reduction in cardiovascular risk factors. The mechanisms seem to extend beyond the magnitude of weight loss alone and include improvements in incretin profiles, insulin secretion, and insulin sensitivity...

  10. Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT).

    Science.gov (United States)

    Haloua, Max H; Volders, José H; Krekel, Nicole M A; Lopes Cardozo, Alexander M F; de Roos, Wifred K; de Widt-Levert, Louise M; van der Veen, Henk; Rijna, Herman; Bergers, Elisabeth; Jóźwiak, Katarzyna; Meijer, Sybren; van den Tol, Petrousjka

    2016-01-01

    Ultrasound-guided breast-conserving surgery (USS) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). Objective. The aim of the present study was to determine whether USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS). A total of 134 patients with T1–T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either USS (65 patients) or PGS (69 patients). Cosmetic outcomes were assessed by a three-member panel using computerized software Breast Cancer Conservative Treatment cosmetic results (BCCT.- core) and by patient self-evaluation, including patient satisfaction. Time points for follow-up were 3, 6, and 12 months after surgery. Overall cosmetic outcome and patient satisfaction were scored on a 4-point Likert scale (excellent, good, fair, or poor), and outcomes were analyzed using a multilevel, mixed effect, proportional odds model for ordinal responses. Ultrasound-guided breast-conserving surgery achieved better cosmetic outcomes, with 20 % excellence overall and only 6 % rated as poor, whereas 14 % of PGS outcomes were rated excellent and 13 % as poor. USS also had consistently lower odds for worse cosmetic outcomes (odds ratio 0.55, p = 0.067) than PGS. The chance of having a worse outcome was significantly increased by a larger lumpectomy volume (ptrend = 0.002); a volume [40 cc showed odds 2.78-fold higher for a worse outcome than a volume B40 cc. USS resulted in higher patient satisfaction compared with PGS. Ultrasound-guided breast-conserving surgery achieved better overall cosmetic outcomes and patient satisfaction than PGS. Lumpectomy volumes[40 cc resulted in significantly worse cosmetic outcomes.

  11. Randomised clinical trial: prucalopride, a colonic pro-motility agent, reduces the duration of post-operative ileus after elective gastrointestinal surgery.

    Science.gov (United States)

    Gong, J; Xie, Z; Zhang, T; Gu, L; Yao, W; Guo, Z; Li, Y; Lu, N; Zhu, W; Li, N; Li, J

    2016-04-01

    Previous studies have shown that recovery of colonic transit is a major determinant of post-operative ileus and clinical recovery after gastrointestinal surgery. Prucalopride is a highly selective 5-hydroxytryptamine receptor-4 agonist with colonic pro-motility effects. To evaluate the effect and safety of prucalopride on post-operative ileus and surgical outcomes after elective gastrointestinal surgery. In this phase II randomised clinical trial, 110 patients undergoing elective gastrointestinal surgery were randomised to either oral prucalopride (2 mg/day) (n = 55) or placebo (n = 55). Intervention was started 24 h after surgery and stopped after defecation or maximally at 7 days. The primary outcome was time to defecation. Secondary outcomes included time to first passage of flatus, tolerance of solid food, nasogastric tube reinsertion, post-operative length of stay, hospital readmission, overall cost, time to walk independently, surgical complications and inflammatory parameters. Patients who received prucalopride had a shorter time to defecation (65.0 vs. 94.5 h, P = 0.001), passage of flatus (53.0 vs. 73.0 h, P 5 days) (16.4% vs. 34.5%, P = 0.026) and the C-reactive protein level on post-operative day 5 (35.67 vs. 59.07 mg/L, P = 0.040) were lower in the prucalopride group. There was no significant difference in post-operative Clavien-Dindo grade III and IV complications (P = 0.606) between the groups. Prucalopride is a safe and effective treatment to reduce post-operative ileus and systemic inflammation without affecting post-operative complications in patients undergoing elective gastrointestinal surgery. ClinicalTrials.gov: NCT02004652. © 2016 John Wiley & Sons Ltd.

  12. Ensayos clínicos en Cirugía Pediátrica: Consideraciones bioéticas Clinical trials in Pediatric Surgery: Bioethical considerations

    Directory of Open Access Journals (Sweden)

    José Carlos Bueno Rodríguez

    2010-04-01

    Full Text Available Los ensayos clínicos son considerados como una de las mejores fuentes primarias de evidencia; sin embargo, este tipo de estudio es poco utilizado en Cirugía. El presente trabajo revisa algunas particularidades bioéticas de los ensayos clínicos en Cirugía Pediátrica. Las principales dificultades y limitaciones bioéticas son: la poca tradición de los cirujanos en la realización de ensayos clínicos, la irreversibilidad del tratamiento quirúrgico, la necesidad de entrenamiento técnico y experiencia manual, la ausencia de criterios de calidad de la técnica empleada y la influencia del periodo de aprendizaje en los resultados. Se presentan posibles soluciones para estas particularidades. Cuando se utilice el ensayo clínico como la mejor opción de diseño para contestar una pregunta de investigación clínica en cirugía con niños, deberán valorarse tanto las ventajas como las limitaciones y las dificultades bioéticas de este tipo de estudio.Clinical trials are considered the best primary source of evidence; however, this kind of study is slightly used in surgery. This paper revises some of the bioethical characteristics of clinical trials in Pediatric Surgery. The main bioethical difficulties and limitations are: surgeons´ little experience in clinical trials, irreversibility of surgical treatments, need of technical training and manual experience, absence of quality criteria concerning the technique used, and influence of the learning period in the results. Possible solutions to these aspects are presented. When clinical trials are used as the best option to answer any clinical research questions in pediatric surgery, their advantages and bioethical limitations and difficulties should taken into consideration.

  13. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

    2015-11-30

    Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is

  14. Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

    2017-02-23

    Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

  15. Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study.

    Science.gov (United States)

    Meybohm, Patrick; Zacharowski, Kai; Cremer, Jochen; Roesner, Jan; Kletzin, Frank; Schaelte, Gereon; Felzen, Marc; Strouhal, Ulrich; Reyher, Christian; Heringlake, Matthias; Schön, Julika; Brandes, Ivo; Bauer, Martin; Knuefermann, Pascal; Wittmann, Maria; Hachenberg, Thomas; Schilling, Thomas; Smul, Thorsten; Maisch, Sonja; Sander, Michael; Moormann, Tobias; Boening, Andreas; Weigand, Markus A; Laufenberg, Rita; Werner, Christian; Winterhalter, Michael; Treschan, Tanja; Stehr, Sebastian N; Reinhart, Konrad; Hasenclever, Dirk; Brosteanu, Oana; Bein, Berthold

    2012-06-01

    Transient ischaemia of non-vital tissue has been shown to enhance the tolerance of remote organs to cope with a subsequent prolonged ischaemic event in a number of clinical conditions, a phenomenon known as remote ischaemic preconditioning (RIPC). However, there remains uncertainty about the efficacy of RIPC in patients undergoing cardiac surgery. The purpose of this report is to describe the design and methods used in the "Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart)-Study". We are conducting a prospective, randomized, double-blind, multicentre, controlled trial including 2070 adult cardiac surgical patients. All types of surgery in which cardiopulmonary bypass is used will be included. Patients will be randomized either to the RIPC group receiving four 5 min cycles of transient upper limb ischaemia/reperfusion or to the control group receiving four cycles of blood pressure cuff inflation/deflation at a dummy arm. The primary endpoint is a composite outcome (all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure) until hospital discharge. The RIPHeart-Study is a multicentre trial to determine whether RIPC may improve clinical outcome in cardiac surgical patients.

  16. Use of the cardioprotectants thymosin β4 and dexrazoxane during congenital heart surgery: proposal for a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Stromberg, Daniel; Raymond, Tia; Samuel, David; Crockford, David; Stigall, William; Leonard, Steven; Mendeloff, Eric; Gormley, Andrew

    2012-10-01

    Neonates and infants undergoing heart surgery with cardioplegic arrest experience both inflammation and myocardial ischemia-reperfusion (IR) injury. These processes provoke myocardial apoptosis and oxygen-free radical formation that result in cardiac injury and dysfunction. Thymosin β4 (Tβ4) is a naturally occurring peptide that has cardioprotective and antiapoptotic effects. Similarly, dexrazoxane provides cardioprotection by reduction of toxic reactive oxygen species (ROS) and suppression of apoptosis. We propose a pilot pharmacokinetic/safety trial of Tβ4 and dexrazoxane in children less than one year of age, followed by a randomized, double-blind, clinical trial of Tβ4 or dexrazoxane versus placebo during congenital heart surgery. We will evaluate postoperative time to resolution of organ failure, development of low cardiac output syndrome, length of cardiac ICU and hospital stays, and echocardiographic indices of cardiac dysfunction. Results could establish the clinical utility of Tβ4 and/or dexrazoxane in ameliorating ischemia-reperfusion injury during congenital heart surgery. © 2012 New York Academy of Sciences.

  17. Safety and efficacy of landiolol hydrochloride for prevention of atrial fibrillation after cardiac surgery in patients with left ventricular dysfunction: Prevention of Atrial Fibrillation After Cardiac Surgery With Landiolol Hydrochloride for Left Ventricular Dysfunction (PLATON) trial.

    Science.gov (United States)

    Sezai, Akira; Osaka, Shunji; Yaoita, Hiroko; Ishii, Yusuke; Arimoto, Munehito; Hata, Hiroaki; Shiono, Motomi

    2015-10-01

    We previously conducted a prospective study of landiolol hydrochloride (INN landiolol), an ultrashort-acting β-blocker, and reported that it could prevent atrial fibrillation after cardiac surgery. This trial was performed to investigate the safety and efficacy of landiolol hydrochloride in patients with left ventricular dysfunction undergoing cardiac surgery. Sixty patients with a preoperative left ventricular ejection fraction of less than 35% were randomly assigned to 2 groups before cardiac surgery and then received intravenous infusion with landiolol hydrochloride (landiolol group) or without landiolol (control group). The primary end point was occurrence of atrial fibrillation as much as 1 week postoperatively. The secondary end points were blood pressure, heart rate, intensive care unit and hospital stays, ventilation time, ejection fraction, biomarkers of ischemia, and brain natriuretic peptide. Atrial fibrillation occurred in 3 patients (10%) in the landiolol group versus 12 (40%) in the control group, and its frequency was significantly lower in the landiolol group (P = .002). During the early postoperative period, levels of brain natriuretic peptide and ischemic biomarkers were significantly lower in the landiolol group than the control group. The landiolol group also had a significantly shorter hospital stay (P = .019). Intravenous infusion was not discontinued for hypotension or bradycardia in either group. Low-dose infusion of landiolol hydrochloride prevented atrial fibrillation after cardiac surgery in patients with cardiac dysfunction and was safe, with no effect on blood pressure. This intravenous β-blocker seems useful for perioperative management of cardiac surgical patients with left ventricular dysfunction. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  18. Clinical Trials in Surgery

    African Journals Online (AJOL)

    remedies for the disease (5). The placebo effect was famously brought to the attention of clinicians by. James Haygarth who proved that the metallic tractors being advocated for the management of furuncles through their 'animal magnetism' were nothing more than an expensive sham as wooden tractors worked just as well ...

  19. Adalimumab in acute sciatica reduces the long-term need for surgery: a 3-year follow-up of a randomised double-blind placebo-controlled trial.

    Science.gov (United States)

    Genevay, S; Finckh, A; Zufferey, P; Viatte, S; Balagué, F; Gabay, C

    2012-04-01

    Two subcutaneous injections of adalimumab in severe acute sciatica significantly reduced the number of back operations in a short-term randomised controlled clinical trial. To determine in a 3-year follow-up study whether the short-term benefit of adalimumab in sciatica is sustained over a longer period of time. The primary outcome of this analysis was incident discectomy. Three years after randomisation, information on surgery could be retrieved in 56/61 patients (92%).A multivariate Cox proportional hazard models, adjusted for potential confounders, was used to determine factors predisposing to surgery. Twenty-three (41%) patients had back surgery within 3 years, 8/29 (28%) in the adalimumab group and 15/27 (56%) in the placebo group, p=0.04. Adalimumab injections reduced the need for back surgery by 61% (HR)=0.39 (95% CI 0.17 to 0.92). In a multivariate model, treatment with a tumour necrosis factor-α antagonist remained the strongest protective factor (HR=0.17, p=0.002). Other significant predictors of surgery were a good correlation between symptoms and MRI findings (HR=11.6, p=0.04), baseline intensity of leg pain (HR=1.3, p=0.06), intensity of back pain (HR=1.4, p=0.03) and duration of sickness leave (HR=1.01 per day, p=0.03). A short course of adalimumab in patients with severe acute sciatica significantly reduces the need for back surgery.

  20. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don’t tell, they won’t know

    Directory of Open Access Journals (Sweden)

    Cynthia de Almeida Mendes

    Full Text Available OBJECTIVES: This study compared radiofrequency ablation versus conventional surgery in patients who had not undergone previous treatment for bilateral great saphenous vein insufficiency, with each patient serving as his own control. METHOD: This was a randomized controlled trial that included 18 patients and was carried out between November 2013 and May 2015. Each of the lower limbs of each patient was randomly assigned to undergo either radiofrequency ablation or conventional surgery. Clinical features (hyperpigmentation, hematoma, aesthetics, pain, skin burn, nerve injury, and thrombophlebitis were evaluated at one week, one month, and six months postoperatively. Hemodynamic assessments (presence of resection or occlusion of the great saphenous vein and recurrent reflux in the sapheno-femoral junction and in the great saphenous vein were performed at one month, six months, and 12 months postoperatively. The independent observer (a physician not involved in the original operation, patient, and duplex ultrasonographer were not made aware of the treatment done in each case. Clinicaltrials.gov: NCT02588911. RESULTS: Among the clinical variables analyzed, only the aesthetic evaluation by the physicians was significant, with radiofrequency ablation being considered better than conventional surgery (average, 0.91 points higher: standard deviation: 0.31; 95% confidence interval: -1.51, -0.30; p=0.003. However, in our study, we observed primary success rates of 80% for radiofrequency ablation and 100% for conventional surgery. CONCLUSIONS: If the physician is not required to inform the patient as to the technique being performed, the patient will not be able to identify the technique based on the signs and symptoms. Our study revealed that both techniques led to high levels of patient satisfaction, but our results favor the choice of conventional surgery over radiofrequency ablation, as patients who underwent conventional surgery had better hemodynamic

  1. Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery.

    Science.gov (United States)

    Rolving, Nanna; Oestergaard, Lisa Gregersen; Willert, Morten Vejs; Christensen, Finn Bjarke; Blumensaat, Frank; Bünger, Cody; Nielsen, Claus Vinther

    2014-03-03

    The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. It is expected that the intervention can provide better functional outcome, less

  2. Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: a strategy to reduce the incidence of postoperative delirium in elderly patients.

    Science.gov (United States)

    Li, Tianjing; Wieland, L Susan; Oh, Esther; Neufeld, Karin J; Wang, Nae-Yuh; Dickersin, Kay; Sieber, Frederick E

    2017-06-01

    Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others

  3. Randomized clinical trial comparing manual suture and different models of mechanical suture in the mimicking of bariatric surgery in swine

    Directory of Open Access Journals (Sweden)

    Fernandes MA

    2014-02-01

    analysis included the formation of foreign body granuloma in the gastroenteroanastomosis and enteroanastomosis in 88.9% of the swine that underwent manual suture and in none of the swine that underwent stapling. There was also a significant statistical difference among swine from Group A, and those from groups B, C and D regarding the degree of inflammation, being more intense in those swine that underwent manual suture. Conclusion: This study shows that both types of suture promoted proper healing of gastroenteroanastomosis and enteroanastomosis, although there was a higher degree of inflammation and an increased occurrence of foreign body granuloma in swine subjected to manual suture, although there have been similarities in safety, efficiency, and effectiveness between the models of linear mechanical staplers tested during the performance of these anastomoses on swine. Keywords: linear mechanical stapler, stapler, manual suture, surgery, gastroenteroanastomosis, enteroanastomosis, swine, randomized clinical trial

  4. Hyaluronic acid fluid agents for the prevention of adhesions after fertility-preserving gynecological surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Metwally, Mostafa; Gorvy, Dylan; Watson, Andrew; Li, Tin Chiu

    2007-05-01

    To investigate the role of hyaluronic acid-based fluid agents in the prevention of adhesions after fertility-preserving gynecological surgery. Meta-analysis. The authors searched the Cochrane Menstrual Disorders and Subfertility Group Specialized Register of Controlled Trials, The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE for randomized controlled trials of hyaluronic acid fluid agents compared with no treatment or placebo. Women undergoing fertility-preserving gynecological surgery. Hyaluronic acid fluid agents. [1] Prevalence and change in adhesion severity at second-look laparoscopy and [2] live birth rate. Four studies were included in the meta-analysis. The use of hyaluronic acid agents was associated with a decrease in the prevalence of adhesions at second-look laparoscopy (odds ratio, 0.31; 95% confidence interval, 0.19 to 0.51) and a lesser chance of deterioration of preexisting adhesions (odds ratio, 0.28; 95% confidence interval, 0.12 to 0.66). There was, however, no evidence for improvement in the prevalence of adhesions (odds ratio, 1.55; 95% confidence interval, 0.82 to 2.92). There is evidence that hyaluronic acid agents may decrease the prevalence of adhesions and prevent the deterioration of preexisting adhesions. However, because of the limited number of studies available, this evidence should still be interpreted with caution.

  5. Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

    Science.gov (United States)

    Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

    2015-06-01

    At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease: 5-Year Outcomes of the PRECOMBAT Study.

    Science.gov (United States)

    Ahn, Jung-Min; Roh, Jae-Hyung; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Lee, Pil Hyung; Chang, Mineok; Park, Hyun Woo; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Choo, Suk Jung; Chung, CheolHyun; Lee, JaeWon; Lim, Do-Sun; Rha, Seung-Woon; Lee, Sang-Gon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo; Chae, In-Ho; Jang, Yangsoo; Jeong, Myung-Ho; Tahk, Seung-Jea; Seung, Ki Bae; Park, Seung-Jung

    2015-05-26

    In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year. This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis. We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis. At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012). During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. Randomised clinical trial: conventional Lichtenstein vs. hernioplasty with self-adhesive mesh in bilateral inguinal hernia surgery.

    Science.gov (United States)

    Porrero, Jose L; Castillo, María J; Pérez-Zapata, Ana; Alonso, María T; Cano-Valderrama, Oscar; Quirós, Esther; Villar, Sol; Ramos, Beatriz; Sánchez-Cabezudo, Carlos; Bonachia, Oscar; Marcos, Alberto; Pérez, Brígido

    2015-10-01

    To compare the results of conventional Lichtenstein hernioplasty with polypropylene mesh (PLP) with a lightweight self-adhesive mesh (Parietene Progrip®; Covidien, Dublin, Ireland) (PPG) used in patients with bilateral inguinal hernia. Randomised clinical trial with 89 patients with a minimum follow-up of 1 year. Every patient had bilateral inguinal hernia and had both prostheses implanted randomly, one on each side. Early postoperative and chronic pain was evaluated using the visual analogue scale. Also recurrence rate and subjective evaluation of patients were analysed. Pain in the early postoperative period was inferior on the side where the self-adhesive mesh had been implanted (6.12 vs. 6.62, p=0.005 during the 1st postoperative day; 2.12 vs. 2.62, p=0.001 during the 7th postoperative day). Differences disappeared with the long-term evaluation (0.71 vs. 0.98, p=0.148 1 year after the surgery). The operative time was significantly shorter on the PPG mesh side (24.37 ± 5.1 in case of the PPG mesh and 29.66 ± 5.6 in case of the PLP mesh, p<0,001). Recurrence occurred in seven patients (7.8%), six of them (6.7%, CI 3.0-14.4) on the PPG mesh side and one (1.1%, CI 0.2-7.8) on the PLP side. These differences were not statistically significant (p=0.125) CONCLUSIONS: Although hernioplasty with self-adhesive mesh reduced early postoperative pain, this reduction was clinically irrelevant and it had no influence on chronic pain. There was a trend towards a higher recurrence rate when self-adhesive meshes were used, and although in this study differences were not statistically significant they should be confirmed in later studies using larger samples. Surgical procedures that do not need fixing sutures are promising, but further studies are needed before they become the gold standard of inguinal hernia repair.

  9. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    Science.gov (United States)

    Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

    2005-01-01

    Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

  10. A Clinical Feasibility Trial for Identification of Exceptional Responders in Whom Breast Cancer Surgery Can Be Eliminated Following Neoadjuvant Systemic Therapy.

    Science.gov (United States)

    Kuerer, Henry M; Rauch, Gaiane M; Krishnamurthy, Savitri; Adrada, Beatriz E; Caudle, Abigail S; DeSnyder, Sarah M; Black, Dalliah M; Santiago, Lumarie; Hobbs, Brian P; Lucci, Anthony; Gilcrease, Michael; Hwang, Rosa F; Candelaria, Rosalind P; Chavez-MacGregor, Mariana; Smith, Benjamin D; Arribas, Elsa; Moseley, Tanya; Teshome, Mediget; Miggins, Makesha V; Valero, Vicente; Hunt, Kelly K; Yang, Wei T

    2017-05-25

    To determine the accuracy of fine-needle aspiration (FNA) and vacuum-assisted core biopsy (VACB) in assessing the presence of residual cancer in the breast after neoadjuvant systemic therapy (NST). Pathologic complete response (pCR) rates after NST have improved dramatically, suggesting that surgery might be avoided in some patients. Safe avoidance of surgery would require accurate confirmation of no residual invasive/in situ carcinoma. Forty patients with T1-3N0-3 triple-negative or HER2-positive cancer receiving NST were enrolled in this single-center prospective trial. Patients underwent ultrasound-guided or mammography-guided FNA and VACB of the initial breast tumor region before surgery. Findings were compared with findings on pathologic evaluation of surgical specimens to determine the performance of biopsy in predicting residual breast disease after NST. Median initial clinical tumor size was 3.3 cm (range, 1.2-7.0 cm); 16 patients (40%) had biopsy-proven nodal metastases. After NST, median clinical tumor size was 1.1 cm (range, 0-4.2 cm). Nineteen patients (47.5%) had a breast pCR and were concordant with pathologic nodal status in 97.5%. Combined FNA/VACB demonstrated an accuracy of 98% (95% CI, 87%-100%), false-negative rate of 5% (95% CI, 0%-24%), and negative predictive value of 95% (95% CI, 75%-100%) in predicting residual breast cancer. VACB alone was more accurate than FNA alone (P = 0.011). After NST, image-guided FNA/VACB can accurately identify patients with a breast pCR. Based on these results, a prospective clinical trial has commenced in which breast surgery is omitted in patients with a breast pCR after NST according to image-guided biopsy.

  11. Effect of Perioperative Intravenous Lidocaine Infusion on Acute and Chronic Pain after Breast Surgery: A Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Chang, Yuan-Ching; Liu, Chien-Liang; Liu, Tsang-Pai; Yang, Po-Sheng; Chen, Ming-Jen; Cheng, Shih-Ping

    2017-03-01

    Intravenous lidocaine infusion has been shown to reduce postoperative pain among patients undergoing abdominal surgery. This study aimed to evaluate the effects of perioperative lidocaine administration in breast surgery. A meta-analysis of randomized controlled trials comparing lidocaine infusion vs. placebo/routine treatment was performed. Standardized mean difference (SMD) or risk ratio (RR) with 95% confidence intervals (CIs) was calculated from pooled data. Random-effects models were used, and heterogeneity was assessed. A total of 4 reports (3 primary studies and 1 extension) with 84 patients randomized to the lidocaine group and 83 patients randomized to the control group were included. There was no difference in pain scores at rest or during activity between the 2 groups from postoperative 2 hours to 3 days. At postoperative 72 hours, the lidocaine group had fewer analgesics consumed (SMD, -0.479; 95% CI, -0.914 to -0.043; P = 0.031). Chronic pain was assessed 3 to 6 months after breast surgery in 51 patients of the lidocaine group and 46 patients of the control group. Patients in the lidocaine group had significantly lower risk for the development of chronic pain (RR, 0.332; 95% CI, 0.141 to 0.781; P = 0.012). The results indicate no significant benefits of intravenous lidocaine infusion in terms of acute postoperative pain. Although lidocaine seems to attenuate the risk of chronic pain after breast surgery, there is insufficient evidence to conclude that lidocaine infusion is of proved benefit because the results were based on a limited number of small trials. © 2016 World Institute of Pain.

  12. Adding pregabalin to a multimodal analgesic regimen does not reduce pain scores following cosmetic surgery: a randomized trial.

    Science.gov (United States)

    Chaparro, Luis Enrique; Clarke, Hance; Valdes, Paola A; Mira, Mauricio; Duque, Lorena; Mitsakakis, Nicholas

    2012-12-01

    Multimodal analgesia increases the chance of successful discharge and pain control after surgery, and pregabalin is being promoted as an effective analgesic, based on placebo-controlled studies. We investigated whether adding pregabalin improved pain control and reduced opioid requests when it was added to a multimodal analgesic regimen for cosmetic surgery. One hundred and ten women who underwent same-day cosmetic surgery were randomized to receive oral pregabalin, 75 mg q12 h for five consecutive days starting the night before surgery, or identical placebos. Participants, outcomes assessors, and the statistician were blinded. The primary outcome was postoperative numerical movement-evoked pain scores at 2, 24, 48, 72, and 96 h after surgery. The secondary outcomes included pain scores at rest; incidence of moderate to severe pain; and analgesic and antiemetic requirements; as well as the incidence of nausea, vomiting, and somnolence. Based on 99 patients who completed the study, we found no difference between the groups in the primary outcome; 72 h after surgery, movement-evoked median pain scores were cosmetic surgery. Several factors could explain our findings, including the possibility of publication bias in the current literature.

  13. Does point of care prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? The POC-OP randomized-controlled trial

    Directory of Open Access Journals (Sweden)

    Alberio Lorenzo

    2009-11-01

    Full Text Available Abstract Background Bleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP, is often live saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. Consequently, strategies to optimize the decision to transfuse are needed. Bleeding during surgery is a dynamic process and may result in major blood loss and coagulopathy due to dilution and consumption. The indication for transfusion should be based on reliable coagulation studies. While hemoglobin levels and platelet counts are available within 15 minutes, standard coagulation studies require one hour. Therefore, the decision to administer FFP has to be made in the absence of any data. Point of care testing of prothrombin time ensures that one major parameter of coagulation is available in the operation theatre within minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Methods/Design The objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will yield more than 80% power to detect a clinically relevant relative risk

  14. A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007).

    Science.gov (United States)

    Antolovic, D; Rakow, A; Contin, P; Ulrich, A; Rahbari, N N; Büchler, M W; Weitz, J; Koch, M

    2012-02-01

    Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, owing to a lack of evidence-based data, a widely accepted consensus on the perioperative management of these patients in the setting of non-cardiac surgery has not yet been reached. Primary objective was to evaluate the safety of continuous versus discontinuous use of ASA in the perioperative period in elective general or abdominal surgery. Fifty-two patients undergoing elective cholecystectomy, inguinal hernia repair or colonic/colorectal surgery were recruited to this pilot study. According to cardiological evaluation, non-high-risk patients who were on long-term treatment with low-dose ASA were eligible for inclusion. Patients were allocated randomly to continuous use of ASA or discontinuation of ASA intake for 5 days before until 5 days after surgery. The primary outcome was the incidence of major haemorrhagic and thromboembolic complications within 30 days after surgery. A total of 26 patients were allocated to each study group. One patient (3.8%) in the ASA continuation group required re-operation due to post-operative haemorrhage. In neither study group, further bleeding complications occurred. No clinically apparent thromboembolic events were reported in the ASA continuation and the ASA discontinuation group. Furthermore, there were no significant differences between both study groups in the secondary endpoints. Perioperative intake of ASA does not seem to influence the incidence of severe bleeding in non-high-risk patients undergoing elective general or abdominal surgery. Further, adequately powered trials are required to confirm the findings of this study.

  15. Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial.

    Science.gov (United States)

    Emmert, Maximilian Y; Puippe, Gilbert; Baumüller, Stephan; Alkadhi, Hatem; Landmesser, Ulf; Plass, Andre; Bettex, Dominique; Scherman, Jacques; Grünenfelder, Jürg; Genoni, Michele; Falk, Volkmar; Salzberg, Sacha P

    2014-01-01

    Atrial fibrillation (AF) is a significant risk factor for embolic stroke originating from the left atrial appendage (LAA). This is the first report of long-term safety and efficacy data on LAA closure using a novel epicardial LAA clip device in patients undergoing cardiac surgery. Forty patients with AF were enrolled in this prospective 'first-in-man' trial. The inclusion criterion was elective cardiac surgery in adult patients with AF for which a concomitant ablation procedure was planned. Intraoperative transoesophageal echocardiography (TEE) was used to exclude LAA thrombus at baseline and evaluate LAA perfusion after the procedure, while computed tomography (CT) was used for serial imagery workup at baseline, 3-, 12-, 24- and 36-month follow-up. Early mortality was 10% due to non-device-related reasons, and thus 36 patients were included in the follow-up consisting of 1285 patient-days and mean duration of 3.5 ± 0.5 years. On CT, clips were found to be stable, showing no secondary dislocation 36 months after surgery. No intracardial thrombi were seen, none of the LAA was reperfused and in regard to LAA stump, none of the patients demonstrated a residual neck >1 cm. Apart from one unrelated transient ischaemic attack (TIA) that occurred 2 years after surgery in a patient with carotid plaque, no other strokes and/or neurological events demonstrated in any of the studied patients during follow-up. This is the first prospective trial in which concomitant epicardial LAA occlusion using this novel epicardial LAA clip device is 100% effective, safe and durable in the long term. Closure of the LAA by epicardial clipping is applicable to all-comers regardless of LAA morphology. Minimal access epicardial LAA clip closure may become an interesting therapeutic option for patients in AF who are not amenable to anticoagulation and/or catheter closure. Further data are necessary to establish LAA occlusion as a true and viable therapy for stroke prevention. The trial is

  16. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA).

    Science.gov (United States)

    Futier, Emmanuel; Paugam-Burtz, Catherine; Godet, Thomas; Khoy-Ear, Linda; Rozencwajg, Sacha; Delay, Jean-Marc; Verzilli, Daniel; Dupuis, Jeremie; Chanques, Gerald; Bazin, Jean-Etienne; Constantin, Jean-Michel; Pereira, Bruno; Jaber, Samir

    2016-12-01

    High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap. A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation. The primary endpoint was absolute risk reduction (ARR) for hypoxaemia at 1 h after extubation and after treatment discontinuation. Secondary outcomes included occurrence of postoperative pulmonary complications within 7 days after surgery, the duration of hospital stay, and in-hospital mortality. The analysis was performed on data from the modified intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT01887015). Between 6 November 2013 and 1 March 2015, 220 patients were randomly assigned to receive either HFNC (n = 108) or standard oxygen therapy (n = 112); all of these patients completed follow-up. The median duration of the allocated treatment was 16 h (interquartile range 14-18 h) with standard oxygen therapy and 15 h (interquartile range 12-18) with HFNC therapy. Twenty-three (21 %) of the 108 patients treated with HFNC 1 h after extubation and 29 (27 %) of the 108 patients after treatment discontinuation had postextubation hypoxaemia, compared with 27 (24 %) and 34 (30 %) of the 112 patients treated with standard oxygen (ARR 4, 95 % CI -8 to 15 %; p = 0.57; adjusted relative risk [RR] 0.87, 95 % CI 0.53-1.43; p = 0.58). Over the 7-day postoperative follow-up period

  17. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  18. Pre-surgery exercise and post-operative physical function of people undergoing knee replacement surgery: A systematic review and meta-analysis of randomized controlled trials

    OpenAIRE

    Peer, Maria; Rush, Robert; Gallacher, P; Gleeson, Nigel

    2017-01-01

    Objective: To summarize the evidence regarding the effectiveness and dose-response characteristics of pre-operative exercise programmes on post-operative physical function following total knee arthroplasty.\\ud Data sources: CINAHL, Cochrane Library, PubMed, SPORTDiscus and EMBASE.\\ud Study selection: Randomized controlled trials were eligible if they provided full description of physiological stress (i.e. mode, frequency, intensity and duration).\\ud Data extraction: Data extraction and evalua...

  19. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  20. The effect of mannitol on intraoperative brain relaxation in patients undergoing supratentorial tumor surgery: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background The risk of brain swelling after dural opening is high in patients with midline shift undergoing supratentorial tumor surgery. Brain swelling may result in increased intracranial pressure, impeded tumor exposure, and adverse outcomes. Mannitol is recommended as a first-line dehydration treatment to reduce brain edema and enable brain relaxation during neurosurgery. Research has indicated that mannitol enhanced brain relaxation in patients undergoing supratentorial tumor surgery; however, these results need further confirmation, and the optimal mannitol dose has not yet been established. We propose to examine whether different doses of 20% mannitol improve brain relaxation in a dose-dependent manner when administered at the time of incision. We will examine patients with preexisting mass effects and midline shift undergoing elective supratentorial brain tumor surgery. Methods This is a single-center, randomized controlled, parallel group trial that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Randomization will be achieved using a computer-generated table. The study will include 220 patients undergoing supratentorial tumor surgery whose preoperative computed tomography/magnetic resonance imaging results indicate a brain midline shift. Patients in group A, group B, and group C will receive dehydration treatment at incision with 20% mannitol solutions of 0.7, 1.0, and 1.4 g/kg, respectively, at a rate of 600 mL/h. The patients in the control group will not receive mannitol. The primary outcome is an improvement in intraoperative brain relaxation and dura tension after dehydration with mannitol. Secondary outcomes are postoperative outcomes and the incidence of mannitol side effects. Discussion The aim of this study is to determine the optimal dose of 20% mannitol for intraoperative infusion. We will examine brain relaxation and outcome in patients undergoing supratentorial tumor surgery. If our results are positive, the study

  1. The effect of mobile app home monitoring on number of in-person visits following ambulatory surgery: protocol for a randomized controlled trial.

    Science.gov (United States)

    Armstrong, Kathleen A; Coyte, Peter C; Bhatia, R Sacha; Semple, John L

    2015-06-03

    Women's College Hospital, Toronto, Canada, offers specialized ambulatory surgical procedures. Patients often travel great distances to undergo surgery. Most patients receiving ambulatory surgery have a low rate of postoperative events necessitating clinic visits. However, regular follow-up is still considered important in the early postoperative phase. Increasingly, telemedicine is used to overcome the distance patients must travel to receive specialized care. Telemedicine data suggest that mobile monitoring and follow-up care is valued by patients and can reduce costs to society. Women's College Hospital has used a mobile app (QoC Health Inc) to complement in-person postoperative follow-up care for breast reconstruction patients. Preliminary studies suggest that mobile app follow-up care is feasible, can avert in-person follow-up care, and is cost-effective from a societal and health care system perspective. We hope to expand the use of mobile app follow-up care through its formal assessment in a randomized controlled trial. In postoperative ambulatory surgery patients at Women's College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app follow-up care compared to conventional, in-person follow-up care in the first 30 days after surgery. This will be a pragmatic, single-center, open, controlled, 2-arm parallel-group superiority randomized trial comparing mobile app and in-person follow-up care over the first month following surgery. The patient population will comprise all postoperative ambulatory surgery patients at WCH undergoing breast reconstruction. The intervention consists of a postoperative mobile app follow-up care using the quality of recovery-9 (QoR9) and a pain visual analog scale (VAS), surgery-specific questions, and surgical site photos submitted daily for the first 2 weeks and weekly for the following 2 weeks. The primary outcome is the total number of physician visits related to the surgery over the first 30-days

  2. Obesity-related cardiovascular risk factors after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention

    National Research Council Canada - National Science Library

    D Hofsø; N Nordstrand; L K Johnson; T I Karlsen; H Hager; T Jenssen; J Bollerslev; K Godang; R Sandbu; J Røislien; J Hjelmesæth

    2010-01-01

    Weight reduction improves several obesity-related health conditions. We aimed to compare the effect of bariatric surgery and comprehensive lifestyle intervention on type 2 diabetes and obesity-related cardiovascular risk factors...

  3. Effectiveness and cost-effectiveness of rehabilitation after lumbar disc surgery (REALISE): design of a randomised controlled trial

    NARCIS (Netherlands)

    Oosterhuis, T.; van Tulder, M.W.; Peul, W.C.; Bosmans, J.E.; Vleggeert-Lankamp, C.L.A.; Smakman, L.; Arts, M.; Ostelo, R.W.J.G.

    2013-01-01

    Background: Patients who undergo lumbar disc surgery for herniated discs, are advocated two different postoperative management strategies: a watchful waiting policy, or referral for rehabilitation immediately after discharge from the hospital. A direct comparison of the effectiveness and

  4. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  5. Does the mode of exercise influence recovery of functional capacity in the early postoperative period after coronary artery bypass graft surgery? A randomized controlled trial.

    Science.gov (United States)

    Hirschhorn, Andrew D; Richards, David A B; Mungovan, Sean F; Morris, Norman R; Adams, Lewis

    2012-12-01

    The purpose of this study was to compare the effectiveness of moderate-intensity stationary cycling and walking exercise programmes in the early postoperative period after first-time coronary artery bypass graft surgery. In this prospective trial, 64 patients (57 men, 7 women, mean age = 66 ± 9 years) performed twice daily, moderate-intensity exercise sessions, of 10-min duration, from postoperative day 3 until discharge from hospital. Patients were randomly assigned to stationary cycling or walking exercise intervention groups. Preoperative and discharge functional exercise capacity and health-related quality of life were assessed using 6-min walk and cycle assessments and the SF-36 version 2.0 questionnaire. Compliance with exercise was calculated as the proportion of scheduled exercise sessions completed. There were no significant differences between intervention groups at hospital discharge for 6-min walk distance (cyclists: 402 ± 93 m vs walkers: 417 ± 86 m, P = 0.803), 6-min cycle work (cyclists: 15.0 ± 6.4 kJ vs walkers: 14.0 ± 6.3 kJ, P = 0.798) or health-related quality of life. There was no significant difference between intervention groups for postoperative length of hospital stay (P = 0.335). Compliance rates for intervention groups were cyclists: 185/246 (75%) scheduled exercise sessions completed vs walkers: 199/242 (82%) scheduled exercise sessions completed (P = 0.162). Stationary cycling provides a well-tolerated and clinically effective alternative to walking in the early postoperative period after coronary artery bypass graft surgery. The optimal frequency, intensity and duration of exercise in the early postoperative period require further investigation. (Clinical trials register: Australian New Zealand Clinical Trials Registry; identification number: ACTRN12608000359336; http://www.anzctr.org.au/trial_view.aspx?ID=82978).

  6. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Kelly Ickmans

    2016-07-01

    Discussion: This study will determine whether pain neuroscience education is worthwhile for patients undergoing surgery for lumbar radiculopathy. It is expected that participants who receive perioperative pain neuroscience education will report less pain and have improved endogenous pain modulation, lower postoperative healthcare costs and improved surgical experience. Lower pain and improved endogenous pain modulation after surgery may reduce the risk of developing postoperative chronic pain.

  7. Evaluation of the efficacy of meloxicam for post-operative management of pain and inflammation in horses after orthopaedic surgery in a placebo controlled clinical field trial.

    Science.gov (United States)

    Walliser, Ulrich; Fenner, Albrecht; Mohren, Nicole; Keefe, Thomas; deVries, Frerich; Rundfeldt, Chris

    2015-05-15

    The benefit of pre and post-operative administration of non-steroidal anti-inflammatory drugs for the relief of post-operative pain and control of inflammation in horses following orthopaedic surgery has not been previously investigated in controlled clinical field trials, and the utility of such treatment is a matter of ongoing dispute. Recently the utility of post-operative pain management was emphasized. It was therefore our aim to determine the efficacy of meloxicam in horses following partial resection of fractured splint bones. This condition was selected since the limited extent of the insult and the defined surgical intervention allowed the conduct of a randomized, double blinded, placebo-controlled, parallel group, multi-centre clinical field study in a homogenous patient population. Sixty-six client owned horses requiring unilateral partial splint bone resection were recruited in 15 centres in Germany and were allocated in a 1:1 ratio to receive meloxicam, 0.6 mg/kg for 5 days. Lameness at trot grades prior to surgery were similar in the meloxicam and placebo treatment groups but were significantly lower in the meloxicam group on day 6 post surgery. Clinical scores for soft tissue swelling and assessment of analgesic and anti-inflammatory efficacy by the investigators at the end of the study were significantly better for the meloxicam compared to the placebo group. No treatment-related adverse reactions were observed. The administration of meloxicam i.v. once prior to surgery followed by once daily oral administration for four consecutive days is efficacious for the control of post-operative pain and inflammation in horses undergoing orthopaedic surgery.

  8. The effects of oral pregabalin on post-operative pain of lower limb orthopedic surgery: A double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Godrat Akhavanakbari

    2013-01-01

    Full Text Available Background: Post-operative pain is one of the problems, wherein lack of control on it has many side-effects such as tachycardia, hypertension, myocardial ischemia, decreased alveolar ventilation, and poor wound healing. Aims: In this study, we evaluated the pre-operative administration of pregabalin sufficiency and security in relieving post-operative pain after lower limb orthopedic surgery and reducing the need for opioids and their possible side-effects. Materials and Methods: This study is a randomized, double-blind clinical trial. It was performed on 60 patients under lower limb surgery by spinal anesthesia. Patients were randomly allocated to two groups, one group has received a 150 mg pregabalin capsule 2 h before surgery and the other group has received placebo as a control. In both groups at 2, 6, 12, and 24 h after surgery, the patients were evaluated and the pain score, the score of sedation, incidence of nausea and vomiting was recorded in the checklists. Then, the data were analyzed by SPSS v16. Results: Visual analog pain scores at all hours in pregabalin group significantly reduced compared to the placebo group ( P < 0.0001. Also, in the pregabalin group nausea and vomiting scores at all hours, sedation levels at 2 h and 6 h post-operatively, and pethidine consumption in all hours have significantly been reduced. Conclusion: A single pre-operative oral dose of pregabalin 150 mg is an effective method for reducing post-operative pain and pethidine consumption in patients undergoing orthopedic surgery.

  9. Attaining surgical competency and its implications in surgical clinical trial design: a systematic review of the learning curve in laparoscopic and robot-assisted laparoscopic colorectal cancer surgery.

    Science.gov (United States)

    Barrie, Jenifer; Jayne, David G; Wright, Judy; Murray, Carolyn J Czoski; Collinson, Fiona J; Pavitt, Sue H

    2014-03-01

    Laparoscopic surgery is increasingly used in the treatment of colorectal cancer and more recently robotic assistance has been advocated. However, the learning curve to achieve surgical proficiency in laparoscopic surgery is ill-defined and subject to many influences. The aim of this review was to comprehensively appraise the literature on the learning curve for laparoscopic and robotic colorectal cancer surgery, and to quantify attainment of surgical proficiency and its implications in surgical clinical trial design. A systematic review using a defined search strategy was performed. Included studies had to state an explicit numerical value of the learning curve evaluated by a single parameter or multiple parameters. Thirty-four studies were included, 28 laparoscopic and 6 robot assisted. Of the laparoscopic studies, nine defined the learning curve on the basis of a single parameter. Nine studies used more than one parameter to define learning, and 11 used a cumulative sum (CUSUM) analysis. One study used both a multiparameter and CUSUM analysis. The definition of proficiency was subjective, and the number of operations to achieve it ranged from 5 to 310 cases for laparoscopic and 15-30 cases for robotic surgery. The learning curve in laparoscopic colorectal surgery is multifaceted and often ill-defined, with poor descriptions of mentorship/supervision. Further, the quantification to attain proficiency is variable. The use of a single parameter to quantify this is simplistic. Multidimensional assessment is recommended; as part of this, the CUSUM model, which assesses trends in multiple surgical outcomes, is useful and appropriate when assessing the learning curve in a clinical setting.

  10. Myofascial techniques have no additional beneficial effects to a standard physical therapy programme for upper limb pain after breast cancer surgery: a randomized controlled trial.

    Science.gov (United States)

    De Groef, An; Van Kampen, Marijke; Vervloesem, Nele; De Geyter, Sophie; Christiaens, Marie-Rose; Neven, Patrick; Vos, Lore; De Vrieze, Tessa; Geraerts, Inge; Devoogdt, Nele

    2017-05-01

    To investigate the effects of myofascial techniques, in addition to a standard physical therapy programme for upper limb pain shortly after breast cancer surgery. Double-blinded (patient and assessor) randomized controlled trial with two groups. University Hospitals Leuven, Belgium Patients: A total of 147 patients with unilateral axillary clearance for breast cancer. All participants received a standard physical therapy programme starting immediately after surgery for four months. The intervention group received additionally eight sessions of myofascial therapy from two up to four months after surgery. The control group received eight sessions of a placebo intervention, including static hand placements at the upper body region. The primary outcome was prevalence rate of upper limb pain. Additionally, pain intensity (Visual Analogue Scale (VAS, 0-100)), pressure hypersensitivity (pressure pain thresholds (PPTs; kg/cm(2))) and pain quality (McGill Pain Questionnaire) were evaluated. All measurements were performed at 2 (=baseline), 4, 9 and 12 months post-surgery. At 4, 9 and 12 months post-surgery, prevalence rates of pain, pain intensity and pain quality were comparable between the intervention and control group. PPT of the upper trapezius muscle was significantly higher in the intervention group at four months with a difference of -1.2 (-1.9 to -0.4) kg/cm(2), P = 0.012). PPT of the supraspinatus muscle was significantly higher in the intervention group at four months (-0.7 (-1.4 to -0.1) kg/cm(2), P = 0.021) and at nine months (-0.5 (-1.1 to 0.0), P = 0.040). Myofascial therapy has no added beneficial effect as standard physical therapy modality in the postoperative stage.

  11. Effect of melatonin on depressive symptoms and anxiety in patients undergoing breast cancer surgery: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Hansen, Melissa V; Andersen, Lærke T; Madsen, Michael T; Hageman, Ida; Rasmussen, Lars S; Bokmand, Susanne; Rosenberg, Jacob; Gögenur, Ismail

    2014-06-01

    Depression, anxiety and sleep disturbances are known problems in patients with breast cancer. The effect of melatonin as an antidepressant in humans with cancer has not been investigated. We investigated whether melatonin could lower the risk of depressive symptoms in women with breast cancer in a three-month period after surgery and assessed the effect of melatonin on subjective parameters: anxiety, sleep, general well-being, fatigue, pain and sleepiness. Randomized, double-blind, placebo-controlled trial undertaken from July 2011 to December 2012 at a department of breast surgery in Copenhagen, Denmark. Women, 30-75 years, undergoing surgery for breast cancer and without signs of depression on Major Depression Inventory (MDI) were included 1 week before surgery and received 6 mg oral melatonin or placebo for 3 months. The primary outcome was the incidence of depressive symptoms measured by MDI. The secondary outcomes were area under the curve (AUC) for the subjective parameters. 54 patients were randomized to melatonin (n = 28) or placebo (n = 26) and 11 withdrew from the study (10 placebo group and 1 melatonin group, P = 0.002). The risk of developing depressive symptoms was significantly lower with melatonin than with placebo (3 [11 %] of 27 vs. 9 [45 %] of 20; relative risk 0.25 [95 % CI 0.077-0.80]), giving a NNT of 3.0 [95 % CI 1.7-11.0]. No significant differences were found between AUC for the subjective parameters. No differences in side effects were found (P = 0.78). Melatonin significantly reduced the risk of depressive symptoms in women with breast cancer during a three-month period after surgery.

  12. A randomized controlled trial of subcutaneous closed-suction Blake drains for the prevention of incisional surgical site infection after colorectal surgery.

    Science.gov (United States)

    Watanabe, Jun; Ota, Mitsuyoshi; Kawamoto, Makoto; Akikazu, Yago; Suwa, Yusuke; Suwa, Hirokazu; Momiyama, Masashi; Ishibe, Atsushi; Watanabe, Kazuteru; Masui, Hidenobu; Nagahori, Kaoru

    2017-03-01

    The effects of subcutaneous closed-suction Blake drain for preventing incisional surgical site infections (SSIs) after colorectal surgery have never been evaluated in a randomized controlled trial (RCT). Thus, we performed a RCT to evaluate the clinical benefits of using a subcutaneous closed-suction Blake drain in patients undergoing colorectal surgery. Consecutive patients who underwent colorectal surgery were enrolled in this study. Patients were randomly assigned to the subcutaneous closed-suction drainage arm or the control (no subcutaneous drainage) arm. The primary endpoint was incidence rate of incisional SSIs. And, we performed logistic regression analysis to detect predictive factors for incisional SSIs after colorectal surgery. From November 2012 to September 2014, a total of 240 patients were enrolled in this study. One-hundred-seventeen patients who were treated by the control arm and 112 patients by the subcutaneous drainage arm were judged to be eligible for analysis. The incidence of incisional SSIs rate was 8.7 % in the overall patients. The incidence of incisional SSIs rate was 12.8 % in the control arm and 4.5 % in the subcutaneous drainage arm. There was significantly reduction of the incidence in the subcutaneous drainage arm than in the control arm (p = 0.025). Logistic regression analysis demonstrated that thickness of subcutaneous fat >3.0 cm, forced expiratory volume in 1 s as percent of forced vital capacity (FEV1.0 %) >70 %, and subcutaneous drain were independent predictors of postoperative incisional SSIs (p = 0.008, p = 0.004, and p = 0.017, respectively). The results of our RCT suggest that a subcutaneous Blake drain is beneficial for preventing incisional SSIs in patients undergoing colorectal surgery.

  13. Early results of a safety and feasibility clinical trial of a novel single-port flexible robot for transoral robotic surgery.

    Science.gov (United States)

    Chan, Jason Y K; Wong, Eddy W Y; Tsang, Raymond K; Holsinger, F Christopher; Tong, Michael C F; Chiu, Philip W Y; Ng, Simon S M

    2017-11-01

    The aim of this study was to describe the early results of a phase 1 safety and feasibility clinical trial of the first clinical use of a novel robot for transoral robotic surgery (TORS)-the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA). Study design of this study is prospective clinical trial. The methods used in this study are prospective innovation, development, exploration, assessment, and long-term study phase 1 clinical trial. Early results of six patients underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) demonstrate access the nasopharynx, oropharynx, larynx, and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all six patients. The early results of this safety and feasibility trial of the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) clearly demonstrate that the device is safe and that it is feasible in performing TORS to access the nasopharynx, oropharynx, larynx, and hypopharynx.

  14. Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol.

    Science.gov (United States)

    Ottridge, Ryan; Mollan, Susan P; Botfield, Hannah; Frew, Emma; Ives, Natalie J; Matthews, Tim; Mitchell, James; Rick, Caroline; Singhal, Rishi; Woolley, Rebecca; Sinclair, Alexandra J

    2017-09-27

    Effective treatments are lacking for idiopathic intracranial hypertension (IIH), a condition characterised by raised intracranial pressure (ICP) and papilloedema, and found primarily in obese women. Weight loss and lowering body mass index (BMI) have been shown to lower ICP and improve symptoms in IIH; however, weight loss is typically not maintained, meaning IIH symptoms return. The Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) will assess whether bariatric surgery is an effective long-term treatment for patients with IIH with a BMI over 35 kg/m2. The National Institute for Health and Care Excellence recommends bariatric surgery in people with a BMI over 35 kg/m2 and a qualifying comorbidity; currently IIH does not qualify as a comorbidity. IIH:WT is a multicentre, open-label, randomised controlled clinical trial of 64 participants with active IIH and a BMI over 35 kg/m2. Participants will be randomised in a 1:1 ratio to bariatric surgery or a dietary weight loss programme and followed up for 5 years. The primary outcome measure is ICP at 12 months. Secondary outcome measures include ICP at 24 and 60 months, and IIH symptoms, visual function, papilloedema, headache, quality of life and cost-effectiveness at 12, 24 and 60 months. IIH:WT is registered as ISRCTN40152829 and on ClinicalTrials.gov as NCT02124486 and is in the pre-results stage. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds.

    Science.gov (United States)

    Heliövaara, Arja; Küseler, Annelise; Skaare, Pål; Shaw, William; Mølsted, Kirsten; Karsten, Agneta; Brinck, Eli; Rizell, Sara; Marcusson, Agneta; Sæle, Paul; Hurmerinta, Kirsti; Rønning, Elisabeth; Najar Chalien, Midia; Bellardie, Haydn; Mooney, Jeanette; Eyres, Phil; Semb, Gunvor

    2017-02-01

    Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. Three parallel randomised clinical trials were undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Study models of 418 patients (273 boys) at the mean age of 5.1 years (range = 4.8-7.0) were available. Dental arch relationships were assessed using the 5-year index by a blinded panel of 16 orthodontists. Kappa statistics were calculated to assess reliability. The trials were tested statistically with t- and Chi-square tests. Good-to-very good levels of intra- and interrater reliability were obtained (0.71-0.94 and 0.70-0.87). Comparisons within each trial showed no statistically significant differences in the mean 5-year index scores or their distributions between the common method and the local team protocol. The mean index scores varied from 2.52 (Trial 2, Arm C) to 2.94 (Trial 3, Arm D). The results of the three trials do not provide statistical evidence that one technique is better than the others. Further analysis of the possible influence of individual surgical skill and learning curve are being pursued in this dataset. ISRCTN29932826.

  16. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial.

    Science.gov (United States)

    Karoui, Mehdi; Rullier, Anne; Luciani, Alain; Bonnetain, Franck; Auriault, Marie-Luce; Sarran, Antony; Monges, Geneviève; Trillaud, Hervé; Le Malicot, Karine; Leroy, Karen; Sobhani, Iradj; Bardier, Armelle; Moreau, Marie; Brindel, Isabelle; Seitz, Jean François; Taieb, Julien

    2015-07-10

    In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 20 to 30% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for these CCs and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery. PRODIGE 22--ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy and feasibility of two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4 + Cetuximab) in a peri-operative strategy in patients with bulky CCs. Patients with CC deemed as high risk T3, T4 and/or N2 on initial abdominopelvic CT scan are randomized to either colectomy and adjuvant chemotherapy (control arm), or 4 cycles of neoadjuvant chemotherapy with FOLFOX-4 (for RAS mutated patients). In RAS wild-type patients a third arm testing FOLFOX+ cetuximab has been added prior to colectomy. Patients in the neoadjuvant chemotherapy arms will receive postoperative treatment for 4 months (8 cycles) to complete their therapeutic schedule. The primary endpoint of the study is the histological Tumor Regression Grade (TRG) as defined by Ryan. The secondary endpoints are: treatment strategy safety (toxicity, primary tumor related complications under chemotherapy, peri-operative morbidity), disease-free and recurrence free survivals at 3 years, quality of life, carcinologic quality and

  17. Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sampaio-Filho, Hélio; Sotto-Ramos, Juliane; Pinto, Erika Horácio; Cabral, Marcia Regina; Longo, Priscila Larcher; Tortamano, Isabel Peixoto; Marcos, Rodrigo Labat; Silva, Daniela Fátima Teixeira; Pavani, Christine; Horliana, Anna Carolina Ratto Tempestini

    2016-09-02

    A comfortable postoperative return to daily activities has increased the need to control inflammation after third molar surgery. Anti-inflammatory drugs and analgesics are not exempt from adverse effects such as allergies and chronic gastritis, and they are not without cost. The association between low-level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated. Among its advantages, we can mention the low risk of side effects, low cost and simplicity of application. The objective of this study is to evaluate the efficiency of low-level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery. Ninety bilateral, symmetrical lower third molar surgeries will be performed in 45 healthy patients. Each patient will be their own control, through a split-mouth crossover study. One side of the mouth will be randomly chosen and, immediately after surgery, will be treated with low-level laser. After 21 days, the contralateral side will be operated on with low-level laser simulation used postoperatively. This regimen (laser application or not) will be repeated at 24 and 48 h after surgery. All patients will be requested to take analgesics (acetaminophen) if they have pain, i.e. in case of pain. Neither the surgeon nor the patients will know the assigned treatment. The primary variable will be postoperative pain assessed using a Visual Analog Scale, and the secondary variables will be trismus, edema, local temperature, dysphagia, presence of infection and painkiller ingestion. These variables will be assessed at baseline, 24 h, 48 h and 7 days after surgery. Blood samples for systemic inflammatory cytokine (TNF-α, IL-1, IL-6 and IL-8) analysis will be assessed at baseline and 24 h after surgery. Some authors believe that using a wavelength of 633 to 670 nm is a good option for laser therapy in the field of acupuncture. This wavelength can penetrate biological tissue to a depth of about 3 mm. However

  18. Perioperative goal-directed hemodynamic optimization using noninvasive cardiac output monitoring in major abdominal surgery: a prospective, randomized, multicenter, pragmatic trial: POEMAS Study (PeriOperative goal-directed thErapy in Major Abdominal Surgery).

    Science.gov (United States)

    Pestaña, David; Espinosa, Elena; Eden, Arieh; Nájera, Diana; Collar, Luis; Aldecoa, César; Higuera, Eva; Escribano, Soledad; Bystritski, Dmitri; Pascual, Javier; Fernández-Garijo, Pilar; de Prada, Blanca; Muriel, Alfonso; Pizov, Reuven

    2014-09-01

    In this study, our objective was to determine whether a perioperative hemodynamic protocol based on noninvasive cardiac output monitoring decreases the incidence of postoperative complications and hospital length of stay in major abdominal surgery patients requiring intensive care unit admission. Secondary objectives were the time to peristalsis recovery and the incidence of wound infection, anastomotic leaks, and mortality. A randomized clinical trial was conducted in 6 tertiary hospitals. One hundred forty-two adult patients scheduled for open colorectal surgery, gastrectomy, or small bowel resection were enrolled. A hemodynamic protocol including fluid administration and vasoactive drugs based on arterial blood pressure, cardiac index, and stroke volume response was compared with standard practice. Patients were followed until hospital discharge (determined by a surgeon blinded to the study) or death. In contrast to previous studies, we designed a pragmatic trial (as opposed to explanatory trials) to mimic real practice and obtain maximal external validity for the study. Fluid administration was similar except for the number of colloid boluses (2.4 ± 1.8 [treated] vs 1.3 ± 1.4 [control]; P < 0.001) and packed red blood cell units (0.6 ± 1.3 [treated] vs 0.2 ± 0.6 [control]; P = 0.019). Dobutamine was used in 25% (intraoperatively) and 19.4% (postoperatively) of the treated patients versus 1.4% and 0% in the control group (P < 0.001). We have observed a reduction in reoperations in the treated group (5.6% vs 15.7%; P = 0.049). However, no significant differences were observed in overall complications (40% vs 41%; relative risk 0.99 [0.67-1.44]; P = 0.397), length of stay (11.5 [8-15] vs 10.5 [8-16]; P = 0.874), time to first flatus (62 hours [40-76] vs 72 hours [48-96]; P = 0.180), wound infection (7 vs 14; P = 0.085), anastomotic leaks (2 vs 5; P = 0.23), or mortality (4.2% vs 5.7%; P = 0.67). The results of our pragmatic study indicate that a perioperative

  19. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial

    NARCIS (Netherlands)

    Hemmes, Sabrine N. T.; Gama de Abreu, Marcelo; Pelosi, Paolo; Schultz, Marcus J.; Severgnini, Paolo; Hollmann, Markus W.; Binnekade, Jan M.; Wrigge, Hermann; Canet, Jaume; Hiesmayr, Michael; Schmid, Werner; Jaber, Samir; Hedenstierna, Göran; Putensen, Christian; Sessler, Daniel I.; Lachmann, Burkhard; Kacmarek, Robert M.; Slutsky, Arthur S.; de Baerdemaeker, Luc; de Hert, Stefan; Heyse, Bjorn; van Limmen, Jurgen; Mulier, Jan-Paul; Velghe, David; Jamaer, Luc; Vandenbrande, Jeroen; Bugedo, Guillermo; Florez, Jorge; Goranović, Tatjana; Mazul-Sunko, Branka; Bluth, Thomas; Güldner, Andreas; Kiss, Thomas; Koch, Thea; Spieth, Peter Markus; Uhlig, Christopher; Yaqub, Jonathan; Bastin, Bea; Geib, Johann; Schaefer, Maximilian S.; Weiss, Martin; Treschan, Tanja A.; Reske, Andreas W.; Simon, Philipp; Brodhun, Alexander; Ferner, Marion; Hartmann, Eric; Laufenberg-Feldmann, Rita; Strys, Lydia; de Robertis, Edoardo; Perilli, Valter; Proietti, Rodolfo; Amantea, Bruno; Caroleo, Santo; Tropea, Francesco; Bacuzzi, Alessandro; Vanoni, Massimo; Cinnella, Gilda; Caggianelli, Girolamo; D'Antini, Davide; La Bella, Daniela; Mollica, Giuseppina; Cortegiani, Andrea; Giarratano, Antonino; Montalto, Francesca; Raineri, Santi Maurizio; Barberis, Bruno; Celentano, Cristian; Grio, Michele; Spagnolo, Luigi; Gratarola, Angelo; Molin, Alexandre; Pellerano, Giulia; Pezzato, Stefano; Rusca, Roberta; Della Rocca, Giorgio; Bos, Lieuwe D. J.; Brunelli, Andrea; Marti, Agnes; Cegarra, Virginia; Merten, Alfred; Moral, Ma Victoria; Parera, Ana; Unzueta, Ma Carmen; Sabaté, Sergi; Sierra, Pilar; Mayoral, Juan F.; Prieto, Mercè; Gil, Manuel Granell; Marín, Conrado Minguez; Mills, Gary H.; Bodger, Phoebe; Vidal Melo, Marcos F.; Sulemanji, Demet; Sprung, Juraj

    2014-01-01

    Background The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression

  20. Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Boshuisen, Kim|info:eu-repo/dai/nl/343391511; Lamberink, Herm J; van Schooneveld, Monique MJ|info:eu-repo/dai/nl/30481427X; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg|info:eu-repo/dai/nl/262684438; Geleijns, Karin|info:eu-repo/dai/nl/275854965; Uiterwaal, Cuno Spm|info:eu-repo/dai/nl/136603947; Braun, Kees PJ|info:eu-repo/dai/nl/207237239

    2015-01-01

    BACKGROUND: The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at

  1. Telerobotic surgery

    Directory of Open Access Journals (Sweden)

    Prokar Dasgupta

    2005-01-01

    Full Text Available With continued advances in medical robotic technology and global telecommunications, the concept of remote telerobotic surgery continues to develop. The ultimate goal of an experienced specialist operating remotely using a robot controlled by high-speed audiovisual connections has been shown to be feasible but is limited by local resources and a lack of evidence from randomised controlled trials. This article looks at the development of this exciting field and its impact on modern urology.

  2. Randomized clinical trial comparing the effects on renal function of hydroxyethyl starch or gelatine during aortic aneurysm surgery.

    Science.gov (United States)

    Mahmood, A; Gosling, P; Vohra, R K

    2007-04-01

    The optimal colloid for renal protection during abdominal aortic aneurysm (AAA) surgery is not known. This study compared the effects of two hydroxyethyl starch (HES) solutions and gelatine on perioperative renal function. Sixty-two patients undergoing AAA surgery were randomized to 6 per cent HES of molecular weight 200/0.62 kDa or 130/0.4 kDa, or 4 per cent gelatine for plasma expansion. Measurements were taken of serum urea and creatinine to mark glomerular filtration, urinary immunoglobulin G : creatinine ratio to mark glomerular membrane function and alpha(1)-microglobulin : creatinine ratio to mark tubular dysfunction before, and for 5 days after, surgery. Serum urea was lower in both HES groups than the gelatine group. Serum creatinine was lower with HES 130/0.4 compared with gelatine at days 1, 2 and 5 after surgery (P = 0.020, P = 0.045 and P = 0.045 respectively). Urinary alpha(1)-microglobulin : creatinine ratio was lower with HES 200/0.62 compared with gelatine at 4 and 8 h (P gelatine at 4 to 24 h, and on days 4 and 5 (P gelatine. There was no difference between the two starch groups. Compared with gelatine, volume expansion with both types of HES during AAA surgery improved renal function and reduced renal injury.

  3. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Raquel Pei Chen Chan

    2009-01-01

    Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.

  4. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial.

    Science.gov (United States)

    Murphy, Glenn S; Szokol, Joseph W; Avram, Michael J; Greenberg, Steven B; Shear, Torin D; Deshur, Mark A; Vender, Jeffery S; Benson, Jessica; Newmark, Rebecca L

    2017-05-01

    Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. The aim of this parallel-group randomized trial was to assess the effect of the long-duration opioid methadone on postoperative analgesic requirements, pain scores, and patient satisfaction after complex spine surgery. One hundred twenty patients were randomized to receive either methadone 0.2 mg/kg at the start of surgery or hydromorphone 2 mg at surgical closure. Anesthetic care was standardized, and clinicians were blinded to group assignment. The primary outcome was intravenous hydromorphone consumption on postoperative day 1. Pain scores and satisfaction with pain management were measured at postanesthesia care unit admission, 1 and 2 h postadmission, and on the mornings and afternoons of postoperative days 1 to 3. One hundred fifteen patients were included in the analysis. Median hydromorphone use was reduced in the methadone group not only on postoperative day 1 (4.56 vs. 9.90 mg) but also on postoperative days 2 (0.60 vs. 3.15 mg) and 3 (0 vs. 0.4 mg; all Pmethadone group at 21 of 27 assessments (all P = 0.001 to methadone group than in the hydromorphone group until the morning of postoperative day 3 (all P = 0.001 to methadone administration reduced postoperative opioid requirements, decreased pain scores, and improved patient satisfaction with pain management.

  5. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hila Hajizadeh

    2017-07-01

    Full Text Available Objectives This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS after periodontal surgery. Materials and Methods Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil S3 Bond (Kuraray Dental, G2: Gluma Desensitizer (Heraeus Kulzer, and G3: placebo (water. The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0, 1 day after treatment (T1, after 1 week (T2, and after 1 month (T3 according to visual analog scale (VAS. Results Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil S3 Bond can have some benefits.

  6. The Effect of Massage on Acute Postoperative Pain in Critically and Acutely Ill Adults Post-thoracic Surgery: Systematic Review and Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Boitor, Madalina; Gélinas, Céline; Richard-Lalonde, Melissa; Thombs, Brett D

    Critical care practice guidelines identify a lack of clear evidence on the effectiveness of massage for pain control. To assess the effect of massage on acute pain in critically and acutely ill adults post-thoracic surgery. Medline, Embase, CINAHL, PsychInfo, Web of Science, Scopus and Cochrane Library databases were searched. Eligible studies were randomized controlled trials (RCTs) evaluating the effect of massage compared to attention control/sham massage or standard care alone on acute pain intensity post-thoracic surgery. Twelve RCTs were included. Of these, nine evaluated massage in addition to standard analgesia, including 2 that compared massage to attention control/sham massage in the intensive care unit (ICU), 6 that compared massage to standard analgesia alone early post-ICU discharge, and 1 that compared massage to both attention control and standard care in the ICU. Patients receiving massage with analgesia reported less pain (0-10 scale) compared to attention control/sham massage (3 RCTs; N = 462; mean difference -0.80, 95% confidence interval [CI] -1.25 to -0.35; p Massage, in addition to pharmacological analgesia, reduces acute post-cardiac surgery pain intensity. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Differences in Epidural and Analgesic Use in Patients with Apparent Stage I Endometrial Cancer Treated by Open versus Laparoscopic Surgery: Results from the Randomised LACE Trial

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    Jannah Baker

    2013-01-01

    Full Text Available Objectives. We compared postoperative analgesic requirements between women with early stage endometrial cancer treated by total abdominal hysterectomy (TAH or total laparoscopic hysterectomy (TLH. Methods. 760 patients with apparent stage I endometrial cancer were treated in the international, multicentre, prospective randomised trial (LACE by TAH (n=353 or TLH (n=407 (2005–2010. Epidural, opioid, and nonopioid analgesic requirements were collected until ten months after surgery. Results. Baseline demographics and analgesic use were comparable between treatment arms. TAH patients were more likely to receive epidural analgesia than TLH patients (33% versus 0.5%, P<0.001 during the early postoperative phase. Although opioid use was comparable in the TAH versus TLH groups during postoperative 0–2 days (99.7% versus 98.5%, P=0.09, a significantly higher proportion of TAH patients required opioids 3–5 days (70% versus 22%, P<0.0001, 6–14 days (35% versus 15%, P<0.0001, and 15–60 days (15% versus 9%, P=0.02 after surgery. Mean pain scores were significantly higher in the TAH versus TLH group one (2.48 versus 1.62, P<0.0001 and four weeks (0.89 versus 0.63, P=0.01 following surgery. Conclusion. Treatment of early stage endometrial cancer with TLH is associated with less frequent use of epidural, lower post-operative opioid requirements, and better pain scores than TAH.

  8. Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following gynecological surgery: a meta-analysis of randomized, controlled trials.

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    Saffer, Craig S; Minkowitz, Harold S; Ding, Li; Danesi, Hassan; Jones, James B

    2015-09-01

    To compare the efficacy and safety of patient-controlled fentanyl iontophoretic transdermal system (ITS) with morphine intravenous (i.v.) patient-controlled analgesia (PCA) for pain management following gynecological surgery. Two-open-label, multicenter, randomized, active-controlled, parallel-group studies (n = 1142) were conducted that compared fentanyl ITS with morphine iv. PCA for postoperative pain. The subgroup of gynecological surgery patients from each trial was utilized for this meta-analysis (n = 604). Of these patients, 295 received fentanyl ITS (40 μg/dose) and 309 received morphine i.v. PCA (1 mg/dose) for up to 72 h. Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control. Gynecological surgery patients (n = 604) included in this meta-analysis had a mean age of 45 years, were predominantly Caucasian (65%) and had a mean body mass index of 29 mg/kg2. There were statistically significantly more patients treated with fentanyl ITS and more investigators who rated their pain control method as 'excellent' on the PGA at 24 h (49.3 vs 37.4%, respectively; p = 0.0029) and IGA at the last assessment (59.5 vs. 38.0%, respectively; p fentanyl ITS than morphine iv. PCA as a method of pain control.

  9. A randomized controlled trial of the effectiveness of an educational intervention on outcomes of parents and their children undergoing inpatient elective surgery: study protocol.

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    He, Hong-Gu; Zhu, Lixia; Chan, Wai-Chi Sally; Xiao, Chunxiang; Klainin-Yobas, Piyanee; Wang, Wenru; Cheng, Kin Fong Karis; Luo, Nan

    2015-03-01

    To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery. Inadequate children's postoperative pain management remains a global problem. Parents are required to be involved in their child's pain assessment and management, yet they often lack relevant knowledge and skills. Education is an effective strategy for enhancing a person's knowledge, attitudes and behaviour. However, few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery. Randomized controlled trial and embedded qualitative process evaluation. One hundred and sixty-two pairs of participants (each comprised of one parent and his/her child undergoing inpatient elective surgery) will be recruited (protocol approved in January 2013). Participants will be randomized to either a Control group (routine care), an Intervention group 1 (routine care and an educational intervention with face-to-face teaching), or an Intervention group 2 (routine care and an educational intervention without face-to-face teaching). Outcome measures will include parents' knowledge, attitude and behaviour related to postoperative pain management; their child's postoperative pain; and parents' satisfaction with their child's pain management at baseline and around 6, 12 and 24 hours after the operation. A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents' knowledge, attitude and behaviour related to postoperative pain management and reduce their child's postoperative pain. © 2014 John Wiley & Sons Ltd.

  10. Beneficial effect of methylprednisolone after mandibular third molar surgery: a randomized, double-blind, placebo-controlled split-mouth trial.

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    Acham, Stephan; Klampfl, Arnold; Truschnegg, Astrid; Kirmeier, Robert; Sandner-Kiesling, Andreas; Jakse, Norbert

    2013-09-01

    Third molar (M3) removal is the model most frequently used for pain trials in oral surgery. Corticosteroids are frequently administered to reduce trismus and swelling after dentoalveolar surgical procedures. The purpose of this investigation was to evaluate the influence of a single, preoperative oral application of methylprednisolone on postoperative trismus, pain intensity, and the subjective need for analgesic medication after surgical removal of impacted mandibular M3 (LM3). Sixteen healthy patients requiring similar bilateral surgical LM3 removal were included in a prospective, randomized, placebo-controlled, double-blind study in a split-mouth design. At random, each patient received either weight-dependent methylprednisolone (40-80 mg) or a placebo orally 1 h prior to surgery. In each case, the right and left LM3 were treated in independent visits. Trismus, swelling, pain measured on a 100-mm visual analog scale, and the postoperative demand of analgesics were assessed. Statistical analysis indicates a significant reduction of trismus, swelling, pain intensity, and patient-controlled intake of analgesics during the whole postsurgical period of investigation (first to seventh day). The results of this study suggest that a single preoperative weight-dependent administration of methylprednisolone is a safe and effective concept for diminishing postoperative discomfort, pain intensity, and the total intake of analgesics after wisdom tooth extractions. In case of missing contraindications, the preoperative administration of methylprednisolone is recommended, a routine medication for more extended procedures in oral surgery.

  11. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Futier, Emmanuel; Lefrant, Jean-Yves; Guinot, Pierre-Gregoire; Godet, Thomas; Lorne, Emmanuel; Cuvillon, Philippe; Bertran, Sebastien; Leone, Marc; Pastene, Bruno; Piriou, Vincent; Molliex, Serge; Albanese, Jacques; Julia, Jean-Michel; Tavernier, Benoit; Imhoff, Etienne; Bazin, Jean-Etienne; Constantin, Jean-Michel; Pereira, Bruno; Jaber, Samir

    2017-10-10

    Perioperative hypotension is associated with an increase in postoperative morbidity and mortality, but the appropriate management strategy remains uncertain. To evaluate whether an individualized blood pressure management strategy tailored to individual patient physiology could reduce postoperative organ dysfunction. The Intraoperative Norepinephrine to Control Arterial Pressure (INPRESS) study was a multicenter, randomized, parallel-group clinical trial conducted in 9 French university and nonuniversity hospitals. Adult patients (n = 298) at increased risk of postoperative complications with a preoperative acute kidney injury risk index of class III or higher (indicating moderate to high risk of postoperative kidney injury) undergoing major surgery lasting 2 hours or longer under general anesthesia were enrolled from December 4, 2012, through August 28, 2016 (last follow-up, September 28, 2016). Individualized management strategy aimed at achieving a systolic blood pressure (SBP) within 10% of the reference value (ie, patient's resting SBP) or standard management strategy of treating SBP less than 80 mm Hg or lower than 40% from the reference value during and for 4 hours following surgery. The primary outcome was a composite of systemic inflammatory response syndrome and dysfunction of at least 1 organ system of the renal, respiratory, cardiovascular, coagulation, and neurologic systems by day 7 after surgery. Secondary outcomes included the individual components of the primary outcome, durations of ICU and hospital stay, adverse events, and all-cause mortality at 30 days after surgery. Among 298 patients who were randomized, 292 patients completed the trial (mean [SD] age, 70 [7] years; 44 [15.1%] women) and were included in the modified intention-to-treat analysis. The primary outcome event occurred in 56 of 147 patients (38.1%) assigned to the individualized treatment strategy vs 75 of 145 patients (51.7%) assigned to the standard treatment strategy

  12. Epsilon aminocaproic acid reduces blood transfusion and improves the coagulation test after pediatric open-heart surgery: a meta-analysis of 5 clinical trials.

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    Lu, Jun; Meng, Haoyu; Meng, Zhaoyi; Sun, Ying; Pribis, John P; Zhu, Chunyan; Li, Quan

    2015-01-01

    Excessive postoperative blood loss after cardiopulmonary bypass is a common problem, especially in patients suffering from congenital heart diseases. The efficacy of epsilon aminocaproic acid (EACA) as a prophylactic treatment for postoperative bleeding after pediatric open-heart surgery has not been determined. This meta-analysis investigates the efficacy of EACA in the minimization of bleeding and blood transfusion and the maintenance of coagulation tests after pediatric open-heart surgery. A comprehensive literature search was performed to identify all randomized clinical trials on the subject. PubMed, Embase, the Cochrane Library, and the Chinese Medical Journal Network were screened. The primary outcome used for the analysis was postoperative blood loss. Secondary outcomes included postoperative blood transfusion, re-exploration rate and postoperative coagulation tests. The mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) were used as summary statistics. Five trials were included in this meta-analysis of 515 patients. Prophylactic EACA was associated with a reduction in postoperative blood loss, but this difference did not reach statistical significance (MD: -7.08; 95% CI: -16.11 to 1.95; P = 0.12). Patients treated with EACA received fewer postoperative blood transfusions, including packed red blood cells (MD: -8.36; 95% CI: -12.63 to -4.09; P = 0.0001), fresh frozen plasma (MD: -3.85; 95% CI: -5.63 to -2.08; P < 0.0001), and platelet concentrate (MD: -10.66; 95% CI: -18.45 to -2.87; P = 0.007), and had a lower re-exploration rate (RR: 0.46; 95% CI: 0.23 to 0.92; P = 0.03). Prophylactic EACA also improved coagulation tests 6 hours after open-heart surgery. Prophylactic EACA minimizes postoperative blood transfusion and helps maintain coagulation in pediatric patients undergoing open-heart surgery. Therefore, the results of this study indicate that adjunctive EACA is a good choice for the prevention of postoperative blood transfusion

  13. Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial.

    Science.gov (United States)

    Price, Brandee A; Bednarski, Brian K; You, Y Nancy; Manandhar, Meryna; Dean, E Michelle; Alawadi, Zeinab M; Bryce Speer, B; Gottumukkala, Vijaya; Weldon, Marla; Massey, Robert L; Wang, Xuemei; Qiao, Wei; Chang, George J

    2017-07-20

    Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation. In order to address this gap, we propose a prospective randomised trial of accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI) that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology (TeleRecovery) to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. ETHICS AND DISSEMINATION: RecoverMI has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial. NCT02613728; Pre-results.

  14. Transcatheter versus Surgical Aortic Valve Replacement in Patients with Diabetes and Severe Aortic Stenosis at High Risk for Surgery: An Analysis of the PARTNER Trial

    Science.gov (United States)

    Lindman, Brian R.; Pibarot, Philippe; Arnold, Suzanne V.; Suri, Rakesh; McAndrew, Thomas C.; Maniar, Hersh S.; Zajarias, Alan; Kodali, Susheel; Kirtane, Ajay J.; Thourani, Vinod H.; Tuzcu, E. Murat; Svensson, Lars G.; Waksman, Ron; Smith, Craig R.; Leon, Martin B.

    2013-01-01

    Objectives To determine whether a less invasive approach to aortic valve replacement (AVR) improves clinical outcomes in diabetic patients with aortic stenosis (AS). Background Diabetes is associated with increased morbidity and mortality after surgical AVR for AS. Methods Among treated patients with severe symptomatic AS at high-risk for surgery in the PARTNER trial, we examined outcomes stratified by diabetes status of patients randomly assigned to transcatheter or surgical AVR. The primary outcome was all-cause mortality at 1 year. Results Among 657 patients enrolled in PARTNER who underwent treatment, there were 275 patients with diabetes (145 transcatheter, 130 surgical). There was a significant interaction between diabetes and treatment group for 1-year all-cause mortality (p=0.048). Among diabetic patients, all-cause mortality at 1 year was 18.0% in the transcatheter group and 27.4% in the surgical group (HR 0.60; 95% CI, 0.36–0.99; p=0.04). Results were consistent among patients treated via transfemoral or transapical routes. In contrast, among non-diabetic patients, there was no significant difference in all-cause mortality at 1 year (p=0.48). Among diabetic patients, the 1-year rates of stroke were similar between treatment groups (3.5% transcatheter vs. 3.5% surgery, p=0.88), but the rates of renal failure requiring dialysis >30 days were lower in the transcatheter group (0% vs. 6.1%, p=0.003). Conclusions Among patients with diabetes and severe symptomatic AS at high-risk for surgery, this post-hoc stratified analysis of the PARTNER trial suggests there is a survival benefit, no increase in stroke, and less renal failure from treatment with transcatheter compared to surgical AVR. PMID:24291272

  15. Comparison of analgesic efficacy of flupirtine maleate and ibuprofen in gynaecological ambulatory surgeries: A randomized controlled trial

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    Vanita Ahuja

    2015-01-01

    Full Text Available Background and Aims: Flupirtine maleate is a centrally acting, non-opioid analgesic with unique muscle relaxant properties as compared to common analgesics. The aim of this study was to compare post-operative analgesic efficacy of flupirtine maleate and ibuprofen in patients undergoing gynaecological ambulatory surgeries. Methods: This prospective, randomised controlled study was conducted in 60 women of American Society of Anesthesiologists physical status I/II, 18-70 years of age and scheduled to undergo gynaecological ambulatory surgeries. The participants were randomised to receive either 100 mg oral flupirtine maleate (group flupirtine, n = 30 or 800 mg oral ibuprofen (group ibuprofen, n = 30, 1 h prior to surgery and then every 8 h for 48 h. Verbal Numerical Rating Scale (VNRS on movement was assessed at 0, 2, 4, 6 and 8 h following surgery. Following discharge from hospital, the patients were interviewed telephonically at 12, 24 and 48 h post-operatively. VNRS was statistically analysed using Mann-Whitney test. Results: VNRS on movement was statistically reduced at 2 h after surgery (P = 0.04 in group flupirtine as compared to group ibuprofen. The analgesic efficacy was similar in both the groups at 4, 6, 8, 12, 24 and