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Sample records for surgery randomized clinical

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

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    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

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

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    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.

  3. 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

  4. Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    2017-03-21

    FINAL REPORT Project Title: Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial...relieving acute extremity pain , reducing medication use, decreasing time to full ambulation and improving quality of life than placebo acupuncture or...designated intervention. Acupuncture was performed by physician acupuncturists. Subjects reported pain level immediately after acupuncture , 24, 28 168

  5. Articaine versus lidocaine for third molar surgery: A randomized clinical study

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    Santos, Thiago-de-S; Santos, Jadson-A.; Maia, Marcelo-C; Mendonça, Carla-G

    2012-01-01

    Objective: Pain reduction has been the subject of continuous research in the field of oral and maxillofacial surgery since postoperative pain with ranging of intensity and duration may affects the patient submitted in an oral surgical procedure. The aim of present study was to compare the analgesic effectiveness between two different anesthetic solutions (articaine and lidocaine) in third molar surgery. Study Design: A prospective, randomized and clinical study with patients submitted to third molar surgery at two distinct times. The visual analogue scale, the McGill Pain Questionnaire and the analgesic consumption record were used to measure the pain after each surgical time. Results: Duration of surgery, latency, the amount of anesthetic used and analgesic consumption showed clinical differences with highlights of articaine, though statistical significance was not observed (Pthird molar. PMID:22157664

  6. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial.

    Science.gov (United States)

    Smith, Stephen Ridley; Draganic, Brian; Pockney, Peter; Holz, Phillip; Holmes, Ryan; Mcmanus, Brendan; Carroll, Rosemary

    2015-09-01

    Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.

  7. 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

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

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    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.

  9. Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481

    Directory of Open Access Journals (Sweden)

    Turner Judith A

    2005-01-01

    Full Text Available Abstract Background Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments. Method and design Two hundred patients with mild to moderate symptoms will be recruited over 3 1/2 years from neurological surgery, primary care, electrodiagnostic clinics. We will exclude patients with clinical or electrodiagnostic evidence of denervation or thenar muscle atrophy. We will randomly assign patients to either a well-defined conservative care protocol or surgery. The conservative care treatment will include visits with a hand therapist, exercises, a self-care booklet, work modification/ activity restriction, B6 therapy, ultrasound and possible steroid injections. The surgical care would be left up to the surgeon (endoscopic vs. open with usual and customary follow-up. All patients will receive a wrist MRI at baseline. Patients will be contacted at 3, 6, 9 and 12 months after randomization to complete the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ. In addition, we will compare disability (activity and work days lost and general well being as measured by the SF-36 version II. We will control for demographics and use psychological measures (SCL-90 somatization and depression scales as well as EDS and MRI predictors of outcomes. Discussion We have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.

  10. Skin closure methods after single port laparoscopic surgery: a randomized clinical trial.

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    Park, Sue Yeon; Kim, Kye Hyun; Yuk, Jin-Sung; Ji, Hyun Young; Lee, Jung Hun

    2015-06-01

    To compare postoperative cosmetic outcomes according to different umbilical closure methods after single port laparoscopic surgery (SP-LS). A total of 138 women who were scheduled to receive elective SP-LS were randomized to undergo closure of the umbilical incision with either a subcutaneous suture only without subcuticular skin suture (case group, n=68) or both a subcutaneous suture and subcuticular skin suture (control group, n=70) after fascial closure. At postoperative months 1 and 3, the umbilical scar was evaluated using the Vancouver scar scale (VSS), the patient and observer scar assessment scale, and a visual analog scale (VAS). Overall satisfaction with scar cosmesis and surgery was assessed with the VAS. There was no significant difference in the clinical characteristics and operative data between the groups. The objective and subjective scar assessments and the overall satisfaction with scar cosmesis were not different between the groups. In the control group, four (5.7%) women experienced wound discharge and were treated with conservative treatments and delayed closure. In women who completed the first and second assessments, the changes in the scar assessment and overall satisfaction with the scar according to time after surgery were not different in either group, but the patient scar assessment scale in both groups and the VSS in the case group improved. After SP-LS, the approximation of the fascia and subcutaneous layer seems to be enough for the closure of an umbilical incision. Skin closure with subcuticular sutures did not improve the postoperative cosmetic outcomes and might lead to impaired wound healing. However, large randomized trials with various closure techniques and materials are needed to confirm this finding. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  11. 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 < .02). However, this 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.

  12. 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.

  13. A randomized clinical trial of continuous aspiration of subglottic secretions in cardiac surgery patients.

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    Kollef, M H; Skubas, N J; Sundt, T M

    1999-11-01

    To determine whether the application of continuous aspiration of subglottic secretions (CASS) is associated with a decreased incidence of ventilator-associated pneumonia (VAP). Prospective clinical trial. Cardiothoracic ICU (CTICU) of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred forty-three patients undergoing cardiac surgery and requiring mechanical ventilation in the CTICU. Patients were assigned to receive either CASS, using a specially designed endotracheal tube (Hi-Lo Evac; Mallinckrodt Inc; Athlone, Ireland), or routine postoperative medical care without CASS. One hundred sixty patients were assigned to receive CASS, and 183 were assigned to receive routine postoperative medical care without CASS. The two groups were similar at the time of randomization with regard to demographic characteristics, surgical procedures performed, and severity of illness. Risk factors for the development of VAP were also similar during the study period for both treatment groups. VAP was seen in 8 patients (5.0%) receiving CASS and in 15 patients (8. 2%) receiving routine postoperative medical care without CASS (relative risk, 0.61%; 95% confidence interval, 0.27 to 1.40; p = 0. 238). Episodes of VAP occurred statistically later among patients receiving CASS ([mean +/- SD] 5.6 +/- 2.3 days) than among patients who did not receive CASS (2.9 +/- 1.2 days); (p = 0.006). No statistically significant differences for hospital mortality, overall duration of mechanical ventilation, lengths of stay in the hospital or CTICU, or acquired organ system derangements were found between the two treatment groups. No complications related to CASS were observed in the intervention group. Our findings suggest that CASS can be safely administered to patients undergoing cardiac surgery. The occurrence of VAP can be significantly delayed among patients undergoing cardiac surgery using this simple-to-apply technique.

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

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    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. Clinical trials to reduce pancreatic fistula after pancreatic surgery-review of randomized controlled trials.

    Science.gov (United States)

    Kitahata, Yuji; Kawai, Manabu; Yamaue, Hiroki

    2016-01-01

    Pancreatic fistula is one of severe postoperative complications that occur after pancreatic surgery, such as pancreaticoduodenectomy (PD) and distal pancreatectomy (DP). Because pancreatic fistula is associated with a higher incidence of life-threatening complications. In order to evaluate procedure or postoperative management to reduce pancreatic fistula after pancreatic surgery, we summarized some randomized controlled trials (RCTs) regarding pancreaticoenterostomy during PD, pancreatic duct stent during PD, procedure to resect pancreatic parenchyma during DP, and somatostatin and somatostatin analogues after pancreatic surgery. At first, we reviewed nine RCTs to compare pancreaticogastrostomy (PG) with pancreaticojejunostomy (PJ) during PD. Next, we reviewed five RCTs, to evaluate the impact of pancreatic duct stent during PD. Regarding DP, we reviewed six RCTs to evaluate appropriate procedure to reduce pancreatic fistula after DP. Finally, we reviewed eight RCTs to evaluate the impact of somatostatin and somatostatin analogues after pancreatic surgery to reduce pancreatic fistula. The best way to prevent pancreatic fistula after pancreatic surgery remains still controversial. However, several RCTs clarify a useful procedure to reduce in reducing the incidence of pancreatic fistula after pancreatic surgery. Further RCTs to study innovative approaches remain a high priority for pancreatic surgeons to prevent pancreatic fistula after pancreatic surgery.

  16. 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 < 0.050). Levels of natural killer lymphocytes decreased during surgery in groups 1 and 2, but increased in controls. Intraoperative levels of natural killer cells were significantly lower in group 1 than in group 3 (mean(s.d.) 212.2(89.3) versus 329.1(167.8) cells/microl; P < 0.050). Perioperative 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.

  17. 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

  18. Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial.

    Science.gov (United States)

    Alalaf, S K; Jawad, A K; Jawad, R K; Ali, M S; Al Tawil, N G

    2015-12-01

    Venous thromboembolism (VTE) is the leading cause of mortality and morbidity in women following gynecologic surgery. To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery. We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE. In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI] 0.002-0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR] 7.1; 95% CI 1.3-36.2), varicose veins (OR 16.8; 95% CI 3.1-76.2), and thrombophilia (OR 39.3; 95% CI 1.5-1006.7). There were no major bleeding events or side effects related to the use of bemiparin. Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery. © 2015 International Society on Thrombosis and Haemostasis.

  19. 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).

  20. A randomized-clinical trial examining a neoprene abdominal binder in gynecologic surgery patients

    Science.gov (United States)

    Szender, J.B.; Hall, K.L.; Kost, E.R.

    2016-01-01

    Summary Purpose of Investigation Pain control and early ambulation are two important postoperative goals. Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications. In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use, pain, and ambulation in the first day after surgery. Materials and Methods The authors randomly assigned 75 patients undergoing abdominal gynecologic surgery to either binder or not after surgery. Demographic data and surgical characteristics were collected. Outcome variables included morphine use, pain score, time to ambulation, and number of ambulations. Results A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by 300%, 260%, and 240% in patients with vertical incisions, age over 50 years, and complex surgeries, respectively. Morphine use and pain scores were not significantly different. Conclusion The binder increased ambulations in the subset of patients at the highest risk for postoperative complications: elderly, cancer patients, and vertical incisions. Routine use of the binder may benefit particularly high-risk gynecologic surgical patients. PMID:25864252

  1. Clinical applications and effectiveness of guided implant surgery: a critical review based on randomized controlled trials.

    Science.gov (United States)

    Colombo, Marco; Mangano, Carlo; Mijiritsky, Eitan; Krebs, Mischa; Hauschild, Uli; Fortin, Thomas

    2017-12-13

    Nowadays implant placement protocols are widespread among clinicians all over the world. However, available literature, only partially analyses what can be potential benefits for the clinicians and patients, often focusing just on specific aspects, such as accuracy. The purpose of this review is to compare computer guided implant placement with conventional treatment protocols. A search strategy according to the P-I-C-O format was developed and executed using an electronic MEDLINE plus manual search from 2000 up to December 2016. This review included only randomized controlled trials (RCTs) focusing on subjects treated with digital workflow for oral implant placement compared to conventional procedures. Data were extracted from eligible papers and analysed. All kinds of outcomes were considered, even patient-related and economical outcomes. The search strategy revealed 16 articles; additional manual searches selected further 21 publications. Afterwards the evaluation of articles, only two studies could be selected for subsequent data extraction. The two identified RCTs analysed primary outcomes as prosthesis failure, implant failure, biological or prosthetic complications, and secondary outcomes as periimplant marginal bone loss. One RCT evaluated also the duration of treatment, post-surgical progress, additional treatment costs and patient satisfaction. The other RCT focused instead on evaluating eventual improvement of patient's quality of life. In both selected studies, were not observed by the authors statistically significant differences between clinical cases treated with digital protocols and those treated with conventional ones. In one RCT, however post-surgical progress evaluation showed more patients' self-reported pain and swelling in conventional group. Within the limitation of this review, based on only two RCTs, the only evidence was that implant survival rate and effectiveness are similar for conventional and digital implant placement procedures

  2. A randomized clinical trial of nursing care for recovery from cardiac surgery.

    Science.gov (United States)

    Gilliss, C L; Gortner, S R; Hauck, W W; Shinn, J A; Sparacino, P A; Tompkins, C

    1993-01-01

    To determine the efficacy of a psychoeducational nursing intervention in patients who receive coronary artery bypass graft and valve repair surgery. A cluster-randomized controlled trial design. Two hospitals in the western United States--a large community hospital with an active cardiovascular surgery practice and a health-sciences research center. 156 patients between 25 and 75 years of age, 125 (81.1%) men, and 31 (19.9%) women, all with primary care givers. Self-efficacy expectations, activities (behavior performance), quality of life, mood state. Supplemental in-hospital education followed by telephone contact from discharge to eighth week after discharge. Patients in the experimental group reported significantly greater self-efficacy expectations for walking and behavior performance for walking, lifting, climbing stairs, general exertion and, where applicable, for working. This trial suggests that a low-intensity psychoeducational nursing intervention can promote self-efficacy expectations for walking in recovery and is associated with more self-reported walking and lifting behavior after cardiac surgery.

  3. 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

    in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR...... 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...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  4. Comparison of the analgesic efficacy of preoperative/postoperative oral dexketoprofen trometamol in third molar surgery: A randomized clinical trial.

    Science.gov (United States)

    Esparza-Villalpando, Vicente; Chavarria-Bolaños, Daniel; Gordillo-Moscoso, Antonio; Masuoka-Ito, David; Martinez-Rider, Ricardo; Isiordia-Espinoza, Mario; Pozos-Guillen, Amaury

    2016-09-01

    The aim of this study was to compare the efficacy of preoperative and postoperative dexketoprofen trometamol for pain control after third molar surgery. Sixty subjects indicated for impacted mandibular third molar surgery were randomly assigned to two groups: preoperative (group 1, n = 30) and postoperative (group 2, n = 30) administration. Group 1 received 25 mg of dexketoprofen trometamol 30 min before surgery and 1 placebo capsule (same color and size with active drug) immediately after surgery. Group 2 received the placebo capsule 30 min before surgery and 25 mg of dexketoprofen trometamol immediately after surgery. Pain intensity was assessed using a numeric rating scale (NRS) during the first 8 h. The time of the need for a second dose of dexketoprofen trometamol, after the first administration, was recorded. The data were analyzed using mixed-model repeated-measures (MMRM), Wilcoxon rank-sum, and Kaplan-Meier analysis. After the 8 h period, no statistically significant difference was observed in the intensity of pain (MMRM, p = 0.41); and no significant difference in the time for a second dose (p = 0.956). In conclusion, preoperative administration of dexketoprofen trometamol is a reasonable clinical approach that is as effective as conventional postoperative pharmacological treatment, with the advantage of allowing early analgesia before pain develops. (ClinicalTrials.gov: NCT02380001). Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  5. 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

  6. Randomized clinical trial of fluid and salt restriction compared with a controlled liberal regimen in elective gastrointestinal surgery.

    Science.gov (United States)

    Kalyan, J P; Rosbergen, M; Pal, N; Sargen, K; Fletcher, S J; Nunn, D L; Clark, A; Williams, M R; Lewis, M P N

    2013-12-01

    Excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery. The aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen. In this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen. The primary outcome was postoperative complications of grade II and above (moderate to severe). Some 240 patients (194 colorectal resections and 46 oesophagogastric resections) were enrolled in the study; 121 patients were randomized to the restricted regimen and 119 to the control (liberal) regimen. During surgery the control group received a median (interquartile range) fluid volume of 2033 (1576-2500) ml and sodium input of 282 (213-339) mmol, compared with 1000 (690-1500) ml and 142 (93-218) mmol respectively in the restricted group. There was no significant difference in major complication rate between groups (38·0 and 39·0 per cent respectively). Median (range) hospital stay was 8 (3-101) days in the controls and 8 (range 3-76) days among those who received restricted fluids. There were four in-hospital deaths in the control group and two in the restricted group. Substantial differences in weight change, serum sodium, osmolality and urine : serum osmolality ratio were observed between the groups. There were no significant differences in major complication rates, length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen. ISRCTN39295230 (http://www.controlled-trials.com). © 2013 The Authors. British Journal of Surgery published by John Wiley & Sons Ltd on behalf of British Journal of Surgery Society Ltd.

  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. 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

  9. Clinical evidence of growth hormone for patients undergoing abdominal surgery: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhou, Yong; Wu, Xiao-Ting; Yang, Gang; Zhuang, Wen; Wei, Mao-Ling

    2005-07-07

    To assess the effectiveness and safety of perioperative growth hormone (GH) in patients undergoing abdominal surgery. We searched the following electronic databases: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database. The search was undertaken in February 2003. No language restrictions were applied. Randomized controlled trials (RCT) comparing GH with placebo in patients undergoing abdominal surgery were extracted and evaluated. Methodological quality was evaluated using the Jadad scale. Eighteen trials involving 646 patients were included. The combined results showed that GH had a positive effect on improving postoperative nitrogen balance (standardized mean difference (SMD) = 3.37, 95%CI (2.46, 4.27), P<0.00001), and decreasing the length of hospital stay (weighted mean difference (WMD) = -2.07, 95%CI (-3.03, -1.11), P = 0.00002), and reducing the duration of postoperative fatigue syndrome (SMD = -1.83, 95%CI (-2.37, -1.30), P<0.00001), but it could increase blood glucose levels (WMD = 0.91, 95%CI (0.56, 1.25), P<0.00001). GH for patients undergoing abdominal surgery is effective and safe, if blood glucose can be controlled well. Further trials are required with a sufficient size to account for clinical heterogeneity and to measure other important outcomes such as infection, morbidity, mortality, fluid retention, immunomodulatory effects, and tumor recurrence.

  10. 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.

  11. Intravenous fluid restriction after major abdominal surgery: A randomized blinded clinical trial

    NARCIS (Netherlands)

    H. Vermeulen (Hester); J. Hofland (Johannes); D.A. Legemate (Dink); D.T. Ubbink (Dirk)

    2009-01-01

    textabstractBackground: 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

  12. Desflurane and sevoflurane in cardiac surgery: a meta-analysis of randomized clinical trials

    NARCIS (Netherlands)

    Landoni, Giovanni; Biondi-Zoccai, Giuseppe G. L.; Zangrillo, Alberto; Bignami, Elena; D'Avolio, Stefania; Marchetti, Chiara; Calabrò, Maria Grazia; Fochi, Oliviero; Guarracino, Fabio; Tritapepe, Luigi; de Hert, Stefan; Torri, Giorgio

    2007-01-01

    OBJECTIVES: The authors performed a meta-analysis to investigate whether the cardioprotective effects of volatile anesthetics translate into decreased morbidity and mortality in patients undergoing cardiac surgery. BACKGROUND: It is commonly believed that the choice of the primary anesthetic agent

  13. Open-Lung Ventilation Improves Clinical Outcomes in Off-Pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Bolzan, Douglas W; Trimer, Renata; Begot, Isis; Nasrala, Mara L S; Forestieri, Patricia; Mendez, Vanessa M F; Arena, Ross; Gomes, Walter J; Guizilini, Solange

    2016-06-01

    To compare pulmonary function, functional capacity, and clinical outcomes among conventional mechanical ventilation (CMV), early open-lung (EOL), and late open-lung (LOL) strategies after off-pump coronary artery bypass surgery (OPCAB). Prospective, randomized, and double-blinded study. Two hospitals of the Federal University of Sao Paulo, Brazil. Ninety-three patients undergoing elective first-time OPCAB. Patients were randomized into 3 groups: CMV (n=31); LOL (n=32) initiated upon intensive care unit (ICU) arrival; EOL (n = 30) initiated after intubation. Spirometry was performed at bedside preoperatively and on postoperative days (PODs) 1, 3, and 5. Partial pressure of arterial oxygen (PaO2) and pulmonary shunt fraction were evaluated presurgically and on POD 1; 6-minute walk test (6MWT) was performed presurgically and on POD 5. Both open-lung groups demonstrated higher forced vital capacity and forced expiratory volume in 1 second on PODs 1, 3 and 5 compared to the CMV group (pLOL groups were compared. Both open-lung strategies were able to promote higher pulmonary function preservation and greater recovery of functional capacity with better clinical outcomes after OPCAB. No difference in outcome was found when comparing initiation of OLS intraoperatively or after ICU arrival. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications.

    Science.gov (United States)

    Ozaki, C Keith; Hamdan, Allen D; Barshes, Neal R; Wyers, Mark; Hevelone, Nathanael D; Belkin, Michael; Nguyen, Louis L

    2015-02-01

    Wound complications negatively affect outcomes of lower extremity arterial reconstruction. By way of an investigator initiated clinical trial, we tested the hypothesis that a silver-eluting alginate topical surgical dressing would lower wound complication rates in patients undergoing open arterial procedures in the lower extremity. The study block-randomized 500 patients at three institutions to standard gauze or silver alginate dressings placed over incisions after leg arterial surgery. This original operating room dressing remained until gross soiling, clinical need to remove, or postoperative day 3, whichever was first. Subsequent care was at the provider's discretion. The primary end point was 30-day wound complication incidence generally based on National Surgical Quality Improvement Program guidelines. Demographic, clinical, quality of life, and economic end points were also collected. Wound closure was at the surgeon's discretion. Participants (72% male) were 84% white, 45% were diabetic, 41% had critical limb ischemia, and 32% had claudication (with aneurysm, bypass revision, other). The overall 30-day wound complication incidence was 30%, with superficial surgical site infection as the most common. In intent-to-treat analysis, silver alginate had no effect on wound complications. Multivariable analysis showed that Coumadin (Bristol-Myers Squibb, Princeton, NJ; odds ratio [OR], 1.72; 95% confidence interval [CI], 1.03-2.87; P = .03), higher body mass index (OR, 1.05; 95% CI, 1.01-1.09; P = .01), and the use of no conduit/material (OR, 0.12; 95% CI, 0.82-3.59; P silver-eluting alginate dressing showed no effect on the incidence of wound complications. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  15. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial.

    Science.gov (United States)

    Yang, Ke; Jin, Ling; Li, Li; Zeng, Siming; Wei, Ruqian; Li, Guirong; Man, Pingyi; Congdon, Nathan

    2016-10-01

    Follow-up after trabeculectomy surgery is important to surgical success, but little is known about the effect of interventions on improving follow-up in low-resource areas. To examine whether text message reminders and free eye medications improve follow-up after trabeculectomy in rural southern China. This randomized clinical trial studied 222 consecutive patients undergoing trabeculectomy from October 1, 2014, through November 31, 2015, at 4 rural hospitals in Guangdong and Guangxi Provinces, China. Data from the intention-to-treat population were analyzed. Patients undergoing trabeculectomy were randomized (1:1) to receive text message reminders 3 days before appointments at 1 and 2 weeks and 1 month after surgery and free topical corticosteroid medication (US$5.30) at each visit or to standard follow-up without reminders or free medication. Follow-up at 1 month postoperatively. Among 222 eligible patients, 13 (5.9%) refused and 209 (94.1%) were enrolled, with 106 (50.7%) randomized to the intervention group (mean [SD] age, 64.4 [12.7] years; 56 women [52.8%]) and 103 (49.3%) to the control group (mean [SD] age, 63.0 [12.7] years; 53 women [51.5%]). A total of 6 patients (2.9%) were unavailable for follow-up. Attendance at 1 month for the intervention group (59 of 102 [57.8%]) was significantly higher than for the control group (34 of 101 [33.7%]) (unadjusted relative risk [RR], 1.72; 95% CI, 1.13-2.63; P = .01). Factors associated with 1-month attendance in multiple regression models included intervention group membership (RR, 1.65; 95% CI, 1.08-2.53; P = .02) and being told to return for suture removal (RR, 1.80; 95% CI, 1.06-3.06; P = .03). One-month attendance among controls not told about suture removal was 3 of 31 (9.7%), whereas it was 44 of 68 (64.7%) among the intervention group with suture removal (unadjusted RR, 6.69; 95% CI, 2.08-21.6; P = .001). In this setting, low-cost interventions may significantly improve

  16. Pre-emptive analgesic effect of lornoxicam in mandibular third molar surgery: a prospective, randomized, double-blind clinical trial.

    Science.gov (United States)

    Mojsa, I M; Stypulkowska, J; Novak, P; Lipczynski, K; Szczeklik, K; Zaleska, M

    2017-05-01

    The aim of this study was to establish whether the pre-emptive use of lornoxicam (16mg) in third molar surgery ensures successful postoperative analgesia and reduces rescue analgesic intake when compared to postoperative application, and in comparison with placebo. Ninety patients were split randomly into three groups: group A received lornoxicam 60min before surgery and placebo 60min after surgery; group B received placebo 60min before surgery and lornoxicam 60min after surgery; group C received placebo 60min before surgery and placebo 60min after surgery. Postoperative pain was recorded on a visual analogue scale and on a numerical rating scale at 1, 2, 4, 6, 8, 12, and 24h after surgery. The patients recorded total dose of paracetamol intake during the 24h after the procedure. The efficacy of postoperative analgesia was greater in lornoxicam groups when compared to the placebo group; there was no difference between the two lornoxicam groups (A and B). Patients in group C took their first rescue analgesic dose earlier after surgery than patients in the two lornoxicam groups. The average dose of paracetamol taken in group C was 1000mg, while it was500 mg in the lornoxicam groups. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  17. 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...

  18. Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

    Science.gov (United States)

    2013-01-01

    Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

  19. Role of Capitonage and Fibrin Sealant in Reducing Seroma Formation after Breast Conservation Surgery: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Rouhollah Miri

    2014-08-01

    Full Text Available Background: Seroma formation is a common complication after breast cancer surgery. Several techniques such as tube drainage, fibrin sealant and suturing methods have been employed to prevent or reduce seroma formation. Capitonnage, a suturing method widely used following hydatid cyst removal, has been used after breast surgery in limited studies. Our aim was to compare the effectiveness of tube drainage, fibrin sealant and capitonnage to prevent early complications.Methods: Eligible patients with breast cancer who were candidate for breast conserving surgery were enrolled and randomized into three different groups (tube drainage, capitonnage, capitonnage plus fibrin sealant. Patients were visited on 5th,12th and 19th days after surgery and were assessed for any probable complications.Results: A total of 90 patients were enrolled. One patient developed seroma in tube drainage and capitonnage group, while no participant from capitonnage plus fibrin sealant group experienced the mentioned complication. Three patients developed skin necrosis, all of them were treated with capitonnage plus fibrin sealant protocol.Conclusions: Based on our observations, it seems that capitonnage alone or in combination with fibrin sealant do not lead to significant differences in frequency of complications after breast cancer surgery such as hematoma, seroma and surgical site infection.

  20. 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

  1. Effect of Prewarming during Induction of Anesthesia on Microvascular Reactivity in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Youn Joung Cho

    Full Text Available General anesthesia may induce inadvertent hypothermia and this may be related to perioperative cardiovascular complications. Microvascular reactivity, measured by the recovery slope during a vascular occlusion test, is decreased during surgery and is also related to postoperative clinical outcomes. We hypothesized that microvascular changes during surgery may be related to intraoperative hypothermia. To evaluate this, we conducted a randomized study in patients undergoing off-pump coronary artery bypass surgery, in which the effect of prewarming on microvascular reactivity was evaluated.Patients scheduled for off-pump coronary artery bypass surgery were screened. Enrolled patients were randomized to the prewarming group to receive forced-air warming during induction of anesthesia or to the control group. Measurement of core and skin temperatures and vascular occlusion test were conducted before anesthesia induction, 1, 2, and 3 h after induction, and at the end of surgery.In total, 40 patients were enrolled and finished the study (n = 20 in the prewarming group and n = 20 in the control group. During the first 3 h of anesthesia, core temperature was higher in the prewarming group than the control group (p < 0.001. The number of patients developing hypothermia was lower in the prewarming group than the control group (4/20 vs. 13/20, p = 0.004. However, tissue oxygen saturation and changes in recovery slope following a vascular occlusion test at 3 h after anesthesia induction did not differ between the groups. There was no difference in clinical outcome, including perioperative transfusion, wound infection, or hospital stay, between the groups.Prewarming during induction of anesthesia decreased intraoperative hypothermia, but did not reduce the deterioration in microvascular reactivity in patients undergoing off-pump coronary artery bypass surgery.ClinicalTrials.gov NCT02186210.

  2. Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection.

    Science.gov (United States)

    Hendry, P O; van Dam, R M; Bukkems, S F F W; McKeown, D W; Parks, R W; Preston, T; Dejong, C H C; Garden, O J; Fearon, K C H

    2010-08-01

    Routine laxatives may expedite gastrointestinal recovery and early tolerance of food within an enhanced recovery after surgery (ERAS) programme. Combined with carbohydrate loading and oral nutritional supplements (ONS), it may further enhance recovery of gastrointestinal function and promote earlier overall recovery. Seventy-four patients undergoing liver resection were randomized in a two-by-two factorial design to receive either postoperative magnesium hydroxide as a laxative, preoperative carbohydrate loading and postoperative ONS, their combination or a control group. Patients were managed within an ERAS programme of care. The primary outcome measure was time to first passage of stool. Secondary outcome measures were gastric emptying, postoperative oral calorie intake, time to functional recovery and length of hospital stay. Sixty-eight patients completed the trial. The laxative group had a significantly reduced time to passage of stool: median (interquartile range) 4 (3-5) versus 5 (4-6) days (P = 0.034). The ONS group showed a trend towards a shorter time to passage of stool (P = 0.076) but there was no evidence of interaction in patients randomized to the combination regimen. Median length of hospital stay was 6 (4-7) days. There were no differences in secondary outcomes between groups. Within an ERAS protocol for patients undergoing liver resection, routine postoperative laxatives result in an earlier first passage of stool but the overall rate of recovery is unaltered. Copyright (c) 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  3. Comparison of continuous infusion and intermittent bolus administration of cisatracurium in cardiac surgery: a randomized clinical trial

    International Nuclear Information System (INIS)

    Mirinejad, M.; Yaghoubi, A.R.; Azarfarin, R.

    2007-01-01

    The aim of this study was to compare continuous infusion and intermittent bolus administration of cisatracurium (CA) with respect to total intraoperative dose and time of recovery from neuromuscular blockade after cardiac surgery. From June 2005 to April 2006 sixty patients who undergoing coronary bypass graft and valve replacement surgery were randomized to receive either intermittent bolus (Group A, n=30) or continuous infusion (Group B, n=30) of CA in Madni heart center in Tabriz, Iran.Total intraoperative dose of CA and time to trainoffour (TOF) ratio=0.8 after operation were measured. Anesthesia technique in two groups was the same. Intensity of neuromuscular blockade maintained on one TOF twitch response of adductor pollicis during operation. Mean received dose of CA was 32.8+-20.6 meu/kg/hr in Group A and 89.7+-39.4 meu/kg/hr in Group B (p=0.003). Total intraoperative dose of CA was 23.6+-4.9 mg in Group A and 39.2+-10.1 mg in Group B (p=0.001). Spontaneous recovery from neuromuscular blockade in ICU (TOF ratio=0.8) was reached in 43.8+-9.2 min in Group A, and 64.2+-15.1 min in Group B (p=0.0001). Intubation time in ICU was not significantly different (Group A=8.3+-5.1 hrs vs. Group B=10.2+-6.2 hrs, p=0.256). Intermittent bolus administration of cisatracurium in cardiac surgery with cardiopulmonary bypass used lower intraoperative dose and gave shorter postoperative recovery time as compared to continuous infusion. (author)

  4. Comparison of the analgesic efficacy of oral ketorolac versus intramuscular tramadol after third molar surgery: A parallel, double-blind, randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Isiordia-Espinoza, M-A; Pozos-Guillen, A; Martinez-Rider, R; Perez-Urizar, J

    2016-09-01

    Preemptive analgesia is considered an alternative for treating the postsurgical pain of third molar removal. The aim of this study was to evaluate the preemptive analgesic efficacy of oral ketorolac versus intramuscular tramadol after a mandibular third molar surgery. A parallel, double-blind, randomized, placebo-controlled clinical trial was carried out. Thirty patients were randomized into two treatment groups using a series of random numbers: Group A, oral ketorolac 10 mg plus intramuscular placebo (1 mL saline solution); or Group B, oral placebo (similar tablet to oral ketorolac) plus intramuscular tramadol 50 mg diluted in 1 mL saline solution. These treatments were given 30 min before the surgery. We evaluated the time of first analgesic rescue medication, pain intensity, total analgesic consumption and adverse effects. Patients taking oral ketorolac had longer time of analgesic covering and less postoperative pain when compared with patients receiving intramuscular tramadol. According to the VAS and UAC results, this study suggests that 10 mg of oral ketorolac had superior analgesic effect than 50 mg of tramadol when administered before a mandibular third molar surgery.

  5. Efficacy and safety of 1% ropivacaine for postoperative analgesia after lower third molar surgery: a prospective, randomized, double-blinded clinical study.

    Science.gov (United States)

    Brković, Božidar; Andrić, Miroslav; Ćalasan, Dejan; Milić, Marija; Stepić, Jelena; Vučetić, Milan; Brajković, Denis; Todorović, Ljubomir

    2017-04-01

    The purpose of this study was to investigate postoperative analgesic effect of ropivacaine administered as main or supplemental injection for the inferior alveolar nerve block (IANB) in patients undergoing lower third molar surgery. The double-blind randomized study comprised 72 healthy patients. All patients received two blocks, the IANB for surgical procedure + IANB after surgery for postoperative pain control, and were divided into three groups: (1) 2 % lidocaine/epinephrine + 1 % ropivacaine, (2) 2 % lidocaine/epinephrine + saline, and (3) 1 % ropivacaine + saline. The occurrence of postoperative pain, pain intensity and analgesic requirements were recorded. Data were statistically analyzed using chi-square, Fisher, and Kruskal-Wallis tests and analysis of variance (ANOVA) with Bonferroni and Tukey correction. Ropivacaine was more successful than lidocaine/epinephrine in obtaining duration of postoperative analgesia, reduction of pain, and analgesic requirements whether ropivacaine was used for surgical block or administered as a supplemental injection after surgery. Ropivacaine (1 %, 2 ml) resulted in effective postoperative analgesia after lower third molar surgery. Since pain control related to third molar surgery requires the effective surgical anesthesia and postoperative analgesia, the use of 1 % ropivacaine could be clinically relevant in a selection of appropriate pain control regimen for both surgical procedure and early postsurgical treatment.

  6. Evaluation of Preemptive Use of Analgesia of The Skin, Before and After Lower Abdominal Surgery: A Prospective, Double-Blind, Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    P Kashefi

    2005-03-01

    Full Text Available Background: Perioperative pain is prevalent and poorly treated. Apart from that it makes the recovery from surgery unpleasent, pain often remains as a residual side effect of surgery, even though the tissue healing is complete. An essential observation is that tissue injury and the resulting nociceptor barrage initiates a cascade of events that can indelibly alter pain perception. Preemptive analgesia is the concept of initiating analgesic therapy before the onset of the noxious stimulus so as to prevent the nociceptor barrage and its consequences. However, anticipated clinical potency of preemptive analgesia, though has firmly grounded in the neurobiology of pain, has not been yet realized. As data accumulates, it has become clear that clinical studies emulating those from the laboratory and designed around a relatively narrow definition of preemptive analgesia have been largely unsupportive of its use. Nevertheless, preemptive analgesic interventions that recognize the intensity, duration, and somatotopic extent of major surgery can help reduce perioperative pain and its longer-term sequelae. surgeons spend a lot of time treating the pain of lower abdominal surgery. Methods: A total number of 48 consecutive patients who were going to undergo elective lower abdominal surgery. Were randomly assigned in two groups of 24 each. In one group the patients received an injection of 0.5 % bupivacaine in the planned skin for incision just before lower abdominal surgery, and in the other group, they received an equal amount of 0.5% bupivacaine after the surgery had been done. Pain was objectified by a numerical visual pain score, in the 24 hours following the lower abdominal surgery. Results: There were no differences in postoperative pain scores on the visual analog scale (VAS: In groups 1and 2, VAS at hour 4 were 6.37±1.13 versus 6.29±1.19; At hour 8 were 5.54 ± 1.17 versus 5.37±1.09; and at hour 12 were 4.5 ± 1.31 versus 4.45 ± 1

  7. N-acetylcysteine for prevention of acute renal failure in patients with chronic renal insufficiency undergoing cardiac surgery: a prospective, randomized, clinical trial.

    Science.gov (United States)

    Sisillo, Erminio; Ceriani, Roberto; Bortone, Franco; Juliano, Glauco; Salvi, Luca; Veglia, Fabrizio; Fiorentini, Cesare; Marenzi, Giancarlo

    2008-01-01

    To assess the preventive effect of the antioxidant N-acetylcysteine on postoperative acute renal failure in patients with renal insufficiency undergoing cardiac surgery. Randomized, placebo-controlled, prospective study. University cardiology center. Two hundred fifty-four consecutive patients with chronic renal insufficiency (estimated creatinine clearance acute renal failure (> 25% increase in serum creatinine from baseline) and the in-hospital clinical course were evaluated. Acute renal failure occurred in 46% of patients and was associated with increased in-hospital mortality (7% vs. 0.7%; p = .024). It occurred in 52% of control patients and 40% of N-acetylcysteine-treated patients (p = .06). In-hospital mortality and need for renal replacement therapy were not affected by N-acetylcysteine, but a lower percentage of N-acetylcysteine-treated patients required mechanical ventilation prolonged for > 48 hrs (3% vs. 18%; p 4 days (13% vs. 33%; p acute renal failure in patients with renal insufficiency undergoing cardiac surgery.

  8. Early Versus Delayed Postoperative Feeding After Major Gynaecological Surgery and its Effects on Clinical Outcomes, Patient Satisfaction, and Length of Stay: A Randomized Controlled Trial.

    Science.gov (United States)

    Balayla, Jacques; Bujold, Emmanuel; Lapensée, Louise; Mayrand, Marie-Hélène; Sansregret, Andrée

    2015-12-01

    To compare early versus delayed postoperative feeding in women undergoing major gynaecological surgery with regard to clinical outcomes, duration of postoperative stay, and patient satisfaction. We conducted a parallel-randomized controlled trial at a tertiary care centre in Montreal, Quebec, between June 2000 and July 2001. Patients undergoing major gynaecological surgery were randomized following a 1:1 allocation ratio to receive either early postoperative feeding in which oral clear fluids were begun up to six hours after surgery followed by solid foods as tolerated, or delayed postoperative feeding, in which clear fluids were begun on the first postoperative day and solid foods on the second or third day as tolerated. The primary outcomes analyzed were duration of postoperative stay and patient satisfaction. Secondary outcomes included mean time to appetite, passage of flatus, and bowel movement, as well as the presence of symptoms of paralytic ileus. A total of 119 patients were randomized; 61 patients were assigned to the early feeding group and 58 to the delayed feeding group. Demographic characteristics, including age, weight, smoking status, and prior surgical history were comparable between both groups. There was no difference in length of postoperative stay between the two groups (86.4 ± 21.0 hours in the early feeding group vs. 85.6 ± 26.2 hours in the delayed feeding group; P > 0.05). No significant difference was noted in patient satisfaction (P > 0.05). No difference was found in the frequency of postoperative ileus, mean time to appetite, passage of flatus, or first bowel movement. The introduction of early postoperative feeding appears to be safe and well tolerated by patients undergoing major gynaecological surgery. The duration of postoperative stay, patient satisfaction, and gastrointestinal symptoms are comparable between patients undergoing early or delayed postoperative feeding.

  9. Cefepime versus Ceftriaxone for perioperative systemic antibiotic prophylaxis in elective orthopedic surgery at Bugando Medical Centre Mwanza, Tanzania: a randomized clinical study.

    Science.gov (United States)

    Marwa, Joel M; Ngayomela, Isidor H; Seni, Jeremiah; Mshana, Stephen E

    2015-12-23

    Antimicrobial prophylaxis reduces the incidence of postoperative wound infections especially among patients undergoing orthopedics surgery. However, there is dearth of information on the clinical effectiveness, spectrum limitations and practical contextual information on third and fourth generation cephalosporins. The aim of this study was to evaluate the efficacy and safety of cefepime and ceftriaxone as peri-operative systemic antimicrobial prophylaxis in elective orthopedic surgery in our center. This study was a prospective, randomized, open label comparative clinical study of patients undergoing elective orthopedic procedures at the Bugando Medical Centre (BMC) between June 2014 and February 2015. Two hundred thirty participants were enrolled in the study and randomly assigned into Ceftriaxone regimen (group A) or Cefepime regimen (group B). Participants in ceftriaxone or cefepime group received 50 mg/kg up to 2 g single dose perioperative intravenous infusion at least 30 min before incision. Both groups were followed for 30 days using a Center for Disease Control superficial surgical site infection criterion for the outcome. A two-tailed margin of equivalence was set at 5% analyzed on the intent to treat. All 230 participants were subjected to final analysis with no patient being lost to follow-up. Superficial surgical site infection occurred in 5 out of 117 (4.3%, 0.6 to 7.9 at 95% CI) patients receiving cefepime compared to 3 out of 113 (2.7%, 0.3 to 5.6 at 95% CI) among patients receiving ceftriaxone regimen. The absolute difference of 1.6% (95% Confidence Interval: -6.3 to 3.1), equivocally lies outside the 5% statistically significant margin of presumed clinical equivalence. The difference between cefepime and ceftriaxone in preventing SSIs following elective clean orthopedic surgery was not statistically significant. Pan African Clinical Trial Registry: PACTR201406000803420.

  10. Effective low dosage of mepivacaine in ultrasound-guided axillary nerve block: a double-blinded, randomized clinical trial of efficacy in patients undergoing distal upper extremity surgery.

    Science.gov (United States)

    Perov, Samuel; Patel, Pranav; Kumar, Sanjeev; McKelvey, George M; Chidiac, Elie; Motlani, Faisal

    2014-05-01

    To evaluate two low-dose volumes (20 mL or 30 mL) of 1.5% mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery. Prospective, double-blinded randomized study. Outpatient surgical setting of a university-affiliated hospital. 64 adult, ASA physical status 1, 2, and 3 patients, aged 28-46 years, scheduled for upper limb surgery. Patients were randomized to two groups to receive either 20 mL of 1.5% mepivacaine solution (n=31) or 30 mL of 1.5% mepivacaine solution (n=33) for ultrasound-guided axillary plexus blockade. Block duration, proportion of surgical and functional successful blocks, onset of sensory and motor blockade measured from 0 to 30 minutes following final needle extraction, total amount of preoperative sedative (midazolam), and intraoperative propofol administered were recorded. Following axillary plexus blockade, neither patient group showed any statistically significant difference in the percentage of functionally successful blockade (30 mL, 100%: 20 mL, 97%; P = 0.48), surgically successful blockade (30 mL, 100%; 20 mL, 94%; P = 0.23), cumulative sensory or motor blockade surgical time, block performance time, preoperative midazolam use, or intraoperative propofol use. Low volumes (30 mL or 20 mL) of 1.5% mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. The impact of perioperative glutamine-supplemented parenteral nutrition on outcomes of patients undergoing abdominal surgery: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Yue, Chao; Tian, Weiliang; Wang, Wei; Huang, Qian; Zhao, Risheng; Zhao, Yunzhao; Li, Qiurong; Li, Jieshou

    2013-05-01

    The objective of this study was to evaluate the impact of perioperative glutamine-supplemented parenteral nutrition (GLN-PN) on clinical outcomes in patients undergoing abdominal surgery. MEDLINE, EMBASE, and the Cochrane Controlled Clinical Trials Register were searched to retrieve the eligible studies. Eligible studies were randomized controlled trials (RCTs) that compared the effect of GLN-PN and standard PN on clinical outcomes in patients undergoing abdominal surgery. Clinical outcomes of interest were postoperative mortality, length of hospital stay, morbidity of infectious complication, and cumulative nitrogen balance. Statistical analysis was conducted by RevMan 5.0 software from the Cochrane Collaboration. Sixteen RCTs with 773 patients were included in this meta-analysis. The results showed a significant decrease in the infectious complication rates of patients undergoing abdominal surgery receiving GLN-PN (risk ratio [RR], 0.48; 95% confidence interval [CI], 0.32 to 0.72; P = 0.0004). The overall effect indicated glutamine significantly reduced the length of hospital stay in the form of alanyl-glutamine (weighted mean difference [WMD], -3.17; 95% CI, -5.51 to -0.82; P = 0.008) and in the form of glycyl-glutamine (WMD, -3.40; 95% CI, -5.82 to -0.97; P = 0.006). A positive effect in improving postoperative cumulative nitrogen balance was observed between groups (WMD, 7.40; 95% CI, 3.16 to 11.63; P = 0.0006), but no mortality (RR, 1.52; 95% CI, 0.21 to 11.9; P = 0.68). Perioperative GLN-PN is effective and safe to shorten the length of hospital stay, reduce the morbidity of postoperative infectious complications, and improve nitrogen balance in patients undergoing abdominal surgery.

  12. Undergraduate Clinical Teaching in Orthopedic Surgery: A Randomized Control Trial Comparing the Effect of Case-Based Teaching and Bedside Teaching on Musculoskeletal OSCE Performance.

    Science.gov (United States)

    Kelly, Martin; Feeley, Iain; Boland, Fiona; O'Byrne, John M

    Musculoskeletal (MSK) complaints are the second most common reason for a hospital outpatient appointment in the US, and account for 19.5% of general practice consultations. Previous studies have shown that passive teaching in medical school does not imbue students with an adequate degree of confidence in MSK evaluation. The aim of this study was to conduct a randomized control trial to compare the effect of the gold standard small group tutorial of bedside teaching against case-based teaching (CBT) in relation to orthopedic surgery in medical students. All third-year medical students at our institution were invited to participate in a randomized control trial comparing CBT and bedside tutorials in relation to MSK. The primary outcome was student performance in an Objective Structured Clinical Examination (OSCE). Participants were randomized into 2 groups, receiving either a bedside tutorial or a case-based tutorial. Participants were then assigned self-directed learning before undergoing a final OSCE assessment. Student feedback was attained through a poststudy questionnaire. Complete data was acquired for 96 study participants (n = 45 CBT; n = 51 bedside tutorial). The results of a linear regression model used to assess differences in the final OSCE scores, adjusting for the baseline OSCE score, gender, age, previous problem-based learning exposure and whether English was their first language or not showed no evidence of a difference between the bedside teaching group and the CBT group (mean difference: 0.34; 95% confidence interval: -3.79 to 4.47; p = 0.872). Almost all (95%) of the study participants felt that CBT was an important component in their learning. There was no difference in OSCE performance between groups. The introduction of CBT before clinical placement in medical school could accentuate the clinical skills of students before transition into the apprenticeship model of clinical attachment. Copyright © 2018 Association of Program Directors in

  13. Adjuvant therapy for melanoma in dogs: results of randomized clinical trials using surgery, liposome-encapsulated muramyl tripeptide, and granulocyte macrophage colony-stimulating factor.

    Science.gov (United States)

    MacEwen, E G; Kurzman, I D; Vail, D M; Dubielzig, R R; Everlith, K; Madewell, B R; Rodriguez, C O; Phillips, B; Zwahlen, C H; Obradovich, J; Rosenthal, R C; Fox, L E; Rosenberg, M; Henry, C; Fidel, J

    1999-12-01

    Spontaneous canine oral melanoma (COM) is a highly metastatic cancer, resistant to chemotherapy, and can serve as a model for cancer immunotherapy. Liposome-encapsulated muramyl tripeptide-phosphatidylethanolamine (L-MTP-PE) can activate the tumoricidal activity of the monocyte-macrophage system following i.v. injection. The objective of these studies was to evaluate the therapeutic effectiveness of L-MTP-PE administered alone and combined with recombinant canine granulocyte macrophage colony-stimulating factor (rcGM-CSF) in dogs undergoing surgery for oral melanoma. Ninety-eight dogs with histologically confirmed, clinically staged, oral melanoma were entered into two randomized, double-blind, surgical adjuvant trials. In trial 1, 50 dogs were stratified based on clinical stage and randomized to once a week L-MTP-PE or lipid equivalent (control). When all of the clinical stages were combined, no difference in disease-free survival or in survival time (ST) were detected. However, within stage I, dogs receiving L-MTP-PE had a significant increase in ST compared with control, with 80% of the dogs treated with L-MTP-PE still alive at >2 years. Within each stage II and stage III, there was no difference detected between the treatment groups. In trial 2, 48 dogs were stratified on the basis of clinical stage and extent of surgery (simple resection or radical excision), treated with L-MTP-PE two times a week, and randomized to rcGM-CSF or saline (placebo) given s.c. daily for 9 weeks. Within each stage and when all of the stages were combined, there was no difference between the treatment groups. In both studies, stage I COM is associated with a better prognosis. No effect on survival was observed with regard to tumor location in the oral cavity, sex, type/extent of surgery, or age. In a subset of dogs tested, pulmonary alveolar macrophage cytotoxicity was enhanced with combined rcGM-CSF and L-MTP-PE but not in dogs treated with L-MTP-PE alone. The present study

  14. Perioperative oral nutritional supplements in normally or mildly undernourished geriatric patients submitted to surgery for hip fracture: a randomized clinical trial.

    Science.gov (United States)

    Botella-Carretero, José I; Iglesias, Borja; Balsa, José A; Arrieta, Francisco; Zamarrón, Isabel; Vázquez, Clotilde

    2010-10-01

    Oral nutritional supplements have been recommended after orthopedic surgery in geriatric patients. This has been shown to be effective even in normally nourished or mildly undernourished geriatric patients. Whether perioperative administration of these products is also effective and suitable is not known. Randomized, controlled, open, paralleled two-arms clinical trial, comparing energy-protein supplements (40 g of protein and 400 kcal per day), with no intervention in normally nourished or mildly undernourished patients. Outcomes were serum proteins, body mass index, postoperative complications among others. 60 Elderly patients were included. Patients in the intervention group (n = 30) ingested 52.2 ± 12.1% of the prescribed supplements per day for 5.8 ± 1.8 days before surgery and until hospital discharge. There was a significant change in serum albumin at follow-up (F = 22.536, P supplemented proteins per day (OR[95%CI] = 0.925[0.869-0.985]) were associated with less postoperative complications (R(2) = 0.323, χ(2) = 11.541, P = 0.003). Perioperative supplements in geriatric patients with hip fracture submitted to surgery showed better recovery of plasma proteins. Higher daily protein intakes were associated with less postoperative complications. Copyright © 2010 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  15. Topical diclofenac versus dexamethasone after strabismus surgery: A double-blind randomized clinical trial of anti-inflammatory effect and ocular hypertensive response

    Directory of Open Access Journals (Sweden)

    Khan Hayat

    2007-01-01

    Full Text Available Background: Compared to steroids non-steroidal anti-inflammatory drugs offer comparable anti-inflammatory action without ocular side-effects. Aim: To compare the anti-inflammatory effect and effect on IOP (Goldmann of topical diclofenac 0.1% with dexamethasone 0.1% after strabismus surgery. Design: Prospective, randomized, double-blind, single-center, clinical trial. Materials and Methods: Forty-three cases of constant horizontal strabismus, qualifying for standard uniocular recession-resection surgery on two horizontal rectus muscles were randomized to either the dexamethasone or diclofenac group. They were excluded if they had previous ocular surgery, recently used anti-inflammatory drugs and had a neurological, systemic or an ocular inflammatory condition. In addition all received ciprofloxacin 0.3% four times daily. Assessment was done on the first postoperative day and at two and four weeks. The inflammatory characteristics graded from nil (0 to severe (3 were: discomfort, chemosis, injection, discharge and drop-intolerance. Their sum provided the total inflammatory score (TIS. Results: Dexamethasone group (n=21 was comparable in age, gender, preoperative IOP, strabismus, anesthesia administered and baseline IOP, to diclofenac (n=22. There were no significant differences in the inflammatory characteristics and TIS. The dexamethasone group had IOP significantly higher at two weeks (95% CI 0.17 to 3.25 and four weeks (95% CI 1.09 to 4.24 compared to diclofenac group and the net change of IOP at four weeks (95% CI 0.60 to 3.14. Compared to the baseline IOP. Conclusion: Topical diclofenac is comparable to dexamethasone in providing anti-inflammatory and analgesic effect with the advantage of significantly lesser IOP rise and should be preferred after strabismus surgery.

  16. A randomized clinical trial comparing the efficacy and safety of ramosetron versus ondansetron in patients undergoing abdominal surgery under general anesthesia

    Directory of Open Access Journals (Sweden)

    Sriramamurthy Kaja

    2014-01-01

    Full Text Available Background: Post-operative nausea and vomiting is one of the most common and distressing complications after anesthesia and surgery. It may lead to serious post-operative complications. Ramosetron is a newer 5-HT3 receptor antagonist and has more potent and longer duration of antiemetic effects compared to first generation 5HT3 receptor antagonists. The purpose of this study was to compare the efficacy of Ramosetron for the prevention of post-operative nausea and vomiting with that of Ondansetron in patients undergoing abdominal surgeries under general anesthesia. Methods: In this randomized, double-blind study, 60 patients, 18-60 years of both genders falling under ASA I-II category scheduled for abdominal surgery were included. Group I received I.V ramosetron 0.3 mg while group II received I.V Ondansetron 4 mg at the time of extubation. The standard general anesthetic technique was used throughout. Postoperatively the incidences of nausea, vomiting, and safety assessments were performed at 1, 2, 6, and 24 h during the first 24 h after surgery. Results: There were no differences between groups with respect to patient demographics. The percentage of patients who had complete response (no PONV, and no need for another rescue antiemetic from 0 to 24 h after anesthesia was 56% with ramosetron and 33% with ondansetron. The corresponding rates at 1, 2, 6, and 24 h after anesthesia were 76% and 63%, 76% and 50%, 100 and 83%, 100 and 93%, respectively. Safety profiles of the two drugs were comparable, as no clinically serious adverse effects caused by study drugs were observed in either of the groups. Conclusion: Our study concludes that prophylactic therapy with ramosetron is highly efficacious than ondansetron in preventing PONV in patients undergoing abdominal surgery under general anesthesia.

  17. Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery

    NARCIS (Netherlands)

    van den Heijkant, T. C.; Costes, L. M. M.; van der Lee, D. G. C.; Aerts, B.; Osinga-de Jong, M.; Rutten, H. R. M.; Hulsewé, K. W. E.; de Jonge, W. J.; Buurman, W. A.; Luyer, M. D. P.

    2015-01-01

    Postoperative ileus (POI) is a common complication following colorectal surgery that delays recovery and increases length of hospital stay. Gum chewing may reduce POI and therefore enhance recovery after surgery. The aim of the study was to evaluate the effect of gum chewing on POI, length of

  18. Robenacoxib versus meloxicam for the management of pain and inflammation associated with soft tissue surgery in dogs: a randomized, non-inferiority clinical trial.

    Science.gov (United States)

    Gruet, Philippe; Seewald, Wolfgang; King, Jonathan N

    2013-05-02

    Non-steroidal anti-inflammatory drugs (NSAIDs) are used routinely to control pain and inflammation after surgery in dogs. Robenacoxib is a new NSAID with high selectivity for the cyclo-oxygenase (COX)-2 isoform of COX. The objective of this study was to evaluate the efficacy and tolerability of robenacoxib for the management of peri-operative pain and inflammation associated with soft tissue surgery in dogs. The study was a prospective, randomized, blinded, positive-controlled, non-inferiority, multi-center clinical trial. A total of 174 dogs undergoing major soft tissue surgery were included and randomly allocated in a 2:1 ratio to receive either robenacoxib (n = 118) or the positive control, meloxicam (n = 56). Each dog received an initial dose subcutaneously prior to surgery (robenacoxib 2 mg/kg, meloxicam 0.2 mg/kg), followed by daily oral doses (robenacoxib 1-2 mg/kg, meloxicam 0.1 mg/kg) for 12 days (range 10-14) after surgery. Pain and inflammation were assessed subjectively using the Glasgow Composite Pain Scale (GCPS) by clinicians as the primary end point and additional evaluations by the clinicians and animal owners as secondary endpoints. Both treatments provided similar pain control, with no significant differences between groups for any efficacy variable using non-parametric analyses (Mann-Whitney U test). In no dog was analgesic rescue therapy administered. Non-inferior efficacy of robenacoxib compared to meloxicam was demonstrated statistically for the primary and all secondary endpoints using parametric analysis of variance, although the data were not normally distributed even after log transformation. For the primary endpoint (reciprocal of the modified GCPS score), the relative efficacy of robenacoxib/meloxicam was 1.12 with a 95% confidence interval of 0.97-1.29. A treatment regimen of robenacoxib by subcutaneous injection followed by oral tablets had good tolerability and non-inferior efficacy compared to meloxicam for the

  19. Marginal Bone Remodeling around healing Abutment vs Final Abutment Placement at Second Stage Implant Surgery: A 12-month Randomized Clinical Trial.

    Science.gov (United States)

    Nader, Nabih; Aboulhosn, Maissa; Berberi, Antoine; Manal, Cordahi; Younes, Ronald

    2016-01-01

    The periimplant bone level has been used as one of the criteria to assess the success of dental implants. It has been documented that the bone supporting two-piece implants undergoes resorption first following the second-stage surgery and later on further to abutment connection and delivery of the final prosthesis. The aim of this multicentric randomized clinical trial was to evaluate the crestal bone resorption around internal connection dental implants using a new surgical protocol that aims to respect the biological distance, relying on the benefit of a friction fit connection abutment (test group) compared with implants receiving conventional healing abutments at second-stage surgery (control group). A total of partially edentulous patients were consecutively treated at two private clinics, with two adjacent two-stage implants. Three months after the first surgery, one of the implants was randomly allocated to the control group and was uncovered using a healing abutment, while the other implant received a standard final abutment and was seated and tightened to 30 Ncm. At each step of the prosthetic try-in, the abutment in the test group was removed and then retightened to 30 Ncm. Horizontal bone changes were assessed using periapical radiographs immediately after implant placement and at 3 (second-stage surgery), 6, 9 and 12 months follow-up examinations. At 12 months follow-up, no implant failure was reported in both groups. In the control group, the mean periimplant bone resorption was 0.249 ± 0.362 at M3, 0.773 ± 0.413 at M6, 0.904 ± 0.36 at M9 and 1.047 ± 0.395 at M12. The test group revealed a statistically significant lower marginal bone loss of 20.88% at M3 (0.197 ± 0.262), 22.25% at M6 (0.601 ± 0.386), 24.23% at M9 (0.685 ± 0.341) and 19.2% at M9 (0.846 ± 0.454). The results revealed that bone loss increased over time, with the greatest change in bone loss occurring between 3 and 6 months. Alveolar bone loss was significantly greater in the

  20. 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.

  1. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial.

    Science.gov (United States)

    Hajizadeh, Hila; Nemati-Karimooy, Atefeh; Majidinia, Sara; Moeintaghavi, Amir; Ghavamnasiri, Marjaneh

    2017-08-01

    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. 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 S 3 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). 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. Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil S 3 Bond can have some benefits.

  2. Effects of co-administered dexamethasone and nimesulide on pain, swelling, and trismus following third molar surgery: a randomized, triple-blind, controlled clinical trial.

    Science.gov (United States)

    Barbalho, J C; Vasconcellos, R J H; de Morais, H H; Santos, L A M; Almeida, R de A C; Rêbelo, H L; Lucena, E E; de Araújo, S Q

    2017-02-01

    This study aimed to determine the effect of the co-administration of dexamethasone 8mg and nimesulide 100mg given 1h before mandibular third molar surgery. A prospective, randomized, triple-blind, split-mouth clinical trial was developed at the study institution in Pernambuco, Brazil. A pilot study was first performed (95% confidence interval, 80% test power, and 5% error), and a sample of 40 patients aged between 18 and 40 years was selected. The patients were randomized and divided into two groups: dexamethasone+placebo and dexamethasone+nimesulide. The following parameters were evaluated: pain (visual analogue scale), total number of rescue analgesics taken, time taken to first rescue analgesic consumption, oedema, trismus, and patient satisfaction. The paired t-test and the Wilcoxon test were used to compare means. Statistically significant differences were found between the groups in pain values at 2, 4, and 12h postoperative, and in the total number of rescue analgesics and time taken to first rescue analgesic ingestion (Pthird molar surgery. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  3. A preliminary randomized clinical trial comparing diode laser and scalpel periosteal incision during implant surgery: impact on postoperative morbidity and implant survival.

    Science.gov (United States)

    Shahnaz, Aysan; Jamali, Raika; Mohammadi, Farnush; Khorsand, Afshin; Moslemi, Neda; Fekrazad, Reza

    2018-01-01

    The aim of this preliminary randomized clinical trial was to compare: (1) post-operative morbidity after application of laser or scalpel incision for flap advancement during implant surgery and bone grafting and (2) implant survival rate following flap advancement with laser or scalpel incision after 6 months of loading. Eighteen patients who were scheduled for dental implant placement and simultaneous bone grafting were randomly assigned to test or control groups. Diode laser (810 nm, 2 W, pulse interval 200 μs; pulse length 100 μs, 400-μm initiated fiber tip), or scalpel (control) was used to sever the periosteum to create a tension-free flap. Visual analogue scale (VAS) pain score, rate of nonsteroid anti-inflammatory drug (NSAID) consumption, intensity of swelling, and ecchymosis were measured for the six postsurgical days. Six months after loading, implant survival was assessed. VAS pain score (during the first four postoperative days), rate of NSAID consumption (during the first three postoperative days), and intensity of swelling (during the first five postoperative days) were significantly lower in the test group compared to the control group (All P values implants were successful in function. Application of laser for performing periosteal releasing incision reduced the incidence and severity of postoperative morbidity of the patients undergone implant surgery in conjunction with bone augmentation procedure. We did not find any detrimental effect of laser incision on the implant survival within 6 months of loading.

  4. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial.

    Science.gov (United States)

    Jayne, David; Pigazzi, Alessio; Marshall, Helen; Croft, Julie; Corrigan, Neil; Copeland, Joanne; Quirke, Phil; West, Nick; Rautio, Tero; Thomassen, Niels; Tilney, Henry; Gudgeon, Mark; Bianchi, Paolo Pietro; Edlin, Richard; Hulme, Claire; Brown, Julia

    2017-10-24

    Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, -1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of

  5. Intravenous sufentanil and morphine for post-cardiac surgery pain relief using patient-controlled analgesia (pca) device: a randomized double-blind clinical trial

    International Nuclear Information System (INIS)

    Alavi, S.M.; Kish, R.F.; Farsad, F.; Imani, F.; Sheikhvatan, M.

    2010-01-01

    Selection of the best analgesic technique in patients undergoing major surgeries can result in lower morbidity and satisfactory postoperative pain relief. In the present study, we tried to compare the effect of morphine and sufentanil on postoperative pain severity and hemodynamic changes by using patient-controlled analgesia (PCA) device in patients who were candidate for coronary artery bypass surgery (CABG). It was a randomized double-blinded clinical trial in which 120 patients aged 30-65 years, ASA physical status I-III, candidate for CABG in Shahid Rajaee hospital in Tehran were included. Before anesthesia, patients were randomly assigned to one of three groups to receive sufentanil (n=40), morphine (n=40) or normal saline (n=40). After tracheal extubation at intensive care unit, PCA was started by, sufentanil 4mg for the first group, morphine 2mg for the second group and normal saline, at same volume for the third group, intravenously with 10 minute lockout interval. Postoperative pain was evaluated by VAS scale, 1, 6, 12, 18 and 24 hours after extubation and systolic blood pressure, arterial oxygen saturation, PCO2 and PO2 were recorded 24 hours after extubation. VAS scores at rest revealed significantly less pain for patients in sufentanil and morphine groups than normal saline group, throughout the twenty-four hours after operation (P<0.001). However, there were no significant differences in the means of VAS scores between sufentanil and morphine groups. Among studied hemodynamic parameters, only systolic blood pressure was reduced more in morphine than sufentanil group (P<0.001). After CABG surgery, administration of intravenous sufentanil and morphine using PCA can lead to similar reduction of postoperative pain severity. (author)

  6. 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

  7. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Tikuišis, R; Miliauskas, P; Samalavičius, N E; Žurauskas, A; Samalavičius, R; Zabulis, V

    2014-04-01

    Perioperative intravenous (IV) infusion of lidocaine has been shown to decrease post-operative pain, shorten time to return of bowel function, and reduce the length of hospital stay. This randomized, prospective, double-blinded, placebo-controlled clinical trial evaluated the impact of IV lidocaine on the quality of post-operative analgesia and other outcomes after hand-assisted laparoscopic colon surgery. Sixty four patients with colon cancer scheduled for elective colon resection were involved in this study. Patients were randomized to receive either lidocaine infusion [lidocaine group (LG)] or normal 0.9 % saline infusion [placebo group (PG)] for a period of 24 h. Anaesthetic and surgical techniques were standardized. Twenty-four-hour post-operative analgesia in the recovery area was maintained by continuous infusion of 0.1 μg/kg/h fentanyl. The primary outcome of the study was post-operative pain control. Pain was assessed using visual analogue scale (VAS) scores at 2, 4, 8, 12, and 24 h after surgery. Patients with a VAS score >3 were treated with ketorolac 30 mg as needed. Secondary outcomes included time to resumption of bowel function and length of hospital stay. Data in the two groups were compared using the two-tailed Student's t test. All statistical tests were two-tailed at a significance level of 0.05. Demographic characteristics and clinical features of both groups were similar. Intensity of pain at rest in LG compared with PG was significantly lower during the first 24 h post-operatively. LG patients reported significantly less pain during movements at 2-, 12-, and 24-h post-surgery than PG patients. The study showed that ketorolac consumption was significantly higher in PG: mean ketorolac consumption in LG was 43.77 ± 13.86 mg and in PG 51.67 ± 13.16 mg (p = 0.047). Compared with placebo, lidocaine infusion produced a 32 % reduction in time to the first drink (Cohen's d = 3.85), 16 % reduction in time to the first full diet

  8. Immediate function on the day of surgery compared with a delayed implant loading process in the mandible: a randomized clinical trial over 5 years.

    Science.gov (United States)

    Jokstad, Asbjorn; Alkumru, Hassan

    2014-12-01

    To appraise the feasibility of loading four implants with a pre-existing denture converted to a fixed dental prosthesis (FDP) on the day of implant surgery compared with waiting for 3- to 4-month healing. Patients with an edentulous, fully healed mandible were recruited in a faculty clinic to partake in a blinded two-arm parallel randomized controlled trial (RCT). The participants received four parallel intraforamina mandibular implants with a moderately rough titanium surface (Brånemark System Mk III or Mk IV TiUnite; Nobel Biocare AB, Göteborg, Sweden). The implants were loaded on the same day by converting the participants' pre-existing denture in the experimental group. The implants were placed using a one-stage surgery procedure, and the participants' pre-existing denture were soft-relined in the control group. For both groups, the permanent 10- to 12-unit FDP consisting of a type-3 cast precious alloy veneered with acrylic and artificial teeth was placed 3-4 months after implant surgery. All participants have been recalled annually for 5 years for appraisal of bone loss and registration of adverse events. Thirty-five of the original 42 participants (83%) returned for clinical and radiological examinations at the 5-year follow-up recall. No selective dropout or specific reasons for dropout was identified in the two study arms; leaving n = 17 (Intention-to-treat group, ITT) in the experimental group, alternatively n = 13 as per protocol group (PP), and n = 18 participants in the control group (ITT = PP). At study commencement, five of the participants assigned to the experimental group did not receive their planned intervention. In the control group, one implant failed to osseointegrate and another failed due to bone loss after 5 years. The crestal bone level changes over 5 years were identical in the experimental and control groups, that is, 1.2 mm (SD = 0.7). There were no differences between the two study arms with regard to incidence of biological and

  9. Immediate function on the day of surgery compared with a delayed implant loading process in the mandible: a randomized clinical trial over 5 years

    Science.gov (United States)

    Jokstad, Asbjorn; Alkumru, Hassan

    2014-01-01

    Objectives To appraise the feasibility of loading four implants with a pre-existing denture converted to a fixed dental prosthesis (FDP) on the day of implant surgery compared with waiting for 3- to 4-month healing. Methods Patients with an edentulous, fully healed mandible were recruited in a faculty clinic to partake in a blinded two-arm parallel randomized controlled trial (RCT). The participants received four parallel intraforamina mandibular implants with a moderately rough titanium surface (Brånemark System Mk III or Mk IV TiUnite; Nobel Biocare AB, Göteborg, Sweden). The implants were loaded on the same day by converting the participants' pre-existing denture in the experimental group. The implants were placed using a one-stage surgery procedure, and the participants' pre-existing denture were soft-relined in the control group. For both groups, the permanent 10- to 12-unit FDP consisting of a type-3 cast precious alloy veneered with acrylic and artificial teeth was placed 3–4 months after implant surgery. All participants have been recalled annually for 5 years for appraisal of bone loss and registration of adverse events. Results Thirty-five of the original 42 participants (83%) returned for clinical and radiological examinations at the 5-year follow-up recall. No selective dropout or specific reasons for dropout was identified in the two study arms; leaving n = 17 (Intention-to-treat group, ITT) in the experimental group, alternatively n = 13 as per protocol group (PP), and n = 18 participants in the control group (ITT = PP). At study commencement, five of the participants assigned to the experimental group did not receive their planned intervention. In the control group, one implant failed to osseointegrate and another failed due to bone loss after 5 years. The crestal bone level changes over 5 years were identical in the experimental and control groups, that is, 1.2 mm (SD = 0.7). There were no differences between the two study arms

  10. Comparison of Flow and Volume Incentive Spirometry on Pulmonary Function and Exercise Tolerance in Open Abdominal Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    Kumar, Amaravadi Sampath; Augustine, Alfred Joseph; Pazhyaottayil, Zulfeequer Chundaanveetil; Ramakrishna, Anand; Krishnakumar, Shyam Krishnan

    2016-01-01

    Introduction Surgical procedures in abdominal area lead to changes in pulmonary function, respiratory mechanics and impaired physical capacity leading to postoperative pulmonary complications, which can affect up to 80% of upper abdominal surgery. Aim To evaluate the effects of flow and volume incentive spirometry on pulmonary function and exercise tolerance in patients undergoing open abdominal surgery. Materials and Methods A randomized clinical trial was conducted in a hospital of Mangalore city in Southern India. Thirty-seven males and thirteen females who were undergoing abdominal surgeries were included and allocated into flow and volume incentive spirometry groups by block randomization. All subjects underwent evaluations of pulmonary function with measurement of Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), Peak Expiratory Flow (PEF). Preoperative and postoperative measurements were taken up to day 5 for both groups. Exercise tolerance measured by Six- Minute Walk Test during preoperative period and measured again at the time of discharge for both groups. Pulmonary function was analysed by post-hoc analysis and carried out using Bonferroni’s ‘t’-test. Exercise tolerance was analysed by Paired ‘T’-test. Results Pulmonary function (FVC, FEV1, and PEFR) was found to be significantly decreased in 1st, 2nd and 3rd postoperative day when compared with preoperative day. On 4th and 5th postoperative day the pulmonary function (FVC, FEV1, and PEFR) was found to be better preserved in both flow and volume incentive spirometry groups. The Six-Minute Walk Test showed a statistically significant improvement in pulmonary function on the day of discharge than in the preoperative period. In terms of distance covered, the volume- incentive spirometry group showed a greater statistically significant improvement from the preoperative period to the time of discharge than was exhibited by the flow incentive spirometry group

  11. Fast-track surgery combined with laparoscopy could improve postoperative recovery of low-risk rectal cancer patients: a randomized controlled clinical trial.

    Science.gov (United States)

    Feng, Fan; Li, Xiao Hua; Shi, Hai; Wu, Guo Sheng; Zhang, Hong Wei; Liu, Xiao Nan; Zhao, Qing Chuan

    2014-06-01

    In this study we aimed to assess the feasibility and safety of fast-track surgery (FTS) combined with laparoscopy for treating patients with rectal cancer and compare the results with those of the conventional perioperative intervention group. A total of 120 patients with rectal cancer were prospectively randomly assigned to the FTS combined with laparoscopy group and the conventional perioperative intervention plus laparoscopy group from November 2011 to November 2012. All patients received radical anterior resection with total mesorectal excision. Their baseline characteristics and the perioperative outcomes were recorded for analyses. Compared with the conventional perioperative intervention group, the fast-track protocol combined with laparoscopy could shorten the time to the first flatus (53.44 ± 23.64 h vs 67.85 ± 20.12 h, P = 0.001) and first defecation (65.23 ± 22.24 h vs 86.98 ± 24.85 h, P = 0.000) after operation, accelerate the decrease of white blood cell count (P laparoscopy may accelerate the clinical recovery of patients with rectal cancer after surgery. © 2014 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

  12. Prophylactic furosemide infusion decreasing early major postoperative renal dysfunction in on-pump adult cardiac surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fakhari S

    2017-01-01

    Full Text Available Solmaz Fakhari,1 Fariba Mirzaei Bavil,2 Eissa Bilehjani,1 Sona Abolhasani,3 Moussa Mirinazhad,2 Bahman Naghipour2 1Department of Anesthesiology, 2Department of Physiology, 3Tabriz University of Medical Sciences, Tabriz, Iran Introduction: Acute renal dysfunction is a common complication of cardiac surgery. Furosemide is used in prevention, or treatment, of acute renal dysfunction. This study was conducted to evaluate the protective effects of intra- and early postoperative furosemide infusion on preventing acute renal dysfunction in elective adult cardiac surgery. Methods: Eighty-one patients, candidates of elective cardiac surgery, were enrolled in this study in either the furosemide (n=41 or placebo (n=40 group. Furosemide (2 mg/h or 0.9% saline was administered and continued up to 12 hours postoperatively. We measured serum creatinine (Scr at preoperative and on the second and fifth postoperative days. Then calculated estimated glomerular filtration rate (eGFR at these times. An increase in Scr of >0.5 mg/dL and/or >25%–50%, compared to preoperative values, was considered as acute kidney injury (AKI. In contrast, an increase in Scr by >50% and/or the need for hemodialysis was regarded as acute renal failure (ARF. At the end we compared the AKI or ARF incidence between the two groups. Results: On the second and fifth postoperative days, Scr was lower, and the eGFR was higher in the furosemide group. AKI incidence was similar in the two groups (11 vs 12 cases; P-value 0.622; however, ARF rate was lower in furosemide group (1 vs 6 cases; P-value 0.044. During the study period, Scr was more stable in the furosemide group, however in the placebo group, Scr initially increased and then decreased to its preoperative value after a few days. Conclusion: This study showed that intra- and early postoperative furosemide infusion has a renal protective effect in adult cardiac surgery with cardiopulmonary bypass. Although this protective effect cannot

  13. Comparative preemptive analgesia evaluation of ibuprofen and etoricoxib in third molars surgery: a randomized, double-blind, placebo-controlled, crossover clinical trial

    OpenAIRE

    Fabio Wildson Gurgel Costa

    2013-01-01

    Third molar surgery is a frequent procedure in dentistry related to variable degrees of postoperative pain. In this context, non-steroidal anti-inflammatory drugs have been commonly used in studies that evaluated the efficacy of preemptive analgesia as a strategy for pain control. Thus, the aim of the present study was to evaluate the preemptive analgesic efficacy and anti-inflammatory effect of ibuprofen and etoricoxib in mandibular third molar surgery, compared with a placebo. A randomized,...

  14. Does high-dose metformin cause lactic acidosis in type 2 diabetic patients after CABG surgery? A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Rahman Ghafari

    2011-06-01

    Full Text Available Metformin is a dimethyl biguanide oral anti-hyperglycemic agent. Lactic acidosis due to metformin is a fatal metabolic condition that limits its use in patients in poor clinical condition, consequently reducing the number of patients who benefit from this medication. In a double blind randomized clinical trial, we investigated 200 type 2 diabetic patients after coronary artery bypass surgery in the open heart ICU of the Mazandaran Heart Center, and randomly assigned them to equal intervention and control groups. The intervention group received regular insulin infusion along with 2 metformin 500 mg tablets every twelve hours, while the control group received only intravenous insulin with 2 placebo tablets every twelve hours. Lactate level, pH, base excess, blood glucose and serum creatinine were measured over five 12 h periods, with data averaged for each period. The primary outcome in this study was high lactate levels. Comparison between the 2 groups was made by independent Student’s t-test. To compare changes in multiple measures in each group and analysis of group interaction, a repeated measurement ANOVA test was used. There was no significant difference between the 2 groups regarding pH, base excess, or bicarbonate intake (P>0.05. No patient showed lactic acidosis in either group. Lactate levels were 23.0 vs 23.4 in the insulin-metformin and insulin only groups when the study was started, respectively. At the end of the study, those levels were 18.7 vs 18.9, respectively. In addition, the ANOVA repeated measurement test did not show a significant difference in terms of changes in the amount of lactate level between the 2 groups during the five measurement tests of the study period (P>0.05. High-dose metformin (1,000 mg twice daily with insulin does not cause lactic acidosis in type 2 diabetic patients after coronary artery

  15. Effect of submucosal dexamethasone injection on postoperative pain, oedema, and trismus following mandibular third molar surgery: a prospective, randomized, double-blind clinical trial.

    Science.gov (United States)

    Mojsa, I M; Pokrowiecki, R; Lipczynski, K; Czerwonka, D; Szczeklik, K; Zaleska, M

    2017-04-01

    The aim of this study was to investigate the effect of the submucosal injection of 1ml dexamethasone (4mg/ml) on pain, swelling, and trismus following the extraction of retained lower third molars. Ninety patients (mean age 23.5 years) were split randomly into three equal study groups (30 patients in each): the 'before' group received dexamethasone 15min before surgery and placebo 15min after surgery; the 'after' group received placebo 15min before surgery and dexamethasone 15min after surgery; the 'placebo' group received placebo 15min before surgery and placebo 15min after surgery. Postoperative pain was recorded by the patients using a visual analogue scale, numerical rating scale, and the McGill Pain Questionnaire at 1, 2, 4, 6, 8, 12, and 24h after surgery. The patients also recorded the total number of analgesic doses consumed during the 24h after the procedure. Swelling (determined using linear measurements of the face) and trismus (determined through measurement of maximum mouth opening) were assessed at 48h, 72h, and 7 days following surgery. Better control of pain, swelling, and trismus was demonstrated for dexamethasone in comparison to placebo. Postoperative dexamethasone provided better pain control than preoperative dexamethasone. There was no difference in total rescue analgesic intake between the preoperative and postoperative dexamethasone groups. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  16. Effects of oral nutritional supplements in normally nourished or mildly undernourished geriatric patients after surgery for hip fracture: a randomized clinical trial.

    Science.gov (United States)

    Botella-Carretero, José I; Iglesias, Borja; Balsa, José A; Zamarrón, Isabel; Arrieta, Francisco; Vázquez, Clotilde

    2008-01-01

    Oral nutritional supplements have been recommended after orthopedic surgery in geriatric patients to reduce postoperative complications. However, tolerability of supplements could be a limitation, and their universal use is not supported by the heterogeneity of previous studies, especially in patients without malnutrition. This study is a randomized, controlled, open, parallel, 3-arm clinical trial comparing supplementation with protein powder dissolved in liquids to aim at 36 g of protein per day, energy and protein supplements to aim at 37.6 g of protein and 500 kcal per day, or no intervention in normally nourished or mildly undernourished patients. Outcomes were serum albumin, prealbumin, retinol-binding globulin, and body mass index, among others. Postoperative complications were also recorded. Ninety patients aged 83.8 +/- 6.6 years were included. The mean ingested amount of supplements was 41.1% +/- 20.6% in the protein powder supplement group and 51.4% +/- 13.2% in the energy protein supplement group (t = 2.278, P = .027). Postoperative supplements had no effect on the nutrition status during in-hospital follow-up, as assessed by serum albumin (P = .251), prealbumin (P = .530), retinol-binding globulin (P = .552), or body mass index (P = .582). Multivariate analysis showed that length of hospital stay with an established complication until its resolution (beta = .230, P = .031), total hospital stay (beta = .450, P Oral nutritional supplements in normally nourished or only mildly undernourished geriatric patients with hip fracture submitted to surgery may be of interest for patients with postoperative complications and long hospital stays.

  17. Positive regulatory effects of perioperative probiotic treatment on postoperative liver complications after colorectal liver metastases surgery: a double-center and double-blind randomized clinical trial.

    Science.gov (United States)

    Liu, Zhihua; Li, Chao; Huang, Meijin; Tong, Chao; Zhang, Xingwei; Wang, Lei; Peng, Hui; Lan, Ping; Zhang, Peng; Huang, Nanqi; Peng, Junsheng; Wu, Xiaojian; Luo, Yanxing; Qin, Huanlong; Kang, Liang; Wang, Jianping

    2015-03-20

    Colorectal liver metastases (CLM) occur frequently and postoperative intestinal infection is a common complication. Our previous study showed that probiotics could decrease the rate of infectious complications after colectomy for colorectal cancer. To determine the effects of the perioperative administration of probiotics on serum zonulin levels which is a marker of intestinal permeability and the subsequent impact on postoperative infectious complications in patients with CLM. 150 patients with CLM were randomly divided into control group (n = 68) and probiotics group (n = 66). Probiotics and placebo were given orally for 6 days preoperatively and 10 days postoperatively to control group and probiotics group respectively. We used the local resection for metastatic tumor ,while for large tumor, the segmental hepatectomy. Postoperative outcome were recorded. Furthermore, complications in patients with normal intestinal barrier function and the relation with serum zonulin were analyzed to evaluate the impact on the liver barrier dysfunction. The incidence of infectious complications in the probiotics group was lower than control group. Analysis of CLM patients with normal postoperative intestinal barrier function paralleled with the serum zonulin level. And probiotics could also reduce the concentration of serum zonulin (P = 0.004) and plasma endotoxin (P zonulin level, the rate of postoperative septicemia and maintain the liver barrier in patients undergoing CLM surgery. we propose a new model about the regulation of probiotics to liver barrier via clinical regulatory pathway. We recommend the preoperative oral intake of probiotics combined with postoperative continued probiotics treatment in patients who undergo CLM surgery. ChiCTR-TRC- 12002841 . 2012/12/21.

  18. 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.

  19. A novel flapless approach versus minimally invasive surgery in periodontal regeneration with enamel matrix derivative proteins: a 24-month randomized controlled clinical trial.

    Science.gov (United States)

    Aimetti, Mario; Ferrarotti, Francesco; Mariani, Giulia Maria; Romano, Federica

    2017-01-01

    This investigation was designed to compare the effectiveness of enamel matrix derivative (EMD) proteins in combination with flapless or flap procedure in periodontal regeneration of deep intrabony defects. Thirty chronic periodontitis patients who had at least one residual periodontal defect with an intrabony component of ≥3 mm were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of EMD to reach periodontal regeneration. Test sites (n = 15) were treated according to a novel flapless approach, whereas control sites (n = 15) by means of minimally invasive surgery (MIST). Clinical and radiographic parameters were recorded at baseline, 12 and 24 months post-operatively. Both therapeutic modalities yielded similar probing depth (PD) reduction and clinical attachment level (CAL) gain at 24 months. In flapless-treated sites, a mean PD reduction of 3.6 ± 1.0 mm and a CAL gain of 3.2 ± 1.1 mm were observed. In the MIST group, they were 3.7 ± 0.6 and 3.6 ± 0.9 mm. The operative chair time was twice as long in the MIST compared to the flapless group, whereas comparable patient-oriented outcomes were observed. The flapless procedure may be successfully applied in the regenerative treatment of deep intrabony defects reaching clinical outcomes comparable with those of minimally invasive surgical approaches and may present important advantages in terms of reduction of operative chair time. The use of EMD as an adjunct to non-surgical periodontal treatment may be considered a suitable option to treat defects mainly in the anterior sextants.

  20. A Prospective Randomized Clinical Study of the Influence of Primary Closure or Dressing on Post-operative Morbidity after Mandibular Third Molar Surgery

    Science.gov (United States)

    Egbor, Peter E; Saheeb, Birch D

    2014-01-01

    Objective: The aim of the following study is to determine the effect of primary closure or dressing on post-operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects were divided into two groups of A and B. Group A had total closure (primary closure) and Group B had whitehead varnish dressing of the socket. Pain, swelling and trismus were evaluated pre-operatively using visual analogue scale, flexible tape measuring method and inter-incisal distance measurement with Vernier Callipers respectively as well as post-operatively on 1st, 2nd, 3rd, 5th and 7th day. Results: The study participants consisted of 27 males and 45 females in a ratio 1:1.7. With a mean age of 24.7 ± 4.9 years (range 19-33 years) for Group A and 25.5 ± 4.3 years (range 20-39 years) for Group B. Post-operative pain was not significantly affected by the closure techniques (P > 0.05). Dressing was found to significantly reduce the degree of swelling and trismus peaking on the 2nd day (P = 0.0207 and P = 0.010 respectively). Conclusion: The use of dressing was more effective than primary closure to reduce the degree of swelling and trismus though its effect on post-operative pain reduction was not significant. PMID:25191094

  1. A comparative prospective randomized clinical study of MTA and IRM as root-end filling materials in single-rooted teeth in endodontic surgery

    NARCIS (Netherlands)

    Lindeboom, Jerome A. H.; Frenken, Joost W. F. H.; Kroon, Frans H. M.; van den Akker, Hans P.

    2005-01-01

    Objective. Randomized clinical prospective study to evaluate the application of MTA and IRM as retrograde sealers in surgical endodontics. Study design. One hundred single-rooted teeth were surgically treated. After randomization, MTA or IRM was used as a retrosealer. Radiographs were taken I week,

  2. The effect of continuous low dose methylprednisolone infusion on inflammatory parameters in patients undergoing coronary artery bypass graft surgery: a randomized-controlled clinical trial.

    Directory of Open Access Journals (Sweden)

    Abbas Ghiasi

    2015-02-01

    Full Text Available This trial was performed to determine if a continuous low-dose infusion of methylprednisolone is as effective as its bolus of high-dose in reducing inflammatory response. The study was single-center, double-blinded randomized clinical trial and performed in a surgical intensive care unit of an academic hospital. In this study, 72 consecutive patients undergoing elective coronary artery bypass grafting (CABG were assigned to receive either a methylprednisolone loading dose (1mg/kg followed by continuous infusion (2mg/Kg/24 hours for 1 day (low-dose regime or a single dose of methylprednisolone (15 mg/kg before cardiopulmonary bypass (high dose regime. Serum concentrations of IL-6 and C- reactive protein (CRP were measured preoperatively and 6, 24 and 48 hours after surgery, and serum creatinine was measured before the operation and 24, 48 and 72 hours postoperatively. The measurements were then compared between the groups to evaluate the efficacy of each regimen. The basic characteristics and measurements were not different between the study groups. There was no significant difference in IL-6 and CRP elevation (P=0.52 and P=0.46, respectively. Early outcomes such as the length of stay in the intensive care unit, intubation time, changes in serum creatinine and blood glucose levels, inotropic support, insulin requirements, and rate of infection were also similar in both groups. A continuous low dose infusion of methylprednisolone was as effective as a single high dose methylprednisolone in reducing the inflammatory response after CABG with extracorporeal circulation with no significant difference in the postoperative measurements and outcomes.

  3. 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.

  4. 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.

  5. A comparison of equivolume, equiosmolar solutions of hypertonic saline and mannitol for brain relaxation in patients undergoing elective intracranial tumor surgery: a randomized clinical trial.

    Science.gov (United States)

    Dostal, Pavel; Dostalova, Vlasta; Schreiberova, Jitka; Tyll, Tomas; Habalova, Jirina; Cerny, Vladimir; Rehak, Svatopluk; Cesak, Tomas

    2015-01-01

    Hyperosmolar solutions have been used in neurosurgery to modify brain bulk and prevent neurological deterioration. The purpose of the study was to compare the effects of equivolume, equiosmolar solutions of mannitol and hypertonic saline (HTS) on brain relaxation and postoperative complications in patients undergoing elective intracranial tumor surgery. In this prospective, randomized study, patients with American Society of Anesthesiologists physical status I to III scheduled to undergo a craniotomy for intracranial tumors were enrolled. Patients received a 3.75 mL/kg intravenous infusion of either 3.2% HTS (group HTS, n=36) or 20% mannitol (group M, n=38). The surgeon assessed the condition of the brain using a 4-point scale after opening the dura. Recorded measures included duration of surgery, blood loss, urine output, volume and type of infused fluids, hemodynamic variables, electrolytes, glucose, creatinine, predefined postoperative complications, and length of intensive care unit and hospital stays. Brain relaxation conditions in group HTS (score 1/2/3/4, n=10/17/2/7) were better than those in group M (score 1/2/3/4, n=3/18/3/14, P=0.0281). Patients in group M had higher urine output, received more crystalloids during surgery, and displayed lower central venous pressure and lower natremia at the end of surgery than did patients in group HTS. No significant differences in postoperative complications or lengths of intensive care unit and hospital stays were observed between the groups. Our results suggest that HTS provides better brain relaxation than mannitol during elective intracranial tumor surgery.

  6. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Patrícia Brigatto

    2014-12-01

    Full Text Available Objective: To evaluate whether the application of bilevel positive airway pressure in the postoperative period of bariatric surgery might be more effective in restoring lung volume and capacity and thoracic mobility than the separate application of expiratory and inspiratory positive pressure. Method: Sixty morbidly obese adult subjects who were hospitalized for bariatric surgery and met the predefined inclusion criteria were evaluated. The pulmonary function and thoracic mobility were preoperatively assessed by spirometry and cirtometry and reevaluated on the 1st postoperative day. After preoperative evaluation, the subjects were randomized and allocated into groups: EPAP Group (n=20, IPPB Group (n=20 and BIPAP Group (n=20, then received the corresponding intervention: positive expiratory pressure (EPAP, inspiratory positive pressure breathing (IPPB or bilevel inspiratory positive airway pressure (BIPAP, in 6 sets of 15 breaths or 30 minutes twice a day in the immediate postoperative period and on the 1st postoperative day, in addition to conventional physical therapy. Results: There was a significant postoperative reduction in spirometric variables (p0.05. Thoracic mobility was preserved only in group BIPAP (p>0.05, but no significant difference was found in the comparison among groups (p>0.05. Conclusion: The application of positive pressure does not seem to be effective in restoring lung function after bariatric surgery, but the use of bilevel positive pressure can preserve thoracic mobility, although this technique was not superior to the other techniques.

  7. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial

    Science.gov (United States)

    Brigatto, Patrícia; Carbinatto, Jéssica C.; Costa, Carolina M.; Montebelo, Maria I. L.; Rasera-Júnior, Irineu; Pazzianotto-Forti, Eli M.

    2014-01-01

    Objective: To evaluate whether the application of bilevel positive airway pressure in the postoperative period of bariatric surgery might be more effective in restoring lung volume and capacity and thoracic mobility than the separate application of expiratory and inspiratory positive pressure. Method: Sixty morbidly obese adult subjects who were hospitalized for bariatric surgery and met the predefined inclusion criteria were evaluated. The pulmonary function and thoracic mobility were preoperatively assessed by spirometry and cirtometry and reevaluated on the 1st postoperative day. After preoperative evaluation, the subjects were randomized and allocated into groups: EPAP Group (n=20), IPPB Group (n=20) and BIPAP Group (n=20), then received the corresponding intervention: positive expiratory pressure (EPAP), inspiratory positive pressure breathing (IPPB) or bilevel inspiratory positive airway pressure (BIPAP), in 6 sets of 15 breaths or 30 minutes twice a day in the immediate postoperative period and on the 1st postoperative day, in addition to conventional physical therapy. Results: There was a significant postoperative reduction in spirometric variables (p0.05). Thoracic mobility was preserved only in group BIPAP (p>0.05), but no significant difference was found in the comparison among groups (p>0.05). Conclusion: The application of positive pressure does not seem to be effective in restoring lung function after bariatric surgery, but the use of bilevel positive pressure can preserve thoracic mobility, although this technique was not superior to the other techniques. PMID:25590448

  8. Perioperative bromelain reduces pain and swelling and improves quality of life measures after mandibular third molar surgery: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Majid, Omer Waleed; Al-Mashhadani, Bashar Adil

    2014-06-01

    The purpose of the present study was to compare the effect of oral bromelain (4 × 250 mg) versus oral diclofenac sodium (4 × 25 mg) on pain, swelling, trismus, and quality of life (QOL) after surgical removal of impacted lower third molars. A randomized, double-blind, placebo-controlled study was planned. The sample included patients requiring extraction under local anesthesia of a single partial bony impacted mandibular third molar. The patients were randomly distributed into 1 of 3 groups: bromelain, diclofenac, and placebo. Treatment started 1 day before surgery and continued for 4 days. The predictor variable was the type of the drug given to the patients. The outcome variables were pain, swelling, and trismus, which were measured at 1, 3, and 7 days postoperatively. The other study variables included QOL measures to assess the patients' perception regarding the effect of surgery on their well-being and daily activities. A validated questionnaire was used to measure QOL. The data were analyzed using analysis of variance, multiple measures analysis of variance, or Pearson's χ(2) test, as appropriate. P third molar under local anesthesia were included in the present study. The bromelain and diclofenac groups both showed a significant reduction in pain compared with the placebo group at all intervals (P third molars, with an effect on the postoperative sequelae comparable to that of preemptive diclofenac sodium. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Effects of intraoperative high-dose vs low-dose remifentanil for postoperative epidural analgesia after gynecological abdominal surgery: a randomized clinical trial.

    Science.gov (United States)

    Yamashita, Soichiro; Yokouchi, Takako; Tanaka, Makoto

    2016-08-01

    To evaluate whether intraoperative high-dose remifentanil infusion increased local anesthetic consumption in postoperative epidural analgesia and postoperative pain scores compared with low-dose remifentanil infusion. Prospective, randomized controlled study. Operating room, university hospital. Thirty female patients scheduled for elective gynecological abdominal surgery. After epidural catheter placement and induction of general anesthesia, patients were randomly assigned to 2 anesthetic regimens. In the first group (high-dose remifentanil group), sevoflurane concentration was held constant at 1.2%, and the remifentanil infusion rate was titrated to maintain systolic blood pressure within 20% of baseline. In the second group (low-dose remifentanil group), the remifentanil infusion rate was held constant at 0.1μg/(kg min), and the sevoflurane concentration was titrated to maintain systolic blood pressure within 20% of baseline. As abdominal wall closure began, 6mL of 0.2% ropivacaine was administrated via epidural catheter; a patient-controlled analgesia device was set to deliver 4mL/h of 0.2% ropivacaine with 3μg/mL of fentanyl, with 2-mL incremental doses and a 15-minute lockout time. Local anesthetic consumption via postoperative epidural catheter and pain intensity with the Prince Henry pain scale were assessed for 48hours after surgery. The mean remifentanil infusion rate was 0.23μg/(kg min) in the high-dose remifentanil group, 2.3 times the rate used in the low-dose remifentanil group. The cumulative amount of local anesthetic used within 48hours of surgery was significant greater in the high-dose remifentanil group than in the low-dose remifentanil group (212±25mL vs. 181±35mL, respectively; Phigh-dose remifentanil infusion increased local anesthetic consumption in postoperative epidural analgesia relative to low-dose remifentanil. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. The Analgesic Effects of Morphine and Tramadol Added to Intra-articular Levobupivacaine-Tenoxicam Combination for Arthroscopic Knee Surgery on Postoperative Pain; a Randomized Clinical Trial.

    Science.gov (United States)

    Oral, Ebru Gelici; Hanci, Ayse; Ulufer Sivrikaya, Gulcihan; Dobrucali, Hale; Turkoglu Kilinc, Leyla

    2015-06-01

    Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often associated with postoperative pain. We aimed to compare the effects of intra-articular levobupivacaine-tenoxicam-tramadol and levobupivacaine-tenoxicam-morphine combinations on postoperative pain in patients undergoing elective arthroscopic knee surgery. A total of 90 ASA I-II patients undergoing elective arthroscopic meniscectomy under general anesthesia were enrolled. The participants were randomly allocated to three groups to receive the following intra-articular medications after completion of the surgery and before deflation of the tourniquet: Group S, 20 mL of saline; Group T, 35 mg of levobupivacaine, 20 mg of tenoxicam, and 100 mg of tramadol in 20 mL saline; and Group M, 35 mg of levobupivacaine, 20 mg of tenoxicam, and 4 mg of morphine in 20 mL saline. Visual analogue scale values at rest (VASr) and at active flexion of knee (VASa) at postoperation hours 1, 2, 4, 8, 12, and 24, duration of analgesia, total analgesic consumption, and number of rescue analgesia at 24 hours were evaluated. VASr and VASa were significantly higher in group S in comparison to other groups (P < 0.05). Duration of analgesia was significantly longer in Group T and Group M than in Group S (P < 0.05). The difference between group T and group M was also significant (P < 0.05). Number of rescue analgesia and total analgesic consumption at postoperative hour 24 was significantly fewer in group M compared with other groups (P < 0.05). Intra-articular levobupivacaine-tenoxicam-morphine combination provides effective pain relief, longer analgesic duration, and less analgesic requirement when compared with intra-articular levobupivacaine-tenoxicam-tramadol combination and saline after knee arthroscopic surgery.

  11. Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

    Science.gov (United States)

    Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

    2017-01-23

    Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

  12. 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.

  13. Randomized clinical trial

    DEFF Research Database (Denmark)

    Jensen, Berit E.S.; Hansen, Jane M.; Larsen, Kasper S.

    2017-01-01

    percutaneous coronary intervention and randomized to either screening or control. Screened high-risk patients were prescribed pantoprazole 40 mg during the 1-year after percutaneous coronary intervention. Results The incidence of UGIB was 0.8 versus 1.3% in screened patients and controls, respectively (P=0...

  14. Improving family functioning after cardiac surgery: a randomized trial.

    Science.gov (United States)

    Gilliss, C L; Neuhaus, J M; Hauck, W W

    1990-11-01

    As part of a randomized clinical trial of in-hospital and postdischarge nursing interventions designed to facilitate the individual patient's recovery and improve the family's functioning after cardiac surgery, we followed 67 patient-spouse pairs for 6 months after surgery. Family health was appraised by using three pencil and paper measurements: the Family APGAR, the Locke-Wallace Marital Adjustment Scale, and the Family Inventory of Resources for Management. Mixed-effects analysis of variance did not detect differences for the main effect of intervention group; however, the main effect of time was significant for both patients' and spouses' APGAR scores and for patients' Marital Adjustment Scale scores, suggesting a pattern of response during recovery from cardiac surgery.

  15. Adjuvant radiation therapy versus surgery alone in operable breast cancer: long-term follow-up of a randomized clinical trial.

    Science.gov (United States)

    Rutqvist, L E; Pettersson, D; Johansson, H

    1993-02-01

    This paper presents long-term results from a randomized trial of pre- or postoperative megavoltage radiation therapy versus surgery alone in pre- and postmenopausal women with operable breast cancer. Treatment outcome after relapse among patients who developed loco-regional recurrences was also analyzed. A total of 960 patients were included in the trial. The mean follow-up was 16 years (range: 13-19 years). The radiation therapy was individually planned. It included the chest wall (and the breast in the preoperative cases) and the regional lymph nodes. The tumor dose was 45 Gy/5 weeks. No adjuvant systemic therapy was used. The results showed a significant benefit with radiation therapy in terms of recurrence-free survival during the entire follow-up period. There was also an overall survival difference-corresponding to a 16% reduction of deaths-in favor of the irradiated patients which, however, was not statistically significant (p = 0.09). Among those 169 patients who developed locoregional recurrences long-term control was only achieved in about one-third of the cases. This figure was similar among those who had received adjuvant radiation therapy (34%) compared to those initially treated with surgery alone (32%). This implied that the overall proportion of patients who eventually developed uncontrolled local disease was significantly higher among those initially allocated to surgery alone (16%) compared to those allocated to pre- or postoperative radiation therapy (6%, p < 0.01). These results suggest that local undertreatment may be deleterious in subgroups of patients.

  16. Longer Immediate Recovery Time After Anesthesia Increases Risk of Respiratory Complications After Laparotomy for Bariatric Surgery: a Randomized Clinical Trial and a Cohort Study.

    Science.gov (United States)

    Sudré, Eliana C M; de Batista, Priscila R; Castiglia, Yara M M

    2015-11-01

    We compared the effects of two anesthesia protocols in both immediate recovery time (IRT) and postoperative respiratory complications (PRCs) after laparotomy for bariatric surgery, and we determined the association between the longer IRT and the increase of PRC incidence. We conducted the study in two stages: (i) in a randomized controlled trial (RCT), patients received either intervention (sevoflurane-remifentanil-rocuronium-ropivacaine) or control protocol (isoflurane-sufentanil-atracurium-levobupivacaine). All patients received general anesthesia plus continuous epidural anesthesia and analgesia. Treatment was masked for all, except the provider anesthesiologist. We defined IRT as time since anesthetics discontinuation until tracheal extubation. Primary outcomes were IRT and PRCs incidence within 15 days after surgery. We also analyzed post-anesthesia care unit (PACU) and hospital length of stays; (ii) after the end of the RCT, we used the available data in an extension cohort study to investigate IRT > 20 min as exposure factor for PRCs. Control protocol (n = 152) resulted in longer IRT (30.4 ± 7.9 vs 18.2 ± 9.6 min; p  20 min (n = 190) presented higher incidence of PRCs (7.37 vs 0.62 %; p bariatric patients. We identified a 4.5-fold increase in the relative risk of PRCs when morbid obese patients are exposed to an IRT > 20 min.

  17. Effectiveness of a New Exercise Program after Lower Limb Arterial Blood Flow Surgery in Patients with Peripheral Arterial Disease: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Edita Jakubsevičienė

    2014-08-01

    Full Text Available Objective: The aim of this study was to evaluate the effectiveness of a supervised exercise program (SEP plus at home nonsupervised exercise therapy (non-SET on functional status, quality of life (QoL and hemodynamic response in post-lower-limb bypass surgery patients. Results: One hundred and seventeen patients were randomized to an intervention (n = 57 or a control group (n = 60. A new individual SEP was designed for patients with peripheral arterial disease (PAD and applied to the studied subjects of the intervention group who also continued non-SET at home, whereas those assigned to the control group received just usual SEP according to a common cardiovascular program. The participants of the study were assessed by a 6-min walking test (6 MWT, an ankle-brachial index (ABI, and the Medical Outcomes Study Short Form-36 (SF-36 of QoL at baseline, at 1 and 6 months after surgery. A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group (p < 0.001. The intervention group had significantly higher QoL score in the physical and mental component of SF-36 (p < 0.05. Conclusions: A 6-month application of the new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls.

  18. Scapula alata in early breast cancer patients enrolled in a randomized clinical trial of post-surgery short-course image-guided radiotherapy.

    Science.gov (United States)

    Adriaenssens, Nele; De Ridder, Mark; Lievens, Pierre; Van Parijs, Hilde; Vanhoeij, Marian; Miedema, Geertje; Voordeckers, Mia; Versmessen, Harijati; Storme, Guy; Lamote, Jan; Pauwels, Stephanie; Vinh-Hung, Vincent

    2012-05-16

    Scapula alata (SA) is a known complication of breast surgery associated with palsy of the serratus anterior, but it is seldom mentioned. We evaluated the risk factors associated with SA and the relationship of SA with ipsilateral shoulder/arm morbidity in a series of patients enrolled in a trial of post-surgery radiotherapy (RT). The trial randomized women with completely resected stage I-II breast cancer to short-course image-guided RT, versus conventional RT. SA, arm volume and shoulder-arm mobility were measured prior to RT and at one to three months post-RT. Shoulder/arm morbidities were computed as a post-RT percentage change relative to pre-RT measurements. Of 119 evaluable patients, 13 (= 10.9%) had pre-RT SA. Age younger than 50 years old, a body mass index less than 25 kg/m2, and axillary lymph node dissection were significant risk factors, with odds ratios of 4.8 (P = 0.009), 6.1 (P = 0.016), and 6.1 (P = 0.005), respectively. Randomization group was not significant. At one to three months' post-RT, mean arm volume increased by 4.1% (P = 0.036) and abduction decreased by 8.6% (P = 0.046) among SA patients, but not among non-SA patients. SA resolved in eight, persisted in five, and appeared in one patient. The relationship of SA with lower body mass index suggests that SA might have been underestimated in overweight patients. Despite apparent resolution of SA in most patients, pre-RT SA portended an increased risk of shoulder/arm morbidity. We argue that SA warrants further investigation. Incidentally, the observation of SA occurring after RT in one patient represents the second case of post-RT SA reported in the literature.

  19. Effectiveness of cold therapy in reducing pain, trismus, and oedema after impacted mandibular third molar surgery: a randomized, self-controlled, observer-blind, split-mouth clinical trial.

    Science.gov (United States)

    Zandi, M; Amini, P; Keshavarz, A

    2016-01-01

    Cold therapy is a conventional and widely used modality for reducing pain, trismus, and oedema after dentoalveolar surgeries. However, information reported in the literature on its effectiveness is insufficient and controversial. This study was performed to evaluate the effect of local cold application in reducing pain, trismus, and swelling after impacted mandibular third molar surgery. Thirty patients (seven males and 23 females) with bilateral symmetrical mandibular impacted third molars were enrolled in this randomized, self-controlled, observer-blind clinical trial. The patients were aged between 18 and 30 years. After surgical removal of the tooth on one side (intervention), ice pack therapy was given for 24h after surgery; for the other side (control), no cold therapy was given. The time interval between the two surgeries was at least 4 weeks. The amount of pain, trismus, and facial swelling was measured on days 2 and 7 postoperative, and patient satisfaction with the cold therapy vs. no cold therapy was assessed. The amount of pain, trismus, and facial swelling, and the extent of patient satisfaction were not significantly different between the intervention and control sides. Cold therapy had no beneficial effects on postoperative sequelae after impacted mandibular third molar surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  20. Effectiveness of a nursing intervention in decreasing the anxiety levels of family members of patients undergoing cardiac surgery: a randomized clinical trial.

    Science.gov (United States)

    Hamester, Letícia; Souza, Emiliane Nogueira de; Cielo, Cibele; Moraes, Maria Antonieta; Pellanda, Lúcia Campos

    2016-08-15

    to verify the effectiveness of nursing orientation provided to families of patients in the immediate post-operative following cardiac surgery before the first visit to the post-anesthesia care unit, in decreasing anxiety levels, compared to the unit's routine orientation. open randomized clinical trial addressing family members in the waiting room before the first visit in the immediate post-operative period. The family members assigned to the intervention group received audiovisual orientation concerning the patients' conditions at the time and the control group received the unit's routine orientation. Outcome anxiety was assessed using the STAI-State. 210 individuals were included, 105 in each group, aged 46.4 years old on average (±14.5); 69% were female and 41% were the patients' children. The mean score obtained on the anxiety assessment in the intervention group was 41.3±8.6, while the control group scored 50.6±9.4 (pansiedade, comparados com a orientação de rotina da unidade. ensaio clínico randomizado, realizado com familiares abordados na sala de espera, antes da primeira visita no pós-operatório imediato. Familiares alocados no grupo intervenção receberam orientações audiovisuais sobre as condições em que o paciente se encontrava naquele momento, e o grupo controle recebeu as orientações de rotina da unidade. O desfecho ansiedade foi avaliado pelo inventário IDATE. foram incluídos 210 sujeitos, 105 em cada grupo, com idade média de 46,4±14,5 anos, sendo 69% do sexo feminino e 41% filhos dos pacientes. Na avaliação da ansiedade, o escore médio para o grupo intervenção foi de 41,3±8,6 pontos e, para o grupo controle, 50,6±9,4 pontos (pansiedade dos acompanhantes, contribuindo para que se sintam mais preparados para esse momento. Registro Brasileiro de Ensaios Clínicos (ReBEC) e The Universal Trial Number (UTN), sob o número U1111-1145-6172. verificar la efectividad de las orientaciones de enfermería - dadas a familiares de

  1. Comparison of the Anxiolytic Effects of Saffron (Crocus sativus. L and Diazepam Before Herniorrhaphy Surgery: A Double Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mahdi Basiri-Moghadam

    2016-03-01

    Full Text Available Background Anxiety is an unpleasant state of feeling agitation and pressure induced by the patient’s fear of hospitalization, anesthesia or surgery. Objectives The present study is aimed to compare the effects of dried extract of saffron and diazepam on soothing the pre-herniorrhaphy surgery anxiety. Patients and Methods In this double blind clinical study, during 8 months, 102 patients were studied in 2012. all the patients in intervention group (n = 50 received 25 mg dried extract of saffron and participants in control group (n = 52 received 5 mg oral diazepam. Level of anxiety of the patients was measured using speillberger state-trait anxiety inventory (STAI before intervention and 3 hours after administration (immediately after entering the surgery room filled out by the patients. The patients in the two groups were compared concerning level of anxiety before/after intervention. The two groups of participants had almost equal demographic features. Results According to the results, level of trait anxiety in the intervention groups decreased from 37.24 ± 7.4 to 34.72 ± 7.45 and the trend among the control group was vice versa and increased from 34.51 ± 10.74 to 38.8 ± 9.97. The data showed significant relation between level of trait anxiety before and after intervention in control and experiment groups (P = 0.019. Conclusions Considering the findings, in comparison to diazepam, dried extract of saffron at 25 mg dose is more effective on soothing anxiety.

  2. The impact of an hematocrit of 20% during normothermic cardiopulmonary bypass for elective low risk coronary artery bypass graft surgery on oxygen delivery and clinical outcome – a randomized controlled study [ISRCTN35655335

    Science.gov (United States)

    von Heymann, Christian; Sander, Michael; Foer, Achim; Heinemann, Anja; Spiess, Bruce; Braun, Jan; Krämer, Michael; Grosse, Joachim; Dohmen, Pascal; Dushe, Simon; Halle, Jürgen; Konertz, Wolfgang F; Wernecke, Klaus-Dieter; Spies, Claudia

    2006-01-01

    Introduction Cardiopulmonary bypass (CPB) induces hemodilutional anemia, which frequently requires the transfusion of blood products. The objective of this study was to evaluate oxygen delivery and consumption and clinical outcome in low risk patients who were allocated to an hematocrit (Hct) of 20% versus 25% during normothermic CPB for elective coronary artery bypass graft (CABG) surgery. Methods This study was a prospective, randomized and controlled trial. Patients were subjected to normothermic CPB (35 to 36°C) and were observed until discharge from the intensive care unit (ICU). Outcome measures were calculated whole body oxygen delivery, oxygen consumption and clinical outcome. A nonparametric multivariate analysis of variance for repeated measurements and small sample sizes was performed. Results In a total of 54 patients (25% Hct, n = 28; 20% Hct, n = 26), calculated oxygen delivery (p = 0.11), oxygen consumption (p = 0.06) and blood lactate (p = 0.60) were not significantly different between groups. Clinical outcomes were not different between groups. Conclusion These data indicate that an Hct of 20% during normothermic CPB maintained calculated whole body oxygen delivery above a critical level after elective CABG surgery in low risk patients. The question of whether a transfusion trigger in excess of 20% Hct during normothermic CPB is still supported requires a larger prospective and randomized trial. PMID:16606474

  3. Restricted Crystalloid Fluid Therapy during Orthotopic Liver Transplant Surgery and its Effect on Respiratory and Renal Insufficiency in the Early Post-operative Period: A Randomized Clinical Trial.

    Science.gov (United States)

    Sahmeddini, M A; Janatmakan, F; Khosravi, M B; Ghaffaripour, S; Eghbal, M H; Nickeghbalian, S; Malek-Hosseini, S A

    2014-01-01

    Respiratory and renal insufficiencies are common dysfunctions during post-liver transplantation period that increase post-operative mortality and morbidity rates. Intra-operative fluid therapy is an important factor associated with pulmonary and renal insufficiency. To evaluate the relation between intra-operative fluid therapy and early renal and respiratory insufficiency after liver transplantation. In this randomized clinical study, 67 adult patients with end-stage liver disease who underwent orthotopic deceased donor liver transplantation were randomly allocated into two groups. The restricted fluid group, which received a controlled fluid administration of normal saline, 5 mL/kg/hr during anesthesia, and non-restricted fluid group received a controlled infusion of normal saline 10 mL/kg/hr during anesthesia. Early post-operative respiratory and renal insufficiency in both groups were assessed. The patients were monitored during the three stages of liver transplantation for their hemodynamic indices. The trial is registered with the Iranian Randomized Clinical Trial Registry, number IRCT2013101811662N4. The baseline demographic and clinical characteristics were similar in both studied groups. The prevalence of respiratory insufficiency in the non-restricted fluid group (15%) significantly (p=0.01) higher than that in the restricted fluid group (0%). The post-operative mean±SD serum creatinine was 1.0±0.1 mg/dL in the non-restricted fluid group and 1.1±0.2 in the restricted fluid group (p=0.43). No patients in the studied groups required post-operative continuous renal replacement therapy. Restricted crystalloid fluid administration during orthotropic liver transplantation though decreased post-operative chance of pulmonary insufficiency, did not increase renal dysfunction.

  4. Comparative Assessment of the Effect of Ibuprofen and Etodolac on Edema, Trismus, and Pain in Lower Third Molar Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Silva de Oliveira, Júlio César; Grossi de Oliveira, Gustavo Augusto; Bassi, Ana Paula Farnezi

    2016-08-01

    To compare the efficacy of ibuprofen (IBU) and etodolac (ETO) for controlling pain, edema, and trismus after extraction of lower third molars. Twenty adolescents and adults with 2 impacted mandibular-third molars (in similar positions) were selected for the study. Patients were randomly assigned either to the IBU group (600 mg of IBU 3 times a day for 3 days) or to the ETO group (300 mg of ETO 3 times a day for 3 days). Drugs were administered immediately after dental extraction. During the first 2 days after extraction, swelling was more pronounced in the IBU group than in the ETO group (P = .033). Seven days after surgery, there was no difference in the degree of edema between the groups. At the 2- and 7-day evaluation points, mouth opening was significantly more reduced in the IBU group than in the ETO group (P trismus, and pain were more effectively controlled with ETO than with IBU. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Efficacy of local dexmedetomidine add-on for spermatic cord block anesthesia in patients undergoing intrascrotal surgeries: randomized controlled multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Hetta DF

    2017-11-01

    Full Text Available Diab Fuad Hetta,1 Emad E Kamal,2 Ali M Mahran,2 Doaa G Ahmed,1 Abdelraheem Elawamy,3 Abdelraouf MS Abdelraouf3 1Department of Anesthesiology and Pain Management, South Egypt Cancer Institute, 2Department of Dermatology and Andrology, 3Department of Anesthesiology and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt Study objective: The objective of this study was to evaluate the effect of adding dexmedetomidine (DEX to bupivacaine on the quality of spermatic cord block anesthesia and postoperative analgesia. Design: This is a randomized, double-blind study. Setting: This study was performed in an educational and research hospital. Patients: One hundred twenty adult males were scheduled for intrascrotal surgeries. Interventions: Patients were divided into two groups: group B received 10 mL of bupivacaine 0.25% for spermatic cord block and intravenous 50 µg of DEX and group BD received 10 mL of bupivacaine 0.25% added to 50 µg of DEX (9.5 mL bupivacaine 0. 25% + 0.5 mL [50 µg] DEX for spermatic cord block, and for masking purposes, the patients received isotonic saline intravenously. Measurements: Time to first analgesic request, analgesic consumption, and visual analog scale (VAS pain score in the first 24 hours postoperatively were assessed. Main results: Time to first rescue analgesic was significantly delayed in group BD in comparison with group B, median (interquartile range, 7 (6–12 hours versus 6 (5–7 hours, (p=0.000, the mean cumulative morphine consumption (mg in the first postoperative 24 hours was significantly lower in group BD compared with group B, 8.13±4.45 versus 12.7±3.79, with a mean difference (95% CI of −4.57 (−6.06 to −3.07 (p=0.000; also, there was a significant reduction of VAS pain score in group BD in comparison with group B at all measured time points, VAS 2 hours (1.28±0.9 vs 1.92±0.8, VAS 6 hours (2.62±1.5 vs 3.93±1.2, VAS 12 hours (2.40±1.1 vs 3.57±0.65, VAS 24 hours (1.90±0

  6. Outpatient Surgery In Day Clinics*

    African Journals Online (AJOL)

    1971-12-18

    Dec 18, 1971 ... arrange for mastectomy within 48 hours on the rare occasion where an unsuspected carcinoma is found, rather than subject all patients to the mental trauma of knowing that they might wake up having had their breast removed. Arden and Lunn' add the following procedures to out- patient surgery: carpal ...

  7. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  8. Trends in Mortality After Primary Cytoreductive Surgery for Ovarian Cancer: A Systematic Review and Metaregression of Randomized Clinical Trials and Observational Studies.

    Science.gov (United States)

    Di Donato, Violante; Kontopantelis, Evangelos; Aletti, Giovanni; Casorelli, Assunta; Piacenti, Ilaria; Bogani, Giorgio; Lecce, Francesca; Benedetti Panici, Pierluigi

    2017-06-01

    Primary cytoreductive surgery (PDS) followed by platinum-based chemotherapy is the cornerstone of treatment and the absence of residual tumor after PDS is universally considered the most important prognostic factor. The aim of the present analysis was to evaluate trend and predictors of 30-day mortality in patients undergoing primary cytoreduction for ovarian cancer. Literature was searched for records reporting 30-day mortality after PDS. All cohorts were rated for quality. Simple and multiple Poisson regression models were used to quantify the association between 30-day mortality and the following: overall or severe complications, proportion of patients with stage IV disease, median age, year of publication, and weighted surgical complexity index. Using the multiple regression model, we calculated the risk of perioperative mortality at different levels for statistically significant covariates of interest. Simple regression identified median age and proportion of patients with stage IV disease as statistically significant predictors of 30-day mortality. When included in the multiple Poisson regression model, both remained statistically significant, with an incidence rate ratio of 1.087 for median age and 1.017 for stage IV disease. Disease stage was a strong predictor, with the risk estimated to increase from 2.8% (95% confidence interval 2.02-3.66) for stage III to 16.1% (95% confidence interval 6.18-25.93) for stage IV, for a cohort with a median age of 65 years. Metaregression demonstrated that increased age and advanced clinical stage were independently associated with an increased risk of mortality, and the combined effects of both factors greatly increased the risk.

  9. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  10. A new and simple suturing technique applied after surgery to correct ingrown toenails may improve clinical outcomes: A randomized controlled trial.

    Science.gov (United States)

    Uygur, Esat; Çarkçi, Engin; Şenel, Ahmet; Kemah, Bahattin; Turhan, Yalçın

    2016-10-01

    In the present study, we investigated the efficacy of a new suturing technique applied after the Winograd procedure has been completed. This study was prospective, randomized, and controlled. In total, 128 patients were recruited and divided into two groups. The outcomes of those treated with the new suturing technique (group I) were compared with those of patients treated with the traditional suturing technique (group II), both of which were applied after the Winograd procedure had been completed. The clinical outcomes and recurrence rates of the two groups were compared. Patients in group I required significantly more time to return to work or school than did those in group II (p = 0.015). We found no significant difference between youths (age < 18 years, n = 55) and adults (age ≥ 19 years, n = 69) in this context (p = 0.161). The recurrence rate was significantly higher in group II than in group I (p = 0.011). The extent of satisfaction was significantly higher in group I (p = 0.042). Our new suturing technique is associated with lower recurrence and higher satisfaction rates. However, the times elapsing before shoes could be worn were similar in the two groups. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...

  12. Comparison between paracetamol, piroxicam, their combination, and placebo in postoperative pain management of upper limb orthopedic surgery (a randomized double blind clinical trial

    Directory of Open Access Journals (Sweden)

    Gholamreza Khalili

    2016-01-01

    Conclusion: IV infusion of 15 mg/kg Paracetamol used as a preventive may provide effective analgesia in comparison with IM 0.4 mg/kg Piroxicam or placebo. Addition of Piroxicam to Paracetamol has not much more benefit than Paracetamol alone, in reducing pain after upper limb orthopedic surgery.

  13. Spinal anaesthesia with articaine 5% vs bupivacaine 0.5% for day-case lower limb surgery: A double-blind randomized clinical trial

    NARCIS (Netherlands)

    T. Dijkstra; J.A. Reesink; B.C. Verdouw; W.S.C.J.M. van der Pol; T. Feberwee; A.G. Vulto (Arnold)

    2008-01-01

    textabstractBackground. A local anaesthetic with fast onset and short reliable duration of anaesthesia may be preferable for out-patient lower limb surgery. Articaine is believed to act faster and to have a shorter duration of action than bupivacaine, but there are no conclusive data available. The

  14. Identifying Parathyroid Glands With Carbon Nanoparticle Suspension Does Not Help Protect Parathyroid Function in Thyroid Surgery: A Prospective, Randomized Control Clinical Study.

    Science.gov (United States)

    Liu, Xu; Chang, Shi; Jiang, Xiaolin; Huang, Peng; Yuan, Zhengtai

    2016-08-01

    Objective We aim to evaluate the technique of identifying parathyroid glands with carbon nanoparticle suspension (CNPS) in thyroid surgeries from the perspectives of degrees of declining intact parathyroid hormone (iPTH), operation time, and time of postoperative stay. Methods A total of 156 patients who underwent thyroid surgeries in General Surgical Department of Xiangya Hospital between May 2012 and May 2015 were involved in the study. A total of 78 patients were injected with CNPS during the surgery (CNPS group); the other 78 patients received normal saline (control group). Cases were classified into 3 surgical approaches: conventional partial thyroidectomy, conventional total thyroidectomy, and endoscopic partial thyroidectomy. Degrees of declining iPTH were tested to determine the severity of parathyroid injury. Operation time and postoperative hospital stay time were recorded. A P value of less than .05 was considered statistically significant. Results For levels of declining iPTH, there was no statistically significant (ss) difference in conventional thyroid surgery. In endoscopic partial thyroidectomy, it was 23.37 ± 16.20 versus 11.94 ± 11.23 pg/mL (P = .02, ss). The operation time of conventional total thyroidectomy was 210.10 ± 83.75 versus 164.84 ± 69.22 minutes (P = .03, ss), while it was 193.04 ± 75.53 versus 127.67 ± 60.06 minutes (P = .007, ss) in endoscopic thyroidectomy. Conclusions CNPS is not beneficial for protecting the function of parathyroid gland in thyroid surgery from the perspective of declining iPTH. Applying CNPS in conventional total thyroidectomy and endoscopic partial thyroidectomy will also lead to significantly prolonged operation time. © The Author(s) 2016.

  15. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial.

    Science.gov (United States)

    Powers, William J; Clarke, William R; Grubb, Robert L; Videen, Tom O; Adams, Harold P; Derdeyn, Colin P

    2011-11-09

    Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically. To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia. Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010. Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majority were academic medical centers. Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. Of 195 patients who were randomized, 97 were randomized to receive surgery and 98 to no surgery. Follow-up for the primary end point until occurrence, 2 years, or termination of trial was 99% complete. No participant withdrew because of adverse events. Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Antithrombotic therapy and risk factor intervention were recommended for all participants. For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgical group and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization. The trial was terminated early for futility. Two-year rates for the primary end point were 21.0% (95% CI, 12.8% to 29.2%; 20 events) for the surgical group and

  16. Effect of platelet-rich fibrin on frequency of alveolar osteitis following mandibular third molar surgery: a double-blinded randomized clinical trial.

    Science.gov (United States)

    Eshghpour, Majid; Dastmalchi, Parisa; Nekooei, Amir Hossein; Nejat, AmirHossein

    2014-08-01

    To evaluate the effectiveness of platelet-rich fibrin (PRF) in preventing the development of alveolar osteitis (AO). In a double-blinded study, patients with bilateral impacted mandibular third molars underwent surgical extractions, with one socket receiving PRF and the other one serving as a control. The surgeon and patient were unaware of the study or control side. The predictor variable was the PRF application and was categorized as PRF and non-PRF. The outcome variable was the development of AO during the first postoperative week. Other study variables included age, gender, smoking status, irrigation volume, extraction difficulty, surgeon experience, and number of anesthetic cartridges. Data were analyzed using χ(2) and t tests, with the significance level set at a P value less than .05. Seventy-eight patients (mean age, 25 yr) underwent 156 impacted third molar surgeries. The overall frequency of AO was 14.74% for all surgeries. The frequency of AO in the PRF group was significantly lower than in the non-PRF group (odds ratio = 0.44; P third molar surgery. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  17. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial

    Science.gov (United States)

    La Monaca, Gerardo; De Angelis, Chiara

    2017-01-01

    Objectives. The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute postoperative pain after the surgical removal of an impacted mandibular third molar. Materials and Methods. The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets. Results. The pain intensity score on the first day was significantly lower in the analgesic group than in the placebo group (p third molar surgery and in delaying the initial onset of pain. This trial is registered with ClinicalTrials.gov Identifier (Registration Number): NCT03049878. PMID:28325960

  18. The efficacy of preventive parasternal single injection of bupivacaine on intubation time, blood gas parameters, narcotic requirement, and pain relief after open heart surgery: A randomized clinical trial study

    Directory of Open Access Journals (Sweden)

    Mahmoud Saeidi

    2011-01-01

    Full Text Available Background: Postsurgical pain usually results in some complications in the patients. This study has tried to investigate the effects of parasternal single injection of bupivacaine on postoperative pulmonary and pain consequences in patients after open heart surgery. Methods: : In a prospective double blind clinical study, 100 consenting patients undergoing elective open heart surgery were randomized into two groups. In case group, bupivacaine was injected at both sides of sternum, immediately before sternal closure. In the control group, no intervention was performed. Then, the patients were investigated regarding intubation period, length of ICU stay, arterial blood gas (ABG parameters, morphine requirement, and their severity of postoperative pain using a visual analogue scale (VAS device. Results: No differences were found between the two groups regarding to age, sex, pump time, operation time, and body mass index and preoperative cardiac ejection fraction. Mean intubation length in case group was much shorter than that in control group. Mean PaO 2 in case group was lower in different checking times in postoperative period. The patients in the case group needed less morphine compared to those in the control group during the 24-hour observation period in the ICU. Finally, mean VAS scores of pain in case group were significantly lower than those in control group at 6, 12, and 24 hours postoperatively. Conclusions: Patients′ pain relief by parasternal single injection of bupivacaine in early postoperative period can facilitate earlier ventilator weaning and tracheal extubation after open heart surgery as well as achieving lower pain scores and narcotic requirements.

  19. Extracranial-Intracranial Bypass Surgery for Stroke Prevention in Hemodynamic Cerebral Ischemia: The Carotid Occlusion Surgery Study: A Randomized Trial

    Science.gov (United States)

    Powers, William J.; Clarke, William R.; Grubb, Robert L.; Videen, Tom O; Adams, Harold P.; Derdeyn, Colin P.

    2013-01-01

    Context Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically. Objective Test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia. Design Parallel group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002–2010. Setting 49 clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majority were academic medical centers. Participants Arteriographically-confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. 195 were randomized: 97 to surgery and 98 to no surgery. Follow-up for the primary endpoint until occurrence, 2 years, or end of trial was 99% complete. No participant withdrew because of adverse events. Interventions Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Anti-thrombotic therapy and risk factor intervention were recommended for all. Main Outcome Measure For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days post surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgical group and participants assigned to surgery who did not receive surgery was the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within two years of randomization. Results The trial was terminated early for futility. Two-year rates for the primary endpoint were 21.0% (95% CI, 12.8% to 29.2%; 20 events) for the surgical group

  20. A randomized controlled clinical trial on the effectiveness of three different mouthrinses (chlorhexidine with or without alcohol and C31G), adjunct to periodontal surgery, in early wound healing.

    Science.gov (United States)

    Gkatzonis, Anastasios M; Vassilopoulos, Spyridon I; Karoussis, Ioannis K; Kaminari, Archontia; Madianos, Phoebus N; Vrotsos, Ioannis A

    2018-02-02

    The use of chlorhexidine (CHX) with or without alcohol has been recommended for a number of clinical applications. On the other hand, there is a plethora of widely subscribed antiseptics, such as agent C31G (alkyl dimethyl glycine/alkyl dimethyl amine oxide), which has not yet been evaluated postsurgically. The effectiveness of three different mouthrinses (CHX with and without alcohol, C31G) in plaque control and early wound healing was compared postoperatively. In this, randomized, double-blind, controlled clinical trial 42 patients were allocated to three groups assigned to 2 weeks rinsing after non-regenerative periodontal flap surgery with or without osseous surgery with C31G (group A), alcohol-free CHX 0.12% (group B) or alcohol-based CHX 0.12% (group C). At days 7 and 14, plaque and early wound healing indices were recorded. At day 14, total bacterial counts were estimated utilizing real-time quantitative polymerase chain reaction (qPCR). Statistics included linear and generalized linear mixed models. At day 7, healing response was not significantly different among groups. At day 14, group A revealed the highest while group C demonstrated the lowest plaque index values (B vs A, odds ratio-OR = 0.18, p = 0.012; C vs A, OR = 0.01, p healing was significantly better in group C compared to B (p = 0.007). Group A showed no significant differences compared to other groups. (1) The presence of alcohol may increase the effectiveness of CHX in early wound healing, (2) C31G might be an alternative solution prescribed during early postoperative period after non-regenerative periodontal flap surgery. The present study found that active agent C31G displayed no significant differences to CHX formulations regarding periodontal wound healing improvement and might be used alternatively after non-regenerative periodontal flap surgery. In addition, an alcohol based 0.12% CHX mouthwash was more effective than an alcohol-free 0.12% CHX and C31G mouthrinse on

  1. Pre-emptive effect of dexamethasone and methylprednisolone on pain, swelling, and trismus after third molar surgery: a split-mouth randomized triple-blind clinical trial.

    Science.gov (United States)

    Alcântara, C E P; Falci, S G M; Oliveira-Ferreira, F; Santos, C R R; Pinheiro, M L P

    2014-01-01

    The aim of this study was to compare the effect of dexamethasone 8 mg and methylprednisolone 40 mg for the control of pain, swelling, and trismus following the extraction of impacted third molars. Sixteen healthy patients with a mean age of 20.3 (standard deviation 1.25) years received a single oral dose of either drug 1 h prior to each surgical procedure (left and right teeth). At 24, 48, and 72 h and 7 days following surgery, swelling was determined using linear measurements on the face and trismus was determined by maximal mouth opening. Postoperative pain was self-recorded by the patients using a visual analogue scale at 8-h intervals for a period of 72 h. Data analysis involved descriptive statistics and the Wilcoxon, and paired t tests (P < 0.05). Dexamethasone controlled swelling better than methylprednisolone at all postoperative evaluations (P < 0.02) and led to greater mouth opening 48 h after surgery (P = 0.029). No statistically significant difference was found between drugs with regard to pain. In conclusion, pre-emptive dexamethasone 8 mg demonstrated better control of swelling and limited mouth opening in comparison to methylprednisolone 40 mg, with no differences between drugs regarding pain control. Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  2. 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...

  3. A Prospective Randomized Clinical Study of the Influence of Primary ...

    African Journals Online (AJOL)

    Objective: The aim of the following study is to determine the effect of primary closure or dressing on post‑operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects ...

  4. The efficacy of continuous-flow cryo and cyclic compression therapy after hip fracture surgery on postoperative pain: design of a prospective, open-label, parallel, multicenter, randomized controlled, clinical trial.

    Science.gov (United States)

    Leegwater, Nick C; Nolte, Peter A; de Korte, Niels; Heetveld, Martin J; Kalisvaart, Kees J; Schönhuth, Casper P; Pijnenburg, Bas; Burger, Bart J; Ponsen, Kees-Jan; Bloemers, Frank W; Maier, Andrea B; van Royen, Barend J

    2016-04-08

    The number of hip fractures and resulting post-surgical outcome are a major public health concern and the incidence is expected to increase significantly. The acute recovery phase after hip fracture surgery in elder patients is often complicated by severe pain, high morphine consumption, perioperative blood loss with subsequent transfusion and delirium. Postoperative continuous-flow cryocompression therapy is suggested to minimize these complications and to attenuate the inflammatory reaction that the traumatic fracture and subsequent surgical trauma encompass. Based on a pilot study in patients undergoing total hip arthroplasty for osteoarthritis, it is anticipated that patients treated with continuous-flow cryocompression therapy will have less pain, less morphine consumption and lower decrease of postoperative hemoglobin levels. These factors are associated with a shorter hospital stay and better long-term (functional) outcome. One hundred and sixty patients with an intra or extracapsular hip fracture scheduled for internal fixation (intramedullary hip nail, dynamic hip screw or cannulated screws) or prosthesis surgery (total hip or hemiarthroplasty) will be included in this prospective, open-label, parallel, multicenter, randomized controlled, clinical superiority trial. Patients will be allocated to two treatment arms: group 'A' will be treated with continuous-flow cryocompression therapy and compared to group 'B' that will receive standard care. Routine use of drains and/or compressive bandages is allowed in both groups. The primary objective of this study is to compare acute pain the first 72 h postoperative, measured with numeric rating scale for pain. Secondary objectives are: (non-) morphine analgesic use; adjusted postoperative hemoglobin level; transfusion incidence; incidence, duration and severity of delirium and use of psychotropic medication; length of stay; location and duration of rehabilitation; functional outcome; short-term patient

  5. Evaluation of fibrin sealant as a wound closure agent in mandibular third molar surgery--a prospective, randomized controlled clinical trial.

    Science.gov (United States)

    Gogulanathan, M; Elavenil, P; Gnanam, A; Raja, V B Krishnakumar

    2015-07-01

    The aim of this randomized controlled trial was to assess the effectiveness of fibrin sealants in achieving haemostasis and wound closure following mandibular third molar extraction, in comparison with conventional suturing. Thirty patients with bilateral mandibular third molar impactions were recruited for the study. Using a split-mouth study design, wound closure following extraction was done using fibrin sealant on the study side and suturing on the control side. Sample allocation was done by simple randomization. The primary outcome measures were (1) the time taken to achieve wound closure and haemostasis and (2) postoperative mouth opening, pain, and swelling. Data analysis involved descriptive statistics and paired t-tests (P<0.05). IBM SPSS software (v.20.0) was used for the data analysis. The study group demonstrated a statistically significant reduction in duration to achieve haemostasis (1.2 vs. 251.9s; P<0.001) and wound closure (152.8 vs. 328.8s; P<0.001) in comparison with the control group. The study group also exhibited significantly reduced pain scores (2.0 vs. 3.5; P<0.001) and increased post-surgical mouth opening (P<0.001). No adverse effects of fibrin sealant were observed. In conclusion, fibrin sealant is a superior intraoral wound closure and haemostatic agent and a worthy alternative to suturing. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  6. Methodology for Speech Assessment in the Scandcleft Project-An International Randomized Clinical Trial on Palatal Surgery

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth

    2009-01-01

    Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcom...... conventions and rules are important. A composite variable for perceptual assessment of velopharyngeal function during speech seems usable; whereas, the method for hypernasality evaluation requires further testing.  ......Objective: To present the methodology for speech assessment in the Scandcleft project and discuss issues from a pilot study. Design: Description of methodology and blinded test for speech assessment. Speech samples and instructions for data collection and analysis for comparisons of speech outcomes...... across five included languages were developed and tested. Participants and Materials: Randomly selected video recordings of 10 5-year-old children from each language (n = 50) were included in the project. Speech material consisted of test consonants in single words, connected speech, and syllable chains...

  7. Meta-analysis of clinical randomized controlled trials comparing ReZOOM with ReSTOR multifocal intraocular lenses in cataract surgery

    Directory of Open Access Journals (Sweden)

    De-Wang Shao

    2014-06-01

    Full Text Available AIM: To systematic review the effectiveness of refractive multifocal intraocular lens(MIOLReZOOM vs diffractive MIOL ReSTOR in the treatment of cataract.METHODS: Randomized controlled trials comparing refractive MIOL ReZOOM with diffractive MIOL ReSTOR were identified by searching CENTRAL, MEDLINE, EMbase, WANFANG MED ONLINE, CMJD, SinoMed, and CNKI. Related journals also were hand-searched. Methodological quality of randomized controlled trials(RCTswas evaluated by simple evaluate method that recommended by the Cochrane Collaboration. Data extracted by two reviewers with designed extraction form. RevMan software(release 5.2was used for data management and analysis.RESULTS:A total of 7 trials(846 eyeswere included for systematic review. Subgroup analyses were used according to different model comparison of ReSTOR MIOL. The results showed a significant difference in the mean of the best distance corrected intermediate visual acuity(BDCIVAin the ReZOOM MIOL group with WMD= -0.11, 95% CI(-0.16, -0.06(PCI(0.05, 0.14(PCI(1.76, 3.91(PCI(1.15, 1.60(P=0.0004and WMD= 1.29, 95% CI(1.09, 1.53(P=0.003. There was no significant difference between the two groups in the mean of the uncorrected distance visual acuity(UCDVA, the uncorrected intermediate visual acuity(UCIVA, the best corrected distance visual acuity(BCDVAand the best distance corrected near visual acuity(BDCNVAwith WMD -0.03, 95% CI(-0.06, 0.01(P=0.15, WMD= -0.04, 95% CI(-0.09, 0.01(P=0.10, WMD= -0.01, 95%CI(-0.04, 0.02(P=0.55and WMD= 0.06, 95% CI(-0.06, 0.17(P=0.32. CONCLUSION: Patients implanted with ReZOOM MIOL can provide better BDCIVA; patients implanted with ReSTOR MIOL show better UCNVA, are less likely to appear light halo, glare and other visual adverse reactions; correction in spectacles cases, patients implanted with ReZOOM or ReSTOR MIOL have considerable performances in the far and near visual acuity.

  8. Power prediction for one-piece and three-piece intraocular lens implantation after cataract surgery in patients with chronic angle-closure glaucoma: a prospective, randomized clinical trial.

    Science.gov (United States)

    Rhiu, Soolienah; Lee, Eun Suk; Kim, Tae-im; Lee, Hye Sun; Kim, Chan Yun

    2012-12-01

    To assess the accuracy of intraocular lens (IOL) power prediction for cataract surgery in chronic angle-closure glaucoma (CACG) patients with different IOLs' implantation. This prospective randomized clinical trial included 45 eyes with CACG and 48 eyes with normal controls undergoing cataract surgery. In the CACG group, 23 eyes (51%) had three-piece IOL implantation and 22 eyes (49%) had one-piece IOL implantation. In the normal control group, 25 eyes (52%) had three-piece IOL implantation and 23 eyes (48%) had one-piece IOL implantation. Using the SRK/T formula, the mean difference between the predicted and actual postoperative spherical equivalent [mean absolute error (MAE)] was obtained and converted to natural logarithm (ln) for statistical analysis. The power of the implanted IOL was calculated to predict postoperative SE using three formulas: SRK II, Holladay II and Hoffer Q by post hoc analysis in each group. The predictive accuracy of each formula was analysed by comparing the lnMAE. In the one-piece IOL group, there was no difference in lnMAE between the CACG and normal control group (p = 0.314). In the three-piece IOL group, the lnMAE of the CACG group was larger than that of the normal control group (p one-piece IOL group. Implantation of one-piece IOLs provides similar power prediction accuracy comparable to normal cataract patients; this result may be explained by the IOL haptic configuration or design. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  9. Venoplant Effect in the Management of the Post-operative Oedema in Plastic Surgery: Results of a Randomized and Controlled Clinical Trial.

    Science.gov (United States)

    D'Andrea, Francesco; D'Andrea, Luca; Manzi, Ercole

    2018-03-05

    Post-operative oedema and ecchymosis represent early post-operative complications, impacting negatively on the final aesthetic outcome of each surgical procedure. In particular, such complications are very frustrating for patients and-sometimes-are difficult to be managed by surgeons. Several strategies are available for managing oedema, although some side effects have been reported. A new promising compound for the management of oedema is Venoplant, and this study aims to assess its effectiveness in decreasing post-operative oedema. Patients were randomly allocated for receiving three different treatments: (1) Venoplant tablets and Venoplant gel; (2) only Venoplant tablets; and (3) not treated with Venoplant. The aesthetical outcome has been evaluated using the Global Aesthetic Improvement Scale (GAIS), compiled by both patient and clinician. The GAIS scale was administered several times: the day following the surgical procedure (T0) after 3 days (T1), after 7 days (T2), after 15 days (T3) and after 1 month (T4). Forty-three patients participated in the study. According to patient's evaluations, at T0 in Group 1 and in Group 2 a significant statistical difference was found compared to the control group (p side effects which are often associated with other therapies. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  10. Clinical trial networks in orthopaedic surgery.

    Science.gov (United States)

    Rangan, A; Jefferson, L; Baker, P; Cook, L

    2014-05-01

    The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169-74. ©2014 The British Editorial Society of Bone & Joint Surgery.

  11. 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.

  12. The effects of perioperative probiotic treatment on serum zonulin concentration and subsequent postoperative infectious complications after colorectal cancer surgery: a double-center and double-blind randomized clinical trial.

    Science.gov (United States)

    Liu, Zhi-Hua; Huang, Mei-Jin; Zhang, Xing-Wei; Wang, Lei; Huang, Nan-Qi; Peng, Hui; Lan, Pin; Peng, Jun-Sheng; Yang, Zhen; Xia, Yang; Liu, Wei-Jie; Yang, Jun; Qin, Huan-Long; Wang, Jian-Ping

    2013-01-01

    Zonulin is a newly discovered protein that has an important role in the regulation of intestinal permeability. Our previous study showed that probiotics can decrease the rate of infectious complications in patients undergoing colectomy for colorectal cancer. The objective was to determine the effects of the perioperative administration of probiotics on serum zonulin concentrations and the subsequent effect on postoperative infectious complications in patients undergoing colorectal surgery. A total of 150 patients with colorectal carcinoma were randomly assigned to the control group (n = 75), which received placebo, or the probiotics group (n = 75). Both the probiotics and placebo were given orally for 6 d preoperatively and 10 d postoperatively. Outcomes were measured by assessing bacterial translocation, postoperative intestinal permeability, serum zonulin concentrations, duration of postoperative pyrexia, and cumulative duration of antibiotic therapy. The postoperative infection rate, the positive rate of blood microbial DNA, and the incidence of postoperative infectious complications-including septicemia, central line infection, pneumonia, urinary tract infection, and diarrhea-were also assessed. The infection rate was lower in the probiotics group than in the control group (P zonulin concentration (P zonulin concentrations in patients undergoing colectomy. We propose a clinical regulatory model that might explain this association. This trial was registered at http://www.chictr.org/en/ as ChiCTR-TRC-00000423.

  13. [Impact of digital technology on clinical practices: perspectives from surgery].

    Science.gov (United States)

    Zhang, Y; Liu, X J

    2016-04-09

    Digital medical technologies or computer aided medical procedures, refer to imaging, 3D reconstruction, virtual design, 3D printing, navigation guided surgery and robotic assisted surgery techniques. These techniques are integrated into conventional surgical procedures to create new clinical protocols that are known as "digital surgical techniques". Conventional health care is characterized by subjective experiences, while digital medical technologies bring quantifiable information, transferable data, repeatable methods and predictable outcomes into clinical practices. Being integrated into clinical practice, digital techniques facilitate surgical care by improving outcomes and reducing risks. Digital techniques are becoming increasingly popular in trauma surgery, orthopedics, neurosurgery, plastic and reconstructive surgery, imaging and anatomic sciences. Robotic assisted surgery is also evolving and being applied in general surgery, cardiovascular surgery and orthopedic surgery. Rapid development of digital medical technologies is changing healthcare and clinical practices. It is therefore important for all clinicians to purposefully adapt to these technologies and improve their clinical outcomes.

  14. Randomization in substance abuse clinical trials.

    Science.gov (United States)

    Hedden, Sarra L; Woolson, Robert F; Malcolm, Robert J

    2006-02-06

    A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA)-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn randomization schemes and other highly adaptive designs. In many

  15. Clinical results of Trabectome surgery for open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Mizoguchi T

    2015-10-01

    Full Text Available Takanori Mizoguchi,1 Shiro Nishigaki,2 Tomoki Sato,3 Harumi Wakiyama,4 Nobuchika Ogino2 1Mizoguchi Eye Clinic, Ophthalmology, Sasebo, 2Nishigaki Eye Clinic, Ophthalmology, Nagoya, 3Sato Eye Clinic, Ophthalmology, Arao, 4Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan Background: The purpose of this study was to determine outcomes when using Trabectome surgery and to evaluate factors associated with its effects in primary open-angle glaucoma (POAG and exfoliation glaucoma (EXG. Methods: This was a prospective, non-randomized, observational, comparative cohort study in which Trabectome surgery was used alone in patients with POAG or EXG. Trabectome surgery was considered to have failed when at least one of the following three criteria was fulfilled: intraocular pressure (IOP ≥21 mmHg and a <20% reduction below the baseline IOP on two consecutive follow-up visits 3 months or more after surgery; need for additional glaucoma surgery; and an increase in number of medications compared with baseline. Results: The subjects were 32 males (34 eyes and 46 females (48 eyes. POAG was observed in 43 eyes and EXG in 39 eyes. IOP after Trabectome surgery decreased significantly from 22.3±6.8 mmHg at baseline to 14.0±3.9 mmHg (23.0% reduction at month 24 in all cases (P<0.0000. The success rate at 2 years was 51.2% for all cases (POAG, 50.9%; EXG, 49.2%. There was no significant difference in success rate between POAG and EXG (P=0.91. Preoperative IOP (P=0.033 and number of medications (P=0.041 were significant factors for surgical success/failure in multivariate logistic regression. No serious complications were observed. Conclusion: Trabectome surgery achieved favorable IOP control and was equally effective in patients with POAG and those with EXG. Its effects were influenced by preoperative IOP and number of preoperative medications. Keywords: Trabectome, primary open-angle glaucoma, exfoliation glaucoma, success rate, risk factors 

  16. Clinical application of thoracic paravertebral anesthetic block in breast surgeries

    Directory of Open Access Journals (Sweden)

    Sara Socorro Faria

    2015-04-01

    Full Text Available INTRODUCTION: Optimum treatment for postoperative pain has been of fundamental importance in surgical patient care. Among the analgesic techniques aimed at this group of patients, thoracic paravertebral block combined with general anesthesia stands out for the good results and favorable risk-benefit ratio. Many local anesthetics and other adjuvant drugs are being investigated for use in this technique, in order to improve the quality of analgesia and reduce adverse effects. OBJECTIVE: Evaluate the effectiveness and safety of paravertebral block compared to other analgesic and anesthetic regimens in women undergoing breast cancer surgeries. METHODS: Integrative literature review from 1966 to 2012, using specific terms in computerized databases of articles investigating the clinical characteristics, adverse effects, and beneficial effects of thoracic paravertebral block. RESULTS: On the selected date, 16 randomized studies that met the selection criteria established for this literature review were identified. Thoracic paravertebral block showed a significant reduction of postoperative pain, as well as decreased pain during arm movement after surgery. CONCLUSION: Thoracic paravertebral block reduced postoperative analgesic requirement compared to placebo group, markedly within the first 24 h. The use of this technique could ensure postoperative analgesia of clinical relevance. Further studies with larger populations are necessary, as paravertebral block seems to be promising for preemptive analgesia in breast cancer surgery.

  17. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    Science.gov (United States)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  18. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  19. Current peripheral bypass surgery: various clinical studies

    NARCIS (Netherlands)

    Slaa, Alexander te

    2011-01-01

    Substantial post-operative edema occurs in the majority of patients who undergo peripheral bypass surgery due to severe peripheral arterial disease (PAD). The pathophysiological mechanisms that underlay edema formation following peripheral bypass surgery include hyperemia, an increased capillary

  20. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  1. Analgesia and pulmonary function after lung surgery: is a single intercostal nerve block plus patient-controlled intravenous morphine as effective as patient-controlled epidural anaesthesia? A randomized non-inferiority clinical trial.

    Science.gov (United States)

    Meierhenrich, R; Hock, D; Kühn, S; Baltes, E; Muehling, B; Muche, R; Georgieff, M; Gorsewski, G

    2011-04-01

    Thoracic epidural anaesthesia (EDA) is regarded as the 'gold standard' for postoperative pain control and restoration of pulmonary function after lung surgery. Easier, less time-consuming, and, perhaps, safer is intercostal nerve block performed under direct vision by the surgeon before closure of the thoracotomy combined with postoperative i.v. patient-controlled analgesia with morphine. We hypothesized that this technique is as effective as thoracic EDA. The study was designed as a single-centre, open labelled, randomized non-inferiority trial. A total of 92 patients undergoing elective lung surgery were randomly assigned to the epidural (n=47) or intercostal group (n=45), and 83 patients completed the study. Pain scores, inspiratory vital capacity, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and peak expiratory flow rate (PEFR) were assessed during the first four postoperative days. Median treatment differences regarding pain scores at rest failed to demonstrate non-inferiority of the intercostal nerve block at the first postoperative day. Patients of the intercostal group reported significantly higher pain scores on coughing during the first and second postoperative days. The epidural group had a significantly higher median FVC, FEV1, and PEFR values on the second postoperative day. No difference was found in pulmonary complications, length of hospital stay, or in-hospital deaths. In patients undergoing lung surgery, single intercostal nerve block plus i.v. patient-controlled analgesia with morphine is not as effective as patient-controlled EDA with respect to pain control and restoration of pulmonary function.

  2. Conjunctival Goblet Cell Density Following Cataract Surgery With Diclofenac Versus Diclofenac and Rebamipide: A Randomized Trial.

    Science.gov (United States)

    Kato, Kumiko; Miyake, Kensaku; Kondo, Nagako; Asano, Sayaka; Takeda, Junko; Takahashi, Akiko; Takashima, Yuko; Kondo, Mineo

    2017-09-01

    To determine the effects of topical diclofenac or betamethasone with concomitant application of topical rebamipide on the conjunctival goblet cell density in eyes after cataract surgery. Randomized clinical trial. Eighty patients who were scheduled for cataract surgery. Patients were randomized into 4 groups according to the postoperative topical drugs to be given; Group A, diclofenac alone; Group B, diclofenac and rebamipide; Group C, betamethasone alone; and Group D, betamethasone and rebamipide. Impression cytology was performed before and at 1 month after the surgery, and the mean density of goblet cells was determined. The mean (± SD) density of goblet cells before the surgery in Group A was 257.0 ± 188.7 cells/mm 2 , and it decreased significantly to 86.5 ± 76.7 cells/mm 2 at 1 month after the surgery (P = .002). In Group B, the goblet cell density was not statistically different between before (238.5 ± 116.6 cells/mm 2 ) and at 1 month after the surgery (211.3 ± 184.4 cells/mm 2 , P = .55). In Groups C and D, the mean density of goblet cells was decreased at 1 month after the surgery, but the decreases were not significant (P = .11 and P = .52, respectively). After cataract surgery with postoperative topical diclofenac, the conjunctival goblet cell density was significantly reduced, and this reduction was blocked by the concomitant use of topical rebamipide. These results suggest that the concomitant use of topical rebamipide with nonsteroidal anti-inflammatory drugs is beneficial, especially in cases with postoperative dry eyes. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  3. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  4. Effect of massage therapy on pain, anxiety, relaxation, and tension after colorectal surgery: A randomized study.

    Science.gov (United States)

    Dreyer, Nikol E; Cutshall, Susanne M; Huebner, Marianne; Foss, Diane M; Lovely, Jenna K; Bauer, Brent A; Cima, Robert R

    2015-08-01

    The purpose of this randomized controlled trial was to evaluate the effect of postoperative massage in patients undergoing abdominal colorectal surgery. One hundred twenty-seven patients were randomized to receive a 20-min massage (n = 61) or social visit and relaxation session (no massage; n = 66) on postoperative days 2 and 3. Vital signs and psychological well-being (pain, tension, anxiety, satisfaction with care, relaxation) were assessed before and after each intervention. The study results indicated that postoperative massage significantly improved the patients' perception of pain, tension, and anxiety, but overall satisfaction was unchanged. In conclusion, massage may be beneficial during postoperative recovery for patients undergoing abdominal colorectal surgery. Further studies are warranted to optimize timing and duration and to determine other benefits in this clinical setting. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

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

    Science.gov (United States)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette; Kroman, Niels; Maibom, Annerikke; Sauerberg, Marie-Louise; Møller, Ann M

    2010-11-01

    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. A randomized controlled multicentre trial with blinded outcome assessment conducted at 3 hospitals in Denmark. One hundred and thirty patients were randomly assigned to brief smoking intervention (n = 65) or standard care (n = 65). The intervention followed the principles of motivational interviewing and included personalized nicotine replacement therapy aimed at supporting smoking cessation from 2 days before to 10 days after surgery. The overall postoperative complication rate (including seroma requiring aspiration) was 61% in both groups risk ratio (RR) 1.00 (95% CI 0.75-1.33). The wound complication rate was 44% versus 45%. The effect on perioperative smoking cessation was modest, 28% intervention versus 11% control group patients, RR 2.49 (95% CI 1.10-5.60). There was no effect on smoking cessation at 12 months, 13% versus 9%. Brief smoking intervention administered shortly before breast cancer surgery modestly increased self-reported perioperative smoking cessation without having any clinical impact on postoperative complications. The study adds to the body of evidence indicating that brief intervention has no clinical importance for surgical patients in regard to postoperative morbidity. Future studies should be designed to determine the optimal time of smoking cessation before surgery.

  7. 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.

  8. 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.

  9. 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.

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

    Science.gov (United States)

    Sadeghi, Mostafa; Atefyekta, Reza; Azimaraghi, Omid; Marashi, Seyed Mojtaba; Aghajani, Yasaman; Ghadimi, Fatemeh; Spahn, Donat R; Movafegh, Ali

    2014-01-01

    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. A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1g 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. 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. Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

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

    Science.gov (United States)

    Sadeghi, Mostafa; Atefyekta, Reza; Azimaraghi, Omid; Marashi, Seyed Mojtaba; Aghajani, Yasaman; Ghadimi, Fatemeh; Spahn, Donat R; Movafegh, Ali

    2014-01-01

    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. A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1g of fibrinogen concentrate 30min 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. 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 72h after surgery. Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  12. Results of Stapes Surgery in Our Clinic

    Directory of Open Access Journals (Sweden)

    Reşit Murat Açıkalın

    2015-12-01

    Full Text Available Aim: The aim of this study was to analyze the results of stapes surgery, which is done to improve the air-bone gap in otosclerosis, and to show its benefit in hearing. Methods: We retrospectively analyzed 42 patients in terms of audiologic evaluation results, smoking status, tinnitus and complications. Air-bone gap closure was classified as successful (gap 10 dB and unsuccessful (no gap closure or worse. Results: The mean preoperative air-bone gap was 37.43 dB. Air-bone gap closure was successful or partially successful in 39 patients (92.86% and unsuccessful in two patients (4.76. There was no relationship between the success of the surgery and smoking. All 42 had tinnitus preoperatively. Tinnitus healed in 28 patients postoperatively. One patient had tympanic membrane perforation postoperatively. Conclusion: Although there are some complications, stapes surgery in patients with otosclerosis is a reliable and effective option.

  13. A randomized trial of preoperative oral carbohydrates in abdominal surgery

    OpenAIRE

    Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

    2014-01-01

    Background Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. Methods A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and ...

  14. Effects of Cell-Saving Devices and Filters on Transfusion in Cardiac Surgery : A Multicenter Randomized Study

    NARCIS (Netherlands)

    Vermeijden, Wytze J.; van Klarenbosch, Jan; Gu, Y. John; Mariani, Massimo A.; Buhre, Wolfgang F.; Scheeren, Thomas W. L.; Hagenaars, Johanna A. M.; Tan, M. Erwin S. H.; Haenen, Jo S. E.; Bras, Leo; van Oeveren, Wim; van den Heuvel, Edwin R.; de Vries, Adrianus J.

    Background: Cell-saving devices (CS) are frequently used in cardiac surgery to reduce transfusion requirements, but convincing evidence from randomized clinical trials is missing. Filtration of salvaged blood in combination with the CS is widely used to improve the quality of retransfused blood, but

  15. Effects of cell-saving devices and filters on transfusion in cardiac surgery : a multicenter randomized study

    NARCIS (Netherlands)

    Vermeijden, Wytze J; van Klarenbosch, Jan; Gu, Y John; Mariani, Massimo A; Buhre, Wolfgang F; Scheeren, Thomas W L; Hagenaars, Johanna A M; Tan, M Erwin S H; Haenen, Jo S E; Bras, Leo; van Oeveren, Wim; van den Heuvel, Edwin R; de Vries, Adrianus J

    BACKGROUND: Cell-saving devices (CS) are frequently used in cardiac surgery to reduce transfusion requirements, but convincing evidence from randomized clinical trials is missing. Filtration of salvaged blood in combination with the CS is widely used to improve the quality of retransfused blood, but

  16. Clinical innovations in Philippine thoracic surgery.

    Science.gov (United States)

    Danguilan, Jose Luis J

    2016-08-01

    Thoracic surgery in the Philippines followed the development of thoracic surgery in the United States and Europe. With better understanding of the physiology of the open chest and refinements in thoracic anesthetic and surgical approaches, Filipino surgeons began performing thoracoplasties, then lung resections for pulmonary tuberculosis and later for lung cancer in specialty hospitals dealing with pulmonary diseases-first at the Quezon Institute (QI) and presently at the Lung Center of the Philippines although some university and private hospitals made occasional forays into the chest. Esophageal surgery began its early attempts during the post-World War II era at the Philippine General Hospital (PGH), a university hospital affiliated with the University of the Philippines. With the introduction of minimally invasive thoracic surgical approaches, Filipino thoracic surgeons have managed to keep up with their Asian counterparts although the problems of financial reimbursement typical of a developing country remain. The need for creative innovative approaches of a focused multidisciplinary team will advance the boundaries of thoracic surgery in the Philippines.

  17. 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

    in patients who had emergency abdominal surgery. METHODS: This was a randomized clinical trial carried out in seven Danish hospitals. Eligible for inclusion were patients with an Acute Physiology And Chronic Health Evaluation (APACHE) II score of at least 10 who were ready to be transferred to the surgical...... 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......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...

  18. Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia).

    Science.gov (United States)

    Paajanen, Hannu; Brinck, Tuomas; Hermunen, Heikki; Airo, Ilari

    2011-07-01

    Chronic groin pain in athletes presents often a diagnostic and therapeutic challenge. Sportsman's hernia (also called "athletic pubalgia") is a deficiency of the posterior wall of the inguinal canal, which is often repaired by laparoscopic mesh placement. Endoscopic mesh repair may offer a faster recovery for athletes with sportsman's hernia than nonoperative therapy. A randomized, prospective study was conducted on 60 patients with a diagnosis of chronic groin pain and suspected sportsman's hernia. Clinical data and MRI were collected on all patients. After 3 to 6 months of groin symptoms, the patients were randomized into an operative or a physiotherapy group (n = 30 patients in each group). Operation was performed using a totally extraperitoneal repair in which mesh was placed behind the symphysis and painful groin area. Conservative treatment included at least 2 months of active physiotherapy, including corticosteroid injections and oral anti-inflammatory analgesics. The outcome measures were pre- and postoperative pain using a visual analogue scale and partial or full recovery to sports activity at 1, 3, 6, and 12 months after randomization. The athletes in both treatment groups had similar characteristics and pain scores. Operative repair was more effective than nonoperative treatment to decrease chronic groin pain after 1 month and up to 12 months of follow-up (P pubalgia). Copyright © 2011 Mosby, Inc. All rights reserved.

  19. Piezoelectric surgery in implant dentistry: clinical applications

    Directory of Open Access Journals (Sweden)

    Lydia Masako Ferreira

    2009-01-01

    Full Text Available Pizosurgery has therapeutic characteristics in osteotomies, such as extremely precise, selective and millimetric cuts and a clear operating field. Piezoelectricity uses ultrasonic frequencies, which cause the points specially designed for osteotomy to vibrate. The points of the instrument oscillate, allowing effective osteotomy with minimal or no injury to the adjacent soft tissues, membranes and nerve tissues. This article presents the various applications of piezoelectricity in oral implant surgery such as: removal of autogenous bone; bone window during elevation of the sinus membrane and removal of fractured implants. The cavitational effect caused by the vibration of the point and the spray of physiological solution, provided a field free of bleeding and easy to visualize. The study showed that the piezoelectric surgery is a new surgical procedurethat presents advantages for bone cutting in many situations in implant dentistry, with great advantages in comparison with conventional instrumentation. Operating time is longer when compared with that of conventional cutters.

  20. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial.

    Science.gov (United States)

    Foxman, Betsy; Cronenwett, Anna E W; Spino, Cathie; Berger, Mitchell B; Morgan, Daniel M

    2015-08-01

    The risk of urinary tract infection (UTI) among women undergoing elective gynecological surgery during which a catheter is placed is high: 10-64% following catheter removal. We conducted the first randomized, double-blind, placebo-controlled trial of the therapeutic efficacy of cranberry juice capsules in preventing UTI after surgery. We recruited patients from a single hospital between August 2011 and January 2013. Eligible participants were undergoing elective gynecological surgery that did not involve a fistula repair or vaginal mesh removal. One hundred sixty patients were randomized and received 2 cranberry juice capsules 2 times a day, equivalent to 2 8 ounce servings of cranberry juice, for 6 weeks after surgery or matching placebo. The primary endpoint was the proportion of participants who experienced clinically diagnosed and treated UTI with or without positive urine culture. Kaplan-Meier plots and log rank tests compared the 2 treatment groups. The occurrence of UTI was significantly lower in the cranberry treatment group compared with the placebo group (15 of 80 [19%] vs 30 of 80 [38%]; odds ratio, 0.38; 95% confidence interval, 0.19-0.79; P = .008). After adjustment for known confounders, including the frequency of intermittent self-catheterization in the postoperative period, the protective effects of cranberry remained (odds ratio, 0.42; 95% confidence interval, 0.18-0.94). There were no treatment differences in the incidence of adverse events, including gastrointestinal upset (56% vs 61% for cranberry vs placebo). Among women undergoing elective benign gynecological surgery involving urinary catheterization, the use of cranberry extract capsules during the postoperative period reduced the rate of UTI by half. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Actuation of the Plastic Surgery Clinic

    International Nuclear Information System (INIS)

    Toledo, F.V. de; Araujo, A.P. de; Beer, A.; Silva Thome, J.A. da

    1986-01-01

    The author comments on the care for patients victim of accidents with radioactive material. He analyses not only the procedures done in the treatment of skin injuries and prevention of complications, but principally the steps to be followed by all surgical team to deal with this special kind of patient. He puts emphasis in the fact that is necessary measuring radiation levels by specialized personnel during all the surgical act, and whenever there is a high level of radiation the drape, gloves, gowns should be changed and contaminated areas clean. The conclusion introduces procedures to be taken after surgery. (author)

  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. Comparative efficacy of amoxicillin/clavulanic acid and levofloxacin in the reduction of postsurgical sequelae after third molar surgery: a randomized, double-blind, clinical trial in a Nigerian university teaching hospital

    Directory of Open Access Journals (Sweden)

    Kizito Chioma Ndukwe

    2016-01-01

    Full Text Available Background: The most common sequelae after surgical removal of mandibular third molar are pain, trismus, swelling, and dysphagia. However, these symptoms can also signal the onset of surgical site infection and alveoli osteitis. The aim of this study was to evaluate the efficacy of prophylactic amoxicillin/clavulanic acid and levofloxacin and preemptive therapy of amoxicillin/clavulanic acid in the reduction of postinflammatory complications, surgical site infection, and alveolar osteitis following the third molar surgery. Patients and Methods: A total of 135 patients were randomized into three equal groups: Group A (preemptive therapy of amoxicillin/clavulanic acid with preoperative dose of 875/125 mg amoxicillin/clavulanic acid followed by 500/125 mg amoxicillin/clavulanic acid 12 hourly for 5 days, Group B (amoxicillin/clavulanic acid prophylaxis with a single preoperative dose of amoxicillin/clavulanic acid 875/125 mg tablets, and Group C (levofloxacin prophylaxis with a single preoperative dose of levofloxacin 1000 mg tablets. All patients had ostectomy using surgical handpiece and burs and received same analgesics (tabs ibuprofen 400 mg 8 hourly for 3 days. Results: No case of surgical site infection or alveoli osteitis was recorded in the study groups. There were no statistically significant differences between the treatment groups with regard to pain, mouth opening, postoperative facial dimension, and body temperature. Conclusion: Amoxicillin/clavulanic acid as a single preoperative bolus should be adequate for the prevention of postoperative wound infection and alveoli osteitis following the third molar extraction as there is no need for an extension of the antibiotic. Moreover, levofloxacin can be utilized as prophylaxis in patients undergoing mandibular third molar extraction if such patients are allergic to penicillins.

  4. [Guidelines for clinical practice for bariatric surgery].

    Science.gov (United States)

    Ciangura, Cécile; Nocca, David; Lindecker, Valérie

    2010-09-01

    Bariatric surgery is intended for subjects with BMI ≥ 40 kg/m(2) or ≥ 35 kg/m(2) with comorbidities. In any case, the indication can only be envisaged in patients who have had access to specialized medical care, and agree with a prolonged medical follow-up. After 60 years old, physiological age and comorbidities need to be highly considered. In genetic obesity and craniopharyngioma, surgery is exceptional. Main contraindications consist in severe disorders in feeding behaviour, non-stabilized psychiatric disorders, alcoholism, drug addiction, inability to participate in prolonged medical follow-up. Surgical process includes many important stages: preparation and information by a multidisciplinary team (identify contraindication, give optimal information, look for and treat comorbidities [as sleep apneoas syndrome, diabetes, cardiopulmonary disease], assess nutritional and psychological status and feeding behaviour); the decision of intervention during a concerted analysis by a multidisciplinary team; follow-up (for life) led to screen for nutritional deficiencies and surgical complications, to reinforce diet and physical activity counselling, to adapt to new situations (as pregnancy), and advise psychological care if necessary. Copyright © 2010. Published by Elsevier Masson SAS.

  5. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed...

  6. Femtosecond lasers in ophthalmology: clinical applications in anterior segment surgery

    Science.gov (United States)

    Juhasz, Tibor; Nagy, Zoltan; Sarayba, Melvin; Kurtz, Ronald M.

    2010-02-01

    The human eye is a favored target for laser surgery due to its accessibility via the optically transparent ocular tissue. Femtosecond lasers with confined tissue effects and minimized collateral tissue damage are primary candidates for high precision intraocular surgery. The advent of compact diode-pumped femtosecond lasers, coupled with computer controlled beam delivery devices, enabled the development of high precision femtosecond laser for ophthalmic surgery. In this article, anterior segment femtosecond laser applications currently in clinical practice and investigation are reviewed. Corneal procedures evolved first and remain dominant due to easy targeting referenced from a contact surface, such as applanation lenses placed on the eye. Adding a high precision imaging technique, such as optical coherence tomography (OCT), can enable accurate targeting of tissue beyond the cornea, such as the crystalline lens. Initial clinical results of femtosecond laser cataract surgery are discussed in detail in the latter portion part of the article.

  7. Robot-assisted laparoscopic surgery versus conventional laparoscopic surgery in randomized controlled trials: A systematic review and meta-analysis.

    Science.gov (United States)

    Roh, Hyunsuk Frank; Nam, Seung Hyuk; Kim, Jung Mogg

    2018-01-01

    This review provides a comprehensive comparison of treatment outcomes between robot-assisted laparoscopic surgery (RLS) and conventional laparoscopic surgery (CLS) based on randomly-controlled trials (RCTs). We employed RCTs to provide a systematic review that will enable the relevant community to weigh the effectiveness and efficacy of surgical robotics in controversial fields on surgical procedures both overall and on each individual surgical procedure. A search was conducted for RCTs in PubMed, EMBASE, and Cochrane databases from 1981 to 2016. Among a total of 1,517 articles, 27 clinical reports with a mean sample size of 65 patients per report (32.7 patients who underwent RLS and 32.5 who underwent CLS), met the inclusion criteria. CLS shows significant advantages in total operative time, net operative time, total complication rate, and operative cost (p < 0.05 in all cases), whereas the estimated blood loss was less in RLS (p < 0.05). As subgroup analyses, conversion rate on colectomy and length of hospital stay on hysterectomy statistically favors RLS (p < 0.05). Despite higher operative cost, RLS does not result in statistically better treatment outcomes, with the exception of lower estimated blood loss. Operative time and total complication rate are significantly more favorable with CLS.

  8. [Implementation of a department of plastic surgery in a university clinic for trauma surgery].

    Science.gov (United States)

    von Dercks, N; Fakler, J; Langer, S; Josten, C

    2014-11-01

    Since May 2012 plastic surgery for trauma patients at the University Hospital Leipzig is provided by an autonomous department. This study analyzed the effect of plastic surgery on the changes in diagnosis-related groups (DRG) at a clinic for trauma surgery. Within the first 2 years 37 patients (29 male and 8 female of which 38 were inpatient cases) were admitted to the clinic for trauma surgery and additionally received plastic surgery treatment. The appropriate DRG assignment as well as associated codes and revenues were recorded and compared with and without plastic surgery. A total of 261 operations were performed on these patients of which 71 were performed by the department of plastic surgery. The mean revenue was 22,156.44 EUR±20,578.22 EUR with a mean cost weighting of 7.2±6.7. Excluding plastic surgery treatment the mean revenue was 19,378.44 EUR±20,688.40 EUR and the mean cost weighting was 6.3±6.7. Thus, additional proceeds by the plastic surgery treatment were 2778.00 EUR±3857.01 EUR per case. The mean increase of the cost weighting was 0.9±1.3. A change of the DRG grouping occurred in 20 out of 38 cases treated. The mean length of stay (LoS) was 40.2±26.6 days. In the first year this was 17.9±22.4 days more than the mean national LoS of the appropriate DRG and 10.9±19.3 days in the second year. This means an average cost reduction of 4774.59 EUR per case. The implementation of a department for plastic surgery increased the revenues. Additional profits should be achieved by process enhancement and not by prolonged LoS.

  9. Clinical significance of computed tomography assessment for third molar surgery

    OpenAIRE

    Nakamori, Kenji; Tomihara, Kei; Noguchi, Makoto

    2014-01-01

    Surgical extraction of the third molar is the most commonly performed surgical procedure in the clinical practice of oral surgery. Third molar surgery is warranted when there is inadequate space for eruption, malpositioning, or risk for cyst or odontogenic tumor formation. Preoperative assessment should include a detailed morphologic analysis of the third molar and its relationship to adjacent structures and surrounding tissues. Due to developments in medical engineering technology, computed ...

  10. Glutamine dipeptide for parenteral nutrition in abdominal surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zheng, Ya-Min; Li, Fei; Zhang, Ming-Ming; Wu, Xiao-Ting

    2006-12-14

    To assess the clinical and economical validity of glutamine dipeptide supplemented to parenteral nutrition (PN) in patients undergoing abdominal surgery. A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. The trials compared the standard PN and PN supplemented with glutamine dipeptide in abdominal surgery. RCTs were identified from the following electronic databases: the Cochrane Library, MEDLINE, EMBASE and ISI web of knowledge (SCI). The search was undertaken in April 2006. Literature references were checked by computer or hand at the same time. Clinical trials were extracted and evaluated by two reviewers independently. Statistical analysis was performed by RevMan4.2 software from Cochrane Collaboration. A P value of nitrogen balance (weighted mean difference (WMD = 8.35, 95% CI [2.98, 13.71], P = 0.002), decreasing postoperative infectious morbidity (OR = 0.24, 95% CI [0.06, 0.93], P = 0.04), shortening the length of hospital stay (WMD= -3.55, 95% CI [-5.26, -1.84], P nitrogen balance in patients undergoing abdominal surgery. Further high quality trials in children and severe patients are required, and mortality and hospital cost should be considered in future RCTs with sufficient size and rigorous design.

  11. 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

  12. Extraocular muscle surgery for extorsion after macular translocation surgery new surgical technique and clinical management.

    Science.gov (United States)

    Holgado, Sandra; Enyedi, Laura B; Toth, Cynthia A; Freedman, Sharon F

    2006-01-01

    To report a new extraocular muscle surgery procedure for large-angle extorsion, and clinical management of subjective tilt and diplopia after full macular translocation (MT360). Consecutive retrospective case series. Seven patients with downward MT360 were evaluated after MT360, both before (preoperative) and after (postoperative) extraocular muscle surgery, with at least 6 months' follow-up. Information gathered included demographics, visual acuity, ocular motility, torsion by Maddox rod, ocular history, and symptoms of visual disturbance. Surgery on extraocular muscles was performed based on the magnitude of torsion measured after MT360 surgery. Maddox rod testing of torsion after MT360, and both preoperative and postoperative extraocular muscle surgery. Mean preoperative torsion was reduced from 45.4+/-11.3 degrees to 8.3+/-4.8 degrees (at 6 months after MT360) (P = 0.03). Extraocular muscle surgery slightly reduced the mean hypertropia of the operated eye (preoperative, 20+/-10 prism diopters [PD], vs. postoperative, 11+/-6 PD) (P = 0.06). Mean exotropia was affected minimally by extraocular muscle surgery (preoperative, 22+/-31 PD, vs. postoperative, 20+/-24 PD). Three patients required a second extraocular muscle surgery (performed on the fellow eye) to correct residual extorsion and diplopia. Overall, 85% (6/7) of patients were free of both diplopia and tilt after 1 or 2 extraocular muscle surgeries. Although our patients continued to have significant horizontal/vertical strabismus postoperatively, the extraocular muscle surgery performed was successful in reducing the torsional misalignment enough such that the remaining diplopia could be successfully ignored or suppressed.

  13. Randomized Clinical Trials on Deep Carious Lesions

    DEFF Research Database (Denmark)

    Bjørndal, Lars; Fransson, Helena; Bruun, Gitte

    2017-01-01

    Deep caries presents a dilemma in terms of which treatment that will render an optimal prognosis by maintaining pulp vitality with absence of apical pathology. Previously, 2 randomized clinical trials were performed testing the short-term effects of stepwise carious tissue removal versus nonselec......Deep caries presents a dilemma in terms of which treatment that will render an optimal prognosis by maintaining pulp vitality with absence of apical pathology. Previously, 2 randomized clinical trials were performed testing the short-term effects of stepwise carious tissue removal versus...... nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when...

  14. Surgery

    Science.gov (United States)

    ... and sterile gloves. Before the surgery begins, a time out is held during which the surgical team confirms ... the Consumer Version. DOCTORS: Click here for the Professional Version What Participants Need to Know About Clinical ...

  15. Clinical significance of computed tomography assessment for third molar surgery.

    Science.gov (United States)

    Nakamori, Kenji; Tomihara, Kei; Noguchi, Makoto

    2014-07-28

    Surgical extraction of the third molar is the most commonly performed surgical procedure in the clinical practice of oral surgery. Third molar surgery is warranted when there is inadequate space for eruption, malpositioning, or risk for cyst or odontogenic tumor formation. Preoperative assessment should include a detailed morphologic analysis of the third molar and its relationship to adjacent structures and surrounding tissues. Due to developments in medical engineering technology, computed tomography (CT) now plays a critical role in providing the clear images required for adequate assessment prior to third molar surgery. Removal of the maxillary third molar is associated with a risk for maxillary sinus perforation, whereas removal of the mandibular third molar can put patients at risk for a neurosensory deficit from damage to the lingual nerve or inferior alveolar nerve. Multiple factors, including demographic, anatomic, and treatment-related factors, influence the incidence of nerve injury during or following removal of the third molar. CT assessment of the third molar prior to surgery can identify some of these risk factors, such as the absence of cortication between the mandibular third molar and the inferior alveolar canal, prior to surgery to reduce the risk for nerve damage. This topic highlight presents an overview of the clinical significance of CT assessment in third molar surgery.

  16. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Luiz Eduardo Imbelloni

    Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

  17. Clinical governance, clinical audit, and the potential value of a database of equine colic surgery.

    Science.gov (United States)

    Mair, Tim

    2009-08-01

    "Clinical governance" is the term used to describe a systematic approach to maintaining and improving the quality of patient care within a health system. This article introduces the concept of clinical governance as a tool for improving the quality of care. It also discusses the potential value of a large database of colic surgery in implementing some of the components of clinical governance in the field of equine colic surgery.

  18. Day surgery for gynaecological laparoscopy: Clinical results from an RCT

    DEFF Research Database (Denmark)

    Gudex, Claire; Sørensen, Jan; Clausen, Ingo

    2006-01-01

    This randomized controlled trial compared the clinical outcome from inpatient and ambulatory laparoscopy for benign gynaecological conditions. While 658 consecutive patients were considered for inclusion into the study, data from 26 inpatients and 40 ambulatory cases were analysed. Inpatient surg...

  19. Expert opinion on laparoscopic surgery for colorectal cancer parallels evidence from a cumulative meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Guillaume Martel

    Full Text Available This study sought to synthesize survival outcomes from trials of laparoscopic and open colorectal cancer surgery, and to determine whether expert acceptance of this technology in the literature has parallel cumulative survival evidence.A systematic review of randomized trials was conducted. The primary outcome was survival, and meta-analysis of time-to-event data was conducted. Expert opinion in the literature (published reviews, guidelines, and textbook chapters on the acceptability of laparoscopic colorectal cancer was graded using a 7-point scale. Pooled survival data were correlated in time with accumulating expert opinion scores.A total of 5,800 citations were screened. Of these, 39 publications pertaining to 23 individual trials were retained. As well, 414 reviews were included (28 guidelines, 30 textbook chapters, 20 systematic reviews, 336 narrative reviews. In total, 5,782 patients were randomized to laparoscopic (n = 3,031 and open (n = 2,751 colorectal surgery. Survival data were presented in 16 publications. Laparoscopic surgery was not inferior to open surgery in terms of overall survival (HR = 0.94, 95% CI 0.80, 1.09. Expert opinion in the literature pertaining to the oncologic acceptability of laparoscopic surgery for colon cancer correlated most closely with the publication of large RCTs in 2002-2004. Although increasingly accepted since 2006, laparoscopic surgery for rectal cancer remained controversial.Laparoscopic surgery for colon cancer is non-inferior to open surgery in terms of overall survival, and has been so since 2004. The majority expert opinion in the literature has considered these two techniques to be equivalent since 2002-2004. Laparoscopic surgery for rectal cancer has been increasingly accepted since 2006, but remains controversial. Knowledge translation efforts in this field appear to have paralleled the accumulation of clinical trial evidence.

  20. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  1. 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.

  2. A randomized controlled trial evaluating early versus traditional oral feeding after colorectal surgery

    Directory of Open Access Journals (Sweden)

    Ahmet Dag

    2011-01-01

    Full Text Available OBJECTIVE: This prospective randomized clinical study was conducted to evaluate the safety and tolerability of early oral feeding after colorectal operations. METHODS: A total of 199 patients underwent colorectal surgery and were randomly assigned to early feeding (n = 99 or a regular diet (n = 100. Patients’ characteristics, diagnoses, surgical procedures, comorbidity, bowel movements, defecation, nasogastric tube reinsertion, time of tolerance of solid diet, complications, and length of hospitalization were assessed. RESULTS: The two groups were similar in terms of gender, age, diagnosis, surgical procedures, and comorbidity. In the early feeding group, 85.9% of patients tolerated the early feeding schedule. Bowel movements (1.7±0.89 vs. 3.27±1.3, defecation (3.4±0.77 vs. 4.38±1.18 and time of tolerance of solid diet (2.48±0.85 vs. 4.77±1.81 were significantly earlier in the early feeding group. There was no change between the groups in terms of nasogastric tube reinsertion, overall complication or anastomotic leakage. Hospitalization (5.55±2.35 vs. 9.0±6.5 was shorter in the early feeding group. CONCLUSIONS: The present study indicated that early oral feeding after elective colorectal surgery was not only well tolerated by patients but also affected the postoperative outcomes positively. Early postoperative feeding is safe and leads to the early recovery of gastrointestinal functions.

  3. Periodontal regeneration compared with access flap surgery in human intra-bony defects 20-year follow-up of a randomized clinical trial: tooth retention, periodontitis recurrence and costs.

    Science.gov (United States)

    Cortellini, Pierpaolo; Buti, Jacopo; Pini Prato, Giovanpaolo; Tonetti, Maurizio S

    2017-01-01

    Compare the long-term outcomes and costs of three treatment modalities in intra-bony defects. Forty-five intra-bony defects in 45 patients had been randomly allocated to receive: modified papilla preservation technique with titanium-reinforced expanded-polytetrafluoroethylene (ePTFE) membranes (MPPT Tit, N = 15); access flap with expanded-PTFE membranes (Flap-ePTFE, N = 15) and access flap alone (Flap, N = 15). Supportive periodontal care (SPC) was provided monthly for 1 year, then every 3 months for 20 years. Periodontal therapy was delivered to sites showing recurrences. Forty-one patients complied with SPC. Four subjects were lost to follow-up. Clinical attachment-level differences between 1 and 20 years were -0.1 ± 0.3 mm (p = 0.58) in the MPPT Tit; -0.5 ± 0.1 mm (p = 0.003) in the Flap-ePTFE and -1.7 ± 0.4 mm (p MPPT Tit (1.4 ± 0.4 mm; p = 0.008) and to Flap-ePTFE (1.1 ± 0.4 mm; p = 0.03). Flap group lost two treated teeth. Five episodes of recurrences occurred in the MPPT Tit, six in the Flap-ePTFE and fifteen in the Flap group. Residual pocket depth at 1-year was significantly correlated with the number of recurrences (p = 0.002). Sites treated with flap had greater OR for recurrences and higher costs of re-intervention than regenerated sites over a 20-year follow-up period with SPC. Regeneration provided better long-term benefits than Flap: no tooth loss, less periodontitis progression and less expense from re-intervention over a 20-year period. These benefits need to be interpreted in the context of higher immediate costs associated with regenerative treatment. These initial observations need to be extended to larger groups and broader clinical settings. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Benign prostatic hyperplasia: clinical treatment can complicate cataract surgery

    Directory of Open Access Journals (Sweden)

    Fernando Facio

    2010-10-01

    Full Text Available PURPOSE: To investigate the effects of alpha-1 adrenergic receptor antagonists for the treatment of benign prostatic hyperplasia (BPH regarding potential risks of complications in the setting of cataract surgery. AIM: To address recommendations, optimal control therapy, voiding symptoms and safety within the setting of cataract surgery. MATERIALS AND METHODS: A comprehensive literature review was performed using MEDLINE with MeSH terms and keywords "benign prostatic hyperplasia", "intraoperative floppy iris syndrome", "adrenergic alpha-antagonist" and "cataract surgery". In addition, reference lists from identified publications were reviewed to identify reports and studies of interest from 2001 to 2009. RESULTS: The first report of intraoperative floppy iris syndrome (IFIS was observed during cataract surgery in patients taking systemic alpha-1 AR antagonists in 2005. It has been most commonly seen related to use of tamsulosin. Changes of medication and washout periods of up to 2 weeks have been attempted to reduce the risk of complications in the setting of cataract surgery. CONCLUSION: Patients under clinical treatment for BPH should be informed about potential risks of this drug class so that it can be discuss with their healthcare providers, in particular urologist and ophthalmologist, prior to cataract surgery.

  5. The effects of different doses of intrathecal meperidine on the incidence and severity of shivering during lower extremity orthopedic surgery under spinal anesthesia: A randomized, placebo-controlled, double blind-clinical trial

    Directory of Open Access Journals (Sweden)

    Azim Honarmand

    2015-01-01

    Conclusions: Using higher dosage of intrathecal meperidine (0.3 mg/kg was more effective than using lower dosage of meperidine (0.1 mg/kg and 0.2 mg/kg in reducing the incidence and severity of shivering during spinal anesthesia in lower extremity orthopedic surgeries.

  6. 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.

  7. Biochemical consequences of bariatric surgery for extreme clinical obesity.

    Science.gov (United States)

    Sarker, Anita; Meek, Claire L; Park, Adrian

    2016-01-01

    Obesity, defined as a body mass index over 30 kg/m(2) for adults, poses a major healthcare challenge with important economic, personal and social consequences. Although public health measures, lifestyle change and pharmacological therapies have an important role in the management of obesity, patients with established morbid obesity (body mass index over 40 kg/m(2)) may also require bariatric surgery. Bariatric or metabolic surgery is associated with effective and enduring weight loss but is also known to improve glucose homeostasis, blood pressure and dyslipidaemia. Patients who have bariatric surgery need lifelong clinical follow-up to identify and prevent nutritional deficiencies and other complications. Clinical biochemistry laboratories have an important role in the nutritional assessment of obese patients and in the identification of complications following bariatric surgery. The aim of this article is to review the different bariatric procedures available and to summarize their complications, especially nutrient deficiencies and those of particular relevance to clinical biochemistry laboratories. © The Author(s) 2015.

  8. 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.

  9. The effect of impregnated autogenous epidural adipose tissue with bupivacaine, methylprednisolone acetate or normal saline on postoperative radicular and low back pain in lumbar disc surgery under spinal anesthesia; A randomized clinical trial study FNx01

    Directory of Open Access Journals (Sweden)

    Saeid Abrishamkar

    2011-01-01

    Full Text Available Background: Low Back Pain (LBP and radicular leg pain (RLP after lumbar disc surgery are great challenges that prevent patients and neurosurgeons in making a surgical decision. By spinal anesthesia, LBP and RLP diminish up to 2 to 3 hours postoperatively. The aim of this study was to determine the effect of impregnated epidural adipose tissue (EAT with bupivacaine or methylprednisolone acetate on reduction of late postoperative pain after spinal anesthesia. Methods: This study was performed on lumbar disc herniation surgery under spinal anesthesia. Sixty six patients entered our study who were divided into three groups, EAT impregnated with bupivacaine (group 1, methylprednisolone acetate (group2 and normal saline (control group. The LBP and RLP were evaluated during the first 24 hours postoperatively and 14 days later by visual analogue scale (VAS. Results: Of 66 patients, 53% were female and 47% male. The average (SE LBP in the first 6 hours after surgery based on VAS were 1.59 ± 0.90 in group one, 2.36 ± 2.38 in group 2 and 3.09 ± 1.41 in control group but the VAS for RLP in this period were 1.95 ± 1.13, 1.31 ± 1.39 and 2.40 ± 1.09, respectively. The average LBP and RLP did not show any differences after 14 days postoperatively. Conclusions: According to our data bupivacaine was effective on LBP relief and steroid was effective on RLP relief during the first 12 hours after surgery.

  10. Clinical applications of gamma-detection probes - radioguided surgery

    International Nuclear Information System (INIS)

    Schneebaum, S.; Stadler, J.; Skornick, Y.

    1999-01-01

    Radioguided surgery (RGS) is a surgical technique that enables the surgeon to identify tissue ''marked'' by a radionuclide before surgery, based on the tissue characteristics, the radioactive tracer and its carrying molecule, or the affinity of both. Thus, yet another tool has been added to the inspection and palpation traditionally used by the surgeon. Current clinical applications of radioguided surgery are: radioimmunoguided surgery (RIGS) for colon cancer, sentinel-node mapping for malignant melanoma (which has become state-of-the-art), sentinel-node mapping for breast, vulvar and penile cancer, and detection of parathyroid adenoma and bone tumour (such as osteid osteoma). Although the same gamma-detecting probe (GDP) may be used for all these applications, the carrier substance and the radionuclide differ. MoAb and peptides are used for RIGS, sulphur colloid for sentinel-node mapping, iodine-125 for RIGS, technetium-99m for sentinel node, parathyroid and bone. The mode of injection also differs, but there are some common principles of gamma-guided surgery. RIGS enables the surgeon to corroborate tumour existence, find occult metastases, and assess the margins of resection; this may result in a change on the surgical plan. Sentinel lymph-node (SLN) scintigraphy for melanoma guides the surgeon to find the involved lymph nodes for lymph-node dissection. SLN for breast cancer is being investigated with promising results. This procedure has also changed the outlook of lymph-node pathology by giving the pathologist designated tissue samples for more comprehensive examination. Gamma-guided surgery will result in more accurate and less unnecessary surgery, better pathology and, hopefully, in better patient survival. (orig.)

  11. Vibration for Pain Reduction in a Plastic Surgery Clinic.

    Science.gov (United States)

    Eichhorn, Mitchell George; Karadsheh, Murad Jehad; Krebiehl, Johanna Ruth; Ford, Dawn Marie; Ford, Ronald D

    2016-01-01

    Patients can experience significant pain during routine procedures in the plastic surgery clinic. Methods for clinical pain reduction are often impractical, time-consuming, or ineffective. Vibration is a safe, inexpensive, and highly applicable modality for pain reduction that can be readily utilized for a wide variety of procedures. This study evaluated the use of vibration as a viable pain-reduction strategy in the clinical plastic surgery setting. Patients requiring at least 2 consecutive procedures that are considered painful were enrolled in the study. These included injections, staple removal, and suture removal. In the same patient, one half of the procedures were performed without vibration and the other half with vibration. After completing the procedures, the patients rated their pain with vibration and without vibration. The patient and the researcher also described the experience with a short questionnaire. Twenty-eight patients were enrolled in the study. Patients reported significantly less pain on the Numeric Rating Scale pain scale when vibration was used compared with the control group (p reduction. It significantly reduces the pain experienced by patients during minor office procedures. Given its practicality and ease of use, it is a welcome tool in the plastic surgery clinic.

  12. Bioelectrical impedance analyzes offers clinically relevant appraisal of body composition, but fails to recognize nutritional risk or differences between surgery and percutaneous coronary interventions treatments--a non-randomized cohort.

    Science.gov (United States)

    Boban, Marko; Peršić, Viktor; Zulj, Marinko; Petricević, Mate; Kramarić, Ruzica Palić; Vcev, Aleksandar

    2014-09-01

    Our aim was to evaluate the adipose tissue percentage content appraised with BIA in patients recently treated for cardiovascular disorders by means of surgery or percutaneous coronary interventions. Study included 208 consecutive patients, in age range 25-84 years, 176 male and 32 female. There were 108 (51.9%) percutaneous coronary interventions and 100 (48.1%) operations. Adipose tissue share appraised by BIA in our settings was 28.6-6.7% with significant differences in relation with gender (pobesity (AUC=0.761; pimpedance analyze bases seem limited, particularly in investigational settings with composited endpoints.

  13. [Clinical research status of laparoscopic gastric cancer surgery in China, Japan and South Korea].

    Science.gov (United States)

    Li, Guoxin; Chen, Xinhua; Yu, Jiang; Liu, Hao

    2018-02-25

    Laparoscopic surgery has its unique minimally invasive advantages, however, taking the complex and difficult D2 lymph node dissection for advanced gastric cancer into consideration, laparoscopic gastrectomy was only applied in the treatment of early gastric cancer at its preliminary stage. With the development of more than a decade, many multicenter clinical data have confirmed the safety, feasibility and effectiveness of laparoscopic radical gastrectomy for early gastric cancer. Based on high-quality evidence-based medicine evidence, laparoscopic gastrectomy has been recommended as an optional treatment for stage I( gastric cancer by the Japanese Gastric Cancer Treatment Guidelines 2014(ver.4). However, the safety and effectiveness of laparoscopic gastrectomy for advanced gastric cancer remains controversial due to the lack of high-level evidence-based clinical evidence. Currently, China, Japan and South Korea are trying to clarify its safety and effectiveness by conducting well-designed multicenter prospective randomized controlled trials. To date, CLASS-01 trial in China, whose secondary endpoint indicated that laparoscopic gastrectomy with D2 lymphadenectomy for advanced gastric cancer can be safely performed by experienced surgeons, has provided the highest level evidence for the controversy in the world. At ASCO 2016, the safety reports from Korea's KLASS-02 trial also presented the similar conclusion. The long-term oncologic outcomes of the both researches were particularly promising. Retrospecting the whole development of gastric cancer surgery, it is not difficult to find that its mainstream direction is gradually shifted from "extended and standardized surgical resection" to "individual and precise surgery" for the safety and postoperative quality of life. The new concept of minimally invasive surgery built on laparoscopic surgery emphasizes more than shortening the surgical incision, but minimizing tissue trauma and maximizing functional preservation. On

  14. Predictors of clinical outcome following lumbar disc surgery

    DEFF Research Database (Denmark)

    Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.

    2016-01-01

    abnormality or pain peripheralization. Preoperative pain peripheralization remained a significant predictor of improved disability (p = 0.04) and LBP (p = 0.02) after accounting for information from the clinical history. Preoperative lumbar multifidus function was not associated with clinical outcome......PURPOSE: Explore the relationships between preoperative findings and clinical outcome following lumbar disc surgery, and investigate the prognostic value of physical examination findings after accounting for information acquired from the clinical history. METHODS: We recruited 55 adult patients...... scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability...

  15. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  16. Day-case stapes surgery: Day-case versus inpatient stapes surgery for otosclerosis: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Laura S. M. Derks

    2016-02-01

    Full Text Available Abstract Background Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-case procedure. The major drive towards day-case surgery has been out of economic considerations. However, it is also increasingly an explicit patient request and leads to shorter waiting times for surgery, a reduced risk of infection and most likely positively influences the patient’s quality of life as a result of rapid discharge and rehabilitation. Even though stapes surgery seems well suited to a day-case approach, given the low complication rates and early recovery, evidence is scarce and of low quality. Methods and design A single-center unblinded randomized controlled trial was designed to (primarily investigate the effect of hearing outcomes of day-case stapes surgery compared to inpatient stapes surgery and (secondarily investigate the effect of both methods on quality of life, tinnitus, vertigo and cost-effectiveness. One hundred and twelve adult otosclerosis patients who are eligible for stapes surgery will be randomly assigned to either the day-case or inpatient treatment group. The primary and secondary outcome measures will be assessed using pure-tone audiometry (at approximately 2 months and 1 year follow-up, questionnaires (at 3 months and 1 year follow-up and costs diaries (weekly the first month after which once a month until 1 year follow-up. Discussion/conclusion This trial allows for a comparison between day-case and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher quality of life and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery. Trial registration Netherlands Trial Register ( www

  17. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Daniela Francescato Veiga

    Full Text Available The evidence to support dressing standards for breast surgery wounds is empiric and scarce.This two-arm randomized clinical trial was designed to assess the effect of dressing wear time on surgical site infection (SSI rates, skin colonization and patient perceptions.A total of 200 breast cancer patients undergoing breast reconstruction were prospectively enrolled. Patients were randomly allocated to group I (dressing removed on the first postoperative day, n = 100 or group II (dressing removed on the sixth postoperative day, n = 100. SSIs were defined and classified according to criteria from the Centers for Disease Control and Prevention. Samples collected before placing the dressing and after 1 day (group I and 6 days (both groups were cultured for skin colonization assessments. Patients preferences and perceptions with regard to safety, comfort and convenience were recorded and analyzed.A total of 186 patients completed the follow-up. The global SSI rate was 4.5%. Six patients in group I and three in group II had SSI (p = 0.497. Before dressing, the groups were similar with regard to skin colonization. At the sixth day, there was a higher colonization by coagulase-negative staphylococci in group I (p<0.0001. Patients preferred to keep dressing for six days (p<0.0001, and considered this a safer choice (p<0.05.Despite group I had a higher skin colonization by coagulase-negative staphylococci on the sixth postoperative day, there was no difference in SSI rates. Patients preferred keeping dressing for six days and considered it a safer choice.ClinicalTrials.gov NCT01148823.

  18. [The clinical application of functional endoscopic sinus surgery and conventional technique in sinus surgery].

    Science.gov (United States)

    Zhang, X; Wang, Z; Wang, N

    1998-12-01

    To properly understand the basic theory and the clinical application of the functional endoscopic sinus surgery and the traditional technique. The indications, extend of excision, operative approach, complication and curative effect of 1,740 cases(3,140 sides) done in the China-Japan Friendship Hospital and Jining Jiaotong Hospital were analysed. Among them, 522 cases(1,032 sides, 30%) received the traditional technique for sinusitis; 1,218 cases(2,108 sides, 70%) received functional endoscopic sinus surgery. Three hundred and ninety-eight cases of traditional ethmoid sinus operation and 352 of functional sinus surgeries were followed-up and their cure rates were 80% and 93% respectively. Both groups had no serious complications. The main indications of functional sinus surgery are infectious nasal sinus diseases or meatus nasi lesion that may interfere with the drainage. Such kinds of diseases have high morbidity than the diffused polyposis and deserves attention. Traditional operations for frontal and maxillary sinusitis should be controlled appropriately, but the traditional sphenoid sinus operation is still an effective treatment for the diffused polyposis.

  19. Humidification during laparoscopic surgery: overview of the clinical benefits of using humidified gas during laparoscopic surgery.

    Science.gov (United States)

    Binda, Maria Mercedes

    2015-11-01

    The peritoneum is the serous membrane that covers the abdominal cavity and most of the intra-abdominal organs. It is a very delicate layer highly susceptible to damage and it is not designed to cope with variable conditions such as the dry and cold carbon dioxide (CO2) during laparoscopic surgery. The aim of this review was to evaluate the effects caused by insufflating dry and cold gas into the abdominal cavity after laparoscopic surgery. A literature search using the Pubmed was carried out. Articles identified focused on the key issues of laparoscopy, peritoneum, morphology, pneumoperitoneum, humidity, body temperature, pain, recovery time, post-operative adhesions and lens fogging. Insufflating dry and cold CO2 into the abdomen causes peritoneal damage, post-operative pain, hypothermia and post-operative adhesions. Using humidified and warm gas prevents pain after surgery. With regard to hypothermia due to desiccation, it can be fully prevented using humidified and warm gas. Results relating to the patient recovery are still controversial. The use of humidified and warm insufflation gas offers a significant clinical benefit to the patient, creating a more physiologic peritoneal environment and reducing the post-operative pain and hypothermia. In animal models, although humidified and warm gas reduces post-operative adhesions, humidified gas at 32 °C reduced them even more. It is clear that humidified gas should be used during laparoscopic surgery; however, a question remains unanswered: to achieve even greater clinical benefit to the patient, at what temperature should the humidified gas be when insufflated into the abdomen? More clinical trials should be performed to resolve this query.

  20. 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

  1. 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

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

    Science.gov (United States)

    Lee, Li-Ang; Yu, Jen-Fang; Lo, Yu-Lun; Chen, Ning-Hung; Fang, Tuan-Jen; Huang, Chung-Guei; Cheng, Wen-Nuan; Li, Hsueh-Yu

    2014-01-01

    Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map), were also investigated at the same time. Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60) rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021). The maximal loudness of low-frequency (40-300 Hz) snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect on most measures of subjective and objective snoring. Multi

  3. Clinical implications of medulloblastoma subgroups: incidence of CSF diversion surgery.

    Science.gov (United States)

    Schneider, Christian; Ramaswamy, Vijay; Kulkarni, Abhaya V; Rutka, James T; Remke, Marc; Tabori, Uri; Hawkins, Cynthia; Bouffet, Eric; Taylor, Michael D

    2015-03-01

    While medulloblastoma was initially thought to comprise a single homogeneous entity, it is now accepted that it in fact comprises 4 discrete subgroups, each with its own distinct demographics, clinical presentation, transcriptomics, genetics, and outcome. Hydrocephalus is a common complication of medulloblastoma and not infrequently requires CSF diversion. The authors report the incidence of CSF diversion surgery in each of the subgroups of medulloblastoma (Wnt, Shh, Group 3, and Group 4). The medical and imaging records for patients who underwent surgery for medulloblastoma at The Hospital for Sick Children were retrospectively reviewed. The primary outcome was the requirement for CSF diversion surgery either before or within 60 days of tumor resection. The modified Canadian Preoperative Prediction Rule for Hydrocephalus (mCPPRH) was compared among subgroups. Of 143 medulloblastoma patients, treated from 1991 to 2013, sufficient data were available for 130 patients (15 with Wnt, 30 with Shh, 30 with Group 3, and 55 with Group 4 medulloblastomas). Of these, 28 patients (22%) ultimately underwent CSF diversion surgery: 0% with Wnt, 29% with Shh, 29% with Group 3, and 43% with Group 4 tumors. Patients in the Wnt subgroup had a lower incidence of CSF diversion than all other patients combined (p = 0.04). Wnt patients had a lower mCPPRH score (lower risk of CSF diversion, p = 0.045), were older, had smaller ventricles at diagnosis, and had no leptomeningeal metastases. The overall rate of CSF diversion surgery for Shh, Group 3, and Group 4 medulloblastomas is around 30%, but no patients in the present series with a Wnt medulloblastoma required shunting. The low incidence of hydrocephalus in patients with Wnt medulloblastoma likely reflects both host factors (age) and disease factors (lack of metastases). The absence of hydrocephalus in patients with Wnt medulloblastomas likely contributes to their excellent rate of survival and may also contribute to a higher quality

  4. Progress in clinical research in surgery and IDEAL.

    Science.gov (United States)

    McCulloch, Peter; Feinberg, Joshua; Philippou, Yiannis; Kolias, Angelos; Kehoe, Sean; Lancaster, Gillian; Donovan, Jenny; Petrinic, Tatjana; Agha, Riaz; Pennell, Christopher

    2018-01-17

    The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations specify desirable qualities for surgical studies, and outline an integrated evaluation pathway for surgery, and similar complex interventions. We used the IDEAL Recommendations to assess methodological progress in surgical research over time, assessed the uptake and influence of IDEAL, and identified the challenges to further methodological progress. Comparing studies from the periods 2000-04 and 2010-14, we noted apparent improvement in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves, but no progress in the use of qualitative research or reporting of modifications during procedure development. Better education about research, integration of rigorous evaluation into routine practice and training, and linkage of such work to awards systems could foster further improvements in surgical evidence. IDEAL has probably contributed only slightly to the improvements described to date, but its uptake is accelerating rapidly. The need for the integrated evaluation template IDEAL offers for surgery and other complex treatments is becoming more widely accepted. Copyright © 2018 Elsevier Ltd. All rights reserved.

  5. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery

    DEFF Research Database (Denmark)

    Bulut, O; Aslak, K K; Levic, K

    2015-01-01

    BACKGROUND: Potential benefits of single-port laparoscopic surgery may include improved cosmetic results, less postoperative pain, surgical trauma and faster recovery. Results of randomized prospective studies with a focus on single-port rectal surgery have not yet been presented. The aim...... of the present study was to compare single-port and conventional laparoscopic surgery for rectal cancer in terms of short-term outcomes including postoperative pain and trauma-induced changes in certain bioactive substances. METHODS: Patients with non-metastasized rectal cancer were prospectively randomized...... to single-port (n = 20) or conventional laparoscopic rectal surgery (n = 20). Postoperative pain was assessed at rest, at coughing and during mobilization, with a numeric pain ranking score and was recorded at 6 h after the operation and subsequently every morning daily for 4 days. Levels of C...

  6. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious

  7. Warming and humidification of insufflation carbon dioxide in laparoscopic colonic surgery: a double-blinded randomized controlled trial.

    Science.gov (United States)

    Sammour, Tarik; Kahokehr, Arman; Hayes, Julian; Hulme-Moir, Mike; Hill, Andrew G

    2010-06-01

    We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced postoperative pain and improved recovery by reducing peritoneal inflammation in laparoscopic colonic surgery. Warming and humidification of insufflation gas is thought be beneficial in laparoscopic surgery, but evidence in prolonged laparoscopic procedures is lacking. We used a multicenter, double-blinded, randomized controlled design. The Study Group received warmed (37 degrees C), humidified (98% RH) insufflation carbon dioxide, and the Control Group received standard gas (19 degrees C, 0% RH). Anesthesia and analgesia were standardized. Intraoperative oesophageal temperature was measured at 15 minutes intervals. At the conclusion of surgery, the primary surgeon was asked to rate camera fogging on a Likert scale. Postoperative opiate usage was determined using Morphine Equivalent Daily Dose (MEDD), and pain was measured using visual analogue scores. Peritoneal and plasma cytokine concentrations were measured at 20 hours postoperatively. Postoperative recovery was measured using defined discharge and complication criteria, and the Surgical Recovery Score. Eighty-two patients were randomized, with 41 in each arm. Groups were well matched at baseline. Intraoperative core temperature was similar in both groups. Median camera fogging score was significantly worse in the Study group (4 vs. 2, P = 0.040). There were marginal differences in pain scores, but no significant differences were detected in MEDD usage, cytokine concentrations, or any recovery parameters measured. Warming and humidification of insufflation CO2 does not attenuate the early inflammatory cytokine response, and confers no clinically significant benefit in laparoscopic colonic surgery.

  8. 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.

  9. 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®

  10. Causes of Ocular Surgery Cancellation and the Need of Anesthesia Preoperative Medicine Clinic (APMC)

    International Nuclear Information System (INIS)

    Shaikh, Rehan Moinuddin; Al-Yafi, A.; Malak, M.

    2007-01-01

    Objective was to evaluate the causes of cancellation rate of elective ocular surgeries in our tertiary care center and to analyze the need of Anesthesia Preoperative Medicine Clinic (APMC). We conducted a prospective study from January 21, 2006 till 30 June, 2006 at King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia. The selected patients for the surgery have gone through pre operative investigations including CBC, Random blood sugar, coagulation profile, renal function tests, urea and electrolytes, IOL calculation and their medical condition assessment for the chronic disease. Study was conducted on 240 patients from whom 180 were adults and 60 were pediatrics. Out of 240 patients, 45 patients were cancelled in which 40 were adults and 5 were pediatric patients. In 45 patients 23 were male and 22 were female having a ratio of 1:1. Age was ranging from one year to 60+ an average of 58 years. Surgeries include was anterior segment, pediatric, retinal and oculoplastic. All these patients 45/240 were postponed at a percentage of 19%. The causes of cancellation were, improper control of diabetes, poor control of hypertension, cardiac problem, chest infection or influenza in children, overburden list and miscellaneous. All these patients were cancelled by anesthesia (28 patients), by surgeon (9 patients) and medical team (8 patients) in the ward as the patients were at high risk for the surgeries. So the reason in maximum patient was lack of anesthesia preoperative medicine clinic. The number of cancellation of ocular surgery can be minimized by proper assessment of the patient at anesthesia pre-operative medicine clinic (APMC). (author)

  11. Acupuncture for acute postoperative pain after back surgery: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Cho, Young-Hun; Kim, Chang-Kyu; Heo, Kwang-Ho; Lee, Myeong Soo; Ha, In-Hyuk; Son, Dong Wuk; Choi, Byung Kwan; Song, Geun-Sung; Shin, Byung-Cheul

    2015-03-01

    Acupuncture is commonly used as a complimentary treatment for pain management. However, there has been no systematic review summarizing the current evidence concerning the effectiveness of acupuncture for acute postoperative pain after back surgery. This systematic review aimed at evaluating the effectiveness of acupuncture treatment for acute postoperative pain (≤1 week) after back surgery. We searched 15 electronic databases without language restrictions. Two reviewers independently assessed studies for eligibility and extracted data, outcomes, and risk of bias. Random effect meta-analyses and subgroup analyses were performed. Five trials, including 3 of high quality, met our inclusion criteria. The meta-analysis showed positive results for acupuncture treatment of pain after surgery in terms of the visual analogue scale (VAS) for pain intensity 24 hours after surgery, when compared to sham acupuncture (standard mean difference -0.67 (-1.04 to -0.31), P = 0.0003), whereas the other meta-analysis did not show a positive effect of acupuncture on 24-hour opiate demands when compared to sham acupuncture (standard mean difference -0.23 (-0.58 to 0.13), P = 0.21). Our systematic review finds encouraging but limited evidence for the effectiveness of acupuncture treatment for acute postoperative pain after back surgery. Further rigorously designed clinical trials are required. © 2014 The Authors. Pain Practice published by Wiley periodicals, Inc. on behalf of World Institute of Pain.

  12. Routine clinical application of virtual reality in abdominal surgery.

    Science.gov (United States)

    Sampogna, Gianluca; Pugliese, Raffaele; Elli, Marco; Vanzulli, Angelo; Forgione, Antonello

    2017-06-01

    The advantages of 3D reconstruction, immersive virtual reality (VR) and 3D printing in abdominal surgery have been enunciated for many years, but still today their application in routine clinical practice is almost nil. We investigate their feasibility, user appreciation and clinical impact. Fifteen patients undergoing pancreatic, hepatic or renal surgery were studied realizing a 3D reconstruction of target anatomy. Then, an immersive VR environment was developed to import 3D models, and some details of the 3D scene were printed. All the phases of our workflow employed open-source software and low-cost hardware, easily implementable by other surgical services. A qualitative evaluation of the three approaches was performed by 20 surgeons, who filled in a specific questionnaire regarding a clinical case for each organ considered. Preoperative surgical planning and intraoperative guidance was feasible for all patients included in the study. The vast majority of surgeons interviewed scored their quality and usefulness as very good. Despite extra time, costs and efforts necessary to implement these systems, the benefits shown by the analysis of questionnaires recommend to invest more resources to train physicians to adopt these technologies routinely, even if further and larger studies are still mandatory.

  13. Progressive Surgical Autonomy in a Plastic Surgery Resident Clinic

    Science.gov (United States)

    Scott, Jillian K.; Gao, Lani; Lee, Tara M.; Waldrop, Jimmy L.; Sargent, Larry A.; Kennedy, J. Woody; Rehm, Jason P.; Brzezienski, Mark A.

    2017-01-01

    Background: Resident clinics are thought to catalyze educational milestone achievement through opportunities for progressively autonomous surgical care, but studies are lacking for general plastic surgery resident clinics (PSRCs). We demonstrate the achievement of increased surgical autonomy and continuity of care in a PSRC. Methods: A retrospective review of all patients seen in a PSRC from October 1, 2010, to October 1, 2015, was conducted. Our PSRC is supervised by faculty plastic surgery attendings, though primarily run by chief residents in an accredited independent plastic surgery training program. Surgical autonomy was scored on a 5-point scale based on dictated operative reports. Graduated chief residents were additionally surveyed by anonymous online survey. Results: Thousand one hundred forty-four patients were seen in 3,390 clinic visits. Six hundred fifty-three operations were performed by 23 total residents, including 10 graduating chiefs. Senior resident autonomy averaged 3.5/5 (SD = 1.5), 3.6/5 (SD = 1.5), to 3.8/5 (SD = 1.3) in postgraduate years 6, 7, and 8, respectively. A linear mixed model analysis demonstrated that training level had a significant impact on operative autonomy when comparing postgraduate years 6 and 8 (P = 0.026). Graduated residents’ survey responses (N = 10; 100% response rate) regarded PSRC as valuable for surgical experience (4.1/5), operative autonomy (4.4/5), medical knowledge development (4.7/5), and the practice of Accreditation Council of Graduate Medical Education core competencies (4.3/5). Preoperative or postoperative continuity of care was maintained in 93.5% of cases. Conclusion: The achievement of progressive surgical autonomy may be demonstrated within a PSRC model. PMID:28607848

  14. 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.

  15. "Hardware breakage in spine surgery (A retrospective clinical study "

    Directory of Open Access Journals (Sweden)

    "Sadat MM

    2001-11-01

    Full Text Available This was a retrospective review of a consecutive series of patients with spinal disease in year 2000, who underwent posterior fusion and instrumentation with Harrington distraction and Cotrel-Dobousset system to evaluate causes of hardware failure. Many cases of clinical failure has been observed in spinal instrumentation used in spinal disorder like spondylolisthesis, fractures, deformities, … . Thirty six cases that were operated because of spinal disorders like spondylolisthesis, fractures, deformities, …, were included in this study. Seventeen of this cases had breakage of device. Factors like age at surgery, type of instrumentation, angles before and after surgery and …, were compared in two groups of patients. The most common instrument breakage was pedicle screw breakage. Pseudoarthrosis was the main factor that was presented in failure group (P value<0.001. Other important causes were, age of patient at surgery (P value=0.04, pedicle screw placement off center in the sagittal or coronal plane of the pedicle (P value=0.04. Instrumentation loads increased significantly as a direct result of variations in surgical technique that produce pseudoarthrosis, pedicle screw placement off center in the sagittal plane of the pedicle, or using less than 6 mm diameter screw. This factor can be prevented with meticulous surgical technique and using proper devices.

  16. Comparison of propofol (1%) with admixture (1:1) of thiopentone (1.25%) and propofol (0.5%) for laryngeal mask airway insertion in children undergoing elective eye surgery: Double-masked randomized clinical trial.

    Science.gov (United States)

    Sinha, Renu; Shende, Dilip; Garg, Rakesh

    2010-03-01

    Intravenous propofol 1% has been the preferred agent for Laryngeal Mask Airway (LMA) insertion. Admixture of thiopentone 1.25% and propofol 0.5% (1:1) has been used by various authors for induction as well as insertion of LMA in adults. There is no previous report where this admixture has been used for insertion of LMA in children. This study has been designed to investigate whether this admixture can be a suitable alternative to propofol, in relation to ease of insertion of the LMA, haemodynamic stability, cost containment, pain on injection and recovery in children. In this randomized, double-masked study, 50 ASA grade 1 and 2 patients of age 3 - 15 years and weighing more than 10 kg were included. The patients were divided into two groups; the P group received propofol 1%, while the Ad group received an admixture of thiopentone 1.25% and propofol 0.5% (1:1). All the children were evaluated for incidence of apnoea, pain on injection, jaw relaxation, ease of LMA insertion, coughing, gagging, laryngospasm, involuntary limb movements, incidence of hypotension and recovery. The demographic data, incidence of apnoea, pain on injection, jaw relaxation, ease of LMA insertion, coughing, gagging and involuntary movements were comparable in both groups. In the P group recovery was faster as compared to the Ad group. The admixture was cost effective as compared to Propofol alone [Indian National Rupees (INR) 24.64 +/- 7.62 vs. INR 48.75 +/- 23.25] (P = 0.001)). Admixture of propofol and thiopentone was a cheap, safe and effective alternative to propofol alone, for LMA insertion in children.

  17. Comparison of propofol (1% with admixture (1:1 of thiopentone (1.25% and propofol (0.5% for laryngeal mask airway insertion in children undergoing elective eye surgery: Double-masked randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Renu Sinha

    2010-01-01

    Full Text Available Intravenous propofol 1% has been the preferred agent for Laryngeal Mask Airway (LMA insertion. Admixture of thiopentone 1.25% and propofol 0.5% (1:1 has been used by various authors for induction as well as insertion of LMA in adults. There is no previous report where this admixture has been used for insertion of LMA in children. This study has been designed to investigate whether this admixture can be a suitable alternative to propofol, in relation to ease of insertion of the LMA, haemodynamic stability, cost containment, pain on injection and recovery in children. In this randomized, double-masked study, 50 ASA grade 1 and 2 patients of age 3 - 15 years and weighing more than 10 kg were included. The patients were divided into two groups; the P group received propofol 1%, while the Ad group received an admixture of thiopentone 1.25% and propofol 0.5% (1:1. All the children were evaluated for incidence of apnoea, pain on injection, jaw relaxation, ease of LMA insertion, coughing, gagging, laryngospasm, involuntary limb movements, incidence of hypotension and recovery. The demographic data, incidence of apnoea, pain on injection, jaw relaxation, ease of LMA insertion, coughing, gagging and involuntary movements were comparable in both groups. In the P group recovery was faster as compared to the Ad group. The admixture was cost effective as compared to Propofol alone [Indian National Rupees (INR 24.64 ± 7.62 vs. INR 48.75 ± 23.25] (P = 0.001. Admixture of propofol and thiopentone was a cheap, safe and effective alternative to propofol alone, for LMA insertion in children.

  18. Randomized trials and quality assurance in gastric cancer surgery.

    Science.gov (United States)

    Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

    2013-03-01

    A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

  19. Effect of vasoconstriction on pain after mandibular third molar surgery: A single-blind, randomized controlled trial.

    Science.gov (United States)

    Martin, Wilhelmus J J M; Skorpil, Nynke E; Ashton-James, Claire E; Tuinzing, D Bram; Forouzanfar, Tymour

    2016-01-01

    Previous research has demonstrated the efficacy of using local compression to reduce postoperative pain after third molar surgery. It has been theorized that compression reduces pain intensity through vasoconstriction. The current research tests the veracity of this vasoconstriction hypothesis by testing the impact of local epinephrine (a local vasoconstrictor) versus a control on patients' pain ratings over 7 days following surgery. Fifty patients scheduled for mandibular third molar surgery were randomly assigned to receive one cartridge of Ultracaine DS Forte (the treatment group) or one cartridge of Ultracaine DS (the control group) after surgical removal of the third molar. Participants used the visual analog scale (VAS) to provide daily ratings of pain intensity for 7 days following surgery. In addition, on day 7, the perceived effectiveness of the pain treatment was measured with the global perceived effect (GPE) scale. A quality- of-life questionnaire was also completed. A repeated-measures ANOVA indicated that the treatment group perceived significantly less pain than the control group on days 2 to 7 following surgery. In addition, 77.8% of the treatment group perceived their pain treatment to be successful, while only 69.6% of the control group reported that their pain was reduced successfully by day 7. The results of this study provide an initial proof of concept that epinephrine may have an analgesic effect on the period following third molar surgery. Further research with larger sample sizes is needed to strengthen evidence for the clinical utility of offering localized epinephrine to patients following third molar surgery.

  20. Clinical observation on different nucleus delivery methods in small incision cataract surgery with non-phacoemulsification

    Directory of Open Access Journals (Sweden)

    Mei-Kui Ke

    2013-11-01

    Full Text Available AIM: To compare the clinical effect and characteristics of lens loop extracting nucleus method, water irrigation and nucleus fragmentation within anterior chamber in small incision cataract surgery with non-phacoemulsification. METHODS:There were 324 cases(324 eyeswith senile cataract randomly divided into three groups, by the lens loop extracting nucleus method(group A, water irrigation(group Band nucleus fragmentation within anterior chamber(group C, to complete the process of nucleus division. The time of nuclear removal, complication during operation, the degree of edema of corneal endothelium on the first day after the surgery and visual acuity after surgery were observed and recorded.RESULTS:The average extracting nucleus time was 45s in lens loop(group A; 34s in water irrigation(group Band 65s in manual fragmentation(group C.The differences of average time are statistically significant(PPP>0.05.Regarding the visual acuity on the first day after surgery, the difference between group A and group C, group B and group C were statistically significant(PPP>0.05.CONCLUSION:Manual fragmentation has obvious advantages in removing nuclear above Ⅳ grade; The water irrigation method has fewer complications with low incidence of corner edema, which is more preferable in removing the nuclear below Ⅳ grade.

  1. 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.

  2. Clinical impact of oncoplastic surgery in a specialist breast practice.

    Science.gov (United States)

    Kollias, James; Davies, Giles; Bochner, Melissa A; Gill, Peter G

    2008-04-01

    Oncoplastic breast surgery is an integral and fundamental component of the clinical management of breast cancer. The aim of this study was to determine the proportion of oncoplastic and reconstructive breast cancer procedures undertaken within a specialist breast practice. An audit of breast-related cancer procedures was undertaken for patients with early breast cancer between 1 January 2001 and 31 December 2005, treated at the Royal Adelaide Hospital and in private practice. The proportion of oncoplastic and breast reconstructive procedures was calculated to determine the clinical effects on a specialist breast-surgical practice. Breast cancer resection procedures accounted for 1514 of 2113 of operations (72%). Most of these (897 of 1514, 59.2%) were wide local excision or re-excision procedures. Total breast reconstruction operations (i.e. autogenous tissue flaps, tissue expander/implant reconstructions) accounted for 251 procedures. Of these, 67 (26.7%) were carried out at the time of simple mastectomy. Contralateral breast procedures (i.e. reduction mammaplasty, mastopexy and augmentation) accounted for 138 procedures and nipple-areola reconstruction/tattoo accounted for 153 procedures. Oncoplastic procedures, such as skin-sparing mastectomy, latissimus dorsi miniflap and therapeutic mammaplasty accounted for 57 of 599 procedures (9.5%). Breast reconstruction and oncoplastic operations accounted for 599 of 2113 procedures (28%). Specialist breast surgeons trained in breast reconstruction and oncoplastic techniques can expect a substantial proportion of their breast practice to include such operative procedures (28% in this series). Subspecialist training in breast surgery should incorporate experience in breast reconstructive and aesthetic surgery for trainees who wish to practise as specialist breast surgeons in the future.

  3. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO).

    Science.gov (United States)

    Liu, Tianyu; Congdon, Nathan; Yan, Xixi; Jin, Ling; Wu, Ying; Friedman, David; He, Mingguang

    2012-08-13

    To evaluate an educational intervention promoting acceptance of cataract surgery in rural China using a randomized controlled design. Patients aged 50 years or older with presenting visual acuity (PVA) less than 6/18 in one or both eyes due to cataract were recruited from 26 screening sessions (13 intervention, 13 control) conducted by five rural hospitals in Guangdong, China. At intervention sessions, subjects were shown a 5-minute informational video, and counseled about cataract, surgery, and surgical cost. During screening, all subjects answered questionnaires on knowledge and attitudes about cataract, their finances, and transportation, and were referred for definitive examination if eligible. Study outcomes were acceptance of surgery (principal outcome) and hospital follow-up. Subjects in the intervention group were younger than controls (P = 0.01), but the groups did not otherwise differ. Among 212 intervention patients and 222 controls, no differences in knowledge and attitude regarding cataract were found. Surgery was accepted by 31.1% of intervention patients and 34.2% of controls (P > 0.50). Predictors of acceptance included younger age, worse logMAR PVA, knowing that cataract can be treated surgically only, greater anticipated loss in income from hospitalization, and greater house floor space per person. Membership in the intervention group was not associated with accepting surgery (odds ratio [OR] = 1.11, 95% confidence interval [CI] 0.67-1.84) or hospital follow-up (OR = 1.03, 95% CI = 0.63-1.67). Educational interventions that successfully impart the knowledge that cataract can be only treated surgically may be more effective in increasing uptake in this setting. (ClinicalTrials.gov number, NCT01123928.).

  4. [Preliminary clinical experience of single incision laparoscopic colorectal surgery].

    Science.gov (United States)

    Wu, S D; Han, J Y

    2016-06-01

    Objective: To discuss the preliminary experience of single incision laparoscopic colorectal surgery. Methods: The clinical data and surgical outcomes of 104 selected patients who underwent single incision laparoscopic colorectal surgery in the 2 nd Department of General Surgery, Shengjing Hospital of China Medical University from January 2010 to September 2015 were retrospectively analyzed. There were 62 male and 42 female patients, aging from 21 to 87 years with a mean of (61±12) years. Eighty-five patients were diagnosed with malignancy while the rest 19 cases were benign diseases. All the procedures were performed by the same surgeon using the rigid laparoscopic instruments. Surgical and oncological outcomes were analyzed in 4 kinds of procedures which are over 5 cases respectively, including low anterior resection, abdominoperineal resection, radical right colon resection and radical sigmoidectomy. Results: Single incision laparoscopic colorectal surgery was performed in 104 selected patients and was successfully managed in 99 cases with a total conversion rate of 4.8%. Radical procedures for malignancy in cases with the number of patients more than 5 were performed for 74 cases. For low anterior resection, 35 cases with an average surgical time of (191±57) minutes, average estimated blood loss of (117±72) ml and average number of harvested lymph nodes of 14.6±1.1. For abdominoperineal resection, 9 cases with an average surgical time of (226±54) minutes, average estimated blood loss of (194±95) ml and average number of harvested lymph nodes of 14.1±1.5. For radical right colon resection, 16 cases with an average surgical time of (222±62) minutes, average estimated blood loss of (142±68) ml and average number of harvested lymph nodes of 15.4±2.4. For radical sigmoidectomy, 14 cases with an average surgical time of (159±32) minutes, average estimated blood loss of (94±33) ml and average number of harvested lymph nodes of 13.9±1.5. The overall

  5. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  6. Biliary tract and pancreatic surgery complicated by acute pancreatitis: a clinical analysis

    OpenAIRE

    Sun, Chenggang; Li, Xin; Sun, Jintang; Zou, Peng; Gao, Shubo; Zhang, Peixun

    2015-01-01

    Objective: To study the clinical treatment features of biliary tract and pancreatic surgery complicated by acute pancreatitis. Methods: A retrospective analysis of 21 cases of biliary tract and pancreatic surgery complicated by acute pancreatitis in the Department of General Surgery in our hospital during May 2005 to July 2011 was performed; the clinical treatment features were analyzed in terms of surgical option, onset interval of acute pancreatitis after last surgery, length of stay in hos...

  7. 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 third molar surgery.

  8. Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

    Science.gov (United States)

    Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

    2014-07-01

    The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  9. Prophylactic Low-Dose Ketamine to Prevent Post Anesthetic Shivering in Orthopedic Surgery: A Randomized-Controlled Study.

    Science.gov (United States)

    Petskul, Suttasinee; Kitsiripant, Chanatthee; Rujirojindakul, Panthila; Chantarokorn, Amphan; Jullabunyasit, Arporn; Thinchana, Sarunyoo

    2016-04-01

    Post anesthetic shivering is one of the most common anesthesia complications. We compared the efficacy of low-dose ketamine with normal saline in preventing post anesthetic shivering in orthopedic surgery. The present study was a prospective, randomized, double-blind, controlled clinical trial involving 183 ASA I-II patients, aged 18 to 65 years whom underwent orthopedic surgery with general anesthesia. The patients were randomly allocated to receive either ketamine 0.25 mg/kg (Group K, n = 91) or normal saline (Group P n = 92) 20 minutes before the completion of surgery. The tympanic temperature was measured before the induction of anesthesia, 30 minutes after induction, and before administration of the study drugs. An investigator, blinded to the patients' group affiliation, graded post anesthetic shivering using the Crossley and Mahajan scale. The primary outcome was to compare incidence of shivering on each group in recovery room. The secondary outcome was side effect of ketamine. Statistical analyses were performed using program R version 3.1.0. A p-value of shivering in both groups was not statistically significantly different (Group K = 13 (14.28%) and Group P = 15 (16.30%), p = 0.42). Furthermore, in both groups, no patient suffered from hallucination, and the other complications were not statistically different. At the recovery room, no significant efficacy difference between low-dose ketamine (0.25 mg/kg) and placebo in the prevention of post operative shivering in patients who underwent orthopedic surgery was observed. Other factors such as preload warm intravenous fluid, using active warming during surgery and control of the room temperature may help prevent shivering.

  10. The ProDisc-C prosthesis: clinical and radiological experience 1 year after surgery.

    Science.gov (United States)

    Nabhan, Abdullah; Ahlhelm, Frank; Shariat, Kaveh; Pitzen, Tobias; Steimer, Oliver; Steudel, Wolf-Ingo; Pape, Dietrich

    2007-08-15

    This is a prospective randomized and controlled study, approved by the local ethical committee of Saarland (Germany). The aim of the current study was to analyze segmental motion following artificial disc replacement using disc prosthesis over 1 year. A second aim was to compare both segmental motion as well as clinical result to the current gold standard (anterior cervical discectomy and fusion [ACDF]). ACDF may be considered to be the gold standard for treatment of symptomatic degenerative disc disease within the cervical spine. However, fusion may result in progressive degeneration of the adjacent segments. Therefore, disc arthroplasty has been introduced. Among these, artificial disc replacement seems to be promising. However, segmental motion should be preserved. This, again, is very difficult to judge and has not yet been proven. A total of 49 patients with cervical disc herniation were enrolled and assigned to either study group (receiving a disc prosthesis) or control group (receiving ACDF, using a cage with bone graft and an anterior plate). Roentgen stereometric analysis (RSA) was used to quantify intervertebral motion immediately as well as 3, 6, 12, 24, and 52 weeks after surgery. Also, clinical results were judged using visual analog scale and neuro-examination at even RSA follow-up. Cervical spine segmental motion decreased over time in the presence of disc prosthesis or fusion device. However, the loss segmental motion is significantly higher in the fusion group, when looked at 3, 6, 12, 24, and 52 weeks after surgery. We observed significant pain reduction in neck and arm after surgery, without significant difference between both groups. Cervical spine disc prosthesis remains cervical spine segmental motion within the first 1 year after surgery. The clinical results are the same when compared with the early results following ACDF.

  11. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... of the nervous elements have been performed. To date, no randomized studies have compared simple discectomy with discectomy followed by an interbody fusion with a titanium cage. METHODS: Eighty-six patients with symptoms of nerve root compression at 1 level were randomly allocated to either discectomy followed...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...

  12. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, Allan Gorm; Petersen, O B; Wara, P

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  13. Early clinical outcomes after small incision lenticule extraction surgery (SMILE).

    Science.gov (United States)

    Recchioni, Alberto; Hartwig, Andreas; Dermott, Jay; Vaswani, Sundeep; Bhatt, Jay; Morris, Robert; O'Donnell, Clare

    2018-02-01

    Dry eye is known to impact on clinical outcomes after laser vision correction and the use of a newer 'all femtosecond laser' surgical approach may be associated with less impact on the ocular surface post-operatively. The purpose of this study was to evaluate the early clinical outcomes and tear instability after the first small incision lenticule extraction (SMILE) cases undertaken by three surgeons at a single site in the UK. Retrospective audit. Seventy-one eyes of 37 patients underwent SMILE surgery using the Zeiss VisuMax laser system (Carl Zeiss Meditec, Germany). Uncorrected and corrected distance visual acuity, spherical equivalent refraction, fluorescein enhanced tear break up time, simulated keratometry and complications were evaluated pre- and post-operatively where applicable. The study population consisted of 21 males and 16 females. The mean±standard deviation age was 33±8years. The results showed that 100% of eyes achieved 20/40 or better and 88% achieved 20/20 or better uncorrected distance visual acuity. The spherical equivalent refraction after surgery was within ±0.50D in 82% of eyes at three months. There was no significant difference in tear break up time from pre-operative levels at three months. Complications were infrequent. This early data from surgeons' first SMILE procedures suggest SMILE provides good outcomes in terms of refractive predictability and visual acuity with minimal impact on the tear film. Longitudinal research will further improve our understanding of the longer-term impact of SMILE on clinical outcomes, ocular surface metrics and patient reported outcomes. Copyright © 2017. Published by Elsevier Ltd.

  14. Open-heart Surgery Complications Following Programmed Education and Nurses' Clinical Competence

    Directory of Open Access Journals (Sweden)

    Mahnaz Rakhshan

    2017-01-01

    Full Text Available Heart surgery can lead to certain complications that, if not diagnosed and treated on time, can be fatal. In view of the fact that nurses' clinical competence affects the quality of clinical judgment, the present study aimed to explore the effect of programmed education and nurses' clinical competence on complications following open-heart surgeries. The results of the present study showed that a closer attention to regular and programmed education and informing of open-heart surgery patients, especially before surgery and at the time of discharge, along with the clinical competence of nurses in ICUs, can reduce the incidence of post-surgery complications. Since the nurses' clinical competence greatly affects their clinical judgments and quality of care, paying greater attention to the nurses' education through systematic programs and increasing the clinical competence can lead to fewer post-heart-surgery complications; this, in turn, reduces the length of stay and the ensuing costs.

  15. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

    2012-01-01

    randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

  16. USE OF POWERED INSTRUMENTATION IN MICROLARYNGEAL SURGERY: A CLINICAL STUDY

    OpenAIRE

    Shankar; Benjamin Rajendra

    2015-01-01

    Micro laryngeal surgery is a common and relatively safe ENT surgery, certain laryngeal conditions require surgery for correction. Surgery for voice problems is quite uncommon, most of the voice disorders can be treated with voice therapy or medical treatment. However there are certain conditions may required operative measures. We have been doing micro laryngeal surgery(MLS) in our institute for quite a long time, but use of powered instruments like, microdebrider technique in...

  17. [Clinical effects of simple hallux valgus surgery for transfer metatarsalgia].

    Science.gov (United States)

    Wang, X J; Bao, B X; Wei, F Y; Zhang, J Z

    2017-09-19

    Objective: To analyze the clinical effects of simple hallux valgus surgery for transfer metatarsalgia. Methods: From September 2011 to November, a total of 21 patients(30 feets)with transfer metatarsalgia of hallux valgus and underwent the simple hallux valgus surgery without lateral metatarsal shortening osteotomy In Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, were enrolled in the study.The hallux valgus angle (HVA), intermetatarsal angle (IMA) , AOFAS scale and analogue score (VAS) were measured pre-operation and a half year, one year, two years after operation.The data were measured repeatedly and analyzed with analysis of variance. Results: The mean preoperative HVA changed [(39.6±9.7), (14.2±7.9), (14.8±7.9), (13.2±6.5)°] at 6 months, 1 year and 2 years follow-up; the mean IMA decreased [(13.8±4.0), (4.5±4.3), (5.8±3.9), (5.4±4.9)°] at 6 months, 1 year and 2 years follow-up(all P surgeries. The mean AOFAS for hallux , AOFAS for lesser toes and VAS were improved from 58.96 to 95.42, from 84.38 to 92.04 and from 7.5 to 1.3, respectively. All the results are statistically significant( P <0.001). Conclusion: These results suggest that a simple osteotomy of the first metatarsal provides excellent outcomes with a low rate of complications when compared with the combining lateral metatarsal shortening osteotomy.

  18. Aggressive clinical approach to obesity improves metabolic and clinical outcomes and can prevent bariatric surgery: a single center experience.

    Science.gov (United States)

    Cadegiani, Flavio A; Diniz, Gustavo C; Alves, Gabriella

    2017-01-01

    -eight (88.4%) patients achieved 10% BW loss, and 32 (74.4%) achieved 20% BW loss. TWE decreased by >50% in 35 (81.4%) patients. Forty (93.0%) patients were able to avoid bariatric surgery. An intensive clinical approach to obesity management can be an effective alternative to bariatric surgery, although further randomized controlled studies are necessary to validate our findings.

  19. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  20. Quality assessment of randomized clinical trial in intensive care.

    Science.gov (United States)

    Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira

    2009-03-01

    A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

  1. 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.

  2. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery.

    Science.gov (United States)

    Edwards, Janet P; Kelly, Elizabeth J; Lin, Yongtao; Lenders, Taryn; Ghali, William A; Graham, Andrew J

    2012-06-01

    Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.

  3. Comparison between conventional and piezoelectric surgical tools for maxillary sinus floor elevation : a randomized controlled clinical trial

    NARCIS (Netherlands)

    Rickert, Daniela; Vissink, Arjan; Huddleston Slater, James; Meijer, Henny J. A.; Raghoebar, Gerry M.

    Aim: The aim of this study was to assess the performance of conventional rotative instruments and a piezoelectric device for maxillary sinus floor elevation surgery, and to assess whether application of a resorbable membrane reduces resorption of an augmented site in a randomized clinical trial.

  4. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  5. Children's surgery: a national survey of consultant clinical practice.

    Science.gov (United States)

    Mason, David G; Shotton, Hannah; Wilkinson, Kathleen A; Gough, Michael J; Alleway, Robert; Freeth, Heather; Mason, Marisa

    2012-01-01

    To survey clinical practice and opinions of consultant surgeons and anaesthetists caring for children to inform the needs for training, commissioning and management of children's surgery in the UK. The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) hosted an online survey to gather data on current clinical practice of UK consultant surgeons and anaesthetists caring for children. The questionnaire was circulated to all hospitals and to Anaesthetic and Surgical Royal Colleges, and relevant specialist societies covering the UK and the Channel Islands and was mainly completed by consultants in District General Hospitals. 555 surgeons and 1561 anaesthetists completed the questionnaire. 32.6% of surgeons and 43.5% of anaesthetists considered that there were deficiencies in their hospital's facilities that potentially compromised delivery of a safe children's surgical service. Almost 10% of all consultants considered that their postgraduate training was insufficient for current paediatric practice and 20% felt that recent Continued Professional Development failed to maintain paediatric expertise. 45.4% of surgeons and 39.2% of anaesthetists considered that the current specialty curriculum should have a larger paediatric component. Consultants in non-specialist paediatric centres were prepared to care for younger children admitted for surgery as emergencies than those admitted electively. Many of the surgeons and anaesthetists had consultant surgeons and anaesthetists providing a competent surgical service for children. Postgraduate curricula must meet the needs of trainees who will be expected to include children in their caseload as consultants. Trusts must ensure appropriate support for consultants to maintain paediatric skills and provide the necessary facilities for a high-quality local surgical service.

  6. Structured postoperative physiotherapy in patients with cervical radiculopathy: 6-month outcomes of a randomized clinical trial.

    Science.gov (United States)

    Wibault, Johanna; Öberg, Birgitta; Dedering, Åsa; Löfgren, Håkan; Zsigmond, Peter; Peolsson, Anneli

    2018-01-01

    OBJECTIVE Structured physiotherapy has been suggested as treatment before as well as after surgery to improve clinical outcomes in patients with cervical radiculopathy (CR), but randomized clinical trials to inform evidence-based clinical guidelines for the treatment of patients with CR after surgery are lacking. The aim of this study was to compare the results of structured postoperative physiotherapy combining neck-specific exercises with a behavioral approach to a standard postoperative approach in patients who had undergone surgery for cervical disc disease with CR at 6 months after surgery. METHODS Patients with cervical disc disease and persistent CR who were scheduled for surgery were randomized preoperatively to structured postoperative physiotherapy (n = 101) or a standard postoperative approach (n = 100). The latter included pragmatic physiotherapy in accordance with the usual Swedish postoperative care. Outcome measures included patient-reported neck disability as measured with the Neck Disability Index (NDI), intensity and frequency of neck and arm pain, global outcome of treatment, and expectation fulfillment, as well as enablement. RESULTS Patients who received structured postoperative physiotherapy reported greater expectation fulfillment (p = 0.01), and those who attended at least 50% of the treatment sessions reported less neck pain frequency (p = 0.05), greater expectation fulfillment (p = 0.001), and greater enablement (p = 0.04) compared with patients who received the standard postoperative approach. No other difference between treatment groups was found (p > 0.15). The NDI and neck and arm pain intensity were improved in both groups at 6 months after surgery (p cervical disc disease with CR. Patients who received structured postoperative physiotherapy reported higher expectation fulfillment, and many patients in the standard postoperative approach group perceived a need for additional treatments after surgery, suggesting that patients with CR

  7. Effect of submucosal injection of dexamethasone after third molar surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Moraschini, V; Hidalgo, R; Porto Barboza, E dS

    2016-02-01

    The aim of this meta-analysis was to analyse the effectiveness of submucosal injection of dexamethasone to control the postoperative signs and symptoms resulting from impacted third molar surgery. An electronic search was conducted, without restriction on date or language, in the PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science databases until June 2015 . The eligibility criteria included non-randomized or randomized clinical trials in humans. After the search and selection process, eight articles were included. The fixed-effects or random-effects model, depending on heterogeneity, was built on the inverse-variance method used. The estimations of intervention were expressed as the mean difference (MD) in millimetres. The results of this meta-analysis suggest that the submucosal injection of dexamethasone presents a reduction in the postoperative signs and symptoms resulting from impacted third molar surgery, especially those associated with oedema and pain. In relation to trismus, the meta-analysis showed no statistically significant difference between dexamethasone and the placebo solution. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  8. Clinical efficacy of dexmedetomidine in the diminution of fentanyl dosage in pediatric cardiac surgery.

    Science.gov (United States)

    Sun, Yingying; Ye, Hongwu; Xia, Yin; Li, Yuanhai; Yuan, Xianren; Wang, Xing

    2017-06-01

    This study aims to explore the clinical efficacy of dexmedetomidine (DEX) in the diminution of fentanyl dosage in pediatric cardiac surgery based on some clinical and biochemical parameters. Fifty pediatric patients (American Society of Anesthesiologists II), 1-6 years old, were randomly allocated into two groups: group F (control group), in which patients received normal saline and high dosage of fentanyl (30 μg/kg), and group D, in which patients were given DEX and low dosage of fentanyl (15 μg/kg). Some hemodynamic and clinical parameters of the two groups were recorded. Furthermore, stress hormone (serum cortisol, norepinephrine, blood glucose) levels and cytokine (interleukin 6, tumor necrosis factor alpha) levels in the two groups were compared with each other. Stress hormone levels, cytokine levels, hemodynamic parameters and the consumption of sevoflurane did not differ between the two groups. Meanwhile, the extubation time was significantly shorter in Group D than F (Pfentanyl supplemented with DEX almost had the same anesthesia effects and inflammation extent compared with high dose of fentanyl, which suggested that infusion DEX might decrease fentanyl consumption in pediatric cardiac surgery.

  9. Colon and rectal surgery for cancer without mechanical bowel preparation: one-center randomized prospective trial.

    Science.gov (United States)

    Scabini, Stefano; Rimini, Edoardo; Romairone, Emanuele; Scordamaglia, Renato; Damiani, Giampiero; Pertile, Davide; Ferrando, Valter

    2010-04-30

    Mechanical bowel preparation is routinely done before colon and rectal surgery, aimed at reducing the risk of postoperative infectious complications. The aim of the study was to assess whether elective colon and rectal surgery can be safely performed without preoperative mechanical bowel preparation. Patients undergoing elective colon and rectal resections with primary anastomosis were prospectively randomized into two groups. Group A had mechanical bowel preparation with polyethylene glycol before surgery, and group B had their surgery without preoperative mechanical bowel preparation. Patients were followed up for 30 days for wound, anastomotic, and intra-abdominal infectious complications. Two hundred forty four patients were included in the study, 120 in group A and 124 in group B. Demographic characteristics, type of surgical procedure and type of anastomosis did not significantly differ between the two groups. There was no difference in the rate of surgical infectious complications between the two groups but the overall infectious complications rate was 20.0% in group A and 11.3% in group B (p .05). Wound infection (p = 0.18), anastomotic leak (p = 0.52), and intra-abdominal abscess (p = 0.36) occurred in 9.2%, 5.8%, and 5.0% versus 4.8%, 4.0%, and 2.4%, respectively. No mechanical bowel preparation seems to be safe also in rectal surgery. These results suggest that elective colon and rectal surgery may be safely performed without mechanical preparation.

  10. Determinants of clinical right ventricular failure after congenital heart surgery in adults

    NARCIS (Netherlands)

    Schuuring, Mark J.; van Gulik, E. Charlotte; Koolbergen, Dave R.; Hazekamp, Mark G.; Lagrand, Wim K.; Backx, Ad P. C. M.; Mulder, Barbara J. M.; Bouma, Berto J.

    2013-01-01

    Right ventricular (RV) failure after cardiac surgery is a clinical entity with high morbidity and mortality. Patients with congenital heart disease (CHD) often undergo right-sided cardiac surgery. The authors aimed to identify determinants of RV failure after cardiac surgery to differentiate

  11. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial.

    Science.gov (United States)

    Garg, Amit X; Shehata, Nadine; McGuinness, Shay; Whitlock, Richard; Fergusson, Dean; Wald, Ron; Parikh, Chirag; Bagshaw, Sean M; Khanykin, Boris; Gregory, Alex; Syed, Summer; Hare, Gregory M T; Cuerden, Meaghan S; Thorpe, Kevin E; Hall, Judith; Verma, Subodh; Roshanov, Pavel S; Sontrop, Jessica M; Mazer, C David

    2018-01-01

    When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] red blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  12. 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.

  13. 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.

  14. Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do NOT meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success.

    Science.gov (United States)

    Parikh, Manish; Chung, Mimi; Sheth, Sheetal; McMacken, Michelle; Zahra, Tasneem; Saunders, John K; Ude-Welcome, Aku; Dunn, Van; Ogedegbe, Gbenga; Schmidt, Ann Marie; Pachter, H Leon

    2014-10-01

    To compare bariatric surgery versus intensive medical weight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery. There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35. Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE. The surgery group had improved HOMA-IR (-4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DM medication requirements (20% vs 88%; P surgery group lost more weight (7. vs 1.0 BMI decrease, P Surgery was very effective short-term in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies.ClinicalTrials.gov ID: NCT01423877.

  15. Preoperative Use of Dexamethasone in Rhinoplasty: A Randomized, Double-blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Valente, Denis S; Steffen, Niveo; Carvalho, Lauro A; Borille, Giuliano B; Zanella, Rafaela K; Padoin, Alexandre V

    2015-01-01

    Postoperative edema and ecchymosis following rhinoplasty are a cause of anxiety for both patients and physicians and can affect the cosmetic results. Corticosteroids have been used to reduce these events. To determine whether preoperative use of dexamethasone sodium phosphate alters the occurrence of edema and ecchymosis following rhinoplasty. Randomized, double-blind, placebo-controlled clinical trial at an institutional referral center among a sample of individuals with rhinomegaly. Patients were randomized into 2 groups. In group 1, dexamethasone was intravenously injected before surgery. In group 2, normal saline solution was intravenously injected before surgery. When patients returned at 1 week after surgery, standardized photographs were obtained. The photographs were analyzed by 5 plastic surgeons who were blinded as to whether dexamethasone or normal saline solution had been injected. The plastic surgeons rated the degree of edema and ecchymosis. Forty-two patients participated in the study. Randomization by lottery resulted in 20 patients in group 1 and 22 patients in group 2. Group 1 showed lower rates of postoperative ecchymosis than group 2; the difference of 0.62 (P = .02) reflects less perceived ecchymosis when dexamethasone was administered. Group 1 also showed lower rates of postoperative edema than group 2; the difference of 0.68 (P = .01) reflects less perceived edema when dexamethasone was administered. Preoperative use of dexamethasone reduced edema and ecchymosis at 7 days after rhinoplasty. Rigorous methods in this trial demonstrate the beneficial effect of preoperative corticosteroid administration in this surgical procedure. 1.

  16. Ketamine in adult cardiac surgery and the cardiac surgery Intensive Care Unit: An evidence-based clinical review

    Directory of Open Access Journals (Sweden)

    Michael Mazzeffi

    2015-01-01

    Full Text Available Ketamine is a unique anesthetic drug that provides analgesia, hypnosis, and amnesia with minimal respiratory and cardiovascular depression. Because of its sympathomimetic properties it would seem to be an excellent choice for patients with depressed ventricular function in cardiac surgery. However, its use has not gained widespread acceptance in adult cardiac surgery patients, perhaps due to its perceived negative psychotropic effects. Despite this limitation, it is receiving renewed interest in the United States as a sedative and analgesic drug for critically ill-patients. In this manuscript, the authors provide an evidence-based clinical review of ketamine use in cardiac surgery patients for intensive care physicians, cardio-thoracic anesthesiologists, and cardio-thoracic surgeons. All MEDLINE indexed clinical trials performed during the last 20 years in adult cardiac surgery patients were included in the review.

  17. Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

    Science.gov (United States)

    Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M

    2017-04-01

    Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

  18. Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Arruda Viani, Gustavo, E-mail: gusviani@gmail.com [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Carrara Fonseca, Ellen [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); De Fendi, Ligia Issa [Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Melani Rocha, Eduardo [Department of Ophthalmology, School of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto (Brazil)

    2012-03-01

    Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.

  19. Effects of guidelines on adeno-tonsillar surgery on the clinical behaviour of otorhinolaryngologists in Italy

    Directory of Open Access Journals (Sweden)

    Motta Giovanni

    2013-01-01

    Full Text Available Abstract Background Several guidelines on adeno-tonsillar disease have been proposed in recent years and some discrepancies in relation both to clinical manifestations and indications for surgical treatment have emerged. The aim of the study was to verify what influence (adeno-tonsillectomy guidelines have had on the clinical behaviour of ENT specialists in Italy. Our study is a retrospective and multi-centre case series with chart review. Methods The survey involved 14,770 children, aged between the ages of 2 and 11, who had undergone adeno-tonsillar surgery between 2002 and 2008 in fourteen Italian tertiary and secondary referral centres. Anova test was used for the statistical analysis, assuming p Results The frequency of adeno-tonsillar surgeries did not change significantly (p>0.05 during the study period and following the Italian policy document publication. Overall, adeno-tonsillectomy was the most frequent intervention (64.1%, followed by adenoidectomy (31.1% and tonsillectomy (4.8%. The indications for surgery did not change significantly for each of the operations (p>0.05, with the exception of adeno-tonsillectomy in case of feverish episodes due to acute recurrent tonsillitis ≥ 5 without nasal obstruction (decreased p= 0.010 , even when the feverish episodes due to acute recurrent tonsillitis were Conclusions The recommendations first developed in Italy in a 2003 policy document and then resumed in guidelines in 2008, were not implemented by ENT units involved in the survey. The study highlights the fact that the indications for adeno-tonsillar operations are based on the overall clinical presentation (comorbidity rather than on a single symptom. Guidelines are necessary to give coherent recommendations based on both the findings obtained through randomized controlled trials and the data collected from observational studies.

  20. 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

  1. 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

    Full Text Available BACKGROUND: Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. OBJECTIVE: To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. PATIENTS AND METHOD: Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30 were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map, were also investigated at the same time. RESULTS: Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60 rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021. The maximal loudness of low-frequency (40-300 Hz snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. CONCLUSIONS: Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect

  2. Effect of probiotics on postoperative quality of gastric bypass surgeries: a prospective randomized trial.

    Science.gov (United States)

    Chen, Jung-Chien; Lee, Wei-Jei; Tsou, Jun-Juin; Liu, Tsang-Pai; Tsai, Pei-Ling

    2016-01-01

    Gastric bypass surgery is the recommended treatment for severely obese patients. However, postoperative symptomatic gastrointestinal (GI) episodes are common complaints. To determine if administration of probiotics improves symptomatic GI episodes after gastric bypass surgery. Hospital-based bariatric center. This double-blind, randomized trial was conducted between March 2010 and September 2010 with 60 patients who underwent gastric bypass for severe obesity and experienced postoperative symptomatic GI episodes. Patients were randomly assigned to the probiotics group A (n = 20; 1 g Clostridium butyricum MIYAIRI twice daily); probiotics group B (n = 20; Bifidobacterium longum BB536 twice daily); or digestive enzymes group (n = 20; Aczym, containing 100 mg takadiastase N, 20 mg cellulase AP, 50 mg lipase MY, and 100 mg pancreatin, twice daily). Quality of life was measured using the modified Gastrointestinal Quality of Life Index (mGIQLI) before and after the 2-week intervention. Preintervention patient characteristics and mGIQLI scores were similar among the 3 groups. After the 2-week intervention, the mean mGIQLI score improved from 57.4 to 63.9 points in the entire sample and also within each group for 7 items specifically for 7: excessive passage of gas, foul smell of flatulence, belching, heartburn, abdominal noises, abdominal bloating, and abdominal pain. Administration of probiotics or digestive enzymes may improve symptomatic GI episodes after gastric bypass surgeries and improve quality of life, at least initially. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  3. 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

  4. Predictors, Prognosis, and Management of New Clinically Important Atrial Fibrillation After Noncardiac Surgery: A Prospective Cohort Study.

    Science.gov (United States)

    Alonso-Coello, Pablo; Cook, Deborah; Xu, Shou Chun; Sigamani, Alben; Berwanger, Otavio; Sivakumaran, Soori; Yang, Homer; Xavier, Denis; Martinez, Luz Ximena; Ibarra, Pedro; Rao-Melacini, Purnima; Pogue, Janice; Zarnke, Kelly; Paniagua, Pilar; Ostrander, Jack; Yusuf, Salim; Devereaux, P J

    2017-07-01

    Despite the frequency of new clinically important atrial fibrillation (AF) after noncardiac surgery and its increased association with the risk of stroke at 30 days, there are limited data informing their prediction, association with outcomes, and management. We used the data from the PeriOperative ISchemic Evaluation trial to determine, in patients undergoing noncardiac surgery, the association of new clinically important AF with 30-day outcomes, and to assess management of these patients. We also aimed to derive a clinical prediction rule for new clinically important AF in this population. We defined new clinically important AF as new AF that resulted in symptoms or required treatment. We recorded an electrocardiogram 6 to 12 hours postoperatively and on the 1st, 2nd, and 30th days after surgery. A total of 211 (2.5% [8351 patients]; 95% confidence interval, 2.2%-2.9%) patients developed new clinically important AF within 30 days of randomization (8140 did not develop new AF). AF was independently associated with an increased length of hospital stay by 6.0 days (95% confidence interval, 3.5-8.5 days) and vascular complications (eg, stroke or congestive heart failure). The usage of an oral anticoagulant at the time of hospital discharge among patients with new AF and a CHADS2 score of 0, 1, 2, 3, and ≥4 was 6.9%, 10.2%, 23.0%, 9.4%, and 33.3%, respectively. Two independent predictors of patients developing new clinically important AF were identified (ie, age and surgery). The prediction rule included the following factors and assigned weights: age ≥85 years (4 points), age 75 to 84 years (3 points), age 65 to 74 years (2 points), intrathoracic surgery (3 points), major vascular surgery (2 points), and intra-abdominal surgery (1 point). The incidence of new AF based on scores of 0 to 1, 2, 3 to 4, and 5 to 6 was 0.5%, 1.0%, 3.1%, and 5.3%, respectively. Age and surgery are independent predictors of new clinically important AF in the perioperative setting. A

  5. [Organization of clinical research: in a large scale department for cardiothoracic surgery].

    Science.gov (United States)

    Sarikouch, S; Schilling, T; Haverich, A

    2010-04-01

    Translation of basic research results into routine patient care is delayed in parts by lack of institutionalization in clinical research. In this article the research structure and organization of our Department of Cardiac, Thoracic, Transplantation and Vascular Surgery are described.Basic research, separately directed, is accomplished in the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) and within the scope of the Excellence cluster "REBIRTH--from Regenerative Biology to Reconstructive Therapy".Clinical research is directed by heads of the subdepartments of our institution (valve and coronary surgery, aortic surgery, surgical electrophysiology, vascular surgery, thoracic surgery, cardiac assist systems, thoracic transplantation, intensive care and pediatric heart surgery).A separate subdepartment for clinical research is responsible for study coordination and accompanies clinical studies from study design and patient screening to publication. This subdepartment also serves as a constant contact to sponsors and superordinated research organizations within the Hannover Medical School.

  6. 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

  7. Clinical and metabolic results of fasting abbreviation with carbohydrates in coronary artery bypass graft surgery.

    Science.gov (United States)

    Feguri, Gibran Roder; Lima, Paulo Ruiz Lúcio; Lopes, Andréa Mazoni; Roledo, Andréa; Marchese, Miriam; Trevisan, Mônica; Ahmad, Haitham; Freitas, Bruno Baranhuk de; Aguilar-Nascimento, José Eduardo de

    2012-01-01

    Limited information is available about preoperative fasting abbreviation with administration of liquid enriched with carbohydrates (CHO) in cardiovascular surgeries. To evaluate clinical variables, security of the method and effects on the metabolism of patients undergoing fasting abbreviation in coronary artery bypass graft (CABG) surgery. Forty patients undergoing CABG were randomized to receive 400 ml (6 hours before) and 200 ml (2 hours before) of maltodextrin at 12.5% (Group I, n=20) or just water (Group II, n=20) before anesthetic induction. Perioperative clinical variables were evaluated. Insulin resistance (IR) was evaluated by Homa-IR index and also by the need of exogenous insulin; pancreatic beta-cell excretory function by Homa-Beta index and glycemic control by tests of capillary glucose. Deaths, bronchoaspiration, mediastinitis, stroke and acute myocardial infarction did not occur. Atrial fibrillation occurred in two patients of each group and infectious complications did not differ among groups (P=0.611). Patients of Group I presented two days less of hospital stay (P=0.025) and one day less in the ICU (P0.05). A decline in the endogenous production of insulin was observed in both groups (P<0.001). Preoperative fasting abbreviation with the administration of CHO in the CABG was safe. The glycemic control improved in the ICU; there was less time in the use of dobutamine and length of hospital and ICU stay was reduced. However, neither IR nor morbimortality during hospital phase were influenced.

  8. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial.

    Science.gov (United States)

    Karkouti, Keyvan; Callum, Jeannie; Wijeysundera, Duminda N; Rao, Vivek; Crowther, Mark; Grocott, Hilary P; Pinto, Ruxandra; Scales, Damon C

    2016-10-18

    Cardiac surgery is frequently complicated by coagulopathic bleeding that is difficult to optimally manage using standard hemostatic testing. We hypothesized that point-of-care hemostatic testing within the context of an integrated transfusion algorithm would improve the management of coagulopathy in cardiac surgery and thereby reduce blood transfusions. We conducted a pragmatic multicenter stepped-wedge cluster randomized controlled trial of a point-of-care-based transfusion algorithm in consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals from October 6, 2014, to May 1, 2015. Following a 1-month data collection at all participating hospitals, a transfusion algorithm incorporating point-of-care hemostatic testing was sequentially implemented at 2 hospitals at a time in 1-month intervals, with the implementation order randomly assigned. No other aspects of care were modified. The primary outcome was red blood cell transfusion from surgery to postoperative day 7. Other outcomes included transfusion of other blood products, major bleeding, and major complications. The analysis adjusted for secular time trends, within-hospital clustering, and patient-level risk factors. All outcomes and analyses were prespecified before study initiation. Among the 7402 patients studied, 3555 underwent surgery during the control phase and 3847 during the intervention phase. Overall, 3329 (45.0%) received red blood cells, 1863 (25.2%) received platelets, 1645 (22.2%) received plasma, and 394 (5.3%) received cryoprecipitate. Major bleeding occurred in 1773 (24.1%) patients, and major complications occurred in 740 (10.2%) patients. The trial intervention reduced rates of red blood cell transfusion (adjusted relative risk, 0.91; 95% confidence interval, 0.85-0.98; P=0.02; number needed to treat, 24.7), platelet transfusion (relative risk, 0.77; 95% confidence interval, 0.68-0.87; Ppoint-of-care hemostatic testing within the context of an integrated

  9. Single-event multilevel surgery in children with spastic diplegia: a pilot randomized controlled trial.

    Science.gov (United States)

    Thomason, Pamela; Baker, Richard; Dodd, Karen; Taylor, Nicholas; Selber, Paulo; Wolfe, Rory; Graham, H Kerr

    2011-03-02

    Single-event multilevel surgery is considered the standard of care to improve gait and functioning of children with spastic diplegic cerebral palsy. However, the evidence base is limited. This pilot study is the first randomized controlled trial of single-event multilevel surgery, to our knowledge. Nineteen children (twelve boys and seven girls with a mean age of nine years and eight months) with spastic diplegia were enrolled. Eleven children were randomized to the surgical group and eight, to the control group. The control group underwent a program of progressive resistance strength training. The randomized phase of the trial concluded at twelve months. The control group then exited the study and progressed to surgery, whereas the surgical group continued to be followed in a prospective cohort study. The primary outcome measures were the Gait Profile Score (GPS) and the Gillette Gait Index (GGI). Secondary outcome measures were gross motor function (Gross Motor Function Measure-66 [GMFM-66]), functional mobility (Functional Mobility Scale [FMS]), time spent in the upright position, and health-related quality of life (Child Health Questionnaire [CHQ]). A total of eighty-five surgical procedures were performed, with a mean of eight procedures per child (standard deviation, four). The surgical group had a 34% improvement in the GPS and a 57% improvement in the GGI at twelve months. The control group had a small nonsignificant deterioration in both indices. The between-group differences for the change in the GPS (-5.5; 95% confidence interval, -7.6 to -3.4) and the GGI (-218; 95% confidence interval, -299 to -136) were highly significant. The differences between the groups with regard to the secondary outcome measures were not significant at twelve months. At twenty-four months after surgery, there was a 4.9% increase in the GMFM-66 score and improvements in the FMS score, time spent in the upright position, and the physical functioning domain of the CHQ in the

  10. [Clinical Practice after Bariatric Surgery: Problems and Complications].

    Science.gov (United States)

    Gebhart, Martina

    2015-12-09

    The number of patients undergoing bariatric surgery because of morbid obesity is increasing rapidly. Therefore, it is an important issue to be aware of outcome and complications after bariatric surgery. This mini-review presents a compilation of important gastrointestinal symptoms, as pain, diarrhea and dumping, and includes treatment options. It characterizes possible micronutrient deficiencies, gives instructions concerning the adaptation of drugs and illustrates possible adverse outcomes, such as excessive weight loss, insufficient weight loss and weight gain after bariatric surgery.

  11. 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

  12. 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%, Pspondylosis. Compared with MLS, SOS appears clinically beneficial for intubation, especially in patients with difficult airway. Chinese Clinical Trial Registry, ChiCTR-IOR-16007821; http://www.chictr.org.cn/showproj.aspx?proj=13203.

  13. Effect of methylprednisolone on the oxidative burst activity, adhesion molecules and clinical outcome following open heart surgery

    DEFF Research Database (Denmark)

    Toft, P; Christiansen, K; Tønnesen, Else Kirstine

    1997-01-01

    Following cardiac surgery with cardiopulmonary bypass (CPB), activated granulocytes may be involved with ischaemia/ reperfusion injury. The purpose of this study was to investigate whether steroids could reduce the oxidative burst activity of granulocytes, the expression of adhesion molecules...... on granulocytes and improve clinical outcome. Sixteen patients undergoing open heart surgery participated in the study. Eight were randomized to receive methylprednisolone (30 mg/kg intravenously) at the start of anaesthesia while eight patients served as a control group. The oxidative burst was measured flow...... not improve the weaning from the ventilator or reduce the stay in the intensive-care unit. In conclusion, treatment with steroids prevented hyperthermia following open heart surgery with CPB and reduced capillary leak during ECC. Methylprednisolone, however, did not reduce the oxidative burst activity...

  14. TRANSCONJUNCTIVAL NONVITRECTOMIZING VITREOUS SURGERY VERSUS 25-GAUGE VITRECTOMY IN PATIENTS WITH EPIRETINAL MEMBRANE: A Prospective Randomized Study.

    Science.gov (United States)

    Reibaldi, Michele; Longo, Antonio; Avitabile, Teresio; Bonfiglio, Vincenza; Toro, Mario D; Russo, Andrea; Viti, Francesca; Nicolai, Michele; Saitta, Andrea; Giovannini, Alfonso; Mariotti, Cesare

    2015-05-01

    To compare the clinical outcomes and the rate of complications of 27-gauge transconjunctival nonvitrectomizing vitreous surgery (NVS) and of 25-gauge transconjunctival sutureless vitrectomy surgery for idiopathic epiretinal membrane removal. In this prospective randomized study, 83 phakic eyes of 83 consecutive patients with an idiopathic epiretinal membrane were randomized to receive 27-gauge NVS (NVS-group) or 25-gauge vitrectomy (Standard-group). Main outcome measures were best-corrected visual acuity, central retinal thickness, nuclear density units' changes, and rate of complications. Thirty-nine eyes of the Standard-group and 40 of the NVS-group were considered in final analysis. Mean best-corrected visual acuity improved significantly in both groups, with a significant better result at 12 months in NVS-group (P = 0.039; t-test). Central retinal thickness decreased significantly in both groups (P gauge NVS is an effective surgical procedure in eyes with epiretinal membrane and it induces less progression of nuclear sclerosis than 25-gauge vitrectomy.

  15. Reduction of postoperative pulmonary complications after lung surgery using a fast track clinical pathway.

    Science.gov (United States)

    Muehling, Bernd M; Halter, Gisela L; Schelzig, Hubert; Meierhenrich, Rainer; Steffen, Peter; Sunder-Plassmann, Ludger; Orend, Karl-Heinz

    2008-07-01

    Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. In terms of lung resections no randomized controlled trials exist to evaluate such patient care programs. In a prospective, randomized controlled pilot study a conservative and fast track treatment regimen in patients undergoing lung resections was compared. Main differences between the two groups consisted in preoperative fasting (6h vs 2h) and analgesia (patient controlled analgesia vs patient controlled epidural analgesia). Study endpoints were pulmonary complications (pneumonia, atelectasis, prolonged air leak), overall morbidity and mortality. Analysis was performed in an intention to treat. Both study groups were similar in terms of age, sex, preoperative forced expiratory volume in one second (FEV(1)), American Society of Anesthesiologists score and operations performed. The rate of postoperative pulmonary complications was 35% in the conservative and 6.6% in the fast track group (p=0.009). A subgroup of patients with reduced preoperative FEV(1) (<75% of predicted value) experienced less pulmonary complications in the fast track group (55% vs 7%, p=0.023). Overall morbidity was not significantly different (46% vs 26%, p=0.172), mortality was comparable in both groups (4% vs 3%). We evaluated an optimized patient care program for patients undergoing lung resections in a prospective randomized pilot study. Using this fast track clinical pathway the rate of pulmonary complications could be significantly decreased as compared to a conservative treatment regimen; our results support the implementation of an optimized perioperative treatment in lung surgery in order to reduce pulmonary complications after major lung surgery.

  16. Treatment of complete staghorn stones: a prospective randomized comparison of open surgery versus percutaneous nephrolithotomy.

    Science.gov (United States)

    Al-Kohlany, Khaled M; Shokeir, Ahmed A; Mosbah, Ahmed; Mohsen, Tarek; Shoma, Ahmed M; Eraky, Ibrahim; El-Kenawy, Mahmoud; El-Kappany, Hamdy A

    2005-02-01

    We studied the role of open surgery versus percutaneous nephrolithotomy (PCNL) in the treatment of complete staghorn stones in a prospective randomized manner. A total of 79 patients with 88 complete staghorn stones, defined as filling the entire collecting system or at least 80% of it, were prospectively randomized for PCNL (43) or open surgery (45). Intraoperative and postoperative morbidity, operative time, hospital stay, and stone clearance at discharge home and followup were compared for both methods. Patients with significant residuals in both groups were subjected to extracorporeal shock wave lithotripsy (Dornier Medical Systems, Inc., Marietta, Georgia) on an outpatient basis. Followup was completed for all cases with a mean duration +/- SD of 4.9 +/- 2.5 months (range 3 to 14). Renal function was evaluated by Tc-mercaptoacetyltriglycine renogram before and after treatment in both groups. Intraoperative complications in terms of bleeding requiring blood transfusion, and pleural, vascular or ureteral injuries were recorded in 7 patients (16.3%) in the PCNL and 17 (37.8%) in the open surgery groups, a difference of significant value (p work (2.5 +/- 0.8 vs 4.1 +/- 1 weeks, p hand both treatment groups were comparable in regard to stone-free rates at discharge home (49% vs 66%) and at followup (74% vs 82%). At followup renal function improved or remained stable in 91% and 86.7% in the PCNL and open surgery groups, respectively. PCNL is a valuable treatment option for complete staghorn stones with a stone-free rate approaching that of open surgery. Moreover, it has the advantages of lower morbidity, shorter operative time, shorter hospital stay and earlier return to work.

  17. Nonopioid versus opioid based general anesthesia technique for bariatric surgery: A randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Mohamed Ahmed Mansour

    2013-01-01

    Full Text Available Objective: The objective of this study was to evaluate the efficacy and safety of giving general anesthesia without the use of any opioids either systemic or intraperitoneal in bariatric surgery. Methods: Prospective randomized controlled trial. Obese patients (body mass index >50 Kg/m 2 undergoing laparoscopic sleeve gastrectomies were recruited and provided an informed signed consent. Patients were randomized using a computer generated randomization table to receive either opioid or non-opioid based anesthesia. The patient and the investigator scoring patient outcome after surgery were blinded to the anesthetic protocol. Primary outcomes were hemodynamics in the form of "heart rate, systolic, diastolic, and mean arterial blood pressure" on induction and ½ hourly thereafter. Pain monitoring through visual analog scale (VAS 30 min after recovery, hourly for 2 h and every 4 h for 24 h was also recorded. Pain monitoring through VAS and post-operative nausea and vomiting 30 min after recovery were also recorded and finally patient satisfaction and acute pain nurse satisfaction. Results: There was no difference in background characteristics in both groups. There were no statistically significant differences in different outcomes as heart rate, mean blood pressure, O 2 saturation in different timings between groups at any of the determined eight time points but pain score and nurse satisfaction showed a trend to better performance with non-opioid treatment. Conclusion: Nonopioid based general anesthesia for Bariatric surgery is as effective as opioid one. There is no need to use opioids for such surgery especially that there was a trend to less pain in non-opioid anesthesia.

  18. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study

    Directory of Open Access Journals (Sweden)

    de Seigneux Sophie

    2012-10-01

    Full Text Available Abstract Background Experimentally, erythropoietin (EPO has nephroprotective as well as immunomodulatory properties when administered after ischemic renal injury. We tested the hypothesis that different doses of recombinant human EPO administered to patients after cardiac surgery would minimize kidney lesions and the systemic inflammatory response, thereby decreasing acute kidney injury (AKI incidence. Methods In this double-blinded randomized control study, 80 patients admitted to the ICU post-cardiac surgery were randomized by computer to receive intravenously isotonic saline (n = 40 versus α-Epoetin (n = 40: either 40000 IU (n = 20 or 20000 IU (n = 20. The study lasted one year. The primary outcome was the change in urinary NGAL concentration from baseline and 48 h after EPO injection. Creatinine, cystatine C and urinary NGAL levels were measured on the day of randomization and 2–4 days after EPO injection. To assess acute inflammatory response, serum cytokines (IL6 and IL8 were measured at randomization and four days after r-HuEPO injection. Patients and care-takers were blinded for the assignment. Results No patient was excluded after randomization. Patient groups did not differ in terms of age, gender, comorbidities and renal function at randomization. The rate of AKI assessed by AKIN criteria was 22.5% in our population. EPO treatment did not significantly modify the difference in uNGAl between 48 hours and randomization compared to placebo [2.5 ng/ml (−17.3; 22.5 vs 0.7 ng/ml (−31.77; 25.15, p = 0.77] and the incidence of AKI was similar. Inflammatory cytokines levels were not influenced by EPO treatment. Mortality and hospital stays were similar between the groups and no adverse event was recorded. Conclusion In this randomized-controlled trial, α-Epoetin administrated after cardiac surgery, although safe, demonstrated neither nephroprotective nor anti-inflammatory properties. Trial registration number NCT

  19. 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...

  20. Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: A randomized controlled pilot study

    NARCIS (Netherlands)

    Dronkers, J.J.; Lamberts, H.; Reutelingsperger, I.M.M.D.; Naber, R.H.; Dronkers-Landman, C.M.; Veldman, A.; Meeteren, N.L.U. van

    2010-01-01

    Objective: Investigation of the feasibility and preliminary effect of a short-term intensive preoperative exercise programme for elderly patients scheduled for elective abdominal oncological surgery. Design: Single-blind randomized controlled pilot study. Setting: Ordinary hospital in the

  1. 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

  2. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

  3. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  4. 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.......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....

  5. 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.

  6. Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.

    Science.gov (United States)

    Butler, Kristina; Yi, John; Wasson, Megan; Klauschie, Jennifer; Ryan, Debra; Hentz, Joseph; Cornella, Jeffrey; Magtibay, Paul; Kho, Roseanne

    2017-05-01

    After vaginal surgery, oral and parenteral narcotics are used commonly for pain relief, and their use may exacerbate the incidence of sedation, nausea, and vomiting, which ultimately delays convalescence. Previous studies have demonstrated that rectal analgesia after surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium rectal suppositories may be used to relieve pain and minimize side effects; however, their efficacy has not been confirmed. We aimed to evaluate the use of belladonna and opium suppositories for pain reduction in vaginal surgery. A prospective, randomized, double-blind, placebo-controlled trial that used belladonna and opium suppositories after inpatient or outpatient vaginal surgery was conducted. Vaginal surgery was defined as (1) vaginal hysterectomy with uterosacral ligament suspension or (2) posthysterectomy prolapse repair that included uterosacral ligament suspension and/or colporrhaphy. Belladonna and opium 16A (16.2/60 mg) or placebo suppositories were administered rectally immediately after surgery and every 8 hours for a total of 3 doses. Patient-reported pain data were collected with the use of a visual analog scale (at 2, 4, 12, and 20 hours postoperatively. Opiate use was measured and converted into parenteral morphine equivalents. The primary outcome was pain, and secondary outcomes included pain medication, antiemetic medication, and a quality of recovery questionnaire. Adverse effects were surveyed at 24 hours and 7 days. Concomitant procedures for urinary incontinence or pelvic organ prolapse did not preclude enrollment. Ninety women were randomly assigned consecutively at a single institution under the care of a fellowship-trained surgeon group. Demographics did not differ among the groups with mean age of 55 years, procedure time of 97 minutes, and prolapse at 51%. Postoperative pain scores were equivalent among both groups at each time interval. The belladonna and opium group used a

  7. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

    Science.gov (United States)

    Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

    2016-09-01

    Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon

  8. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. The effect of yoga in stress reduction for dental students performing their first periodontal surgery: A randomized controlled study

    Directory of Open Access Journals (Sweden)

    Rajesh Shankarapillai

    2012-01-01

    Full Text Available Context: The dental students experience a lot of stress, which increase when they perform their first surgical procedure. Yoga as an anxiolytic tool in anxiety reduction has been practiced over centuries in India. Aim: To assess the efficacy of yoga in reducing the state trait anxiety of dental students before their first periodontal surgery performance. Settings and Design: A randomized controlled study using a two-way split plot design (pre-post-test was conducted in the department of periodontics, Pacific Dental College, Udaipur, India. Materials and Methods: One hundred clinical dental students who were ready to perform their first periodontal surgery were selected. Students were randomly assigned to two groups and were given a 60-min session on stress reduction. Group A, yogic intervention group, were instructed to do yoga and their performances were monitored for a period of one week and Group B, control group, were given a lecture on stress reduction without any yoga instructions. The investigator who was unaware of the groups had taken the state trait anxiety score of the students three times a before assigning them to each group, b prior to the surgical procedure and c immediately after the performance of surgery. Statistical Analysis Used: Analyses of variance (ANOVA by SPSS V.16. Results: The statistical results showed a significant reduction in the VAS and state trait anxiety of Group A compared to Group B (ANOVA; P<0.001. Conclusions: This study concludes that Yogic breathing has a significant effect on the reduction of state trait anxiety level of dental students.

  10. Association of time-to-surgery with outcomes in clinical stage I-II pancreatic adenocarcinoma treated with upfront surgery.

    Science.gov (United States)

    Swords, Douglas S; Zhang, Chong; Presson, Angela P; Firpo, Matthew A; Mulvihill, Sean J; Scaife, Courtney L

    2017-12-13

    Time-to-surgery from cancer diagnosis has increased in the United States. We aimed to determine the association between time-to-surgery and oncologic outcomes in patients with resectable pancreatic ductal adenocarcinoma undergoing upfront surgery. The 2004-2012 National Cancer Database was reviewed for patients undergoing curative-intent surgery without neoadjuvant therapy for clinical stage I-II pancreatic ductal adenocarcinoma. A multivariable Cox model with restricted cubic splines was used to define time-to-surgery as short (1-14 days), medium (15-42), and long (43-120). Overall survival was examined using Cox shared frailty models. Secondary outcomes were examined using mixed-effects logistic regression models. Of 16,763 patients, time-to-surgery was short in 34.4%, medium in 51.6%, and long in 14.0%. More short time-to-surgery patients were young, privately insured, healthy, and treated at low-volume hospitals. Adjusted hazards of mortality were lower for medium (hazard ratio 0.94, 95% confidence interval, .90, 0.97) and long time-to-surgery (hazard ratio 0.91, 95% confidence interval, 0.86, 0.96) than short. There were no differences in adjusted odds of node positivity, clinical to pathologic upstaging, being unresectable or stage IV at exploration, and positive margins. Medium time-to-surgery patients had higher adjusted odds (odds ratio 1.11, 95% confidence interval, 1.03, 1.20) of receiving an adequate lymphadenectomy than short. Ninety-day mortality was lower in medium (odds ratio 0.75, 95% confidence interval, 0.65, 0.85) and long time-to-surgery (odds ratio 0.72, 95% confidence interval, 0.60, 0.88) than short. In this observational analysis, short time-to-surgery was associated with slightly shorter OS and higher perioperative mortality. These results may suggest that delays for medical optimization and referral to high volume surgeons are safe. Published by Elsevier Inc.

  11. Clinical Practice Guidelines Decrease Unnecessary Echocardiograms Before Hip Fracture Surgery.

    Science.gov (United States)

    Adair, Chris; Swart, Eric; Seymour, Rachel; Patt, Joshua; Karunakar, Madhav A

    2017-04-19

    Preoperative assessment of geriatric patients with a hip fracture may include transthoracic echocardiography (TTE), which increases resource utilization and cost and may delay surgery. The purpose of this study was to evaluate preoperative TTE utilization at a single institution in order to determine (1) how often TTE is ordered in accordance with clinical practice guidelines (CPGs), (2) how frequently TTE reveals cardiac disease that may alter medical or anesthesia management, and (3) whether following CPGs reduces unnecessary TTE utilization without potentially missing important disease. A retrospective review of data on 100 geriatric patients with a hip fracture who had undergone preoperative TTE was performed. Charts were reviewed to evaluate if TTE had been obtained in accordance with the published CPGs from the American College of Cardiology/American Heart Association (ACC/AHA). TTE reports were reviewed for the presence of disease that was important enough to cause modifications in anesthesia or perioperative management, including new left ventricular systolic or diastolic dysfunction, moderate or severe valvular disease, and pulmonary hypertension. Finally, the sensitivity and specificity of accordance with the ACC/AHA CPGs for predicting which patients would have TTE that identified important disease were calculated. The TTE was ordered in accordance with the published ACC/AHA CPGs for 66% of the patients. TTE revealed disease with the potential to modify anesthesia or medical management in 14% of the patients-for all of whom the TTE had been indicated according to ACC/AHA guidelines (i.e., the guidelines were 100% sensitive). In this study population, following the ACC/AHA guidelines could have prevented the performance of TTE in 34% of the patients without missing any disease (40% specificity). Preoperative TTE for patients with a hip fracture is frequently obtained outside the recommendations of established CPGs. Utilization of CPGs such as the ACC

  12. Nigerian Journal of Surgery

    African Journals Online (AJOL)

    Comparative efficacy of amoxicillin/clavulanic acid and levofloxacin in the reduction of postsurgical sequelae after third molar surgery: A randomized, double blind, clinical trial in a Nigerian University Teaching Hospital.

  13. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    Science.gov (United States)

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  14. Experience with day-care surgery in a Private Surgical Clinic in ...

    African Journals Online (AJOL)

    A retrospective study of 251 operations carried out in a private surgical consultation clinic in Nakuru, Kenya was undertaken. A review was carried out of the clinical notes of patients who had surgery at this clinic between Jan. 1993 and June 1998 and who were regularly followed up to their formal discharge from the clinic.

  15. A randomized, single-center study of equivalence of 2 intraocular lenses used in cataract surgery.

    Science.gov (United States)

    Constantinou, Marios; Jhanji, Vishal; Jing, Xie; Lamoureux, Ecosse L; Boffa, Umberto; Taylor, Hugh R; Vajpayee, Rasik B

    2013-03-01

    To compare the outcomes of 2 intraocular lenses (IOLs) for the treatment of age-related cataracts. Prospective, randomized trial. Patients with age-related cataracts were recruited and randomized to receive phacoemulsification and implantation of either the AcrySof SA60AT lens (Alcon, Inc, Fort Worth, TX) or the low-cost Tecsoft Flex lens (Fred Hollows Foundation, Tilganga, Nepal). A total of 300 patients were available for description and analysis (148 in the AcrySof group and 152 in the Tecsoft group). Patients underwent phacoemulsification and implantation of the AcrySof SA60AT lens or the Tecsoft Flex lens. They were followed up and examined at baseline, 1 week, 1 month, 6 months, and 12 months after cataract surgery. Uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), incidence of posterior capsule opacification (PCO), Visual Function Index questionnaire results, and safety of the implanted IOLs. No significant difference (P>0.05) was found in UDVA and BDVA after surgery between the 2 groups. The equivalence test of the 95% confidence intervals showed that both lenses had an equal improvement of UDVA and BDVA as well as similar rates of PCO after cataract surgery. There was no significant difference between the 2 groups with regard to visual functioning or the incidence of adverse surgical events during (P>0.05) or after (P>0.05) the surgery. The Tecsoft Flex IOL is a low-cost suitable alternative that is similar to the AcrySof IOL in terms of safety and visual outcomes. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  16. Acute pancreatitis following scoliosis surgery: description and clinical course in 14 adolescents.

    Science.gov (United States)

    El Bouyousfi, Maalik; Leveque, Christine; Miladi, Lotfi; Irtan, Sabine; Hamza, Jamil; Oualha, Mehdi

    2016-10-01

    Acute pancreatitis is a possible complication after scoliosis surgery. Although some risk factors have been documented in the literature, clinical description of pancreatitis diagnosis and ensuing course still remain very poor. The aim of this study was to describe characteristics of acute pancreatitis after scoliosis surgery. A descriptive, retrospective and single-center study of fourteen adolescents with postoperative acute pancreatitis after spine fusion surgery in scoliosis management between April 2003 and August 2012 was performed. Acute pancreatitis occurred within 9.5 days (4-51) after surgery. Abdominal pain was atypical and was expressed in only half of the children. Ileus, nausea and vomiting were the most frequent signs. None of the acute pancreatitis cases was severe. Acute pancreatitis is an early complication of scoliosis surgery. Clinical signs are atypical and non-severe and can induce misleading forms. Presence of delayed digestive problems should alert the clinician to the risk of pancreatitis in the aftermath of scoliosis surgery.

  17. Clinics of Oblivion: Makeover Culture and Cosmetic Surgery

    Directory of Open Access Journals (Sweden)

    Meredith Jones

    2011-09-01

    Full Text Available This paper examines cosmetic surgery tourism, arguing that it can be meaningfully analysed as part of makeover culture. It shows that while cosmetic surgery tourism sits at a junction of cosmetic surgery and medical tourism, it also has much in common with contemporary tourism practices. The paper posits cosmetic surgery tourism not only as an economic and globalised phenomenon but also as a set of practices that are experienced, and that take place on the body (see also Cook, 2010; Bell et al. 2011. Chris Rojek’s work on contemporary tourist practices is deployed in order to argue that the cosmetic surgery tourist’s body is itself the ‘site’ to be visited and discovered; it is also the souvenir that is brought home. When body and site are brought together in cosmetic surgery tourism, they form a potent nexus that is unique to a contemporary moment tied up with globalisation and consumption, where both identity and self-transformation are managed through the body.

  18. Enhanced recovery pathways optimize health outcomes and resource utilization: A meta-analysis of randomized controlled trials in colorectal surgery

    DEFF Research Database (Denmark)

    Adamina, Michel; Kehlet, Henrik; Tomlinson, George A

    2011-01-01

    was halved (relative risk, 0.52; 95% CrI, 0.36–0.73) and readmission was not increased (relative risk, 0.59; 95% CrI, 0.14–1.43) when compared with patients undergoing traditional care. Conclusion Adherence to ERP achieves a reproducible improvement in the quality of care by enabling standardization...... in costs that threatens the stability of health care systems. Enhanced recovery pathways (ERP) have been proposed as a means to reduce morbidity and improve effectiveness of care. We have reviewed the evidence supporting the implementation of ERP in clinical practice. Methods Medline, Embase......, and the Cochrane library were searched for randomized, controlled trials comparing ERP with traditional care in colorectal surgery. Systematic reviews and papers on ERP based on data published in major surgical and anesthesiology journals were critically reviewed by international contributors, experienced...

  19. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Laizner, Andréa Maria; Maheu, Christine; Gélinas, Céline

    2016-11-07

    Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http

  20. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  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. Effects of cell-saving devices and filters on transfusion in cardiac surgery: a multicenter randomized study.

    Science.gov (United States)

    Vermeijden, Wytze J; van Klarenbosch, Jan; Gu, Y John; Mariani, Massimo A; Buhre, Wolfgang F; Scheeren, Thomas W L; Hagenaars, Johanna A M; Tan, M Erwin S H; Haenen, Jo S E; Bras, Leo; van Oeveren, Wim; van den Heuvel, Edwin R; de Vries, Adrianus J

    2015-01-01

    Cell-saving devices (CS) are frequently used in cardiac surgery to reduce transfusion requirements, but convincing evidence from randomized clinical trials is missing. Filtration of salvaged blood in combination with the CS is widely used to improve the quality of retransfused blood, but there are no data to justify this approach. To determine the contribution of CS and filters on transfusion requirements, we performed a multicenter factorial randomized clinical trial in two academic and four nonacademic hospitals. Patients undergoing elective coronary, valve, or combined surgical procedures were included. The primary end point was the number of allogeneic blood products transfused in each group during hospital admission. From 738 included patients, 716 patients completed the study (CS+filter, 175; CS, 189; filter, 175; neither CS nor filter, 177). There was no significant effect of CS or filter on the total number of blood products (fraction [95% confidence interval]: CS, 0.96 [0.79, 1.18]; filter, 1.17 [0.96, 1.43]). Use of a CS significantly reduced red blood cell transfusions within 24 hours (0.75 [0.61,0.92]), but not during hospital stay (0.86 [0.71, 1.05]). Use of a CS was significantly associated with increased transfusions of fresh frozen plasma (1.39 [1.04, 1.86]), but not with platelets (1.25 [0.93, 1.68]). Use of a CS significantly reduced the percentage of patients who received any transfusion (odds ratio [95% confidence interval]: 0.67 [0.49, 0.91]), whereas filters did not (0.92 [0.68, 1.25]). Use of a CS, with or without a filter, does not reduce the total number of allogeneic blood products, but reduces the percentage of patients who need blood products during cardiac surgery. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  3. Hospital-level Variation in Utilization of Surgery for Clinical Stage I-II Pancreatic Adenocarcinoma.

    Science.gov (United States)

    Swords, Douglas S; Mulvihill, Sean J; Skarda, David E; Finlayson, Samuel R G; Stoddard, Gregory J; Ott, Mark J; Firpo, Matthew A; Scaife, Courtney L

    2017-07-11

    To (1) evaluate rates of surgery for clinical stage I-II pancreatic ductal adenocarcinoma (PDAC), (2) identify predictors of not undergoing surgery, (3) quantify the degree to which patient- and hospital-level factors explain differences in hospital surgery rates, and (4) evaluate the association between adjusted hospital-specific surgery rates and overall survival (OS) of patients treated at different hospitals. Curative-intent surgery for potentially resectable PDAC is underutilized in the United States. Retrospective cohort study of patients ≤85 years with clinical stage I-II PDAC in the 2004 to 2014 National Cancer Database. Mixed effects multivariable models were used to characterize hospital-level variation across quintiles of hospital surgery rates. Multivariable Cox proportional hazards models were used to estimate the effect of adjusted hospital surgery rates on OS. Of 58,553 patients without contraindications or refusal of surgery, 63.8% underwent surgery, and the rate decreased from 2299/3528 (65.2%) in 2004 to 4412/7092 (62.2%) in 2014 (P < 0.001). Adjusted hospital rates of surgery varied 6-fold (11.4%-70.9%). Patients treated at hospitals with higher rates of surgery had better unadjusted OS (median OS 10.2, 13.3, 14.2, 16.5, and 18.4 months in quintiles 1-5, respectively, P < 0.001, log-rank). Treatment at hospitals in lower surgery rate quintiles 1-3 was independently associated with mortality [Hazard ratio (HR) 1.10 (1.01, 1.21), HR 1.08 (1.02, 1.15), and HR 1.09 (1.04, 1.14) for quintiles 1-3, respectively, compared with quintile 5] after adjusting for patient factors, hospital type, and hospital volume. Quality improvement efforts are needed to help hospitals with low rates of surgery ensure that their patients have access to appropriate surgery.

  4. 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.

  5. Adolescent Idiopathic Scoliosis – case report of a patient with clinical deterioration after surgery

    Directory of Open Access Journals (Sweden)

    Weiss Hans-Rudolf

    2007-12-01

    Full Text Available Abstract Background Although there is no evidence that the long-term effects of scoliosis surgery are superior to the long-term effects of Adolescent Idiopathic Scoliosis (AIS itself, patients can fear the consequences of not under going this surgery due to incorrect or insufficient information. The main indication for surgical treatment in patients with AIS, is cosmetic. However spinal surgery may, along with other negative side effects, actually cause postoperative clinical deterioration. This complication of surgery has not yet been described in international literature. Case presentation A 15-year old female patient originally presenting with a well-compensated double curve pattern scoliosis. The patient was advised to undergo surgery due to the long-term negative impact of signs and symptoms of scoliosis upon her health. The patient agreed to surgery, which was performed in one of Germanys leading centres for spinal surgery. The thoracolumbar curve was corrected and fused, while the thoracic curve, clearly showing wedged vertebrae, defined as structural scoliosis, remained untreated. This operation left the patient with an unbalanced appearance, with radiological and clinical imbalance to the right. The clinical appearance of the patient though clearly deteriorated post-surgery. Furthermore, the wedged disc space below the fusion area indicates future problems with possible destabilisation accompanied probably by low back pain. Conclusion Scoliosis surgery for patients with AIS is mainly indicated for cosmetic or psychological reasons. Therefore the treatment leading to the best possible clinical appearance and balance has to be chosen. Patients should be informed that surgery will not necessarily improve their health status. Clinical deterioration after surgery may occur, and such information is crucial for an adequate informed consent.

  6. Subsidence after anterior cervical inter-body fusion. A randomized prospective clinical trial.

    Science.gov (United States)

    Kast, Erich; Derakhshani, Sharam; Bothmann, Matthias; Oberle, Joachim

    2009-04-01

    In ventral fusion after anterior cervical discectomy there is still a remarkable number of cage subsidence and segmental kyphosis seen. The aim of the present study is to assess whether the cage design influences the extent of correction loss during follow-up. Sixty patients with single-level cervical disc herniation were randomly treated with two different cervical inter-body cages (group 1: Solis cage, Stryker Company and group 2: Shell cage, AMT Company). Clinical and radiological follow-up was done before and after surgery, 3 and 6 months post-surgery. Clinical follow-up was done with the help of Odom's criteria. Both groups were similar in the baseline parameters (age, sex, treated level). Statistically, the subsidence was significantly higher at 3 and 6-month follow-ups in group 1 than in group 2, however, clinical results showed no significant differences. In 67%, subsidence was seen in the anterior lower aspect of the treated segment. Segmental kyphosis was seen in seven patients of group 1 and two patients of group 2. A significant correlation is found between Odom's criteria and subsidence. Although there was no significant difference in a short-term clinical result between the two treatment groups, we recommend the use of cages which preserve the determined segmental height and lordosis.

  7. Clinical observation on vitreous surgery in treating idiopathic macular hole

    Directory of Open Access Journals (Sweden)

    Min Liu

    2013-12-01

    Full Text Available AIM: To observe the surgical effect and influential factors of idiopathic macular hole(IMHtreated with vitrectomy and internal limiting membrane peeling combined with intravitreal gas tamponade.METHODS: The clinical data of 22 IMH patients(23 eyeswere retrospectively analyzed. All the patients were diagnosed with IMH by optical coherence tomography(OCTand their macular hole patterns were measured before and after surgery by OCT in addition to the routine examinations. All patients were treated with vitrectomy, internal limiting membrane peeling combined with gas injection(air or inert gas. The postoperative visual acuity, macular hole closure rate and the incidence of surgical complications were observed. The correlation between the patients' age, course of disease, preoperative best corrected visual acuity(BCVA, macular hole diameter, the type of vitreous cavity filling gas, the postoperative BCVA, and the macular hole closure rate was analyzed with SPSS 13.0 statistical software.RESULTS: Postoperative OCT examination results showed that the macular hole closure rate was 100%. The macular hole closure rate was 79%(11 eyes of 14 eyesafter the first intravitreal air injection and 100%(9 eyesafter fist intravitreal inert gas injection(100mL/L C3F8. There was no significant difference between the air injection and inert gas injection(χ2=2.1214, P>0.05. The mean preoperational BCVA was 0.11±0.05 and the mean postoperative BCVA 0.23±0.12; there was a statistically significant difference between them(t=4.023,Pt=3.92, PPr=-0.415, P=0.256, duration of disease(r=0.193, P= 0.498, preoperative VA(r=0.152, P=0.673had no significant influence on IMH visual outcomes.CONCLUSION: The vitrectomy combined with internal limiting membrane peeling and intravitreal gas tamponade is an effective treatment for IMH; the macular hole diameter is the major influence factor in the postoperative closure and visual prognosis of IMH; while the preoperative visual acuity

  8. Comparing the outcomes of incisions made by colorado microdissection needle, electrosurgery tip, and surgical blade during periodontal surgery: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rampalli Viswa Chandra

    2016-01-01

    Full Text Available Context: Electrosurgery offers many unique advantages such as hemostasis and precise tissue cutting; however, there are a number of disadvantages including thermal injury and delayed wound healing. Aims: The aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip, and surgical blade during periodontal surgery. Settings and Design: Twenty-two individuals participated in this study. Three quadrants in each individual were randomly assigned into each of the following experimental groups: Colorado® microdissection needle (CMD, electrosurgery tip (EC and surgical blade (BP, in which, incisions were given with Colorado® microdissection needle, straight electrocautery tip, and a scalpel blade, respectively. Materials and Methods: Blood loss (BL was measured immediately after surgery, and changes in interdental papilla dimensions were recorded at baseline, 7, 30, 120, and 180 days after surgery. Measures of periodontal disease were recorded at baseline, 120, and 180 days after surgery. Postoperative pain and wound healing were recorded at 1, 7, and 15 days after surgery. Results: The use of CMD for periodontal surgery showed better results over EC in all parameters. CMD resulted in lesser bleeding and less postoperative pain and attained similar results to that of BP in clinical parameters of periodontal disease. Conclusions: Colorado® microdissection needle may be a better choice for incisions as it seems to show less tissue damage than cautery and offers tissue healing comparable to scalpel blade.

  9. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know.

    Science.gov (United States)

    Mendes, Cynthia de Almeida; Martins, Alexandre de Arruda; Fukuda, Juliana Maria; Parente, José Ben-Hur Ferraz; Munia, Marco Antonio Soares; Fioranelli, Alexandre; Teivelis, Marcelo Passos; Varella, Andrea Yasbek Monteiro; Caffaro, Roberto Augusto; Kuzniec, Sergio; Wolosker, Nelson

    2016-11-01

    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. 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. 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. 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 assessments.

  10. 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

  11. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don’t tell, they won’t know

    Science.gov (United States)

    de Almeida Mendes, Cynthia; de Arruda Martins, Alexandre; Fukuda, Juliana Maria; Parente, José Ben-Hur Ferraz; Munia, Marco Antonio Soares; Fioranelli, Alexandre; Teivelis, Marcelo Passos; Varella, Andrea Yasbek Monteiro; Caffaro, Roberto Augusto; Kuzniec, Sergio; Wolosker, Nelson

    2016-01-01

    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 assessments

  12. Dienogest as preoperative treatment of submucous myomas for hysteroscopic surgery: a prospective, randomized study.

    Science.gov (United States)

    Laganà, Antonio Simone; Giacobbe, Valentina; Triolo, Onofrio; Granese, Roberta; Ban Frangež, Helena; Vrtačnik-Bokal, Eda; Ietto, Chiara; Palmara, Vittorio Italo

    2016-01-01

    The aim of this single-center, prospective, randomized, parallel-group study was to compare Dienogest and Danazol as endometrial preparation in patients who have to undergo hysteroscopic surgery for submucous myomas. We enrolled 80 consecutive eligible patients, in reproductive age, affected by submucous myomas. Pre- and posttreatment characterization of endometrium was performed by hysteroscopic visual observation and histologic confirmation. The enrolled patients were randomly assigned to two groups: 40 were treated with 2 mg of Dienogest/die, 40 with 100 mg of Danazol/die, both orally for 5 weeks, starting on day 1 of menstruation. Posttreatment comparison of endometrial patterns showed a significant more marked effect of Dienogest, respect to Danazol, in atrophying endometrium ("normotrophic non-responders" versus "hypotrophic"-"atrophic", p = 0.028). Intraoperative data showed no significant difference between the two groups for cervical dilatation time (p = 0.326), while in the Dienogest group, we found a significant reduction of operative time (p = 0.001), infusion volume (p = 0.001), and severity of bleeding (p = 0.042). Moreover, Dienogest caused less side effects (p = 0.008). According to our data analysis, Dienogest, respect to Danazol, is more effective for the preparation of the endometrium in patients who have to undergo hysteroscopic surgery for submucous myomas, and causes less side effects.

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

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    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.

  14. Burnout and Work Demands Predict Reduced Job Satisfaction in Health Professionals Working In a Surgery Clinic

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    Dragan Mijakoski

    2015-03-01

    CONCLUSIONS: Adequate management of work demands, particularly excessive workload, time pressure, and lack of staff can lead to prevention of burnout and reduced job satisfaction in surgery clinic HPs, and contribute to better quality of patient care.

  15. To drain or not to drain after thyroid surgery: A randomized ...

    African Journals Online (AJOL)

    Methods: This was a randomized controlled trial, carried out at a tertiary national referral hospital (Mulago, Kampala). Over a 6 month period in 2011, we recruited 68 patients. Socio-demographic information and clinical parameters were recorded. Outcomes measures were evaluated. Data were double entered into epidata ...

  16. Clinical Challenges in Upper Gastrointestinal Malignancies after Bariatric Surgery

    NARCIS (Netherlands)

    W.H.W. Tse (Win Hou W); H.M. Kroon (Herman); J.J.B. van Lanschot (Jan)

    2017-01-01

    textabstractBackground/Aims: The incidence of morbid obesity has exponentially increased over the last decades. Bariatric surgery (BS) has been proven effective in inducing weight loss and resolving comorbidities associated with morbid obesity. However, BS can also lead to major diagnostic and

  17. 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

  18. 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

  19. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

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    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  20. Does Vitamin D3 Have an Impact on Clinical and Biochemical Parameters Related to Third Molar Surgery.

    Science.gov (United States)

    Oteri, Giacomo; Cicciù, Marco; Peditto, Matteo; Catalano, Antonino; Loddo, Saverio; Pisano, Michele; Lasco, Antonino

    2016-03-01

    The purpose of this study was to evaluate the clinical effect on the biochemical inflammatory markers of a single oral high dose of cholecalciferol in vitamin D-deficient patients undergoing the surgical removal of lower third molars.A randomized, split-mouth, single-blind study was conducted on 25 vitamin D-deficient patients ranging between 18 and 40 years of age requiring lower third molars extraction and referred at the Oral Surgery Unit of the School of Dentistry of the University of Messina.All patients, with vitamin D3 blood levels ≦30 ng/mL, underwent bilateral surgical removal. The first extraction (control group) being conducted with the administration of a placebo, the second one (test group) being conducted with the preliminary administration of 300,000 IU of cholecalciferol 4 days before the procedure.At each surgery, clinical indexes, such as pain, edema and any functional limitation have been recorded. Clinical and biochemical parameters were registered 4 days before, immediately after, 3 and 7 days after the surgical procedure. The data obtained were processed using paired t-test. The clinical outcome parameters showed a slight to moderate improvement between the control and the vitamin-D treatment group, with statistical significance being obtained regarding the edema at defined time points. Interleukin-1-beta, interleukin-6, and tumor necrosis factor-alpha values were significantly lower (P surgery. The increase of vitamin D serum levels showed an impact on the outcome of the third molar surgery, eliciting a reduced inflammatory response and leading to a more favorable clinical course.

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

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    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

  2. The Hispanic Clinic for Pediatric Surgery: A model to improve parent-provider communication for Hispanic pediatric surgery patients.

    Science.gov (United States)

    Jaramillo, Joshua; Snyder, Elizabeth; Dunlap, Jonathan L; Wright, Robert; Mendoza, Fernando; Bruzoni, Matias

    2016-04-01

    26 million Americans have limited English proficiency (LEP). It is well established that language barriers adversely affect health and health care. Despite growing awareness of language barriers, there is essentially a void in the medical literature regarding the influence of language disparity on pediatric surgery patients. This study was designed to assess the impact of patient-provider language concordance on question-asking behavior and patient satisfaction for pediatric surgery patients. Participants included families of patients in a General Pediatric Surgery Clinic categorized into 3 groups by patient-provider language concordance: concordant English-speaking, LEP concordant Spanish-speaking, and LEP discordant Spanish-speaking using an interpreter. Clinical visits were audio recorded and the number of patient-initiated questions and the length of clinical encounter were measured. Families were administered a surgery-specific, 5-point Likert scale questionnaire modeled after validated surveys concerning communication, trust, perceived discrimination and patient-provider language concordance. Regression models were performed to analyze associations between language concordance and patient's question-asking behavior and between language concordance and survey results. A total of 156 participants were enrolled including 57 concordant-English, 52 LEP concordant-Spanish and 47 LEP-discordant-Spanish. There was significant variation in the mean number of patient-initiated questions among the groups (p=0.002). Both the English and Spanish concordant groups asked a similar number of questions (p=0.9), and they both asked more questions compared to the Spanish-discordant participants (p=0.002 and p=0.001). Language discordance was associated with fewer questions asked after adjustment for socioeconomic status. Language concordant participants rated higher scores of communication. Both Spanish-concordant and Spanish-discordant patients reported significantly increased

  3. TENS effects on dysesthesia and quality of life after breast cancer surgery with axilectomy: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Andreza Carvalho Rabelo Mendonça

    Full Text Available Abstract Introduction: After breast cancer surgery, many women may present quality of life (QOL impairment due to the presence of discomfort as dysesthesia in the anterolateral region of the chest, armpit and/or medial part of the arm caused by intercostobrachial nerve injury (ICBN. Objective: To investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS on dysesthesia intensity at the intercostobrachial nerve (ICBN dermatome and QOL in women after breast cancer surgery. Methods: A randomized, double-blinded, placebo controlled clinical trial was conducted. Women undergoing axillary lymphadenectomy (AL, with dysesthesia on ICBN dermatome were included. Patients were divided into active and placebo TENS groups. TENS was applied with a frequency of 100 Hz, pulse duration of 100 µs and amplitude at the highest sensory intensity tolerable for 20 minutes during 20 sessions, three times a week, on alternating days. In the placebo TENS group, electrical current was delivered only during the first 45 seconds of application. Skin sensitivity was assessed by esthesiometry. Dysesthesia intensity was assessed with a visual analogue scale (VAS and QOL with the EORTC QLQ-C30 and the specific EORTC QLQ-BR23 which is the Breast Cancer Module. Results: VAS decreased significantly over the 20 sessions in the active TENS group (p<0.006 and no difference was found between groups. There weren’t significant differences in EORTC QLQ-C30 and EORTC QLQ-BR23 after 20 sessions or between groups. Conclusion: TENS decreased dysesthesia intensity in the ICBN dermatome after breast cancer surgery, but did not improve quality of life.

  4. 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.

  5. 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.

  6. Clinical assessment and management of general surgery patients via synchronous telehealth.

    Science.gov (United States)

    Cain, Steven M; Moore, Robert; Sturm, Lauren; Mason, Travis; Fuhrman, Caitlin; Smith, Robin; Bojicic, Irfan; Carter, Brandon

    2017-02-01

    Objective This paper describes how a clinical team at Landstuhl Regional Medical Center (LRMC) successfully integrated synchronous telehealth (TH) into their routine clinical practice. Methods and materials Synchronous TH encounters were performed using Polycom® software on surgeons' computers with high-definition (HD) cameras on monitors at distant sites and PolyCom HDX9000® Telehealth Practitioner Carts at originating sites. Patients provided consented and were presented to general surgeons by nurses and medical technicians at Army health clinics throughout the European Theater. Results In calendar year (CY) 2014, five general surgeons and two surgical physician assistants (PAs) at Landstuhl Regional Medical Center along with registered nurses (RNs) at six originating clinic sites throughout Europe completed 130 synchronous TH encounters for 101 general surgery patients resulting in 73 completed and 16 recommended surgeries. Eighty-eight percent of patients had a completed or recommended surgery. No surgeries or procedures planned after initial TH evaluation were cancelled. Originating site clinics ranged in distance from 68 miles to 517 miles. Acceptance by providers, patients and clinic staff was high. Conclusion Synchronous TH was effective and safe in evaluating common general surgical conditions. We excluded sensitive and complex conditions requiring a nuanced physical examination. The TH efforts of the general surgery staff have resulted in high-quality, seamless and predictable TH activities that continue to expand into other surgical and medical specialties beyond general surgery. Seven surgeons and two PAs use synchronous TH regularly serving patients over a broad geographic area.

  7. Industry sponsorship and selection of comparators in randomized clinical trials.

    Science.gov (United States)

    Lathyris, D N; Patsopoulos, N A; Salanti, G; Ioannidis, J P A

    2010-02-01

    Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products. Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period. Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors. Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition.

  8. A study of the correlation between patient-reported outcomes and clinical outcomes after cataract surgery in ophthalmic clinics.

    Science.gov (United States)

    Mollazadegan, Kaziwe; Lundström, Mats

    2015-05-01

    To analyse the relationship between patient-reported outcome measures and clinical outcome measures in 42 individual Swedish cataract surgery settings. The study material consisted of follow-up data on cataract extractions collected by the Swedish National Cataract Register in 2008-2011. Patient-reported outcome was measured using the Catquest-9SF questionnaire. A total of 9707 pairs of questionnaires completed before and after a cataract extraction were analysed together with clinical data. The analyses were performed for each clinic. For almost all clinics, a factor related to a poor patient-reported outcome after surgery was a good preoperative self-assessed visual function. For some clinics, up to 50% of the patients stated that they were very satisfied with their vision before surgery. For single clinics, different factors such as large anisometropia (≥3D), capsule complications, biometry prediction error (≥3D) and ocular comorbidity were related to a poor patient-reported outcome. In situations where the clinical outcome was good and the patient-reported outcome was poor, problems with near-vision activities after surgery was the main factor noted. Analysing factors related to a poor patient-reported outcome for each clinic showed large variation. Weak indication for surgery, refractive problems after surgery, surgical complications and a poor chance of visual recovery due to ocular comorbidity were among the reasons for a poor patient-reported outcome. Post-operative care in terms of establishing a good near vision seemed to be another problem for some clinics. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  9. Economic impact of clinical variability in preoperative testing for major outpatient surgery.

    Science.gov (United States)

    Gil-Borrelli, Christian Carlo; Agustí, Salomé; Pla, Rosa; Díaz-Redondo, Alicia; Zaballos, Matilde

    2016-05-01

    With the purpose of decreasing the existing variability in the criteria of preoperative evaluation and facilitating the clinical decision-making process, our hospital has a protocol of preoperative tests to use with ASA I and ASA II patients. The aim of the study was to calculate the economic impact caused by clinicians' non-adherence to the protocol for the anaesthesiological evaluation of ASA 1 and ASA II patients. A retrospective study of costs with a random sample of 353 patients that were seen in the consultation for Anesthesiology over a period of one year. Aspects related to the costs, patient's profiles and specialties were analysed, according to the degree of fulfillment of the protocol. The lack of adherence to the the protocol was 70%. 130 chest X-rays and 218 ECG were performed without indication. This generated an excess costs of 34 € per patient. Taking into account the expenses of both tests and the attended population undergoing ambulatory surgery during the one-year period, an excess spending for the hospital of between 69.164 € and 83.312 € was estimated. Clinical variability should be reduced and the creation of synergies between the different departments should be enhanced in order to adjust the request for unnecessary complementary tests to decrease health care and to improve the quality of patient care. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  10. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study.

    Science.gov (United States)

    Berlucchi, Marco; Castelnuovo, Paolo; Vincenzi, Andrea; Morra, Bruno; Pasquini, Ernesto

    2009-06-01

    Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.

  11. Should women at increased risk for breast and ovarian cancer be randomized to prophylactic surgery? An ethical and empirical assessment.

    Science.gov (United States)

    Tambor, E S; Bernhardt, B A; Geller, G; Helzlsouer, K J; Doksum, T; Holtzman, N A

    2000-04-01

    More information is needed about the relative effectiveness of prophylactic surgery, chemoprevention, and surveillance in reducing breast and ovarian cancer risk in women with an inherited susceptibility mutation. We assessed practical and ethical barriers to conducting randomized clinical trials (RCTs) to compare preventive interventions for breast and ovarian cancer. Eighty-seven at-risk women who attended an education and counseling session about BRCA1/2 testing were asked about their willingness to participate in hypothetical research studies for breast and ovarian cancer risk reduction. In addition, 247 Maryland physicians from five specialties completed a mail survey including a question about their likelihood of recommending RCT participation to an at-risk woman. Nineteen percent of at-risk women reported willingness to participate in a hypothetical RCT for breast cancer risk reduction and 17% for ovarian cancer risk reduction. Women with children and women likely to have a prophylactic mastectomy if found to have a susceptibility mutation were significantly more willing to participate in an RCT. A majority of women would be willing to participate in nonrandomized trials or registries. Fifty-two percent of physicians responded that they would be likely to recommend RCT participation to a woman carrying a breast cancer susceptibility mutation. Oncologists were the most likely to recommend an RCT. Although the results of nonrandomized trials may be difficult to interpret because of such issues as selection bias. Greater feasibility combined with fewer ethical concerns make nonrandomized trials a more viable alternative to randomized trials for evaluation of preventive interventions for breast and ovarian cancer when prophylactic surgery is one of the treatments being evaluated.

  12. High Spinal Anesthesia Enhances Anti-Inflammatory Responses in Patients Undergoing Coronary Artery Bypass Graft Surgery and Aortic Valve Replacement: Randomized Pilot Study.

    Directory of Open Access Journals (Sweden)

    Trevor W R Lee

    Full Text Available Cardiac surgery induces many physiologic changes including major inflammatory and sympathetic nervous system responses. Here, we conducted a single-centre pilot study to generate hypotheses on the potential immune impact of adding high spinal anaesthesia to general anaesthesia during cardiac surgery in adults. We hypothesized that this strategy, previously shown to blunt the sympathetic response and improve pain management, could reduce the undesirable systemic inflammatory responses caused by cardiac surgery.This prospective randomized unblinded pilot study was conducted on 14 patients undergoing cardiac surgery for coronary artery bypass grafting and/or aortic valve replacement secondary to severe aortic stenosis. The primary outcome measures examined longitudinally were serum pro-inflammatory (IL-6, IL-1b, CCL2, anti-inflammatory (IL-10, TNF-RII, IL-1Ra, acute phase protein (CRP, PTX3 and cardiovascular risk (sST2 biomarkers.The kinetics of pro- and anti-inflammatory biomarker was determined following surgery. All pro-inflammatory and acute phase reactant biomarker responses induced by surgical stress were indistinguishable in intensity and duration between control groups and those who also received high spinal anaesthesia. Conversely, IL-10 levels were markedly elevated in both intensity and duration in the group receiving high spinal anesthesia (p = 0.005.This hypothesis generating pilot study suggests that high spinal anesthesia can alter the net inflammatory response that results from cardiac surgery. In appropriately selected populations, this may add incremental benefit by dampening the net systemic inflammatory response during the week following surgery. Larger population studies, powered to assess immune, physiologic and clinical outcomes in both acute and longer term settings, will be required to better assess potential benefits of incorporating high spinal anesthesia.ClinicalTrials.gov NCT00348920.

  13. 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).

  14. Event detection using population-based health care databases in randomized clinical trials

    DEFF Research Database (Denmark)

    Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik

    2013-01-01

    To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....

  15. Resident Cosmetic Clinic: Practice Patterns, Safety, and Outcomes at an Academic Plastic Surgery Institution.

    Science.gov (United States)

    Qureshi, Ali A; Parikh, Rajiv P; Myckatyn, Terence M; Tenenbaum, Marissa M

    2016-10-01

    Comprehensive aesthetic surgery education is an integral part of plastic surgery residency training. Recently, the ACGME increased minimum requirements for aesthetic procedures in residency. To expand aesthetic education and prepare residents for independent practice, our institution has supported a resident cosmetic clinic for over 25 years. To evaluate the safety of procedures performed through a resident clinic by comparing outcomes to benchmarked national aesthetic surgery outcomes and to provide a model for resident clinics in academic plastic surgery institutions. We identified a consecutive cohort of patients who underwent procedures through our resident cosmetic clinic between 2010 and 2015. Major complications, as defined by CosmetAssure database, were recorded and compared to published aesthetic surgery complication rates from the CosmetAssure database for outcomes benchmarking. Fisher's exact test was used to compare sample proportions. Two hundred and seventy-one new patients were evaluated and 112 patients (41.3%) booked surgery for 175 different aesthetic procedures. There were 55 breast, 19 head and neck, and 101 trunk or extremity aesthetic procedures performed. The median number of preoperative and postoperative visits was 2 and 4 respectively with a mean follow-up time of 35 weeks. There were 3 major complications (2 hematomas and 1 infection requiring IV antibiotics) with an overall complication rate of 1.7% compared to 2.0% for patients in the CosmetAssure database (P = .45). Surgical outcomes for procedures performed through a resident cosmetic clinic are comparable to national outcomes for aesthetic surgery procedures, suggesting this experience can enhance comprehensive aesthetic surgery education without compromising patient safety or quality of care. 4 Risk. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  16. 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

    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...... radiotherapy, did not change these results. CONCLUSION: Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this. REGISTRATION NUMBER: NCT0029779 (http://www.clinicaltrials.gov).......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...

  17. Success and spontaneous pregnancy rates following systemic methotrexate versus laparoscopic surgery for tubal pregnancies: A randomized trial

    DEFF Research Database (Denmark)

    Krag Moeller, Lars Bo; Moeller, Charlotte; Thomsen, Sten Grove

    2009-01-01

    . A total of 106 women diagnosed with ectopic pregnancy (EP). Methods. Between March 1997 and September 2000, 1,265 women were diagnosed with EP, 395 (31%) were eligible, 109 (9%) were randomized of whom 106 had an EP. The study was originally powered to a sample size of 422 patients. The women were......, subsequent intrauterine, and recurrent ectopic pregnancies. Results. The success rates were 74% following MTX treatment and 87% after surgery (n.s.); the subsequent spontaneous intrauterine pregnancy rate was 73% after MTX and 62% after surgery; and the EP rate was 9.6% after MTX and 17.3% following surgery......Objective. To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery. Design. Prospective, randomized, open multicenter study. Setting. Seven Danish departments of obstetrics and gynecology. Sample...

  18. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mariana André Honorato Franzoi

    Full Text Available ABSTRACT Objective: to investigate the effects of music listening, for 15 minutes, on the preoperative anxiety levels in children undergoing elective surgery in comparison with conventional pediatric surgical care. Method: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26 and control group (n = 26. Anxiety was assessed in both groups by the application of the modified Yale Preoperative Anxiety Scale and measurement of the physiological variables, upon arrival and 15 minutes after the first measurement. Results: there was a statistically significant difference in preoperative anxiety between the two groups only in relation to the physiological variable, since the respiratory rate of preschool children in the experimental group reduced in the second measurement compared to the control group (p = 0.0453. The experimental group showed a statistically significant reduction in anxiety levels after 15 minutes of music listening (p = 0.0441, specifically with regard to the behavioral domains of activity, vocalization, emotional expression and apparent awakening state. Conclusion: music listening emerges as a potential nursing intervention for relief of preoperative anxiety in children undergoing surgical procedures. RBR-7mcr59.

  19. 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.

  20. Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial.

    Science.gov (United States)

    van Bakelen, N B; Buijs, G J; Jansma, J; de Visscher, J G A M; Hoppenreijs, Th J M; Bergsma, J E; Stegenga, B; Bos, R R M

    2013-12-01

    Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicenter randomized controlled trial (RCT) was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Plate removal was necessary in 16 of the 134 patients (11.9%) treated with titanium and in 21 of the 87 patients (24.1%) treated with the biodegradable system within the first 2 post-operative years [p = .016, HR biodegradable (95% CI) = 2.2 (1.1-4.2), HR titanium = 1]. Occlusion, VAS, and MFIQ scores showed that both groups had good mandibular function and were (almost) free of pain 1 and 2 years post-operatively (http://controlled-trials.com ISRCTN 44212338).

  1. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

    Directory of Open Access Journals (Sweden)

    Amit X. Garg

    2018-01-01

    Full Text Available Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017. Patients: Patients (~4800 undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery, where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 . Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess

  2. 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

  3. Clinical course of Crohn's disease first diagnosed at surgery for acute abdomen.

    Science.gov (United States)

    Latella, G; Cocco, A; Angelucci, E; Viscido, A; Bacci, S; Necozione, S; Caprilli, R

    2009-04-01

    The severity of clinical activity of Crohn's disease is high during the first year after diagnosis and decreases thereafter. Approximately 50% of patients require steroids and immunosuppressants and 75% need surgery during their lifetime. The clinical course of patients with Crohn's disease first diagnosed at surgery has never been investigated. To assess the clinical course of Crohn's disease first diagnosed at surgery for acute abdomen and to evaluate the need for medical and surgical treatment in this subset of patients. Hospital clinical records of 490 consecutive Crohn's disease patients were reviewed. Patients were classified according to the Vienna criteria. Sex, extraintestinal manifestations, family history of inflammatory bowel diseases, appendectomy, smoking habit and medical/surgical treatments performed during the follow-up period were assessed. Kaplan-Meier survival method and Cox proportional hazards regression model. Of the 490 Crohn's disease patients, 115 had diagnosis of Crohn's disease at surgery for acute abdomen (Group A) and 375 by conventional clinical, radiological, endoscopic and histologic criteria (Group B). Patients in Group A showed a low risk of further surgery (Log Rank test pacute abdomen showed a low risk for reintervention and less use of steroids and immunosuppressants during follow-up than those not operated upon at diagnosis. Early surgery may represent a valid approach in the initial management of patients with Crohn's disease, at least in the subset of patients with ileal and complicated disease.

  4. Increasing smoking cessation care in a preoperative clinic: a randomized controlled trial.

    Science.gov (United States)

    Wolfenden, Luke; Wiggers, John; Knight, Jenny; Campbell, Elizabeth; Spigelman, Allan; Kerridge, Ross; Moore, Karen

    2005-07-01

    Evidence suggests that preoperative clinics, like other hospital outpatient clinics and inpatient wards, fail to systematically provide smoking cessation care to patients having planned surgery. The aim of the study was to assess the efficacy, acceptability, and cost of a multifaceted intervention to facilitate the provision of comprehensive smoking cessation care to patients attending a preoperative clinic. Two hundred ten smoking patients attending a preoperative clinic at a major teaching hospital in Australia took part in the study. One hundred twenty-four patients were randomly assigned to an experimental group and 86 patients to a usual cessation care group. A multifaceted intervention was developed that included the use of opinion leaders, consensus processes, computer-delivered cessation care, computer-generated prompts for care provision by clinic staff, staff training, and performance feedback. Ninety-six percent of experimental group patients received behavioral counseling and tailored self-help material. Experimental group patients were significantly more likely than usual care patients to report receiving brief advice by nursing (79% vs. 47%; P < 0.01) and anaesthetic (60% vs. 39%; P < 0.01) staff. Experimental group patients who were nicotine dependent were also more likely to be offered preoperative nicotine replacement therapy (NRT) (82% vs. 8%; P < 0.01) and be prescribed postoperative NRT (86% vs. 0%; P < 0.01). The multifaceted intervention was found to be acceptable by staff. A multifaceted clinical practice change intervention may be effective in improving the delivery of smoking cessation care to preoperative surgical patients.

  5. The clinical utility of new combination phenylephrine/ketorolac injection in cataract surgery

    Directory of Open Access Journals (Sweden)

    Lawuyi LE

    2015-07-01

    Full Text Available Lola Elizabeth Lawuyi, Avinash Gurbaxani Moorfields Eye Hospital Dubai, Dubai, UAE Abstract: The maintenance of mydriasis throughout cataract extraction surgery and the control of ocular inflammation are crucial for successful surgical outcomes. The development of miosis during cataract surgery compromises the visualization of the surgical field and working space for surgeons. This may lead to complications that include posterior capsular tear and associated vitreous loss, longer surgical time, and postoperative inflammation. Postoperative inflammation is often uncomfortable and frustrating for patients. It causes pain, redness, and photophobia. This compromises the best-uncorrected vision following surgery and often leads to multiple clinic visits. This article examines the literature published on the current treatments used to manage mydriasis, pain, and inflammation in cataract extraction surgery. Combination phenylephrine/ketorolac injection offers an exciting new class of medication for use in cataract surgery. With the recent approval of Omidria™ (combination of phenylephrine 1% and ketorolac 0.3% by the US Food and Drug Administration (FDA for intraocular use, we review the clinical utility of this new combination injection in cataract surgery. PubMed, MEDLINE, and conference proceedings were searched for the relevant literature using a combination of the following search terms: cataract extraction surgery, pupil dilation (mydriasis, miosis, phenylephrine, ketorolac, Omidria™, intracameral mydriatic. Relevant articles were reviewed and their references checked for further relevant literature. All abstracts were reviewed and full texts retrieved where available. Keywords: cataract extraction surgery, ketorolac, mydriasis, miosis, Omidria™, phenylephrine

  6. Splanchnic organ injury during coronary surgery with or without cardiopulmonary bypass: a randomized, controlled trial.

    Science.gov (United States)

    Ascione, Raimondo; Talpahewa, Sudath; Rajakaruna, Chanaka; Reeves, Barnaby C; Lovell, A Timothy; Cohen, Alan; Angelini, Gianni D

    2006-01-01

    We investigated the efficacy of coronary surgery with or without cardiopulmonary bypass in protecting the function of the small intestine, liver, and pancreas. Patients were randomized to off-pump coronary artery bypass grafting (OPCAB) or coronary artery bypass grafting with cardiopulmonary bypass (CABG-CPB). Small intestine function was assessed by differential four sugars (O = methyl-D-glucose, D-xylose, L-rhamnose, and lactulose) permeability and absorption tests. Liver function was assessed by monoethylglycinexylidide/lidocaine ratios and by serial measurements of transaminases (aspartate transaminase and alanine-amino transferase), bilirubin, and alkaline phosphatase. Pancreatic function was assessed by serial measurements of insulin/glucagon ratio, amylase, and glucose. Forty patients were recruited (20 per group). Permeability and absorption were more impaired in the OPCAB group immediately after surgery, but returned to baseline levels in both groups by postoperative day 5 (interaction of surgery type and time; p = 0.05 and p = 0.02, respectively). Monoethylglycinexylidide/lidocaine ratios were not different in the two groups. Aspartate transaminase and alanine-amino transferase levels were higher in the CABG-CPB group for the first postoperative day, but levels converged by day 3 (interaction of surgery type and time; p < 0.0001 and p = 0.04, respectively). The bilirubin level for the OPCAB group overshot the CABG-CPB group at 36 hours before returning to a similar level 60 hours postoperatively. Amylase levels were higher in the CABG-CPB group than in the OPCAB group (1.17 times; p = 0.03); other markers of pancreatic function showed no differences between the groups. Early small intestine function is worse with OPCAB; all functions recover to similar levels in both groups by day 5. Conversely, pancreatic function is worse with the CABG-CPB group than with the OPCAB group. Hepatic metabolic function does not differ by type of surgery to the end of the

  7. Limited Evidence for Robot-assisted Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Broholm, Malene; Onsberg Hansen, Iben; Rosenberg, Jacob

    2016-04-01

    To evaluate available evidence on robot-assisted surgery compared with open and laparoscopic surgery. The databases Medline, Embase, and Cochrane Library were systematically searched for randomized controlled trials comparing robot-assisted surgery with open and laparoscopic surgery regardless of surgical procedure. Meta-analyses were performed on each outcome with appropriate data material available. Cochrane Collaboration's tool for assessing risk of bias was used to evaluate risk of bias on a study level. The GRADE approach was used to evaluate the quality of evidence of the meta-analyses. This review included 20 studies comprising 981 patients. The meta-analyses found no significant differences between robot-assisted and laparoscopic surgery regarding blood loss, complication rates, and hospital stay. A significantly longer operative time was found for robot-assisted surgery. Open versus robot-assisted surgery was investigated in 3 studies. A lower blood loss and a longer operative time were found after robot-assisted surgery. No other difference was detected. At this point there is not enough evidence to support the significantly higher costs with the implementation of robot-assisted surgery.

  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. Postoperative pain management with transdermal fentanyl after forefoot surgery: a randomized, placebo-controlled study

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    Merivirta R

    2015-01-01

    Full Text Available Riika Merivirta,1 Mikko Pitkänen,2 Jouko Alanen,3 Elina Haapoja,1 Mari Koivisto,4 Kristiina Kuusniemi11Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine of Turku University Hospital and University of Turku, Turku, 2Department of Anaesthesia, Hospital Orton, Invalid Foundation, Helsinki, 3Terveystalo Clinic Hospital, Helsinki, 4Department of Biostatistics, University of Turku, Turku, FinlandBackground: Quality of life is decreased in patients with hallux valgus deformity, mainly because of pain. Significant improvement is usually achieved by surgery. However, postoperative pain can be moderate to severe for 2–3 days. The aim of the present study was to evaluate the use of transdermal fentanyl for postoperative pain management after forefoot surgery.Methods: Sixty patients undergoing hallux valgus or hallux rigidus surgery were allocated to receive a patch delivering either fentanyl 12 µg/hour or placebo for postoperative pain. The consumption of rescue opioid oxycodone, the primary outcome measure, was evaluated daily until the fourth postoperative day. Total consumption of oxycodone during the study period was also assessed. Pain scores and possible adverse effects were evaluated every 6 hours during the first 24 hours and on the fourth postoperative day.Results: The use of rescue opioid was low in both groups, the median (range consumption of oxycodone being 10 (0–50 mg on the day of surgery (no difference between the groups, P=0.31 and 0 (0–35 mg thereafter. The total combined consumption was 10 (0–105 mg in the fentanyl group and 20 (0–70 mg in the placebo group (P=0.23. There were no statistically significant differences in pain scores or adverse effects between the groups.Conclusion: As a part of multimodal analgesia with ibuprofen and acetaminophen, a patch delivering fentanyl 12 µg/hour did not significantly decrease the consumption of rescue opioid or pain scores after forefoot surgery

  10. Efficiency of Calatonia on clinical parameters in the immediate post-surgery period: a clinical study

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    Elaine Ferreira Lasaponari

    2013-09-01

    Full Text Available OBJECTIVE: to assess the efficiency of the Calatonia technique about clinical parameters and pain in the immediate post-surgical phase. METHOD: a randomised study was carried out with 116 patients subjected to a cholecystectomy, by laparoscopy, divided into an experimental group (58 patients and a placebo group (58 patients. The experimental group received the Calatonia technique, while the placebo was only subjected to non-intentional touches. RESULTS: The placebo group and the experimental group were considered homogeneous in terms of the variables: sex, age, physical status classification, duration of surgical procedures and also the time spent recovering in the Post-Anaesthetic Recovery Room. The only variable to show a statistically significant difference was the axillary temperature of the body. In relation to pain, the experimental group showed significant results, and hence it is possible to deduce that the relaxation caused by the Calatonia technique brought some relief of the general situation of pain. CONCLUSION: The application of Calatonia can take up the function of a resource complementary to assistance in the period immediately after surgery. Brazilian Register of Clinical Trials, UTN U1111-1129-9629.

  11. Clinical effects of conjunctival sac flushing using different concentration of povidoneiodine on corneal epithelium before cataract surgeries

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    Xue-Lian Gu

    2015-10-01

    Full Text Available AIM:To determine the most optimal concentration of the safe usage of povidone-iodine(PVP-Iin the flushing to disinfect the conjunctive sac before cataract surgeries, in order to provide a scientific basis for clinical eye surgery work.METHODS:Sixty-two patients with phacoemulsification and intraocular lens implantation in our hospital from October 2012 to October 2014 were randomly divided into 0.25g/L PVP-I group(Ⅰand 5g/L PVP-I group(Ⅱ. Sterilizing effect and the complications postoperative were analyzed.RESULTS:The sterilizing effects of the two groups after flushing conjunctiva sac using different concentrations of PVP-I were both remarkable, but the difference between the two groups was not statistically significant(P>0.05. No endophthalmitis occurred in the two groups. Observing the corneal condition after rinsing, no severe conjunctival hyperemia, corneal edema and other serious complications occurred. There was slightly punctate corneal epithelial shedding in groupⅡ, and the difference was statistically significant(PPCONCLUSION:Using 0.25g/L PVP-I in the conjunctiva sac rinsing before surgeries can inhibit the growth of bacteria in the conjunctival sac, reduce the impact on the corneal epithelium thereby reducing the incidence of postoperative complications and the positive rate of bacterial culture, increasing the comfort degree of patients, bringing a better area for the surgeries.

  12. 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.

  13. A randomized controlled trial of skin care protocols for facial resurfacing: lessons learned from the Plastic Surgery Educational Foundation's Skin Products Assessment Research study.

    Science.gov (United States)

    Pannucci, Christopher J; Reavey, Patrick L; Kaweski, Susan; Hamill, Jennifer B; Hume, Keith M; Wilkins, Edwin G; Pusic, Andrea L

    2011-03-01

    The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.

  14. Perioperative dexketoprofen or lornoxicam administration for pain management after major orthopedic surgery: a randomized, controlled study.

    Science.gov (United States)

    Sivrikoz, Nükhet; Koltka, Kemalettin; Güresti, Ece; Büget, Mehmet; Sentürk, Mert; Özyalçın, Süleyman

    2014-01-01

    Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for multimodal postoperative pain management. The purpose of this study was to evaluate the postoperative pain relief and opioid-sparing effects of dexketoprofen and lornoxicam after major orthopedic surgery. After obtaining ethical committee approval and informed consent, 120 patients undergoing elective hip or knee replacement under general anesthesia were randomized to receive two intravenous injections of 50 mg dexketoprofen (GD), 8 mg lornoxicam (GL) or saline as placebo (GP) intravenously. Postoperatively, patient-controlled analgesia (PCA) morphine was started as a 0.01 mg.kg-1 bolus dose, with lockout time of 10 minutes without continuous infusion. Pain assessment was made using the Visual Analogue Scale (VAS) at rest or during movement at postoperative 1, 2, 4, 6, 8, 12, and 24 hours. The three groups were similar in terms of age, gender, American Society of Anesthesiologists (ASA) class, number of patients who underwent hip or knee surgery, weight, height, and operation duration. Patients in GD and GL demonstrated significantly reduced pain scores at rest and active motion compared to GP, with lower scores in the dexketoprofen group. Patients in GD and GL used significantly less morphine in the postoperative period compared to GP. The total morphine consumption of patients in GD was lower than in GL. Intravenous application of 50 mg dexketoprofen twice a day and 8 mg lornoxicam twice a day improved analgesia and decreased morphine consumption following major orthopedic surgery. When the two active drugs were compared, it was found that dexketoprofen was superior to lornoxicam in terms of analgesic efficacy and opioid consumption.

  15. 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.

  16. Impact of protein supplementation after bariatric surgery: A randomized controlled double-blind pilot study.

    Science.gov (United States)

    Schollenberger, Asja E; Karschin, Judith; Meile, Tobias; Küper, Markus A; Königsrainer, Alfred; Bischoff, Stephan C

    2016-02-01

    Bariatric patients are at risk of protein deficiency. The aim of this study was to determine possible benefits of postoperative protein supplementation weight reduction, body composition, and protein status. Twenty obese patients who underwent bariatric surgery were randomized either to the protein (PRO) group, which received a daily protein supplement over 6 months postoperatively, or to the control (CON) group, which received an isocaloric placebo in a double-blind fashion. Data on protein and energy intake, body weight, body composition, blood proteins, and grip force was collected preinterventionally and at 1, 3, and 6 months postoperatively. In both groups body weight was significantly reduced to a similar extent (after 6 months: PRO group 25.4 ± 7.2%, CON group 20.9 ± 3.9%; intergroup comparison P > 0.05). Protein intake was steadily increased in the PRO group, but not in the CON group, and reached maximum at month 6 (25.4 ± 3.7% of energy intake versus 15.8 ± 4.4%; P bariatric surgery improves body composition by enhancing loss of body fat mass and reducing loss of lean body mass within the 6 months follow up. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Early versus conventional stoma closure following bowel surgery: A randomized controlled trial

    Science.gov (United States)

    Nelson, Thirugnanasambandam; Pranavi, Amuda R.; Sureshkumar, Sathasivam; Sreenath, Gubbi S.; Kate, Vikram

    2018-01-01

    Background/Aim: To compare early stoma closure with conventional stoma closure following defunctioning diversion stoma surgery with respect to the frequency of complications, health-related quality of life (QoL), and length of hospitalization (LoH). Patients and Methods: This study was designed as a prospective parallel-arm randomized controlled trial. Patients who underwent temporary stoma following bowel surgery between February 2014 and November 2015 were included. The rate of complications (medical and surgical) following early and conventional stoma closure was assessed. Health-related QoL and LoH were also measured. Results: One hundred patients were included, with 50 cases in each group. Postoperative complications including laparostoma (6% vs. 2%;P = 0.307), wound infection (32% vs. 18%; P = 0.106), intra-abdominal collection (14% vs. 18%; P = 0.585), anastomotic leak (4%vs. 8%;P = 0.400), and medical complications were comparable (22% vs. 32%;P = 0.257). The length of hospital stay, overall mortality and morbidity (64% vs. 44%; P = 0.05) were similar across the two groups. There was a significant reduction in the cost towards stoma care (96% vs. 2%; P = 0.001) in the early stoma closure group. Patients in the early stoma closure group also had a significantly better QoL. Conclusion: Early stoma closure does not carry an increased risk of postoperative complications, reduces cost towards stoma care, and leads to better a QoL. PMID:29451185

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

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    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.

  19. Evidence for early nasogastric tube removal after infrarenal aortic surgery: a randomized trial.

    Science.gov (United States)

    Gouëffic, Yann; Rozec, Bertrand; Sonnard, Alice; Patra, Philippe; Blanloeil, Yvonnick

    2005-10-01

    Nasogastric tube (NGT) decompression after abdominal surgery is still largely used to prevent nausea and vomiting. However, indications are based more on practice than on studies. Moreover, prolonged NGT decompression can lead to complications. In this prospective and randomized study, we evaluated the effects of early withdrawal of NGTs in patients undergoing surgery of the infrarenal aorta. Between October 2001 and May 2002, consecutive patients underwent scheduled infrarenal aortic operations. Patients were prospectively randomised into two groups: group 1, NGT maintenance until the passage of flatus; and group 2, NGT removal at the time of tracheal extubation. Preoperative and perioperative data were collected. The main end point was the occurrence of nausea and vomiting. Secondary end points were tolerance of NGT withdrawal and postoperative complications. Criteria were compared between groups by using Mann-Whitney or Fisher exact tests. Forty-six patients underwent aortic operations. Six patients were subsequently excluded from the study. Of the 40 randomized subjects, 20 patients were included in each group. Preoperative and intraoperative data were similar in both groups. There was no statistical difference between groups regarding nausea and vomiting. In group 1, the occurrence of respiratory complications was more frequent compared with group 2 (5 vs 0 complications; P = .023). There was no significant difference in intensive care unit stay, but the hospital stay was shorter in group 2 (mean, 9 +/- 3 days vs 15 +/- 9 days; P = .016). There were no differences in other adverse events. This study does not support a significant effect of early removal of NGTs on nausea and vomiting in patients undergoing open repair of the infrarenal aorta. However, these findings suggest that NGT maintenance increases the risk of respiratory complications and the length of hospital stay.

  20. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery.

    Science.gov (United States)

    Westermann, Lauren B; Crisp, Catrina C; Oakley, Susan H; Mazloomdoost, Donna; Kleeman, Steven D; Benbouajili, Janine M; Ghodsi, Vivian; Pauls, Rachel N

    2016-01-01

    Placement of vaginal packing after pelvic reconstructive surgery is common; however, little evidence exists to support the practice. Furthermore, patients have reported discomfort from the packs. We describe pain and satisfaction in women treated with and without vaginal packing. This institutional review board-approved randomized-controlled trial enrolled patients undergoing vaginal hysterectomy with prolapse repairs. The primary outcome was visual analog scales (VASs) for pain on postoperative day 1. Allocation to "packing" ("P") or "no-packing" ("NP") arms occurred intraoperatively at the end of surgery. Visual analog scales regarding pain and satisfaction were completed early on postoperative day 1 before packing removal. Visual analog scale scores for pain, satisfaction, and bother attributable to packing were recorded before discharge. All packing and perineal pads were weighed to calculate a "postoperative vaginal blood loss." Perioperative data were collected from the hospital record. Our sample size estimation required 74 subjects. Ninety-three women were enrolled. After exclusions, 77 were randomized (P, 37; NP, 40). No differences were found in surgical information, hemoglobin levels, or narcotic use between groups. However, "postoperative vaginal blood loss" was greater in packed subjects (P discharge (P, 35.0 vs NP, 40.0; P = 0.43] were not significantly different between treatment arms. Likewise, VAS scores for satisfaction before removal of packing (P, 81.0 vs NP, 90.0; P = 0.08] and before discharge (P, 90.0 vs NP, 90.5; P = 0.60] were not significantly different. Packed patients noted lower nursing verbal pain scores (P = 0.04) and used less ketorolac (P = 0.01). Bother from packing was low overall. Although there was no difference based on VAS, women receiving vaginal packing had lower nursing documented pain and used less ketorolac than packed women. Vaginal packing may provide benefit and can remain part of the surgical practice.

  1. Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p dental implants can be immediately used successfully for retaining lower complete dentures, as shown after a 1-year follow up. © 2016 Wiley Periodicals, Inc.

  2. Selecting treatment for patients with malignant epidural spinal cord compression-does age matter?: results from a randomized clinical trial.

    Science.gov (United States)

    Chi, John H; Gokaslan, Ziya; McCormick, Paul; Tibbs, Phillip A; Kryscio, Richard J; Patchell, Roy A

    2009-03-01

    Randomized clinical trial. OBJECTIVE.: To determine if age affects outcomes from differing treatments in patients with spinal metastases. Recently, class I data were published supporting surgery with radiation over radiation alone for patients with malignant epidural spinal cord compression (MESCC). However, the criteria to properly select candidates for surgery remains controversial and few independent variables which predict success after treatment have been identified. Data for this study was obtained in a randomized clinical trial comparing surgery versus radiation for MESCC. Hazard ratios were determined for the effect of age and the interaction between age and treatment. Age estimates at which prespecified relative risks could be expected were calculated with greater than 95% confidence to suggest possible age cut points for further stratification. Multivariate models and Kaplan-Meier curves were tested using stratified cohorts for both treatment groups in the randomized trial each divided into 2 age groups. Secondary data analysis with age stratification demonstrated a strong interaction between age and treatment (hazard ratio = 1.61, P = 0.01), such that as age increases, the chances of surgery being equal to radiation alone increases. The best estimate for the age at which surgery is no longer superior to radiation alone was calculated to be between 60 and 70 years of age (95% CI), using sequential prespecified relative risk ratios. Multivariate modeling and Kaplan-Meier curves for stratified treatment groups showed that there was no difference in outcome between treatments for patients >or=65 years of age. Ambulation preservation was significantly prolonged in patients variable in predicting preservation of ambulation and survival for patients being treated for spinal metastases. Our results provide compelling evidence for the first time that particular age cut points may help in selecting patients for surgical or nonsurgical intervention based on outcome.

  3. Centrifugal pump and roller pump in adult cardiac surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Saczkowski, Richard; Maklin, Michelle; Mesana, Thierry; Boodhwani, Munir; Ruel, Marc

    2012-08-01

    Centrifugal pump (CP) and roller pump (RP) designs are the dominant main arterial pumps used in cardiopulmonary bypass (CPB). Trials reporting clinical outcome measures comparing CP and RP are controversial. Therefore, a meta-analysis was undertaken to evaluate clinical variables from randomized controlled trials (RCTs). Keyword searches were performed on Medline (1966-2011), EmBase (1980-2011), and CINAHL (1981-2011) for studies comparing RP and CP as the main arterial pump in adult CPB. Pooled fixed-effects estimates for dichotomous and continuous data were calculated as an odds ratio and weighted-mean difference, respectively. The P value was utilized to assess statistical significance (P pump-related malfunction or mishap. The meta-analysis of RCTs comparing CP and RP in adult cardiac surgery suggests no significant difference for hematological variables, postoperative blood loss, transfusions, neurological outcomes, or mortality. © 2012, Copyright the Authors. Artificial Organs © 2012, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  4. Clinical efficacy for ptosis patients with severe undercorrection after frontal muscle flap suspension surgery

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    Xin Chen

    2017-10-01

    Full Text Available AIM: To observe the treatment for ptosis patients with severe undercorrection after frontal muscle flap suspension surgery.METHODS: Totally 46 patients(67 eyeswere randomly divided into 2 groups: 23 cases(33 eyesin Group A were given conjoint fascial sheath(CFSsuspension surgery; 23 cases(34 eyesin Group B Whitnall ligament suspension. Postoperative follow-up was 6mo. Corrected rate, recurrence rate and postoperative adverse reactions were compared and analyzed. RESULTS:The corrected rates of the two groups were both satisfied without significant difference between the two groups(P>0.05. the Whitnall ligament suspension surgery had less recurrence than CFS suspension surgery, but the difference was not statistically significant(P>0.05. The rate of hypophasis after CFS suspension surgery was significantly less than that after Whitnall ligament suspension(PCONCLUSION: The two operations both have satisfied corrected rate and low recurrence rate, the Whitnall ligament suspension surgery is less damaging and more easy to operate, while CFS suspension surgery is repeatable and less rate of hypophasis.

  5. Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial.

    Science.gov (United States)

    Jüttler, Eric; Schwab, Stefan; Schmiedek, Peter; Unterberg, Andreas; Hennerici, Michael; Woitzik, Johannes; Witte, Steffen; Jenetzky, Ekkehart; Hacke, Werner

    2007-09-01

    Decompressive surgery (hemicraniectomy) for life-threatening massive cerebral infarction represents a controversial issue in neurocritical care medicine. We report here the 30-day mortality and 6- and 12-month functional outcomes from the DESTINY trial. DESTINY (ISRCTN01258591) is a prospective, multicenter, randomized, controlled, clinical trial based on a sequential design that used mortality after 30 days as the first end point. When this end point was reached, patient enrollment was interrupted as per protocol until recalculation of the projected sample size was performed on the basis of the 6-month outcome (primary end point=modified Rankin Scale score, dichotomized to 0 to 3 versus 4 to 6). All analyses were based on intention to treat. A statistically significant reduction in mortality was reached after 32 patients had been included: 15 of 17 (88%) patients randomized to hemicraniectomy versus 7 of 15 (47%) patients randomized to conservative therapy survived after 30 days (P=0.02). After 6 and 12 months, 47% of patients in the surgical arm versus 27% of patients in the conservative treatment arm had a modified Rankin Scale score of 0 to 3 (P=0.23). DESTINY showed that hemicraniectomy reduces mortality in large hemispheric stroke. With 32 patients included, the primary end point failed to demonstrate statistical superiority of hemicraniectomy, and the projected sample size was calculated to 188 patients. Despite this failure to meet the primary end point, the steering committee decided to terminate the trial in light of the results of the joint analysis of the 3 European hemicraniectomy trials.

  6. The psychological and social characteristics of patients referred for NHS cosmetic surgery: quantifying clinical need.

    Science.gov (United States)

    Cook, Sharon A; Rosser, Robert; Toone, Helen; James, M Ian; Salmon, Peter

    2006-01-01

    Elective cosmetic surgery is expanding in the UK in both the public and private sectors. Because resources are constrained, many cosmetic procedures are being excluded within the National Health Service. If guidelines on who can receive such surgery are to be evidence-based, information is needed about the level of dysfunction in patients referred for elective surgery and whether this is related to their degree of physical abnormality. Consecutive patients referred to a regional plastic surgery and burns unit for assessment for elective cosmetic surgery completed standardised measures of physical and psychosocial dysfunction, and indicated their perception of the degree of their abnormality and their preoccupation with it. We distinguished between patients referred for physical reasons or appearance reasons only, and compared levels of physical and psychosocial dysfunction in each with published values for community and clinical samples. Surgeons indicated patients' degree of objective abnormality, and we identified the relationship of dysfunction with perceived and objective abnormality and preoccupation. Whether patients sought surgery for physical or appearance reasons, physical function was normal. Those seeking surgery for appearance reasons only had moderate psychosocial dysfunction, but were not as impaired as clinical groups with psychological problems. Patients seeking the correction of minor skin lesions for purely appearance reasons reported excellent physical and psychosocial function. Level of function was related (negatively) to patients' preoccupation with abnormality rather than to their perceived or objective abnormality. In general, patients referred for elective cosmetic surgery did not present with significant levels of dysfunction. Moreover, levels of functioning were related to preoccupation rather than to objective abnormality. Therefore, for most patients, whether surgical treatment is generally appropriate is questionable. Future guidelines

  7. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  8. Day-case stapes surgery: Day-case versus inpatient stapes surgery for otosclerosis: a randomized controlled trial

    OpenAIRE

    Derks, Laura S. M.; Wegner, Inge; Tange, Rinze A.; Kamalski, Digna M. A.; Grolman, Wilko

    2016-01-01

    Background Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of) the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-case procedure. The major drive towards day-case surgery has been out of economic considerations. However, it is also increasingly an explicit patient request and leads to shorter waiting times for ...

  9. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study.

    Science.gov (United States)

    Kim, Kyung Mi; Huh, Jin; Lee, Soo Kyung; Park, Eun Young; Lee, Jung Min; Kim, Hyo Ju

    2017-05-19

    As a drug originally introduced for its anticonvulsant effects, gabapentin has been recently shown to be effective in the treatment of nausea and vomiting in various clinical settings. This study compared the antiemetic efficacy of oral gabapentin, intravenous ramosetron and gabapentin plus ramosetron in patients receiving fentanyl-based patient-controlled analgesia after laparoscopic gynecologic surgery. One hundred and thirty two patients undergoing laparoscopic gynecologic surgery under general anesthesia were allocated randomly into three groups: group G received 300 mg oral gabapentin 1 h before anesthesia, group R received 0.3 mg intravenous ramosetron at the end of surgery, and group GR received a combination of 300 mg oral gabapentin 1 h before anesthesia and 0.3 mg intravenous ramosetron at the end of surgery. Postoperative nausea, retching, vomiting, rescue antiemetic drug use, pain, rescue analgesic requirements and adverse effects were assessed at 0-2, 2-24 and 24-48 h after surgery. Postoperative nausea and vomiting (PONV) was defined as the presence of nausea, retching or vomiting. The incidence of complete response (no PONV and no rescue antiemetics up to 48 h postoperatively) was significantly higher in group GR (26/40, 65%) than group G (16/40, 40%; P = 0.025) and group R (18/44, 41%; P = 0.027), whereas there was no significant difference between group G and group R (P = 0.932). There were no significant between-group differences in the incidence of emetic episodes, use of rescue antiemetics, severe emesis, use of rescue analgesics or any adverse effects. Postoperative pain scores were also similar among groups. The combination with gabapentin and ramosetron is superior to either drug alone for prevention of PONV after laparoscopic gynecologic surgery. ClinicalTrials.gov NCT02617121 , registered November 25, 2015.

  10. Biliary tract and pancreatic surgery complicated by acute pancreatitis: a clinical analysis.

    Science.gov (United States)

    Sun, Chenggang; Li, Xin; Sun, Jintang; Zou, Peng; Gao, Shubo; Zhang, Peixun

    2015-01-01

    To study the clinical treatment features of biliary tract and pancreatic surgery complicated by acute pancreatitis. A retrospective analysis of 21 cases of biliary tract and pancreatic surgery complicated by acute pancreatitis in the Department of General Surgery in our hospital during May 2005 to July 2011 was performed; the clinical treatment features were analyzed in terms of surgical option, onset interval of acute pancreatitis after last surgery, length of stay in hospital and Ranson score. There was no statistic difference between the two groups (A: The onset interval of acute pancreatitis after last surgery acute pancreatitis after last surgery > 0.5 year) in pathogenetic condition and length of stay in hospital. All patients were discharged after treatment, a follow-up of 6-18 months found no recurrence of pancreatitis. There is no relevance between the treatment feature and onset interval of biliary and pancreatic surgery complicated by acute pancreatitis. The disease is still treated meanly with symptomatic and supportive treatment, while the etiological treatment is also particularly important.

  11. Nutritional Recommendations for Adult Bariatric Surgery Patients: Clinical Practice12

    Science.gov (United States)

    Sherf Dagan, Shiri; Goldenshluger, Ariela; Globus, Inbal; Schweiger, Chaya; Kessler, Yafit; Kowen Sandbank, Galit; Ben-Porat, Tair; Sinai, Tali

    2017-01-01

    Bariatric surgery is currently the most effective treatment for morbid obesity and its associated metabolic complications. To ensure long-term postoperative success, patients must be prepared to adopt comprehensive lifestyle changes. This review summarizes the current evidence and expert opinions with regard to nutritional care in the perioperative and long-term postoperative periods. A literature search was performed with the use of different lines of searches for narrative reviews. Nutritional recommendations are divided into 3 main sections: 1) presurgery nutritional evaluation and presurgery diet and supplementation; 2) postsurgery diet progression, eating-related behaviors, and nutritional therapy for common gastrointestinal symptoms; and 3) recommendations for lifelong supplementation and advice for nutritional follow-up. We recognize the need for uniform, evidence-based nutritional guidelines for bariatric patients and summarize recommendations with the aim of optimizing long-term success and preventing complications. PMID:28298280

  12. Nutritional Recommendations for Adult Bariatric Surgery Patients: Clinical Practice.

    Science.gov (United States)

    Sherf Dagan, Shiri; Goldenshluger, Ariela; Globus, Inbal; Schweiger, Chaya; Kessler, Yafit; Kowen Sandbank, Galit; Ben-Porat, Tair; Sinai, Tali

    2017-03-01

    Bariatric surgery is currently the most effective treatment for morbid obesity and its associated metabolic complications. To ensure long-term postoperative success, patients must be prepared to adopt comprehensive lifestyle changes. This review summarizes the current evidence and expert opinions with regard to nutritional care in the perioperative and long-term postoperative periods. A literature search was performed with the use of different lines of searches for narrative reviews. Nutritional recommendations are divided into 3 main sections: 1 ) presurgery nutritional evaluation and presurgery diet and supplementation; 2 ) postsurgery diet progression, eating-related behaviors, and nutritional therapy for common gastrointestinal symptoms; and 3 ) recommendations for lifelong supplementation and advice for nutritional follow-up. We recognize the need for uniform, evidence-based nutritional guidelines for bariatric patients and summarize recommendations with the aim of optimizing long-term success and preventing complications. © 2017 American Society for Nutrition.

  13. Marginal artery stump pressure in left colic artery-preserving rectal cancer surgery: a clinical trial.

    Science.gov (United States)

    Guo, Yuchen; Wang, Daguang; He, Liang; Zhang, Yang; Zhao, Shishun; Zhang, Luyao; Sun, Xuan; Suo, Jian

    2017-07-01

    The aim of this clinical trial is to evaluate the influence of high and low ligation of the inferior mesenteric artery with apical lymph node dissection on the anastomotic blood supply, lymph node retrieval rate, operative time and anastomotic leakage rate in rectal cancer surgery. A total of 57 Chinese patients were randomly distributed into group A and group B and underwent radical resection of rectal cancer. Patients in group A underwent high ligation of the inferior mesenteric artery, and patients in group B underwent apical lymph node resection around the root of the inferior mesenteric artery with preservation of the left colic artery. The marginal artery stump pressure was measured after colon and artery reconstruction. Systemic pressure, distal colon length, operative time and lymph node retrieval rate were measured and recorded. The results were analysed and related to patient characteristics and post-operative complications. The anastomotic blood supply negatively and linearly correlated with age and distal colon length and showed a positive linear correlation with systemic pressure. Patients who received low ligation with apical lymph node dissection had a better anastomotic blood supply than those who received high ligation. No differences were found in lymph node retrieval rate, operative time and anastomotic leakage rate. Anastomotic leakage was associated with a worse anastomotic blood supply. Low ligation with apical lymph node dissection in rectal cancer treatment provides better anastomotic blood supply but is not associated with differences in node retrieval rate or operation time. © 2015 Royal Australasian College of Surgeons.

  14. Nebulized Versus IV Amikacin as Adjunctive Antibiotic for Hospital and Ventilator-Acquired Pneumonia Postcardiac Surgeries: A Randomized Controlled Trial.

    Science.gov (United States)

    Hassan, Nehal A; Awdallah, Faten Farid; Abbassi, Maggie M; Sabry, Nirmeen A

    2018-01-01

    Nebulized antibiotics offer high efficacy due to significant local concentrations and safety with minimal blood levels. This study evaluates the efficacy and nephrotoxicity of nebulized versus IV amikacin in postcardiothoracic surgical patients with nosocomial pneumonia caused by multidrug-resistant Gram- negative bacilli. Prospective, randomized, controlled study on surgical patients divided into two groups. Postcardiac surgery ICU. The first gtroup was administered IV amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered IV piperacillin/tazobactam empirically. Recruited patients were diagnosed by either hospital-acquired pneumonia or ventilator-associated pneumonia where 56 (42.1%) patients were diagnosed with hospital-acquired pneumonia, 51 (38.34%) patients were diagnosed with early ventilator-associated pneumonia, and 26 (19.54%) patients with late ventilator-associated pneumonia. Clinical cure in both groups assessed on day 7 of treatment was the primary outcome. Efficacy was additionally evaluated through assessing the length of hospital stay, ICU stay, days on amikacin, days on mechanical ventilator, mechanical ventilator-free days, days to reach clinical cure, and mortality rate. Lower nephrotoxicity in the nebulized group was observed through significant preservation of kidney function (p < 0.001). Although both groups were comparable regarding length of hospital stay, nebulizer group showed shorter ICU stay (p = 0.010), lower number of days to reach complete clinical cure (p = 0.001), fewer days on mechanical ventilator (p = 0.035), and fewer days on amikacin treatment (p = 0.022). Nebulized amikacin showed better clinical cure rates, less ICU stay, and fewer days to reach complete recovery compared to IV amikacin for surgical patients with nosocomial pneumonia. It is also a less nephrotoxic option associated with less deterioration in kidney function.

  15. Infections in orthopaedic surgery : clinical and experimental studies

    OpenAIRE

    Vogely, Henri Charles

    2000-01-01

    The diagnostic difficulties, variability in outcome and the heterogeinity of the problem of orthopaedic infections stimulated the author to a study of the literature, and several clinical and experimental studies. The diagnosis prosthesis-related infection can only be reached with an acceptable degree of certainty by combination of clinical, laboratory and imaging investigations. Fourty-seven patients with a prosthetic hip infection treated in our hospital were retrospectively divided into th...

  16. Clinical outcomes and advantages of laparoscopic surgery for primary Crohn's disease: are they significant?

    Science.gov (United States)

    Tanaka, Shinnosuke; Matsuo, Katsuichi; Sasaki, Takamitsu; Nakano, Masahiho; Shimura, Hideo; Yamashita, Yuichi

    2009-01-01

    The clinical outcomes and advantages of laparoscopic surgery for Crohn's disease have not yet been recognized in general. The aim of this study was to critically assess the clinical outcomes, safety, cosmesis, quality of life (QOL) and feasibility of laparoscopic surgery for primary Crohn's disease. The study subjects consisted of 48 patients who had primary surgical treatment for Crohn's disease, 28 through conventional laparotomy and 20 in whom surgery was laparoscopically assisted. The short-term and long-term outcomes, cosmesis, and postoperative QOL were evaluated in both groups. There were no statistically significant differences in the patient characteristics between the two groups. In the laparoscopic group, non-resected procedures were significantly more frequent (p cosmetic results were very satisfactory in 11 patients (64.7%). There were no severe complications and no increase of the recurrence rate for laparoscopic surgery. Moreover, there was no definite clinical disadvantage and no prolonged operating time in the laparoscopic procedures. Laparoscopic surgery for primary Crohn's disease is safe and feasible in selected patients without severe adhesion, fistula or abscess, and was associated with better cosmesis than conventional open surgery. Therefore, laparoscopic procedures should be considered as the preferred operative approach for a primary bowel resection.

  17. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Renal effects of dexmedetomidine during coronary artery bypass surgery: a randomized placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Scheinin Harry

    2011-05-01

    Full Text Available Abstract Background Dexmedetomidine, an alpha2-adrenoceptor agonist, has been evaluated as an adjunct to anesthesia and for the delivery of sedation and perioperative hemodynamic stability. It provokes dose-dependent and centrally-mediated sympatholysis. Coronary artery bypass grafting (CABG with extracorporeal circulation is a stressful procedure increasing sympathetic nervous system activity which could attenuate renal function due the interrelation of sympathetic nervous system, hemodynamics and renal function. We tested the hypothesis that dexmetomidine would improve kidney function in patients undergoing elective CABG during the first two postoperative days. Methods This was a double-blind, randomized, parallel-group study. Patients with normal renal function and scheduled for elective CABG were randomized to placebo or to infusion of dexmedetomidine to achieve a pseudo steady-state plasma concentration of 0.60 ng/ml. The infusion was started after anesthesia induction and continued until 4 h after surgery. The primary endpoint was creatinine clearance. Other variables included urinary creatinine and output, fractional sodium and potassium excretion, urinary potassium, sodium and glucose, serum and urinary osmolality and plasma catecholamine concentrations. The data were analyzed with repeated-measures ANOVA or Cochran-Mantel-Haenszel test. Results Sixty-six of 87 randomized patients were evaluable for analysis. No significant between-group differences were recorded for any indices of renal function except for a mean 74% increase in urinary output with dexmedetomidine in the first 4 h after insertion of a urinary catheter (p Conclusions Use of intravenous dexmedetomidine did not alter renal function in this cohort of relatively low-risk elective CABG patients but was associated with an increase in urinary output. This study was carried out in 1994-1997 and was thus not registered.

  19. Effects of pulsed electromagnetic fields on swelling and pain after implant surgery: a double-blind, randomized study.

    Science.gov (United States)

    Menini, M; Bevilacqua, M; Setti, P; Tealdo, T; Pesce, P; Pera, P

    2016-03-01

    The aim of this split-mouth, double-blind, randomized study was to determine whether pulsed electromagnetic field therapy (PEMF) can improve swelling and the management of pain after full-arch immediate loading implant surgery. Eleven patients were selected for the study. Each patient received four distal tilted implants in the upper or lower jaw and underwent full-arch immediate loading rehabilitation. After surgery, two PEMF devices were applied to each patient, one on each cheek. In a random manner, one of these PEMF devices was switched on (test side); the other served as a placebo (control side). Forty-eight hours after surgery clinicians estimated postoperative swelling through photographic documentation, comparing the condition before and after surgery, while pain was assessed using a verbal rating scale. The patient's degree of comfort in relation to the PEMF devices was analyzed by questionnaire using a numerical rating scale. No statistically significant difference was observed between the test and control sides for swelling or pain (P>0.05). Most of the patients did not present swelling or pain at 48h after surgery, regardless of whether the PEMF device was activated or not. Various outcomes were found in the comfort evaluation. Within the limitations of this study, PEMF does not reduce postoperative swelling or pain after implant surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  20. Comparison of Carbon Dioxide Laser With Surgical Blade for Removal of Epulis Fissuratum. A Randomized Clinical Trial.

    Science.gov (United States)

    Karimi, Abbas; Sobouti, Farhad; Torabi, Sara; Bakhshandehfard, Ali; Amirian, Armaghan; Shariati, Mahsa; Morshedi, Ehsan; Barati, Maryam

    2016-01-01

    Introduction: Epulis fissuratum is often formed as a result of a poor fitting denture. The conventional treatment for this fibrous hyperplastic tissue is to excise it using a scalpel and to close the wound by a continuous or an interrupted suture. The increased utilization of lasers in dentistry also includes the utilization of carbon dioxide (CO 2 ) lasers in place of surgical scalpels in soft tissue surgeries. The objective of this study is to assess the feasibility of utilizing CO 2 laser in place of scalpel in surgical treatment of epulis fissuratum. Methods: In this clinical trial research (IRCT code: IRCT2016071124969N2), 19 patients were selected with nearly symmetrical epulis fissuratums in the anterior part of the jaws. The hyperplastic tissue was evenly divided into two sections in each patient. One section was randomly selected and cut by CO 2 laser and the other section by a surgical scalpel. The wound created by the scalpel was closed by appropriate number of interrupted sutures. Surgery duration and bleeding as well as vestibular depth, re-epithelialization and edema in both sections were noted and recorded after 7 and 14 days postoperatively. Results: The time of surgery and the amount of bleeding during surgery in the laser section was less and the vestibular depth was more than surgical scalpel section ( P < 0.05). Surgical scalpel wound at day seventh healed significantly better than the section treated by the CO 2 laser ( P < 0.05). Wound in both sections healed similarly on day 14 and no statistical difference was observed. Edema presence was also equal in both sides after 7th and 14th following the surgery. Conclusion: According to the results it could be concluded that the use of CO 2 laser may result in less surgery time, less bleeding during surgery, more vestibular depth, better re-epithelialization of the wound and less need for suturing. CO 2 laser may be a clinically preferred method for surgical treatment of epulis fissuratum.

  1. Safety and effects of two red blood cell transfusion strategies in pediatric cardiac surgery patients: a randomized controlled trial

    NARCIS (Netherlands)

    de Gast-Bakker, D. H.; de Wilde, R. B. P.; Hazekamp, M. G.; Sojak, V.; Zwaginga, J. J.; Wolterbeek, R.; de Jonge, E.; Gesink-van der Veer, B. J.

    2013-01-01

    To investigate the safety and effects of a restrictive red blood cell (RBC) transfusion strategy in pediatric cardiac surgery patients. Randomized controlled trial. Pediatric ICU in an academic tertiary care center, Leiden University Medical Center, Leiden, The Netherlands. One hundred seven

  2. Use of hip and knee clinical scoring systems in prosthesis surgery in Norwegian hospitals

    OpenAIRE

    Stavem, Knut; Arnesen, Øyvind

    2005-01-01

    In a postal survey of all orthopaedic surgery departments performing total hip or knee replacements in Norway, we inquired about the use of hip or knee scoring systems and their impact. All 63 eligible hospitals responded to the questionnaire. Thirteen (21%) reported routine use of hip clinical scoring systems, and five (9%) used knee clinical scoring systems. The Harris hip score and The Knee Society clinical rating system were the most prevalent. We received five different versions of the H...

  3. Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT01771315)

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren

    2014-01-01

    BACKGROUND: Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from...... are conducted by the researcher responsible for the trial. The effect is measured 1, 3, 6 and 12 months post-surgery. The primary outcome is self-reported physical function measured by The Western Ontario and McMaster Universities Arthritis Index. Secondary outcomes are self-reported health-related quality...... to the orthopaedic outpatient clinic during the rehabilitation period. METHOD/DESIGN: The design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external...

  4. Surgery planning and navigation by laser lithography plastic replica. Features, clinical applications, and advantages

    International Nuclear Information System (INIS)

    Kihara, Tomohiko; Tanaka, Yuuko; Furuhata, Kentaro

    1995-01-01

    The use of three-dimensional replicas created using laserlithography has recently become popular for surgical planning and intraoperative navigation in plastic surgery and oral maxillofacial surgery. In this study, we investigated many clinical applications that we have been involved in regarding the production of three-dimensional replicas. We have also analyzed the features, application classes, and advantages of this method. As a result, clinical applications are categorized into three classes, which are 'three-dimensional shape recognition', 'simulated surgery', and 'template'. The distinct features of three-dimensional replicas are 'direct recognition', 'fast manipulation', and 'free availability'. Meeting the requirements of surgical planning and intraoperative navigation, they have produced satisfactory results in clinical applications. (author)

  5. 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

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  6. Clinical results of salvage surgery in hypopharynx carcinoma after chemoradiotherapy

    International Nuclear Information System (INIS)

    Mitani, Hiroki; Gakibuchi, Masao; Asano, Takayuki; Sakurai, Hiroyuki; Kurita, Tomoyuki; Inoue, Youjiro

    2008-01-01

    The incidence of post-operative complications and treatment results of 60 cases of hypopharynx carcinoma receiving laryngo-pharyngo-esophagectomy followed by reconstruction with jejunum after chemoradiotherapy (CRT) from 1997 to 2006 in 6 hospitals was analyzed. The overall complication rate was 57%. There were 3 cases with carotid artery rupture (5%), 4 with jejunum necrosis (6%), 6 with major salivary fistula (10%), 8 with minor salivary fistula (13%), 8 with abscess alone (13%), 3 with trachea stoma necrosis (5%), and 3 with skin flap necrosis (5%). The death rate due to surgical complications was 3% (2/60). When the cases were divided into two groups, namely the cases with fistula and the cases without fistula, the number of days that permitted drinking was 18.1 in the latter and 81.8 in the former. The 5-year overall survival rate among all cases was 37%. We found that salvage surgery after CRT was effective for recurrent cases. These findings suggest that reconstruction with jejunum is a suitable type of operation with better surgical results. Care is required to reduce the incidence of post-operative complications. (author)

  7. Treatment Success: Investigating Clinically Significant Change in Quality of Life Following Bariatric Surgery.

    Science.gov (United States)

    Reynolds, Claire L; Byrne, Susan M; Hamdorf, Jeffrey M

    2017-07-01

    One of the most important outcomes following bariatric surgery is an improvement in health-related quality of life (QOL). This study aimed to explore what degree of weight loss is required after bariatric surgery in order to achieve a clinically significant change in QOL from pre-surgery to 4 to 5 years after surgery. Participants were assessed prior to having surgery (N = 280) and were invited to participate in a follow-up study 4 to 5 years after surgery. Sixty-seven of the original participants agreed to take part and completed a Web-based survey, which included the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. Several analyses were conducted to examine the association between weight loss and clinically significant change in QOL. Mean age was 48.13 ± 10.37 years, 51 (76%) were female, 62 (92.5%) Caucasian, and mean baseline body mass index (BMI) was 41.11 ± 6.03 kg/m 2 . The mean percent of excess weight loss (EWL) was 46% (17% total weight loss), and 64% (n = 43) achieved a clinically significant change in QOL. The majority of those who lost ≥40% EWL had a clinically significant change in QOL, and their odds of achieving this change were 2.81 times higher than those that did not. Results indicated that an EWL of ≥40% may be sufficient for the majority of patients to achieve clinically significant change, but that ≥50% is a better predictor of clinically significant change.

  8. The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

    Science.gov (United States)

    Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

    2016-03-01

    Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p posttraumatic stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

  9. Infections in orthopaedic surgery : clinical and experimental studies

    NARCIS (Netherlands)

    Vogely, Henri Charles

    2000-01-01

    The diagnostic difficulties, variability in outcome and the heterogeinity of the problem of orthopaedic infections stimulated the author to a study of the literature, and several clinical and experimental studies. The diagnosis prosthesis-related infection can only be reached with an acceptable

  10. Does examiner bias in undergraduate oral and clinical surgery ...

    African Journals Online (AJOL)

    Objective. Oral and long case clinical examinations are open to subjective influences to some extent, and students may be marked unfairly as a result of gender or racial bias or language problems. These concerns are of topical relevance in South Africa. The purpose of this study was to assess whether these factors ...

  11. [Clinical-radiological evaluation of the impaction allografting and cemented rod technique in revision knee surgery].

    Science.gov (United States)

    Mateo-Negreira, J; López-Cuello, P; Pipa-Muñiz, I; Rodríguez García, N; Murcia-Mazón, A; Suárez-Suárez, M A

    2016-01-01

    Long term clinical and radiological evaluation of results, survival, and peri- operative and post-operative complications of the patients who have been operated on for revision total hip arthroplasty using the impaction allografting and cemented rod technique. An observational, analytical, prospective and non-random study was conducted on 26 patients who underwent revision total hip arthroplasty in our Hospital (1997-98). They were clinically and radiologically assessed, and a survival analysis of the implant was performed. Statistically significant differences were identified in the pre- and post-operative values, according to Harris and Merle D́Aubigne scores. The femoral components survival was considered as an endpoint of the revision replacement, which was 84% at a mean of 13 years. There were 9 intraoperative complications (6 were fractures) and they significantly affected the length of hospital stay. No post-operative complications were observed in 70% of the patients. None of the analysed variables had any influence on the radiological subsidence of the femoral component. Several techniques aim to solve the bone stock deficiency in revision total hip arthroplasty, but only impaction grafting attempts to recover it. The Ling's technique shows an improvement over the Merle D́Aubigne and Harris scores, in the medium-long term. The intraoperative complications are mainly an increase in the length of hospital stay and the number of days needed to be able to sit down. Ling's technique is a good option to consider in young patients where it is foreseeable that there is a new revision surgery in the future. Copyright © 2015 SECOT. Published by Elsevier Espana. All rights reserved.

  12. Philosophers assess randomized clinical trials: the need for dialogue.

    Science.gov (United States)

    Miké, V

    1989-09-01

    In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.

  13. Fluoride concentration from dental sealants: a randomized clinical trial.

    Science.gov (United States)

    Campus, G; Carta, G; Cagetti, M G; Bossù, M; Sale, S; Cocco, F; Conti, G; Nardone, M; Sanna, G; Strohmenger, L; Lingström, P

    2013-07-01

    A randomized clinical trial was performed in schoolchildren (6-7 yrs) to evaluate fluoride concentration in interproximal fluid after the placement of 3 different sealants. The sample consisted of 2,776 children randomly divided: 926 in the high-viscosity Glass-ionomer Cement group (GIC group), 923 in the fluoride Resin-based group (fluoride-RB group), and 927 in the no-fluoride Resin-based group (RB group). In total, 2,640 children completed the trial. Sealants were applied following manufacturer's instructions. Interproximal fluid samples were collected at baseline and 2, 7, and 21 days after application of sealants, by insertion of a standardized paperpoint into the interproximal mesial space of the sealed tooth for 15 seconds. Fluoride concentration was evaluated by means of a fluoride ion-selective electrode. At 2 days after sealant application, fluoride concentration was significantly higher in GIC and fluoride-RB groups compared with that in the RB group (p sealants increased the fluoride concentrations in interproximal fluid more than did a Resin-based sealant containing fluoride.

  14. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Guo, Jiao; Pan, Ling-Hui; Li, Yun-Xi; Yang, Xiang-Di; Li, Le-Qun; Zhang, Chun-Yan; Zhong, Jian-Hong

    2016-03-01

    Surgical site infection (SSI) is the third most frequent type of nosocomial infections. Triclosan-coated sutures are often used to reduce the risk of SSI, but studies examining this have given conflicting results. Therefore, this meta-analysis was performed to assess the efficacy of triclosan-coated sutures for reducing risk of SSI in adults. PubMed, EMBASE, Google Scholar, and ClinicalTrials.gov were searched to identify randomized clinical trials evaluating triclosan-coated sutures for preventing SSI on patients 18 y or older. Thirteen randomized clinical trials involving 5256 participants were included. Triclosan-coated sutures were associated with lower risk of SSI than uncoated sutures across all surgeries (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.65-0.88, P triclosan-coated sutures in abdominal surgeries (RR 0.70, 95% CI 0.50-0.99, P = 0.04) and group with prophylactic antibiotic (RR 0.79, 95% CI 0.63-0.99, P = 0.04). However, such risk reduction was not observed in cardiac surgeries, breast surgeries, or group without prophylactic antibiotic. Triclosan-coated sutures can decrease the incidence of SSI in abdominal surgeries and might not interfere with wound healing process. Nevertheless, further studies are needed to examine whether triclosan-coated sutures are effective at preventing SSI in non-abdominal surgeries and to further study the interaction of antibiotic prophylaxis with triclosan-coated sutures. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Laparoscopy to Predict the Result of Primary Cytoreductive Surgery in Patients With Advanced Ovarian Cancer: A Randomized Controlled Trial.

    Science.gov (United States)

    Rutten, Marianne J; van Meurs, Hannah S; van de Vrie, Roelien; Gaarenstroom, Katja N; Naaktgeboren, Christiana A; van Gorp, Toon; Ter Brugge, Henk G; Hofhuis, Ward; Schreuder, Henk W R; Arts, Henriette J G; Zusterzeel, Petra L M; Pijnenborg, Johanna M A; van Haaften, Maarten; Fons, Guus; Engelen, Mirjam J A; Boss, Erik A; Vos, M Caroline; Gerestein, Kees G; Schutter, Eltjo M J; Opmeer, Brent C; Spijkerboer, Anje M; Bossuyt, Patrick M M; Mol, Ben Willem; Kenter, Gemma G; Buist, Marrije R

    2017-02-20

    Purpose To investigate whether initial diagnostic laparoscopy can prevent futile primary cytoreductive surgery (PCS) by identifying patients with advanced-stage ovarian cancer in whom > 1 cm of residual disease will be left after PCS. Patients and Methods This multicenter, randomized controlled trial was undertaken within eight gynecologic cancer centers in the Netherlands. Patients with suspected advanced-stage ovarian cancer who qualified for PCS were eligible. Participating patients were randomly assigned to either laparoscopy or PCS. Laparoscopy was used to guide selection of primary treatment: either primary surgery or neoadjuvant chemotherapy followed by interval surgery. The primary outcome was futile laparotomy, defined as a PCS with residual disease of > 1 cm. Primary analyses were performed according to the intention-to-treat principle. Results Between May 2011 and February 2015, 201 participants were included, of whom 102 were assigned to diagnostic laparoscopy and 99 to primary surgery. In the laparoscopy group, 63 (62%) of 102 patients underwent PCS versus 93 (94%) of 99 patients in the primary surgery group. Futile laparotomy occurred in 10 (10%) of 102 patients in the laparoscopy group versus 39 (39%) of 99 patients in the primary surgery group (relative risk, 0.25; 95% CI, 0.13 to 0.47; P laparoscopy group, three (3%) of 102 patients underwent both primary and interval surgery compared with 28 (28%) of 99 patients in the primary surgery group ( P laparoscopy reduced the number of futile laparotomies in patients with suspected advanced-stage ovarian cancer. In women with a plan for PCS, these data suggest that performance of diagnostic laparoscopy first is reasonable and that if cytoreduction to < 1 cm of residual disease seems feasible, to proceed with PCS.

  16. Using an International Medical Advisory Board to guide clinical governance in a corporate refractive surgery model.

    Science.gov (United States)

    Vukich, John A

    2009-07-01

    To describe the role played by the International Medical Advisory Board (IMAB) in clinical and corporate governance at Optical Express, a corporate provider of refractive surgery. A review of goals, objectives, and actions of the IMAB. The IMAB has contributed to study design, data analysis, and selection of instruments and procedures. Through interactions with Optical Express corporate and clinical staff, the IMAB has supported management's effort to craft a corporate culture focused on continuous improvement in the safety and visual outcomes of refractive surgery. The IMAB has fashioned significant changes in corporate policies and procedures and has had an impact on corporate culture at Optical Express.

  17. 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.

  18. 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

  19. A Randomized Controlled Trial of Skin Care Protocols for Facial Resurfacing: Lessons Learned from the Plastic Surgery Educational Foundation’s Skin Products Assessment Research Study

    Science.gov (United States)

    Pannucci, Christopher J.; Reavey, Patrick L.; Kaweski, Susan; Hamill, Jennifer B.; Hume, Keith M.; Wilkins, Edwin G.; Pusic, Andrea L.

    2011-01-01

    Background The Skin Products Assessment Research (SPAR) Committee was created by the Plastic Surgery Educational Foundation (PSEF) in 2006. SPAR study aims were to (1) develop an infrastructure for PSEF-conducted, industry sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ONDS) versus conventional therapy as treatment adjuncts for facial resurfacing procedures. Methods The SPAR study was designed as a multi-center, double-blind, randomized controlled trial (RCT). The study was conducted in women with Fitzpatrick type I-IV skin, moderate to severe facial photo damage, and peri-ocular and/or peri-oral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to ONDS or a standard care regimen. The study endpoints were time to re-epithelization, erythema, and pigmentation changes. Results Fifty-six women were enrolled and 82% were followed beyond re-epithelization. There were no significant differences in mean time to re-epithelialization between ONDS and control groups. The ONDS group had a significantly higher median erythema score on day of surgery (after 4 weeks of product use) which did not persist after surgery. Test-retest photo evaluations demonstrated that both inter- and intra-rater reliability were adequate for primary study outcomes. Conclusions In a clinical RCT, we demonstrated no significant difference in time to re-epithelization between patients who used the ONDS or a standard care regimen as an adjunct to facial resurfacing procedures. The SPAR research team has also provided a discussion of future challenges for PSEF sponsored clinical research for readers of this article. PMID:21364435

  20. Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

    Science.gov (United States)

    Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

    2016-08-01

    Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

  1. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  2. Three year results of enucleation surgery with or without preoperative radiation therapy (PERT) in the prospective randomized collaborative ocular melanoma study (COMS) large tumor trial

    International Nuclear Information System (INIS)

    Earle, John D.; Schachat, Andrew P.; Fine, Stuart L.; Hawkins, Barbara S.; Diener-West, Marie

    1997-01-01

    Purpose: To describe the three year results of enucleation surgery following standard enucleation and standard enucleation preceded by preoperative radiation in the COMS. Materials and Methods: The COMS is a prospective randomized multicenter controlled clinical trial. Central Units are charged with carefully defined quality assurance. 1003 patients with large choroidal melanoma were seen at over 40 COMS centers across North America. Members of these centers are required to pass initial and periodic subsequent certification procedures. Patients were randomized to enucleation versus enucleation preceded by 20 Gy external beam radiation followed by enucleation. Enucleation alone was performed in 503 patients, 491 patients received PERT, and 9 patients were not treated as assigned. All patients have been enrolled for two years or longer and 89% for three years or longer. Results: This report summarizes the three year local complications and local recurrences after enucleation surgery with or without PERT. The short term complications of enucleation surgery in this cohort have been previously described. Incidence and prevalence rates will be reported for the following local complications (cumulative incidence over all follow up time). Conclusion: Ptosis was reported in nearly twice as many patients treated with enucleation alone as in patients who received PERT. Tumor recurrence in the orbit was seen in 4 (0.8%) of patients treated with enucleation alone but in only one patient (0.2%) who received PERT. No treatment recommendation will be made by the COMS until mortality data become available

  3. Evaluation of Functional Outcomes after Stapes Surgery in Patients with Clinical Otosclerosis in a Teaching Institution

    Directory of Open Access Journals (Sweden)

    Souza, José Celso Rodriques de

    2015-11-01

    Full Text Available Introduction Otosclerosis is a primary disease of the temporal bone that leads to stapes ankylosis. Hearing loss is the main symptom. Treatment includes surgery, medical treatment, and sound amplification therapy alone or in combination. Objective To evaluate the functional outcomes of patients with clinical diagnosis of otosclerosis undergoing primary stapes surgery in a teaching institution. Method Retrospective descriptive study. Results A total of 210 ears of 163 patients underwent stapes surgery. Of the 163 patients, 116 (71.2% underwent unilateral surgery and 47 (28.8% underwent bilateral surgery. Six of the 210 operated ears had obliterative otosclerosis. The average preoperative and postoperative air–bone gap was 32.06 and 4.39 dB, respectively. The mean preoperative and postoperative bone conduction threshold was 23.17 and 19.82 dB, respectively. A total of 184 (87.6% ears had a residual air–bone gap <10 dB, and 196 (93.3% had a residual air–bone gap ≤15 dB. Two patients (0.95% had severe sensorineural hearing loss. Conclusion Stapes surgery showed excellent functional hearing outcomes in this study. This surgery may be performed in educational institutions with the supervision of experienced surgeons.

  4. Surgery

    Science.gov (United States)

    ... surgery has several common causes, including the following: Infections at the operative site Lung problems such as pneumonia or collapsed lung ... the trauma of an operation. The risk of infections at the operative site, DVTs, and UTIs can be decreased by meticulous ...

  5. [Organization of clinical research: in general and visceral surgery].

    Science.gov (United States)

    Schneider, M; Werner, J; Weitz, J; Büchler, M W

    2010-04-01

    The structural organization of research facilities within a surgical university center should aim at strengthening the department's research output and likewise provide opportunities for the scientific education of academic surgeons. We suggest a model in which several independent research groups within a surgical department engage in research projects covering various aspects of surgically relevant basic, translational or clinical research. In order to enhance the translational aspects of surgical research, a permanent link needs to be established between the department's scientific research projects and its chief interests in clinical patient care. Importantly, a focus needs to be placed on obtaining evidence-based data to judge the efficacy of novel diagnostic and treatment concepts. Integration of modern technologies from the fields of physics, computer science and molecular medicine into surgical research necessitates cooperation with external research facilities, which can be strengthened by coordinated support programs offered by research funding institutions.

  6. A prospective, randomized study of preoperative autologous donation for hip replacement surgery.

    Science.gov (United States)

    Billote, Dinna B; Glisson, Silas N; Green, David; Wixson, Richard L

    2002-08-01

    Preoperative autologous blood donation is commonly performed to meet potential perioperative transfusion needs and is a common practice prior to total hip arthroplasty. Using standardized transfusion guidelines, we prospectively analyzed the effectiveness of preoperative autologous donation as a method for decreasing allogeneic transfusion among patients undergoing unilateral primary total hip replacement who were eligible to donate autologous blood. Patients who were scheduled for primary total hip replacement surgery and who had a preoperative baseline hemoglobin level >or=120 g/L were randomized either to donate two units of blood (autologous donors) or not to donate any blood (nondonors). The donors and nondonors were compared with regard to demographic data, blood-loss volumes, hemoglobin measurements, and transfusion rates. Randomization continued until data were obtained from at least forty patients per treatment group. Of the ninety-six patients who completed the study, forty-two were autologous donors and fifty-four were nondonors. There were no significant differences between the donors and nondonors with regard to age, male:female ratio, estimated blood volume, baseline physical condition, or operative blood loss. The hemoglobin values at the time of enrollment (baseline), at the time of hospital discharge, and six weeks postoperatively were not significantly different between the two groups, although values at the time of admission (129 +/- 13 g/L versus 138 +/- 12 g/L) and in the recovery room (104 +/- 12 g/L versus 115 +/- 13 g/L) were significantly lower in the autologous donor group (p group required an allogeneic transfusion. Twenty-nine (69%) of the forty-two donors received an autologous transfusion. Thirty-four (41%) of eighty-two autologous units were wasted. At a charge of $379 per autologous unit, there was an additional cost of $758 for each patient in the donor group. Preoperative autologous donation provided no benefit for nonanemic

  7. Impact of bariatric surgery on clinical depression. Interrupted time series study with matched controls.

    Science.gov (United States)

    Booth, Helen; Khan, Omar; Prevost, A Toby; Reddy, Marcus; Charlton, Judith; Gulliford, Martin C

    2015-03-15

    Obesity is associated with depression. This study aimed to evaluate whether clinical depression is reduced after bariatric surgery (BS). Obese adults who received BS procedures from 2002 to 2014 were sampled from the UK Clinical Practice Research Datalink. An interrupted time series design, with matched controls, was conducted from three years before, to a maximum of seven years after surgery. Controls were matched for body mass index (BMI), age, gender and year of procedure. Clinical depression was defined as a medical diagnosis recorded in year, or an antidepressant prescribed in year to a participant ever diagnosed with depression. Adjusted odds ratios (AOR) were estimated. There were 3045 participants (mean age 45.9; mean BMI 44.0kg/m(2)) who received BS, including laparoscopic gastric banding in 1297 (43%), gastric bypass in 1265 (42%), sleeve gastrectomy in 477 (16%) and six undefined. Before surgery, 36% of BS participants, and 21% of controls, had clinical depression; between-group AOR, 2.02, 95%CI 1.75-2.33, P<0.001. In the second post-operative year 32% had depression; AOR, compared to time without surgery, 0.83 (0.76-0.90, P<0.001). By the seventh year, the prevalence of depression increased to 37%; AOR 0.99 (0.76-1.29, P=0.959). Despite matching there were differences in depression between BS and control patients, representing the highly selective nature of BS. Depression is frequent among individuals selected to undergo bariatric surgery. Bariatric surgery may be associated with a modest reduction in clinical depression over the initial post-operative years but this is not maintained. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  8. Bariatric Surgery in the United Kingdom: A Cohort Study of Weight Loss and Clinical Outcomes in Routine Clinical Care

    Science.gov (United States)

    Douglas, Ian J.; Bhaskaran, Krishnan; Batterham, Rachel L.; Smeeth, Liam

    2015-01-01

    Background Bariatric surgery is becoming a more widespread treatment for obesity. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking. The objective of this study was to measure the association between bariatric surgery, weight, body mass index, and obesity-related co-morbidities. Methods and Findings This was an observational retrospective cohort study using data from the United Kingdom Clinical Practice Research Datalink. All 3,882 patients registered in the database and with bariatric surgery on or before 31 December 2014 were included and matched by propensity score to 3,882 obese patients without surgery. The main outcome measures were change in weight and body mass index over 4 y; incident diagnoses of type 2 diabetes mellitus (T2DM), hypertension, angina, myocardial infarction (MI), stroke, fractures, obstructive sleep apnoea, and cancer; mortality; and resolution of hypertension and T2DM. Weight measures were available for 3,847 patients between 1 and 4 mo, 2,884 patients between 5 and 12 mo, and 2,258 patients between 13 and 48 mo post-procedure. Bariatric surgery patients exhibited rapid weight loss for the first four postoperative months, at a rate of 4.98 kg/mo (95% CI 4.88–5.08). Slower weight loss was sustained to the end of 4 y. Gastric bypass (6.56 kg/mo) and sleeve gastrectomy (6.29 kg/mo) were associated with greater initial weight reduction than gastric banding (2.77 kg/mo). Protective hazard ratios (HRs) were detected for bariatric surgery for incident T2DM, 0.68 (95% CI 0.55–0.83); hypertension, 0.35 (95% CI 0.27–0.45); angina, 0.59 (95% CI 0.40–0.87);MI, 0.28 (95% CI 0.10–0.74); and obstructive sleep apnoea, 0.55 (95% CI 0.40–0.87). Strong associations were found between bariatric surgery and the resolution of T2DM, with a HR of 9.29 (95% CI 6.84–12.62), and between bariatric surgery and the resolution of

  9. Pregabalin as a perioperative strategy for pain management in patients undergoing cosmetic surgery. A randomized, double-blind, and placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Lorena Duque

    2008-11-01

    Full Text Available BACKGROUND: Preoperative Gabapentin has demonstrated to be as analgesic strategy in the control of perioperative pain. Pregabalin -an analogue of Gabapentin- has only a few trials demonstrating its effectiveness on this clinical setting. We wanted to assess the effectiveness of pregabalin given not only as a single dose in the preoperative period, but also continuing its administration 75 mg bid up to the fourth day after surgery. METHODS: Previous consent by the Ethical Committee of the University, we enrolled 110 patients undergoing ambulatory liposuction. They were randomized and blindedallocated to receive Pregabalin (75 mg bid versus placebo, starting 12 hours before surgery up to the fourth day after surgery. We use the postoperative pain intensity by numerical rating scale, pain intensity by categorical pain scale and tramadol-ibuprofen request as primary outcomes. RESULTS: We had 9 dropouts during the recruitment and follow up. 24 hours after surgery we had 18/51 (35.3% versus 16/50 (32% (p=0.7. We also found no difference in opioid request at the same time point, being 6.3 mg morphine equivalents in the pregabalin versus 6.7 mg in the Placebo Group. Subsequent evaluations at 48, 72 and 96 hours demonstrated no difference between groups for analgesic request and pain intensity. CONCLUSION: Perioperative use of Pregabalin (75 mg bid does not offer benefit as analgesic strategy in terms of pain intensity and opioid requirement in patients undergoing cosmetic liposuction.

  10. Transperitoneal versus retroperitoneal laparoscopic pyeloplasty in children: Randomized clinical trial.

    Science.gov (United States)

    Badawy, Haytham; Zoaier, Amr; Ghoneim, Tamer; Hanno, Ahmed

    2015-06-01

    Laparoscopic pyeloplasty achieves good cosmetic and functional outcomes. Both transperitoneal and retroperitoneal approaches are used. No single study to date has compared the two approaches in a prospective randomized design. We present a prospective randomized comparison between both approaches in children in a trial to define which technique is better with regard to multiple factors including operative time, hospital stay, recovery of bowel movement, analgesic requirement and complication rate. In the period from June 2010 to September 2012, 38 children (25 boys and 13 girls) were operated laparoscopically. Children were randomized into Group I (19 children) operated by the transperitoneal approach, and Group II (19 children) operated by the retroperitoneal approach. Both groups were compared as regards to the operative time, anesthetic changes, and postoperative recovery. A minimum sample size required was calculated to be 19 for each arm based on previous studies of laparoscopic pyeloplasty, using a mean difference in operative time = 40 min, effect size = 0.95, an alpha of 0.05 and power 80% and an online sample size calculator. Statistical analysis was performed using SPSS software using the Fischer exact test, chi square test and Mann-Whitney U test. The operative time was the primary endpoint for comparison between both approaches. Our series is the first in the literature that compares in a prospective randomized design the transperitoneal and retroperitoneal laparoscopic pyeloplasty in children. Shouma et al. is the only prospective randomized study to compare both techniques in adult pyeloplasty. They had a significantly shorter operative time in the transperitoneal group however, the author in the discussion mentioned that he was at the start of the learning curve for retroperitonoscopic pyeloplasty when he conducted his study, which affected the result of the operative time. Hence, as mentioned above, we stressed the importance of a single surgeon

  11. Randomized Controlled Trial Evaluating the Efficacy of Peritoneal Resuscitation in the Management of Trauma Patients Undergoing Damage Control Surgery.

    Science.gov (United States)

    Smith, Jason W; Matheson, Paul J; Franklin, Glen A; Harbrecht, Brian G; Richardson, J David; Garrison, R Neal

    2017-04-01

    Peritoneal resuscitation (PR) represents a unique modality of treatment for severely injured trauma patients requiring damage control surgery. These data represent the outcomes of a single institution randomized controlled trial into the efficacy of PR as a management option in these patients. From 2011 to 2015, one hundred and three patients were enrolled in a prospective randomized controlled trial evaluating the use of PR in the treatment of patients undergoing damage control surgery compared with conventional resuscitation (CR) alone. Patient demographics, clinical variables, and outcomes were collected. Univariate and multivariate analysis was performed with a priori significance at p ≤ 0.05. After initial screening, 52 patients were randomized to the PR group and 51 to the CR group. Age, sex, initial pH, and mechanism of injury were used for randomization. Method of abdominal closure was standardized across groups. Time to definitive abdominal closure was reduced in the PR group compared with the CR group (4.1 ± 2.2 days vs 5.9 ± 3.5 days; p ≤ 0.002). Volume of resuscitation and blood products transfused in the initial 24 hours was not different between the groups. Primary fascial closure rate was higher in the PR group (83% vs 66%; p ≤ 0.05). Intra-abdominal complications were lower in the PR compared with the CR group (8% vs 18%), with abscess formation rate (3% vs 14%; p < 0.05) being significant. Patients in the PR group had a lower 30-day mortality rate, despite similar Injury Severity Scores (13% vs 28%; p = 0.06). Peritoneal resuscitation enhances management of damage control surgery patients by reducing time to definitive abdominal closure, intra-abdominal infections, and mortality rates. Copyright © 2017. Published by Elsevier Inc.

  12. Clinical application of navigation surgery using augmented reality in the abdominal field.

    Science.gov (United States)

    Okamoto, Tomoyoshi; Onda, Shinji; Yanaga, Katsuhiko; Suzuki, Naoki; Hattori, Asaki

    2015-04-01

    This article presents general principles and recent advancements in the clinical application of augmented reality-based navigation surgery (AR based NS) for abdominal procedures and includes a description of our clinical trial and subsequent outcomes. Moreover, current problems and future aspects are discussed. The development of AR-based NS in the abdomen is delayed compared with another field because of the problem of intraoperative organ deformations or the existence of established modalities. Although there are a few reports on the clinical use of AR-based NS for digestive surgery, sophisticated technologies in urology have often been reported. However, the rapid widespread use of video- or robot assisted surgeries requires this technology. We have worked to develop a system of AR-based NS for hepatobiliary and pancreatic surgery. Then we developed a short rigid scope that enables surgeons to obtain 3D view. We recently focused on pancreatic surgery, because intraoperative organ shifting is minimal. The position of each organ in overlaid image almost corresponded with that of the actual organ with about 5 mm of mean registration errors. Intraoperative information generated from this system provided us with useful navigation. However, AR-based NS has several problems to overcome such as organ deformity, evaluation of utility, portability or cost.

  13. Effect of preoperative two-dimensional animation information on perioperative anxiety and knowledge retention in patients undergoing bowel surgery: a randomized pilot study.

    Science.gov (United States)

    Tou, S; Tou, W; Mah, D; Karatassas, A; Hewett, P

    2013-05-01

    The use of multimedia information provided preoperatively can potentially reduce anxiety in patients and improve the hospital experience. However, the use of two-dimensional (2D) animation (cartoon) to provide information to patients undergoing colorectal surgery has not been investigated. This study investigated the effect of preoperative 2D information on anxiety and knowledge retention in patients undergoing bowel surgery. Patients were randomized to one of two groups; the video group watched a 13-min cartoon animation whereas the nonvideo group did not. Anxiety levels were measured at the preadmission clinic, postvideo, on the day of admission for surgery, within 24-h after surgery and before discharge using the Spielberger state-trait anxiety inventory and visual analogue scale. Both groups completed a knowledge retention questionnaire and the video group completed a feedback questionnaire about the animation. Thirty-one patients (16 video, 15 nonvideo) participated in the study. There was no significant difference in baseline anxiety score between two groups. An immediate reduction (P = 0.03) in anxiety score was observed in the video group after watching the video compared with baseline. There was a significant reduction in anxiety score in the video group at discharge compared with the nonvideo group (P = 0.03). There was no significant difference in knowledge retention between two groups. Eighty-eight per cent of patients who watched the video found it beneficial. 2D animation is an effective medium for delivering information to patients undergoing bowel surgery and can potentially reduce anxiety related to surgery and improve the hospital experience. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

  14. Perineural Versus Systemic Dexamethasone in Front-Foot Surgery Under Ankle Block: A Randomized Double-Blind Study.

    Science.gov (United States)

    Marty, Philippe; Rontes, Olivier; Chassery, Clément; Vuillaume, Corine; Basset, Bertrand; Merouani, Mehdi; Marquis, Constance; Bataille, Benoit; Chaubard, Martine; Mailles, Marie Claude; Ferré, Fabrice; Delbos, Alain

    2018-04-06

    Among the different adjuvants, dexamethasone is one of the most accepted to prolong the effect of local anesthetics. This study aims to determine the superiority of perineural over systemic dexamethasone administration after a single-shot ankle block in metatarsal osteotomy. We performed a prospective, double-blind, randomized study. A total of 100 patients presenting for metatarsal osteotomy with an ankle block were randomized into 2 groups: 30 mL ropivacaine 0.375% + perineural dexamethasone 4 mg (1 mL) + 2.5 mL of systemic saline solution (PNDex group, n = 50) and 30 mL ropivacaine 0.375% + 1 mL of perineural saline solution + intravenous dexamethasone 10 mg (2.5 mL) (IVDex group, n = 50). The primary end point was the duration of analgesia defined as the time between the performance of the ankle block and the first administration of rescue analgesia with tramadol. Time period to first rescue analgesia with tramadol was similar in the IVDex group and the PNDex group. Data are expressed as mean (SD) or median (range). Duration of analgesia was 23.2 (9.5) hours in the IVDex group and 19 (8.2) hours in the PNDex group (P = 0.4). Consumption of tramadol during the first 48 hours was 0 mg (0-150 mg) in the IVDex group versus 0 mg (0-250 mg) in the PNDex group (P = 0.59). Four (8%) and 12 (24%) patients reported nausea or vomiting in the IVDex group and the PNDex group, respectively (P = 0.03). In front-foot surgery, perineural and systemic administrations of dexamethasone are equivalent for postoperative pain relief when used as an adjuvant to ropivacaine ankle block. This study was registered at ClinicalTrials.gov, identifier NCT02904538.

  15. Off-label use of recombinant factor VIIa for treatment of haemorrhage: results from randomized clinical trials

    DEFF Research Database (Denmark)

    Johansson, Per Ingemar

    2008-01-01

    , secondary to surgery, infection and stem cell transplantation. Three pilot studies reported a significant reduction in transfusion requirements and/or blood loss in the rFVIIa-treated groups, but these have not been confirmed in large randomized trials. No difference in thromboembolic complications between......Background Recombinant factor VIIa (rFVIIa) is used for haemophilic patients with inhibitors against coagulation factor VIII or IX, but there is also an off-label use of rFVIIa for patients with massive bleeding. The aim of the present study was to review the randomized clinical trials (RCT....... Conclusion There is little evidence to support routine use of rFVIIa for patients with massive bleeding based on the results of the randomized trials performed. In patients with a normal haemostatic system, administration of rFVIIa may be associated with an increased risk of thromboembolic events...

  16. Clinical and radiographic comparison of primary molars after formocresol and electrosurgical pulpotomy: a randomized clinical trial.

    Science.gov (United States)

    Bahrololoomi, Zahra; Moeintaghavi, Amir; Emtiazi, Maryam; Hosseini, Ghofran

    2008-01-01

    Vital pulpotomy is a single-stage procedure defined as the surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. The aim of this study was to compare the clinical and radiographic success rates for electrosurgical vs formocresol pulpotomy in human primary molar teeth. This was a prospective, randomized clinical trial. In this randomized clinical trial, pulpotomies were performed on 70 primary molars in children aged 5-10 years. The teeth were treated using either a conventional formocresol (35 teeth) or electrosurgical technique (35 teeth). Following the pulpotomy procedure, the teeth were evaluated for clinical and radiographic success for three, six and nine months. The teeth were evaluated for the presence of pain, abscess, fistula, mobility, internal and external resorption, and radiolucency. The data were assessed with Fishers' Exact test. After nine months of follow-up, the clinical and radiographic success rates were 96 and 84% respectively in the electrosurgical group and 100 and 96.8% respectively in the formocresol group. There was no statistically significant difference between the success rates in the two groups ( P > 0.05). Our results showed the failure rates for electrosurgical pulpotomy to be equal to those for formocresol pulpotomy. Although electrosurgical pulpotomy is a nonpharmacological technique giving favorable results, it is still a preservative technique. Further studies using larger samples and longer evaluation periods are recommended.

  17. Compliance of randomized controlled trials in trauma surgery with the CONSORT statement.

    Science.gov (United States)

    Lee, Seon-Young; Teoh, Penelope J; Camm, Christian F; Agha, Riaz A

    2013-10-01

    Randomized controlled trials (RCTs) are the criterion standard for assessing new interventions. However, bias can result from poor reporting, which also makes critical appraisal and systematic review challenging. The Consolidated Standards of Reporting Trials (CONSORT) criteria for nonpharmacological trials published in 2008 provided a set of 23 mandatory items that should be reported in an RCT. This is the first study to assess the compliance of RCTs in trauma with the CONSORT criteria for nonpharmacological trials. The MEDLINE database was searched using the MeSH term wounds and injuries for English-language articles published between January 2009 and December 2011. Relevant articles were scored by two reviewers and compared against surrogate markers of article quality (such as journal impact factor). Eighty-three articles were deemed suitable for inclusion. The mean CONSORT score was 11.2 of 23 items (49%; range, 3.38-18.17). Compliance was poorest for items relating to the adherence of care providers (0%), abstract (5%), and implementation of randomization (6%). Only 40% declared conflicts of interest, 73% declared permission from an ethics review committee, 43% declared sources of funding, and 10% stated a trial registry number. There was a significant correlation between the CONSORT score and the impact factor of the publishing journal (ρ = 0.37, p = 0.0006) but not for the number of patients or authors or single versus multicentre trials The reporting quality of RCTs in trauma surgery needs improvement. We suggest ways by which this could be improved including the following: better education, awareness, and a cohesive strategy among all stakeholders and the hard wiring of compliance through electronic journal submission systems.

  18. Wound complications after ankle surgery. Does compression treatment work? A randomized, controlled trial.

    Science.gov (United States)

    Winge, Rikke; Ryge, Camilla; Bayer, Lasse; Klausen, Tobias Wirenfeldt; Gottlieb, Hans

    2018-01-27

    Infection rates following ankle fractures are as high as 19% in selected material and is the most common complication following this type of surgery, with potential catastrophic consequences. The purpose of this study was to test a regime of intermittent pneumatic compression, a compression bandage and a compression stocking and its effect on the rate of wound complications. The hypothesis was that compression could lower the infection rate from 20 to 5%. We performed a randomized, controlled, non-blinded trial, including 153 adult patients with unstable ankle fractures. Patients were randomized to either compression (N = 82) or elevation (N = 71). Patients with open fracture, DVT, pulmonary embolism, dementia, no pedal pulse, or no Danish address were excluded. Primary endpoint was infection. Secondary endpoints were necrosis and wound dehiscence. After 2 weeks, 1.4% (0.0;7.6) in the compression group had infection compared to 4.6% (1.0;12.9) in the control group, p = 0.35. The rate of necrosis after 2 weeks was 7.0% (95% CI 2.3;15.7) in the compression group compared with 26.2% (95% CI 16.0;38.5) in the elevation group, p = 0.004. No difference was shown regarding wound dehiscence. Based on this study, we cannot conclude if compression therapy prevents infection or not. This is mainly due to under-powering of the study. The effect on necrosis was in favor of compression, but the trial was not powered to show a difference regarding this endpoints and the result is thus hypothesis generating. Further research is needed before a thorough recommendation on the use of compression treatment that can be made.

  19. Development and implementation of a clinical pathway approach to simulation-based training for foregut surgery.

    Science.gov (United States)

    Miyasaka, Kiyoyuki W; Buchholz, Joseph; LaMarra, Denise; Karakousis, Giorgos C; Aggarwal, Rajesh

    2015-01-01

    Contemporary demands on resident education call for integration of simulation. We designed and implemented a simulation-based curriculum for Post Graduate Year 1 surgery residents to teach technical and nontechnical skills within a clinical pathway approach for a foregut surgery patient, from outpatient visit through surgery and postoperative follow-up. The 3-day curriculum for groups of 6 residents comprises a combination of standardized patient encounters, didactic sessions, and hands-on training. The curriculum is underpinned by a summative simulation "pathway" repeated on days 1 and 3. The "pathway" is a series of simulated preoperative, intraoperative, and postoperative encounters in following up a single patient through a disease process. The resident sees a standardized patient in the clinic presenting with distal gastric cancer and then enters an operating room to perform a gastrojejunostomy on a porcine tissue model. Finally, the resident engages in a simulated postoperative visit. All encounters are rated by faculty members and the residents themselves, using standardized assessment forms endorsed by the American Board of Surgery. A total of 18 first-year residents underwent this curriculum. Faculty ratings of overall operative performance significantly improved following the 3-day module. Ratings of preoperative and postoperative performance were not significantly changed in 3 days. Resident self-ratings significantly improved for all encounters assessed, as did reported confidence in meeting the defined learning objectives. Conventional surgical simulation training focuses on technical skills in isolation. Our novel "pathway" curriculum targets an important gap in training methodologies by placing both technical and nontechnical skills in their clinical context as part of managing a surgical patient. Results indicate consistent improvements in assessments of performance as well as confidence and support its continued usage to educate surgery residents

  20. Complications of nonbiliary laparoscopic gastrointestinal surgery : Radiologic findings and clinical courses

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Seon Ah; Lee, Sang Hoon; Won, Yong Sung; Park, Young Ha; Kim, Jun Gi [St. Vincent' s Hospital, College of Medicine, The Catholic University, Suwon (Korea, Republic of); Kim, Hyun [St. Mary' s Hospital, College of Medicine, The Catholic University, Taejon (Korea, Republic of)

    2000-05-01

    To evaluate the radiological findings and clinical course of the complications arising after nonbiliay laparoscopic gastrointestinal surgery (NLGS). We retrospectively reviewed the clinical records of 131 patients who underwent NLGS (83 cases involving colorectal surgery, 18 splenectomies, 14 appendectomies, ten adrenalectomies, three lumbar sympathectomies, two Duhamel's operation, and one peptic ulcer perforation repair) over a four-year period. Among these 131 patients, the findings of fifteen in whom postoperative complications were confirmed were analysed. The radiologic examinations these patients underwent included CT (n=3D8), barium enema and fistulography (n=3D4), ultrasonography (n=3D3), ascending venography of the lower legs (n=3D2), and penile Doppler sonography (n=3D1). We evaluated the radiologic findings and clinical courses of early (within 2 weeks) and late (after 2 weeks) postoperative complications. Sixteen cases of postoperative complications developed in fifteen patients ; in 14 (17%) after colorectal surgery and in one (6%) after splenectomy. Eleven of the sixteen cases (69%) involved early complications, consisting of an abscess in three, ischemic colitis in two, hemoperitoneum in one, perforation of the colon in one, pancreatitis in one, recto-vaginal fistula in one, deep vein thrombosis after colorectal surgery in one, and abscess after splenectomy in one. The remaining five cases (31%) involved late complications which developed after colorectal surgery, comprising anastomosic site stricture in two, abdominal wall (trocar site) metastasis in one, colo-cutaneous fistula in one, and impotence in one. Among the 16 cases involving postoperative complications, recto-vaginal fistula, colon perforation, and abdominal wall metastasis were treated by surgery, while the other thirteen cases were treated conservatively. Various postoperative complications develop after NLGS, with a higher rate of these being noted in cases involving colorectal

  1. Complications of nonbiliary laparoscopic gastrointestinal surgery : Radiologic findings and clinical courses

    International Nuclear Information System (INIS)

    Jung, Seon Ah; Lee, Sang Hoon; Won, Yong Sung; Park, Young Ha; Kim, Jun Gi; Kim, Hyun

    2000-01-01

    To evaluate the radiological findings and clinical course of the complications arising after nonbiliay laparoscopic gastrointestinal surgery (NLGS). We retrospectively reviewed the clinical records of 131 patients who underwent NLGS (83 cases involving colorectal surgery, 18 splenectomies, 14 appendectomies, ten adrenalectomies, three lumbar sympathectomies, two Duhamel's operation, and one peptic ulcer perforation repair) over a four-year period. Among these 131 patients, the findings of fifteen in whom postoperative complications were confirmed were analysed. The radiologic examinations these patients underwent included CT (n=3D8), barium enema and fistulography (n=3D4), ultrasonography (n=3D3), ascending venography of the lower legs (n=3D2), and penile Doppler sonography (n=3D1). We evaluated the radiologic findings and clinical courses of early (within 2 weeks) and late (after 2 weeks) postoperative complications. Sixteen cases of postoperative complications developed in fifteen patients ; in 14 (17%) after colorectal surgery and in one (6%) after splenectomy. Eleven of the sixteen cases (69%) involved early complications, consisting of an abscess in three, ischemic colitis in two, hemoperitoneum in one, perforation of the colon in one, pancreatitis in one, recto-vaginal fistula in one, deep vein thrombosis after colorectal surgery in one, and abscess after splenectomy in one. The remaining five cases (31%) involved late complications which developed after colorectal surgery, comprising anastomosic site stricture in two, abdominal wall (trocar site) metastasis in one, colo-cutaneous fistula in one, and impotence in one. Among the 16 cases involving postoperative complications, recto-vaginal fistula, colon perforation, and abdominal wall metastasis were treated by surgery, while the other thirteen cases were treated conservatively. Various postoperative complications develop after NLGS, with a higher rate of these being noted in cases involving colorectal

  2. Exploring outcomes of a nurse practitioner-managed cardiac surgery follow-up intervention: a randomized trial.

    Science.gov (United States)

    Sawatzky, Jo-Ann V; Christie, Sandra; Singal, Rohit K

    2013-09-01

    To describe and compare the outcomes of a nurse practitioner-managed cardiac surgery follow-up model of care with the standard model of primary care provider follow-up for coronary artery bypass graft surgery patients. Advances in healthcare have had a favourable impact on length of stay following cardiac surgery; however, the shorter length of stay has not been accompanied by enhanced support to bridge the gap between acute care and the community setting. Prospective (2009-2010) randomized study. Elective cardiac surgery patients (N = 200) were randomly assigned to the nurse practitioner follow-up intervention or to the standard model of follow-up care. The main outcomes were health-related quality of life, patient satisfaction, symptoms, and health resource use. Outcome data were elicited via telephone interviews at 2 and 6 weeks postdischarge. Baseline differences between the two groups were non-significant; however, at 2 weeks postdischarge, the intervention group reported significantly fewer symptoms and higher physical functioning status. At 2 and 6 weeks postdischarge, the intervention group was significantly more satisfied with the amount of help, as well as the quality of the services received. Differences in healthcare resource use were not statistically significant. This evidence suggests that the nurse practitioner-managed model of follow-up care effectively bridges the gap between institutional and primary care in the cardiac surgery population. © 2013 Blackwell Publishing Ltd.

  3. Fixity of ports to the abdominal wall during laparoscopic surgery: a randomized comparison of cutting versus blunt trocars.

    Science.gov (United States)

    Hamade, A M; Issa, M E; Haylett, K R; Ammori, B J

    2007-06-01

    Dislodgement of ports from the abdominal wall is a common problem during laparoscopic surgery. The aim of this study was to evaluate port stability using either cutting or blunt-tipped trocars. Patients undergoing laparoscopic surgery were randomized to have the secondary ports inserted using either cutting or blunt-tipped trocars. The fixity of ports to the abdominal wall was evaluated at the start and completion of surgery by measuring the total traction force required to displace the ports. Similarly, the friction forces required to displace instruments within the ports were measured. Thirty patients were randomized into two groups (15 patients in each group), and a total of 114 ports (cutting, n = 51; blunt, n = 63) were evaluated. The groups were comparable in age, gender, body mass index, and operating time. The total traction forces needed to displace the 5-mm and 10-mm ports were significantly lower when cutting trocars were used at both the beginning (2.6 vs. 11.8 N, p fixity to the abdominal wall during laparoscopic surgery declines with time. The insertion of ports using a blunt-tipped trocar is associated with significantly greater stability and fixity of the port to the abdominal wall. The use of blunt-tipped trocars is recommended for routine practice in laparoscopic surgery.

  4. Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    MSoltanzadeh

    2011-09-01

    Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

  5. 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....

  6. Identifying randomized clinical trials in Spanish-language dermatology journals.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  7. Dose response of exercise training following roux-en-Y gastric bypass surgery: A randomized trial.

    Science.gov (United States)

    Woodlief, Tracey L; Carnero, Elvis A; Standley, Robert A; Distefano, Giovanna; Anthony, Steve J; Dubis, Gabe S; Jakicic, John M; Houmard, Joseph A; Coen, Paul M; Goodpaster, Bret H

    2015-12-01

    Roux-en-Y gastric bypass (RYGB) surgery can cause profound weight loss and improve overall cardiometabolic risk factors. Exercise (EX) training following RYGB can provide additional improvements in insulin sensitivity (SI ) and cardiorespiratory fitness. However, it remains unknown whether a specific amount of EX post-RYGB is required to achieve additional benefits. We performed a post hoc analysis of participants who were randomized into either a 6-month structured EX program or a health education control (CON). The EX group (n = 56) was divided into tertiles according to the amount of weekly exercise performed, compared with CON (n = 42): low-EX = 54 ± 8; middle-EX = 129 ± 4; and high-EX = 286 ± 40 min per week. The high-EX lost a significantly greater amount of body weight, total fat mass, and abdominal deep subcutaneous abdominal fat compared with CON (P weight loss, changes in body composition, and improvements in cardiorespiratory fitness and skeletal muscle mitochondrial capacity. © 2015 The Obesity Society.

  8. Intrathecal sufentanil versus fentanyl for lower limb surgeries - A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    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.

  9. Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

    Science.gov (United States)

    Chen, Fa-Ming; Gao, Li-Na; Tian, Bei-Min; Zhang, Xi-Yu; Zhang, Yong-Jie; Dong, Guang-Ying; Lu, Hong; Chu, Qing; Xu, Jie; Yu, Yang; Wu, Rui-Xin; Yin, Yuan; Shi, Songtao; Jin, Yan

    2016-02-19

    Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry. We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure. A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p 0.05). This study

  10. Supplemental Peri-Operative Oxygen and Incision Site Infection after Surgery for Perforated Peptic Ulcer: A Randomized, Double-Blind Monocentric Trial.

    Science.gov (United States)

    Schietroma, Mario; Cecilia, Emanuela Marina; De Santis, Giuseppe; Carlei, Francesco; Pessia, Beatrice; Amicucci, Gianfranco

    2016-02-01

    The clinical role of hyperoxia for preventing surgical site infection (SSI) remains uncertain because randomized controlled trials on this topic have reported disparate results. One of the principal reasons for this outcome may be that prior trials have entered heterogeneous populations of patients and a variety of procedures. The aim of our study was to assess the influence of hyperoxygenation on SSI using a homogeneous study population. From January 2004 to April 2013, we studied, in a randomized trial, 239 patients, who underwent open