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Sample records for surgery prospective randomized

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

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    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.

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

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    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.

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

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    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.

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

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    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

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

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    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.

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

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    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.

  7. A prospective, randomized study of preoperative autologous donation for hip replacement surgery.

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    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

  8. 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.

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

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    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.

  10. Improvement of recovery parameters using patient-controlled epidural analgesia after oncological surgery. A prospective, randomized single center study*

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    Zgâia, Armeana Olimpia; Lisencu, Cosmin Ioan; Rogobete, Alexandru; Vlad, Cătălin; Achimaş-Cadariu, Patriciu; Lazăr, Gabriel; Muntean, Maximilian; Ignat, Florin; Ormindean, Vlad; Irimie, Alexandru

    2017-01-01

    Purpose: The aim of this study was to compare patient-controlled epidural analgesia (PCEA) versus conventional opioid intravenous (IV) infusion after gastrointestinal cancer surgery regarding several post-surgery parameters of recovery. Methods: One hundred and one patients were prospectively randomized to receive either thoracic/lumbar PCEA (PCEA group) or the standard analgesia technique used in our hospital, conventional IV infusion of morphine (IVMO group) after gastrointestinal cancer surgery. Pain intensity, time of mobilization and bowel function recovery were analyzed post-surgery. We also evaluated postoperative complications and length of Postoperative-Intermediate Intensive Care Unit (PI-ICU) stay and hospital stay. Results: Pain intensity was significantly less in the PCEA group in comparison with the IVMO Group at awakening 2, 8, 24, 30 and 48 hours after surgery (p apparition of first stool were significantly faster (1.74 versus 2.26 days, 3.06 versus 3.78 days, 2.1 versus 3.14 days and 3.73 versus 5.28 days, respectively) in the PCEA group than in the IVMO group (p pain control, improves postoperative recovery after gastrointestinal cancer surgery compared with conventional intravenous morphine infusion. Therefore, it is more acceptable than conventional pain management. PMID:28913495

  11. Improvement of recovery parameters using patient-controlled epidural analgesia after oncological surgery. A prospective, randomized single center study.

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    Zgâia, Armeana Olimpia; Lisencu, Cosmin Ioan; Rogobete, Alexandru; Vlad, Cătălin; Achimaş-Cadariu, Patriciu; Lazăr, Gabriel; Muntean, Maximilian; Ignat, Florin; Ormindean, Vlad; Irimie, Alexandru

    2017-04-01

    The aim of this study was to compare patient-controlled epidural analgesia (PCEA) versus conventional opioid intravenous (IV) infusion after gastrointestinal cancer surgery regarding several post-surgery parameters of recovery. One hundred and one patients were prospectively randomized to receive either thoracic/lumbar PCEA (PCEA group) or the standard analgesia technique used in our hospital, conventional IV infusion of morphine (IVMO group) after gastrointestinal cancer surgery. Pain intensity, time of mobilization and bowel function recovery were analyzed post-surgery. We also evaluated postoperative complications and length of Postoperative-Intermediate Intensive Care Unit (PI-ICU) stay and hospital stay. Pain intensity was significantly less in the PCEA group in comparison with the IVMO Group at awakening 2, 8, 24, 30 and 48 hours after surgery (p apparition of first stool were significantly faster (1.74 versus 2.26 days, 3.06 versus 3.78 days, 2.1 versus 3.14 days and 3.73 versus 5.28 days, respectively) in the PCEA group than in the IVMO group (p pain control, improves postoperative recovery after gastrointestinal cancer surgery compared with conventional intravenous morphine infusion. Therefore, it is more acceptable than conventional pain management.

  12. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

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    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  13. A prospective, randomized, double blind controlled trial

    African Journals Online (AJOL)

    Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital, Nairobi: A prospective, randomized, double blind controlled trial.

  14. Non-randomized controlled prospective study on perioperative levels of stress and dysautonomia during dental implant surgery.

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    Morino, Miyuki; Masaki, Chihiro; Seo, Yoshinori; Mukai, Chisato; Mukaibo, Taro; Kondo, Yusuke; Shiiba, Shunji; Nakamoto, Tetsuji; Hosokawa, Ryuji

    2014-07-01

    The purpose of this study was to compare pre- and postoperative autonomic activities and changes in salivary stress biomarkers between patients who received only local anesthesia and those who received local anesthesia together with intravenous sedation in dental implant surgery. A total of 21 patients were enrolled in this non-randomized controlled prospective study; 7 subjects underwent implant surgery under local anesthesia with intravenous sedation and 14 subjects underwent surgery under only local anesthesia. Stress was evaluated by measuring salivary levels of chromogranin A (CgA) and a spectral analysis of heart rate variability (HRV) at baseline (on a day other than the day of surgery), 1h preoperatively, and 1h postoperatively. HRV analysis yields low- (LF) and high-frequency (HF) components, the LF/HF ratio, and the component coefficient of variance (CCV[HF]), which provide indices of sympathetic and parasympathetic regulatory activity. CgA levels were significantly higher (p<0.05) at baseline in patients who received sedation than those who did not, but CgA levels did not differ prior to surgery. Also, the values of most parameters, including LF, HF, LF/HF (L/H), and CCV(HF), did not significantly differ between groups or among the three time points. Only ΔL/H and ΔCCV(HF) were significantly lower (p<0.05) at 1h preoperatively in patients who received sedation than those who received only local anesthesia. CgA levels were high in both groups immediately before surgery, and thus CgA values immediately before surgery may not be a reliable indicator of the need for intravenous sedation. Also, spectral analysis of HRV, especially ΔL/H and ΔCCV(HF), could be useful for assessing tension and anxiety. Copyright © 2014. Published by Elsevier Ltd.

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

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    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.

  16. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

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    Vanlal Darlong

    2015-01-01

    Full Text Available Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED 95 ; Group 75: Received atracurium at 75% dose of ED 95 ; Group 100: Received atracurium of 100% dose of ED 95 . Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001. Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001 with the least satisfaction in Group 0. The laryngeal mask airway (LMA insertion score was statistically significant in the four groups (P - 0.001. However, number of attempts for LMA placement was comparable among the four groups (P - 0.766. Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better

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

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    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.

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

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    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

  19. Surgery versus nonsurgical treatment of cervical radiculopathy: a prospective, randomized study comparing surgery plus physiotherapy with physiotherapy alone with a 2-year follow-up.

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    Engquist, Markus; Löfgren, Håkan; Öberg, Birgitta; Holtz, Anders; Peolsson, Anneli; Söderlund, Anne; Vavruch, Ludek; Lind, Bengt

    2013-09-15

    Prospective randomized controlled trial. To study the outcome of anterior cervical decompression and fusion combined with a structured physiotherapy program compared with the same physiotherapy program alone for patients with cervical radiculopathy. Knowledge concerning the effects of interventions for patients with cervical radiculopathy is scarce due to a lack of randomized studies. Sixty-three patients were randomized to surgery with postoperative physiotherapy (n = 31) or physiotherapy alone (n = 32). The surgical group was treated with anterior cervical decompression and fusion. The physiotherapy program included general/specific exercises and pain-coping strategies. The outcome measures were disability (Neck Disability Index), neck and arm pain intensity (visual analogue scale), and the patient's global assessment. Patients were followed for 24 months. The result from the repeated-measures analysis of variance showed no significant between-group difference for Neck Disability Index (P = 0.23). For neck pain intensity, the repeated-measures analysis of variance showed a significant between-group difference during the study period in favor of the surgical group (P = 0.039). For arm pain intensity, no significant between-group differences were found according to the repeated-measures analysis of variance (P = 0.580). Eighty-seven percent of the patients in the surgical group rated their symptoms as "better/much better" at the 12-month follow-up compared with 62% in the nonsurgical group (P cervical radiculopathy, it was shown that surgery with physiotherapy resulted in a more rapid improvement during the first postoperative year, with significantly greater improvement in neck pain and the patient's global assessment than physiotherapy alone, but the differences between the groups decreased after 2 years. Structured physiotherapy should be tried before surgery is chosen. 2.

  20. The effect of parenteral testosterone administration prior to hypospadias surgery: A prospective, randomized and controlled study.

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    Asgari, S A; Safarinejad, M R; Poorreza, F; Asl, A Safaei; Ghanaie, M Mansour; Shahab, E

    2015-06-01

    The goal of hypospadias surgery is to provide a functionally and cosmetically normal penis. Whether this goal will be to the patient's satisfaction depends largely on the original anatomy, surgical technique and surgeon's experience. It has been suggested that androgen administration is associated with better outcomes in hypospadias repair; however, few studies have included control groups and the issue is still controversial. To evaluate the effects of parenteral testosterone administration on the results of hypospadias repair in children with untreated hypospadias. A total of 182 children with midshaft or distal hypospadias and a mean age of 30 months (range 18-52 months) were enrolled in this study. Consecutive children were randomly allocated to the study group (testosterone administration) (Group 1, n = 91) or control group (Group 2, n = 91). Only children with a flat urethral plate were included in this study. The control group did not receive any pre-operative treatment. Children with a previous history of hypospadias repair and any proven endocrine disorder were excluded. The study children received 2 mg/kg testosterone enanthate monthly for two months before surgery. Tubularized incised plate (TIP) urethroplasty, with or without chordee correction, was performed for all children in both groups by the same urologist. Hypospadias repair was performed 4 weeks after the second dose of testosterone administration. Postoperative complications were recorded, including: urethrocutaneous fistulas, urethral diverticula, meatal stenosis, and glanular dehiscence. The mean stretched penile length and circumference were measured at baseline and at 1 month and 2 months post operation. All children were examined every month for any adverse affects to testosterone treatment, like pubic and axillary hair, and height acceleration, up to 3 months post operation. An increase in penile length (from 28.1 ± 2.2 mm to 38.5 ± 2.6 mm) (P = 0.001) and penile circumference (from 35

  1. Erectile dysfunction and hormonal imbalance in morbidly obese male is reversed after gastric bypass surgery: a prospective randomized controlled trial.

    Science.gov (United States)

    Reis, L O; Favaro, W J; Barreiro, G C; de Oliveira, L C; Chaim, E A; Fregonesi, A; Ferreira, U

    2010-10-01

    The effects of weight loss on erectile function and hormones have not been well studied. The aim of this study was to measure the degree to which sexual function and in particular erectile function and hormonal environment change after substantial weight loss, surgically and non-surgically induced in the morbidly obese male in a prospective randomized long-term controlled trial. Furthermore, how surgery makes a difference when treating morbidly obese men was envisaged in this context. We prospectively studied 20 morbidly obese men for 24 months, divided into two groups: group A included 10 patients who underwent life style modifications (exercise and diet) for 4 months and subsequently gastric bypass, and another 10 patients in group B were kept on weekly follow-up. None of the men were taking phosphodiesterase type-5 inhibitors. All patients underwent International Index of Erectile Function (IIEF)-5 questionnaire, serum oestradiol, prolactin (PRL), luteinizing (LH) and follicle-stimulating (FSH) hormones, free and total testosterone (FT and TT) at baseline (time 0), surgery - 4 months latter baseline (time 1) and final evaluation - 24 months (time 2). From times 0 to 1, group A presented a mean body mass index (BMI) reduction of 12.6 (p 0.05). The BMI reductions between times 0 and 2 were 24.7 (p 0.05) for groups A and B respectively. BMI average between the two groups was similar at time 0 (p = 0.2142), and different at times 1 (p = 0.0033) and 2 (p hormonal impact verified could justify the improvement in erectile function. Lifestyle modifications impacted BMI without hormonal or sexual impact in morbidly obese. New studies are warranted in the field to support our data.

  2. Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

    Science.gov (United States)

    2016-08-01

    be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery...Readiness, da Vinci Simulator, Virtual Reality, Simulation Curriculum, GEARS - Global Evaluative Assessment of Robotic Skills, Surgical Education 16...technical performance and Global Evaluative Assessment of Robotic Skills (GEARS) scoring will be correlated by the Principal Investigator (Dr

  3. Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial.

    Science.gov (United States)

    Ari, Seyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Caca, Ihsan

    2009-08-01

    The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based

  4. 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.

  5. 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.

  6. The role of Rajyoga meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass surgery: A prospective randomized control study

    OpenAIRE

    Usha Kiran; Suruchi Ladha; Neeti Makhija; Poonam Malhotra Kapoor; Minati Choudhury; Sambhunath Das; Parag Gharde; Vishwas Malik; Balram Airan

    2017-01-01

    Introduction: Rajyoga meditation is a form of mind body intervention that is promoted by the Brahma Kumaris World Spiritual University. This form of meditation can be easily performed without rituals or mantras and can be practiced anywhere at any time. The practice of Rajyoga meditation can have beneficial effects on modulating anxiety and cortisol level in patients undergoing major cardiac surgery. Materials and Methods: A prospective randomized control study was carried out in a single ter...

  7. Web-Based Education Prior to Outpatient Orthopaedic Surgery Enhances Early Patient Satisfaction Scores: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    van Eck, Carola F; Toor, Aneet; Banffy, Michael B; Gambardella, Ralph A

    2018-01-01

    A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores. Randomized controlled trial; Level of evidence, 1. All patients undergoing knee arthroscopy with meniscectomy, chondroplasty, or anterior cruciate ligament reconstruction or shoulder arthroscopy with rotator cuff repair were eligible for inclusion and were randomized to the study or control group. The control group received routine education by the surgeon, whereas the study group received additional web-based education. At the first postoperative visit, all patients completed the OAS CAHPS (Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems) survey. Differences in patient satisfaction scores between the study and control groups were determined with an independent t test. A total of 177 patients were included (104 [59%] males; mean age, 42 ± 14 years); 87 (49%) patients were randomized to receive additional web-based education. Total patient satisfaction score was significantly higher in the study group (97 ± 5) as compared with the control group (94 ± 8; P = .019), specifically for the OAS CAHPS core measure "recovery" (92 ± 13 vs 82 ± 23; P = .001). Age, sex, race, workers' compensation status, education level, overall health, emotional health, procedure type and complexity, and addition of a video did not influence patient satisfaction scores. Supplemental web-based patient education prior to outpatient orthopaedic surgery enhances patient satisfaction scores.

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

    Directory of Open Access Journals (Sweden)

    Biffi Roberto

    2012-05-01

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

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

    Science.gov (United States)

    Biffi, Roberto; Fattori, Luca; Bertani, Emilio; Radice, Davide; Rotmensz, Nicole; Misitano, Pasquale; Cenciarelli, Sabine; Chiappa, Antonio; Tadini, Liliana; Mancini, Marina; Pesenti, Giovanni; Andreoni, Bruno; Nespoli, Angelo

    2012-05-23

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

  10. Evaluation of postoperative discomfort following third molar surgery using submucosal dexamethasone - a randomized observer blind prospective study.

    Science.gov (United States)

    Warraich, Riaz; Faisal, Muhammad; Rana, Madiha; Shaheen, Anjum; Gellrich, Nils-Claudius; Rana, Majeed

    2013-07-01

    Surgical removal of impacted lower third molar is still the most frequent procedure done by Oral and Maxillofacial surgeons and is often associated with pain, swelling and trismus. These postoperative sequelae can cause distress to the patient as a result of tissue trauma and affect the patient's quality of life after surgery. Use of antiseptic mouthwashes, drains, muscle relaxants, cryotherapy, antibiotics, corticosteroids and physiotherapy seems to decrease postoperative discomfort. Among them corticosteroids are well-known adjuncts to surgery for suppressing tissue mediators of inflammation, thereby reducing transudation of fluids and lessening edema. The rationale of this study is to determine the effectiveness of submucosal injection of dexamethasone in reducing postoperative discomfort after third molar surgery. 100 patients requiring surgical removal of third molar under local anesthesia were randomly divided into 2 groups, group I receiving 4 mg dexamethasone as submucosal injection and the control group II received no steroid administration. Facial swelling was quantified by anatomical facial landmarks. Furthermore, pain and patient satisfaction, as well as neurological score and the degree of mouth opening were observed from each patient. Patients receiving dexamethasone showed significant reduction in pain, swelling, trismus, a tendency to less neurological complaints and improved quality of life compared with the control group. Submucosal injection of dexamethasone is more efficient to manage postoperative discomfort after removal of third molars compared to no steroid administration. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. 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.

  12. Off-pump Versus On-pump Coronary Artery Bypass Surgery: Graft Patency Assessment With Coronary Computed Tomographic Angiography: A Prospective Multicenter Randomized Controlled Pilot Study.

    Science.gov (United States)

    Noiseux, Nicolas; Stevens, Louis-Mathieu; Chartrand-Lefebvre, Carl; Soulez, Gilles; Prieto, Ignacio; Basile, Fadi; Mansour, Samer; Dyub, Adel M; Kieser, Teresa M; Lamy, André

    2017-11-01

    A large multicenter randomized trial (RCT) is needed to assess off-pump coronary artery bypass graft (CABG) patency when performed by skilled surgeons. This prospective multicenter randomized pilot study compares graft patency after on-pump and off-pump techniques and addresses the feasibility of such an RCT. Consecutive patients were prospectively recruited for ≥64-slice computed tomography angiography graft patency assessment 1 year after randomization to off-pump or on-pump CABG. Blinded assessment of graft patency was performed, and the results were categorized as normal, ≥50% stenosis, or occlusion. A multilevel model with random effects on the patient was used to account for correlation of results in patients with multiple grafts. A total of 157 patients (3 centers, 84 off-pump and 73 on-pump patients, 512 grafts, assessability rate 98.4%) were included. Patency index (% nonoccluded grafts) was 89% for the off-pump technique and 95% for the on-pump technique (P=0.09). Patency was similar for arterial and vein grafts (both 92%; P=0.88), as well as between target territories (89% to 94%; P=0.53). In this pilot study, 1-year graft patency results after off-pump and on-pump surgery were similar. This feasibility trial demonstrates that a large multicenter RCT to compare CABG patency after on-pump with that after off-pump techniques is feasible and can be reliably undertaken using computed tomography angiography.

  13. 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.

  14. 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

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

    International Nuclear Information System (INIS)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner; Brunner, Thomas B.; Witzigmann, Helmut; Marti, Lukas; Bechstein, Wolf-Otto; Bruns, Christiane; Jungnickel, Henry; Schreiber, Stefan; Grabenbauer, Gerhard G.; Meyer, Thomas; Fietkau, Rainer

    2015-01-01

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

  16. Water exchange enhanced cecal intubation in potentially difficult colonoscopy. Unsedated patients with prior abdominal or pelvic surgery: a prospective, randomized, controlled trial.

    Science.gov (United States)

    Luo, Hui; Zhang, Linhui; Liu, Xiaodong; Leung, Felix W; Liu, Zhiguo; Wang, Xiangping; Xue, Ling; Wu, Kaichun; Fan, Daiming; Pan, Yanglin; Guo, Xuegang

    2013-05-01

    Colonoscopy is widely used for management of colorectal diseases. A history of abdominal or pelvic surgery is a well-recognized factor associated with difficult colonoscopy. Although water exchange colonoscopy (WEC) was effective in small groups of male U.S. veterans with such a history, its application in other cultural settings is uncertain. To investigate the application of WEC in such patients. Prospective, randomized, controlled, patient-blinded study. Tertiary-care referral center in China. Outpatients with prior abdominal or pelvic surgery undergoing unsedated diagnostic, screening, or surveillance colonoscopy. Patients were randomized to examination by either WEC or conventional air colonoscopy (AC). Cecal intubation rate. A total of 110 patients were randomized to the WEC (n = 55) or AC (n = 55) group. WEC significantly increased the cecal intubation rate (92.7% vs 76.4%; P = .033). The maximum pain scores (± standard deviation) were 2.1 ± 1.8 (WEC) and 4.6 ± 1.7 (AC), respectively (P WEC would be willing to have a repeat unsedated colonoscopy (90.9% vs 72.7%, P = .013). Single center; unblinded but experienced endoscopists. This randomized, controlled trial confirms that the water exchange method significantly enhanced cecal intubation in potentially difficult colonoscopy in unsedated patients with prior abdominal or pelvic surgery. The lower pain scores and higher proportion accepting repeat of the unsedated option suggest that WEC is promising. It may enhances compliance with colonoscopy in specific populations. ( NCT01485133.). Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  17. The role of Rajyoga meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass surgery: A prospective randomized control study.

    Science.gov (United States)

    Kiran, Usha; Ladha, Suruchi; Makhija, Neeti; Kapoor, Poonam Malhotra; Choudhury, Minati; Das, Sambhunath; Gharde, Parag; Malik, Vishwas; Airan, Balram

    2017-01-01

    Rajyoga meditation is a form of mind body intervention that is promoted by the Brahma Kumaris World Spiritual University. This form of meditation can be easily performed without rituals or mantras and can be practiced anywhere at any time. The practice of Rajyoga meditation can have beneficial effects on modulating anxiety and cortisol level in patients undergoing major cardiac surgery. A prospective randomized control study was carried out in a single tertiary care center. One hundred and fifty patients undergoing elective coronary artery bypass surgery were enrolled in the study. The patients were randomized in two groups namely, Group 1 (Rajyoga group) and Group 2 (Control Group). Anxiety was measured on a visual analog scale 1-10 before the start of Rajyoga training or patient counseling (T1), on the morning of the day of surgery (T2), on the 2nd postoperative day (T3), and on the 5th postoperative day (T4). The serum cortisol level was measured in the morning of the day of surgery (T1), on the 2nd postoperative day (T2) and on the 5th postoperative day (T3), respectively. In the study, it was seen that the anxiety level of the patients before the surgery (T1) and on the day of surgery (T2) were comparable between the two groups. However on the 2nd postoperative day (T3), the patients who underwent Rajyoga training had lower anxiety level in comparison to the control group (3.12 ± 1.45 vs. 6.12 ± 0.14, P < 0.05) and on the 5th postoperative day (T4) it was seen that Rajyoga practice had resulted in significant decline in anxiety level (0.69 ± 1.1 vs. 5.6 ± 1.38, P < 0.05). The serum cortisol level was also favorably modulated by the practice of Rajyoga meditation. Mindbody intervention is found to effective in reducing the anxiety of the patients and modulating the cortisol level in patients undergoing wellknown stressful surgery like coronary artery bypass surgery.

  18. The role of Rajyoga meditation for modulation of anxiety and serum cortisol in patients undergoing coronary artery bypass surgery: A prospective randomized control study

    Directory of Open Access Journals (Sweden)

    Usha Kiran

    2017-01-01

    Full Text Available Introduction: Rajyoga meditation is a form of mind body intervention that is promoted by the Brahma Kumaris World Spiritual University. This form of meditation can be easily performed without rituals or mantras and can be practiced anywhere at any time. The practice of Rajyoga meditation can have beneficial effects on modulating anxiety and cortisol level in patients undergoing major cardiac surgery. Materials and Methods: A prospective randomized control study was carried out in a single tertiary care center. One hundred and fifty patients undergoing elective coronary artery bypass surgery were enrolled in the study. The patients were randomized in two groups namely, Group 1 (Rajyoga group and Group 2 (Control Group. Anxiety was measured on a visual analog scale 1–10 before the start of Rajyoga training or patient counseling (T1, on the morning of the day of surgery (T2, on the 2nd postoperative day (T3, and on the 5th postoperative day (T4. The serum cortisol level was measured in the morning of the day of surgery (T1, on the 2nd postoperative day (T2 and on the 5th postoperative day (T3, respectively. Results: In the study, it was seen that the anxiety level of the patients before the surgery (T1 and on the day of surgery (T2 were comparable between the two groups. However on the 2nd postoperative day (T3, the patients who underwent Rajyoga training had lower anxiety level in comparison to the control group (3.12 ± 1.45 vs. 6.12 ± 0.14, P < 0.05 and on the 5th postoperative day (T4 it was seen that Rajyoga practice had resulted in significant decline in anxiety level (0.69 ± 1.1 vs. 5.6 ± 1.38, P < 0.05. The serum cortisol level was also favorably modulated by the practice of Rajyoga meditation. Conclusion: Mindbody intervention is found to effective in reducing the anxiety of the patients and modulating the cortisol level in patients undergoing wellknown stressful surgery like coronary artery bypass surgery.

  19. 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.

  20. Prophylactic low-energy shock wave therapy improves wound healing after vein harvesting for coronary artery bypass graft surgery: a prospective, randomized trial.

    Science.gov (United States)

    Dumfarth, Julia; Zimpfer, Daniel; Vögele-Kadletz, Margit; Holfeld, Johannes; Sihorsch, Florian; Schaden, Wolfgang; Czerny, Martin; Aharinejad, Seyedhossein; Wolner, Ernst; Grimm, Michael

    2008-12-01

    Wound healing disorders after vein harvesting for coronary artery bypass graft surgery increase morbidity and lower patient satisfaction. Low-energy shock wave therapy (SWT) reportedly improves healing of diabetic and vascular ulcers by overexpression of vascular endothelial growth fractor and downregulation of necrosis factor kappaB. In this study, we investigate whether prophylactic low-energy SWT improves wound healing after vein harvesting for coronary artery bypass graft surgery. One hundred consecutive patients undergoing coronary artery bypass graft surgery were randomly assigned to either prophylactic low-energy SWT (n = 50) or control (n = 50). Low-energy SWT was applied to the site of vein harvesting after wound closure under sterile conditions using a commercially available SWT system (Dermagold; Tissue Regeneration Technologies, Woodstock, GA). A total of 25 impulses (0.1 mJ/mm(2); 5 Hz) were applied per centimeter wound length. Wound healing was evaluated and quantified using the ASEPSIS score. (ASEPSIS stands for Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay). Patient demographics, operative data, and postoperative adverse events were monitored. Patient characteristics and operative data including wound length (SWT 39 +/- 13 cm versus control 37 +/- 11 cm, p = 0.342) were comparable between the two groups. We observed lower ASEPSIS scores indicating improved wound healing in the SWT group (4.4 +/- 5.3) compared with the control group (11.6 +/- 8.3, p = 0.0001). Interestingly, we observed a higher incidence of wound healing disorders necessitating antibiotic treatment in the control group (22%) as compared with the SWT group (4%, p = 0.015). No SWT-associated adverse events were observed in the treatment group. As shown in this prospective randomized study, prophylactic application of low-energy SWT improves wound healing after vein

  1. A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

    Science.gov (United States)

    Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

    2016-01-01

    The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (phallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

  2. 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

  3. Local infiltration analgesia in urogenital prolapse surgery: a prospective randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Kristensen, Billy B; Rasmussen, Yvonne H; Agerlin, Marianne

    2011-01-01

    To evaluate the analgesic effect of high-volume infiltration analgesia in urogenital prolapse surgery and provide a detailed description of the infiltration technique.......To evaluate the analgesic effect of high-volume infiltration analgesia in urogenital prolapse surgery and provide a detailed description of the infiltration technique....

  4. The efficacy of Labetalol versus Nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study.

    Science.gov (United States)

    El-Shmaa, Nagat S; Ezz, Hoda Alsaid Ahmed; Younes, Ahmed

    2017-06-01

    To assess the efficacy of labetalol versus nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study. Carried out in operating room in university hospital. 60 patients of both sexes, American Society of Anesthesiologists (ASA) physical status I and II, age range from 20 to 60years; scheduled for elective sinus endoscopic surgery under general anesthesia (GA). Patients were divided into two groups (30 each). NTG group received nitroglycerin infusion at a dose of 2-5μg/kg/min, LAB group received labetalol infusion at a dose of 0.5-2mg/min. Surgical condition was assessed by surgeon using average category scale (ACS) of 0-5, a value of 2-3 being ideal. In both groups mean arterial blood pressure (MAP) was gradually reduced till the ideal ACS for assessment of surgical condition, the target of ACS was 2-3 or lower. Both studied drugs achieved desired hypotension and improved visualization of surgical field by decreasing bleeding in the surgical site, but ideal surgical conditions were created at mild hypotension (MAP 70-75) in LAB group while same conditions were created at MAP of 65-69mmHg in NTG group. Mean heart rate (HR) was significantly higher in NTG group as compared to LAB group. Blood loss decreased significantly in LAB group. Both labetalol and NTG are effective and safe drugs for induction of controlled hypotension during sinus endoscopic surgery. While, labetalol was better as it offered optimum operative condition with mild decrease in blood pressure, decreased surgical bleeding and less tachycardia during the surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-09-25

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

  6. A Prospective Randomized Controlled Trial Comparing the Efficacy of Fascia Iliaca Compartment Block Versus Local Anesthetic Infiltration After Hip Arthroscopic Surgery.

    Science.gov (United States)

    Garner, Malgorzata; Alshameeri, Zeiad; Sardesai, Anand; Khanduja, Vikas

    2017-01-01

    To compare the efficacy of fascia iliaca compartment block (FICB) with local anesthetic infiltration (LAI) of the arthroscopy portals for pain control after hip arthroscopy. A prospective single-blinded randomized controlled trial that involved patients who underwent hip arthroscopy was performed. Participants were randomized to receiving either FICB or LAI of the portal tracts with local anesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. The primary outcome measure was the postoperative level of pain as assessed by numeric pain score at 1, 3, 6, and 24 hours after the procedure in both groups. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups. The study had to be terminated early because there was a significant statistical difference in the primary outcome measure after the recruitment of 46 patients: 20 in the LAI group and 26 in the FICB group. Severity of pain in the FICB group was higher especially during the first hour postoperatively (P = .02). This was associated with a higher consumption of opioids and other analgesics, which resulted in more side effects such as nausea and vomiting. LAI provided a better analgesia after arthroscopic surgery of the hip in comparison with FICB and was also associated with reduced consumption of opioids and a lower rate of side effects. Level I, single-blinded randomized controlled study. Copyright © 2016 Arthroscopy Association of North America. All rights reserved.

  7. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

    Science.gov (United States)

    Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

    2013-02-15

    Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

  8. Two-stage revision surgery with preformed spacers and cementless implants for septic hip arthritis: a prospective, non-randomized cohort study

    Directory of Open Access Journals (Sweden)

    Logoluso Nicola

    2011-05-01

    Full Text Available Abstract Background Outcome data on two-stage revision surgery for deep infection after septic hip arthritis are limited and inconsistent. This study presents the medium-term results of a new, standardized two-stage arthroplasty with preformed hip spacers and cementless implants in a consecutive series of adult patients with septic arthritis of the hip treated according to a same protocol. Methods Nineteen patients (20 hips were enrolled in this prospective, non-randomized cohort study between 2000 and 2008. The first stage comprised femoral head resection, debridement, and insertion of a preformed, commercially available, antibiotic-loaded cement hip spacer. After eradication of infection, a cementless total hip arthroplasty was implanted in the second stage. Patients were assessed for infection recurrence, pain (visual analog scale [VAS] and hip joint function (Harris Hip score. Results The mean time between first diagnosis of infection and revision surgery was 5.8 ± 9.0 months; the average duration of follow up was 56.6 (range, 24 - 104 months; all 20 hips were successfully converted to prosthesis an average 22 ± 5.1 weeks after spacer implantation. Reinfection after total hip joint replacement occurred in 1 patient. The mean VAS pain score improved from 48 (range, 35 - 84 pre-operatively to 18 (range, 0 - 38 prior to spacer removal and to 8 (range, 0 - 15 at the last follow-up assessment after prosthesis implantation. The average Harris Hip score improved from 27.5 before surgery to 61.8 between the two stages to 92.3 at the final follow-up assessment. Conclusions Satisfactory outcomes can be obtained with two-stage revision hip arthroplasty using preformed spacers and cementless implants for prosthetic hip joint infections of various etiologies.

  9. The effect of crystalloid versus Low molecular weight colloid solution on post-operative nausea and vomiting after ambulatory gynecological surgery - a prospective randomized trial

    LENUS (Irish Health Repository)

    Hayes, Ivan

    2012-07-31

    AbstractBackgroundIntravenous fluid is recommended in international guidelines to improve patient post-operative symptoms, particularly nausea and vomiting. The optimum fluid regimen has not been established. This prospective, randomized, blinded study was designed to determine if administration of equivolumes of a colloid (hydroxyethyl starch 130\\/0.4) reduced post operative nausea and vomiting in healthy volunteers undergoing ambulatory gynecologic laparoscopy surgery compared to a crystalloid solution (Hartmann’s Solution).Methods120 patients were randomized to receive intravenous colloid (N = 60) or crystalloid (N = 60) intra-operatively. The volume of fluid administered was calculated at 1.5 ml.kg-1 per hour of fasting. Patients were interviewed to assess nausea, vomiting, anti-emetic use, dizziness, sore throat, headache and subjective general well being at 30 minutes and 2, 24 and 48 hours post operatively. Pulmonary function testing was performed on a subgroup.ResultsAt 2 hours the proportion of patients experiencing nausea (38.2 % vs 17.9%, P = 0.03) and the mean nausea score were increased in the colloid compared to crystalloid group respectively (1.49 ± 0.3 vs 0.68 ± 0.2, P = 0.028). The incidence of vomiting and anti-emetic usage was low and did not differ between the groups. Sore throat, dizziness, headache and general well being were not different between the groups. A comparable reduction on post-operative FVC and FEV-1 and PEFR was observed in both groups.ConclusionsIntra-operative administration of colloid increased the incidence of early postoperative nausea and has no advantage over crystalloid for symptom control after gynaecological laparoscopic surgery.

  10. Comparative efficacy of nimesulide and ketoprofen on inflammatory events in third molar surgery: a split-mouth, prospective, randomized, double-blind study.

    Science.gov (United States)

    Pouchain, E C; Costa, F W G; Bezerra, T P; Soares, E C S

    2015-07-01

    This study aimed to compare the effect of nimesulide and ketoprofen on inflammatory parameters related to the surgical removal of third molars. A split-mouth, prospective, randomized, double-blind study was conducted in patients undergoing removal of four third molars. Eighteen eligible patients were allocated to one of two groups to receive treatment two times a day with either ketoprofen 100 mg or nimesulide 100 mg for a period of 3 days. The rescue medication intake (number) and pain intensity were evaluated at 6, 12, 24, and 48 h, and at 7 days postoperatively. Swelling and maximum mouth opening were evaluated at 24 h, 72 h, and 7 days postoperatively. The peak pain score occurred at 6h after surgery in the nimesulide group and at 12h in the ketoprofen group. There was no statistically significant difference between the groups, although pain relief was observed after 48 h in the nimesulide group and after 7 days in the ketoprofen group. For each group, there was a statically significant difference in pain scores among the studied periods (Pthird molars. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  11. 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,

  12. Role of addition of dexamethasone to lignocaine 2% with adrenaline in dental nerve blocks for third molar surgery: A prospective randomized control trial

    Science.gov (United States)

    Deo, Saroj Prasad

    2016-01-01

    Context: Dexamethasone has been frequently used in oral surgical procedure and accepted by oral and maxillofacial surgeon community worldwide. However, this is the first clinical trial that used dexamethasone as adjuvant with lignocaine in dental nerve block (DNB). Aims: The purpose of this double-blind, randomized control trial (RCT) was to compare the effect of dexamethasone with normal saline (NS) in a lignocaine DNB. Settings and Design: This prospective, double-blind, RCT was carried out after obtaining approval from the Institutional Ethical Committee. Subjects and Methods: In forty patients, the present placebo-controlled clinical trial was conducted; allocated randomly into two groups: study group (SG) or control group (CG). The single-dose submucosal dexamethasone or NS injection was administered immediately after 2% lignocaine with epinephrine 1:2,00,000 nerves block during mandibular third molar surgery (TMS). Visual analog scale score, number, and exact time nonsteroidal anti-inflammatory drugs were administered were used to measure postoperative analgesia in 2nd and 7th days. Statistical Analysis Used: All the data were entered into the Spreadsheet (Excel, Microsoft) and Chi-square test, Mann–Whitney U-test, Student's paired and unpaired t-test, and Fisher exact test were used. Results: This study found maximum duration of DNB in SG was 248.88 min and in CG was 175.44 min, whereas minimum duration in SG was 197 min and in CG was 140.78 min. Conclusions: Dexamethasone prolongs the action of lignocaine 2% in DNB for TMS. PMID:28299268

  13. A prospective, randomized, controlled trial of robot-assisted vs freehand pedicle screw fixation in spine surgery.

    Science.gov (United States)

    Kim, Ho-Joong; Jung, Whan-Ik; Chang, Bong-Soon; Lee, Choon-Ki; Kang, Kyoung-Tak; Yeom, Jin S

    2017-09-01

    The purpose of this study was to compare the accuracy and safety of an instrumented posterior lumbar interbody fusion (PLIF) using a robot-assisted minimally invasive (Robot-PLIF) or a conventional open approach (Freehand-PLIF). Patients undergoing an instrumented PLIF were randomly assigned to be treated using a Robot-PLIF (37 patients) and a Freehand-PLIF (41 patients). For intrapedicular accuracy, there was no significant difference between the groups (P = 0.534). For proximal facet joint accuracy, none of the 74 screws in the Robot-PLIF group violated the proximal facet joint, while 13 of 82 in the Freehand-PLIF group violated the proximal facet joint (P Robot-PLIF and Freehand-PLIF groups, respectively (P Robotic-assisted pedicle screw placement was associated with fewer proximal facet joint violations and better convergence orientations. Copyright © 2016 John Wiley & Sons, Ltd.

  14. 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.

  15. Comparison of multi-modal early oral nutrition for the tolerance of oral nutrition with conventional care after major abdominal surgery: a prospective, randomized, single-blind trial.

    Science.gov (United States)

    Sun, Da-Li; Li, Wei-Ming; Li, Shu-Min; Cen, Yun-Yun; Xu, Qing-Wen; Li, Yi-Jun; Sun, Yan-Bo; Qi, Yu-Xing; Lin, Yue-Ying; Yang, Ting; Lu, Qi-Ping; Xu, Peng-Yuan

    2017-02-10

    Early oral nutrition (EON) has been shown to improve recovery of gastrointestinal function, length of stay and mortality after abdominal surgery; however, early oral nutrition often fails during the first week after surgery. Here, a multi-modal early oral nutrition program is introduced to promote recovery of gastrointestinal function and tolerance of oral nutrition. Consecutive patients scheduled for abdominal surgery were randomized to the multimodal EON group or a group receiving conventional care. The primary endpoint was the time of first defecation. The secondary endpoints were outcomes and the cost-effectiveness ratio in treating infectious complications. The rate of infectious-free patients was regarded as the index of effectiveness. One hundred seven patients were randomly assigned to groups. Baseline characteristics were similar for both groups. In intention-to-treat analysis, the success rate of oral nutrition during the first week after surgery in the multimodal EON group was 44 (83.0%) versus 31 (57.4%) in the conventional care group (P = 0.004). Time to first defecation, time to flatus, recovery time of bowel sounds, and prolonged postoperative ileus were all less in the multimodal EON group (P oral nutrition group (P oral nutrition program was an effective way to improve tolerance of oral nutrition during the first week after surgery, decrease the length of stay and improve cost-effectiveness after abdominal surgery. Registration number: ChiCTR-TRC-14004395 . Registered 15 March 2014.

  16. Effect of flap design and duration of surgery on acute postoperative symptoms and signs after extraction of lower third molars: A randomized prospective study

    Directory of Open Access Journals (Sweden)

    Nicola Mobilio

    2017-09-01

    Full Text Available Background. Different surgical variables are assumed to play a role in postoperative course after lower third molar extraction. The aim of study was to assess whether flap design and duration of surgery can influence acute postoperative symptoms and signs after lower third molar extraction. Methods. Twenty-five patients scheduled for lower third molar extraction were included in this study and randomly assigned to two groups in terms of flap design: group A (envelope flap and group B (triangular flap. Swelling and trismus were assessed before and after surgery on days 0, 2 and 7. Pain was assessed for seven days after surgery. Maximum postoperative pain was chosen as the main outcome variable. ANOVA was used to assess differences between the groups regarding maximum postoperative pain, trismus and swelling at 2- and 7-day intervals. Pearson's correlation coefficient was used to assess correlation between duration of surgery and postoperative symptoms and signs. Results. No significant difference was found between the two flap designs for any postoperative symptoms and signs. The duration of surgery was found to be correlated with both trismus (r = -0.44, P = 0.04 and swelling (r = 0.59, P = 0.004 as assessed 2 days after surgery. No associations were found between duration of surgery and maximum postoperative pain and trismus and swelling at 7-day interval. Conclusion. Within the limits of the present study, the duration of surgery, and not the flap design, affected the acute postoperative symptoms and signs after lower third molar extraction.

  17. 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.

  18. 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

  19. 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.

  20. Intraoperative Low-Dose Ketamine Infusion Reduces Acute Postoperative Pain Following Total Knee Replacement Surgery: A Prospective, Randomized Double-Blind Placebo-Controlled Trial

    International Nuclear Information System (INIS)

    Pelin Cengiz, P.; Gokcinar, D.; Karabeyoglu, I.; Topcu, H.; Cicek, G. S.; Gogus, N.

    2014-01-01

    Objective: To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery. Study Design: A randomized, double-blind comparative study. Place and Duration of Study: Ankara Numune Training and Research Hospital, Turkey, from January and June 2011. Methodology: Sixty adults undergoing total knee arthroplasty were enrolled in this study. The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion (6.25 g/kg/minute) or the same volume of saline. A visual analogue scale (VAS) was used to measure each patient's level of pain at 1, 3, 6, 12, and 24 hours after surgery. Time to first analgesic request, postoperative morphine consumption and the incidence of side effects were also recorded. Results: Low-dose ketamine infusion prolonged the time to first analgesic request. It also reduced postoperative cumulative morphine consumption at 1, 3, 6, 12, and 24 hours postsurgery (p < 0.001). Postoperative VAS scores were also significantly lower in the ketamine group than placebo, at all observation times. Incidences of side effects were similar in both study groups. Conclusion: Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects. (author)

  1. Comparison between retrograde intrarenal surgery and extracorporeal shock wave lithotripsy in the treatment of lower pole kidney stones up to 15 mm. Prospective, randomized study.

    Science.gov (United States)

    Vilches, R M; Aliaga, A; Reyes, D; Sepulveda, F; Mercado, A; Moya, F; Ledezma, R; Hidalgo, J P; Olmedo, T; Marchant, F

    2015-05-01

    Extracorporeal Shock Wave Lithotripsy (ESWL) is currently the recommended treatment for intra-renal calculi smaller than 2 cm. However the low Stone Free Rate (SFR) in lower pole calculi gives rise to new techniques, such us retrograde intrarenal surgery (RIRS), for improve the surgery outcomes. To compare the efficacy of a treatment with ESWL with RIRS, in terms of SFR after surgery, in patients with kidney stones up to 15 mm in the lower pole. A prospective study was carried out in order to assess the results of ESWL and RIRS in patients with lower pole stones less than 15 mm. Among a total of 55 patients, 31 were underwent to ESWL (Group 1) and the remaining 24 to RIRS (Group 2). Clinical data recorded, including general characteristics of each patient, were: calculi size, side, operative time, complications according to Clavien scale, SFR and the presence of residual fragments at 2 months post-treatment assessed by a CT scan. STATA 11 was used to perform the statistical analysis. There were no differences for general descriptors among groups with the exception of a significantly longer operative time for RIRS. The rates of SFR and residual fragments lesser than 3 mm. were lower in the RIRS group than in ESWL ones. RIRS also showed a lower rate of clinically significant fragments (0% vs 42.3%. P stones between 10/15 mm RIRS showed higher SFR (75% vs. 41.2%) and a lower rate of stones>3 mm (0% vs. 58.8%), being statistically significant (P stone RIRS has the same results than ESWL in terms of SFR. Regarding absence of a clinically significant residual fragment, RIRS was superior to ESWL. A bigger sample size is required in order to confirm this results. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  3. 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.

  4. Comparison of analgesic efficacy of levobupivacaine, levobupivacaine and clonidine, and levobupivacaine and dexmedetomidine in wound infiltration technique for abdominal surgeries: A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    B Jyothi

    2017-01-01

    Full Text Available Background: This study was designed to evaluate the postoperative analgesic efficacy of levobupivacaine (L alone and its combination with clonidine (C or dexmedetomidine (D in wound infiltration technique for abdominal surgeries. Materials and Methods: After ethical committee approval, a double-blind randomized controlled study was conducted on 90 patients (power of study 80%, physical status American Society of Anesthesiologists Grade I and II, aged 18–60 years scheduled for abdominal surgeries over 1 year duration. A standard general anesthetic technique was used. Patients were randomly allocated into three groups, by computer-generated random number table. Patients received wound infiltration during wound closure. Group L received 29 ml of 0.25% levobupivacaine plus 1 ml 0.9% normal saline, Group LC received 29 ml of 0.25% levobupivacaine with 1 ml (3 mcg/kg clonidine, and Group LD received 29 ml of 0.25% levobupivacaine with 1 ml (2 mcg/kg dexmedetomidine. Postoperative rescue analgesia was provided with injection tramadol. Statistical analysis for duration of analgesia was determined by one-way analysis of variance and side effects by Chi-square test. Results: The total duration of analgesia in LD group was 23.4 h, when compared to LC group 20.9 h and L group 11.65 h (P = 0.0001 with excellent to good quality of analgesia in adjuvant group (P < 0.001 and incidence of minimal side effects such as sedation, nausea, and vomiting. Conclusion: Clonidine and dexmedetomidine were the effective adjuvants to levobupivacaine for single shot wound infiltration analgesic technique; however, dexmedetomidine was found to be superior to clonidine.

  5. Hyaluronic acid-carboxymethylcellulose reduced postoperative bowel adhesions following laparoscopic urologic pelvic surgery: a prospective, randomized, controlled, single-blind study.

    Science.gov (United States)

    Ha, U-Syn; Koh, Jun Sung; Cho, Kang Jun; Yoon, Byung Il; Lee, Kyu Won; Hong, Sung Hoo; Lee, Ji Youl

    2016-06-10

    To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose following laparoscopic radical prostatectomy. This was a randomized, controlled, single-blind, parallel-group study using hyaluronic acid-carboxymethylcellulose in patients who underwent laparoscopic radical prostatectomy. Sixty patients were enrolled in the study. All patients were randomly assigned to either the hyaluronic acid-carboxymethylcellulose treatment group (n = 30) or the control group (n = 30). Viscera slide ultrasounds and plain X-rays were obtained at enrollment (V0), postoperative week 12 (V1), and 24 (V2). The primary end point was the difference in the excursion distance in the viscera slide ultrasound between V0 and V2. A total of 50 patients completed this study. The average excursion distance at V2 in the experimental group (n = 25) was significantly longer than in the control group (n = 25, 2.7 ± 1.2 vs. 1.3 ± 1.0 cm, respectively; p hyaluronic acid-carboxymethylcellulose. This randomized study demonstrated that hyaluronic acid-carboxymethylcellulose treatment resulted in a reduction in bowel adhesion to the abdominal wall after laparoscopic pelvic surgery and had good clinical safety. ClinicalTrials.gov Identifier: NCT02773251 Date: May 12, 2016.

  6. Comparison of New Technology Integrated and Nonintegrated Arterial Filters Used in Cardiopulmonary Bypass Surgery: A Randomized, Prospective, and Single Blind Study

    Directory of Open Access Journals (Sweden)

    Özgür Gürsu

    2013-01-01

    Full Text Available Background. Innovative cardiopulmonary bypass (CPB settings have been developed in order to integrate the concepts of “surface-coating,” “blood-filtration,” and “miniaturization.” Objectives. To compare integrated and nonintegrated arterial line filters in terms of peri- and postoperative clinical variables, inflammatory response, and transfusion needs. Material and Methods. Thirty-six patients who underwent coronary bypass surgery were randomized into integrated (Group In and nonintegrated arterial line filter (Group NIn groups. Arterial blood samples for the assessments of complete hemogram, biochemical screening, interleukin-6, interleukin-2R, and C-reactive protein were analyzed before and after surgery. Need for postoperative dialysis, inotropic therapy and transfusion, in addition to extubation time, total amount of drainage (mL, length of intensive care unit, and hospital stay, and mortality rates was also recorded for each patient. Results. Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn, but need for erythrocyte transfusion was significantly higher in Group NIn. C-reactive protein values did not differ significantly except for postoperative second day's results, which were found significantly lower in Group In than in Group NIn. Conclusion. Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In.

  7. Three-dimensional evaluation of postoperative swelling after third molar surgery using 2 different cooling therapy methods: a randomized observer-blind prospective study.

    Science.gov (United States)

    Rana, Majeed; Gellrich, Nils-Claudius; Ghassemi, Alireza; Gerressen, Marcus; Riediger, Dieter; Modabber, Ali

    2011-08-01

    In most cases, the removal of third molars leads to a significant degree of tissue trauma, resulting in common postoperative symptoms and signs of pain, facial swelling, dysfunction, and limited mouth opening (trismus). The beneficial effects of cold treatment on postoperative swelling, edema, pain, and inflammation, as well as the reduction in bleeding and hematomas, have been described. The aim of the present study was to compare postoperative cooling therapy using cooling compresses with that using the water-circulating cooling face mask by Hilotherm. We recorded the beneficial effects on postoperative facial swelling, pain, trismus, and neurologic complaints. A total of 30 patients were scheduled to undergo third molar surgery and were divided randomly into 2 groups for treatment with either the Hilotherm or conventional cooling with cooling compresses. Cooling was performed one time for 45 minutes immediately after surgery. Facial swelling was quantified using a 3-dimensional optical scanning technique. The pain and neurologic scores and the degree of mouth opening were observed for each patient. Patients receiving cooling therapy using Hilotherm demonstrated less facial swelling, less pain, a tendency toward fewer neurologic complaints, and were more satisfied than the patients who had received conventional cooling. The results of our study have shown that the Hilotherm is more efficient for managing postoperative swelling and pain after the removal of third molars than conventional cooling using compresses. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  8. Fosaprepitant versus ondansetron for the prevention of postoperative nausea and vomiting in patients who undergo gynecologic abdominal surgery with patient-controlled epidural analgesia: a prospective, randomized, double-blind study.

    Science.gov (United States)

    Soga, Tomohiro; Kume, Katsuyoshi; Kakuta, Nami; Hamaguchi, Eisuke; Tsutsumi, Rie; Kawanishi, Ryosuke; Fukuta, Kohei; Tanaka, Katsuya; Tsutsumi, Yasuo M

    2015-10-01

    Postoperative nausea and vomiting (PONV) is the most common postoperative complication. The postoperative use of opioids is known to increase the incidence. We compared fosaprepitant, a neurokinin-1 (NK1) receptor antagonist, and ondansetron for their preventive effects on PONV in patients who underwent gynecologic abdominal surgery with patient-controlled epidural analgesia. This prospective, double-blind, randomized study comprised 44 patients who underwent gynecologic abdominal surgery. They were randomly allocated to receive 150 mg intravenous fosaprepitant (n = 24; NKI group) or 4 mg ondansetron (n = 20; ONS group) before anesthesia, which was maintained with volatile anesthetics, remifentanil, fentanyl, and rocuronium. All patients received postoperative fentanyl by patient-controlled epidural anesthesia. The incidence of nausea and vomiting, complete response rate (i.e., no vomiting and no rescue antiemetic use), rescue antiemetic use, nausea score (0-3), and visual analog scale score (VAS 0-10) for pain were recorded at 2, 24, 48, and 72 h after surgery. No (0 %) patient in the NKI group experienced vomiting after surgery; however, 4-6 (20-30 %) of 20 patients in the ONS group experienced vomiting. This difference was significant at 0-24, 0-48, and 0-72 h. During the study period, no significant differences existed between the NK1 and ONS groups in the incidence of PONV, complete response rate, rescue antiemetic use, nausea score, and VAS score for pain. Compared to ondansetron, fosaprepitant more effectively decreased the incidence of vomiting in patients who underwent gynecologic abdominal surgery with patient-controlled epidural analgesia.

  9. Bariatric Surgery and Infertility: A Prospective Study.

    Science.gov (United States)

    Consalvo, Vincenzo; Canero, Antonio; Salsano, Vincenzo

    2017-12-22

    Obesity is a worldwide disease affecting 13% of the world's adult female population. The reasons and the fetal risk are still unclear. The effect of weight loss as a result of bariatric surgery seems to induce an improvement in fertility in obese women. The main purpose of this prospective study is to demonstrate if there is an association between bariatric surgery-induced weight loss and an improvement in the fertility of women at reproductive age. From June 2013 to April 2016, all bariatric female patients from our institutes were prospectively evaluated for suitability in this study. A pool of 52 eligible patients was extracted from our database in the recruitment period. Of these, 28 underwent bariatric surgery and 24 did not. Both groups were observed for two-year follow-up. During follow-up, anthropometrics parameters, blood analysis, and comorbidities were checked and a gynaecological consultation was prescribed. Fifty participants were studied. Twenty-seven successfully underwent bariatric surgery with a percentage of excess weight loss (EWL) >70% at 24 months, while 23 accepted the observation and control for 24 months as an integral part of the pre-surgical bariatric program. The contingency table analysis showed an extremely significant association (Pbariatric surgery) and event (pregnancy), with a relative risk (RR) = 15.33 and confidence interval (CI) 95%=2.213 to 106.26. Bariatric surgery improves fertility in obese women at two years' postoperative. Every obese woman with difficulties becoming pregnant should undergo a bariatric surgery consultation. Further studies are necessary to confirm our results.

  10. Comparison Between Ultrasound-Guided Supraclavicular and Interscalene Brachial Plexus Blocks in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective, Randomized, Parallel Study.

    Science.gov (United States)

    Ryu, Taeha; Kil, Byung Tae; Kim, Jong Hae

    2015-10-01

    Although supraclavicular brachial plexus block (SCBPB) was repopularized by the introduction of ultrasound, its usefulness in shoulder surgery has not been widely reported. The objective of this study was to compare motor and sensory blockades, the incidence of side effects, and intraoperative opioid analgesic requirements between SCBPB and interscalene brachial plexus block (ISBPB) in patients undergoing arthroscopic shoulder surgery. Patients were randomly assigned to 1 of 2 groups (ISBPB group: n = 47; SCBPB group: n = 46). The side effects of the brachial plexus block (Horner's syndrome, hoarseness, and subjective dyspnea), the sensory block score (graded from 0 [no cold sensation] to 100 [intact sensation] using an alcohol swab) for each of the 5 dermatomes (C5-C8 and T1), and the motor block score (graded from 0 [complete paralysis] to 6 [normal muscle force]) for muscle forces corresponding to the radial, ulnar, median, and musculocutaneous nerves were evaluated 20 min after the brachial plexus block. Fentanyl was administered in 50 μg increments when the patients complained of pain that was not relieved by the brachial plexus block. There were no conversions to general anesthesia due to a failed brachial plexus block. The sensory block scores for the C5 to C8 dermatomes were significantly lower in the ISBPB group. However, the percentage of patients who received fentanyl was comparable between the 2 groups (27.7% [ISBPB group] and 30.4% [SCBPB group], P = 0.77). SCBPB produced significantly lower motor block scores for the radial, ulnar, and median nerves than did ISBPB. A significantly higher incidence of Horner's syndrome was observed in the ISBPB group (59.6% [ISBPB group] and 19.6% [SCBPB group], P blocks. However, SCBPB produces a better motor blockade and a lower incidence of Horner's syndrome than ISBPB.

  11. 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

  12. A prospective randomized study comparing short- and intermediate-term perioperative outcome variables after spinal or general anesthesia for lumbar disk and laminectomy surgery.

    Science.gov (United States)

    Jellish, W S; Thalji, Z; Stevenson, K; Shea, J

    1996-09-01

    General or regional anesthesia may be used for lumbar laminectomy. To determine whether one method is superior, 122 patients were randomly assigned to receive either a standard general anesthetic (GA) or spinal anesthesia (SA) supplemented with intravenous (IV) propofol sedation. Data from the intraoperative period through hospital discharge were collected and compared. Demographically, both groups were similar. Total anesthesia (131.0 +/- 4.3 vs 106.6 +/- 3.2 min) and surgical times (81.5 +/- 3.6 vs 67.1 +/- 2.8 min) were longer in the GA group. Intraoperative hemodynamics were similar between groups except that the incidence of increased blood pressure was more frequent with GA (26.2% vs 3.3%). Blood loss was less during SA (133 +/- 18 mL vs 221 +/- 32 mL). Postanesthesia care unit (PACU) heart rates and mean arterial pressures were higher in the GA group. Peak pain scores in the PACU were higher after GA compared with SA (58 +/- 4 vs 22 +/- 3) as were the number of patients who required analgesics. Severe nausea was more common in the GA group both in the PACU and during the 24 h after surgery. Analgesic requirements after discharge from the PACU, urinary retention, and days in the hospital did not differ between groups. This study suggests that SA may be superior to GA both intraoperatively and postoperatively for lumbar spine procedures lasting less than 2 h.

  13. A randomized prospective analysis of alteration of hemostatic function in patients receiving tranexamic acid and hydroxyethyl starch (130/0.4 undergoing off pump coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Murali Chakravarthy

    2012-01-01

    Full Text Available Postoperative hemorrhagic complications is still one of the major problems in cardiac surgeries. It may be caused by surgical issues, coagulopathy caused by the side effects of the intravenous fluids administered to produce plasma volume expansion such as hydroxyl ethyl starch (HES. In order to thwart this hemorrhagic issue, few agents are available. Fibrinolytic inhibitors like tranexamic acid (TA may be effective modes to promote blood conservation; but the possible complications of thrombosis of coronary artery graft, precludes their generous use in coronary artery bypass graft surgery. The issue is a balance between agents that promote coagulation and those which oppose it. Therefore, in this study we have assessed the effects of concomitant use of HES and TA. Thromboelastogram (TEG was used to assess the effect of the combination of HES and TA. With ethical committee approval and patient′s consent, 100 consecutive patients were recruited for the study. Surgical and anesthetic techniques were standardized. Patients fulfilling our inclusion criteria were randomly allocated into 4 groups of 25 each. The patients in group A received 20 ml/kg of HES (130/0.4, 10 mg/kg of T.A over 30 minutes followed by infusion of 1 mg/kg/hr over the next 12 hrs. The patients in group B received Ringer′s lactate + TA at same dose. The patients in the Group C received 20 ml/kg of HES. Group D patients received RL. Fluid therapy was goal directed. Total blood loss was assessed. Reaction time (r, α angle, maximum amplitude (MA values of TEG were assessed at baseline, 12, 36 hrs. The possible perioperative myocardial infraction (MI was assessed by electrocardiogram (ECG and troponin T values at the baseline, postoperative day 1. Duration on ventilator, length of stay (LOS in the intensive care unit (ICU were also assessed. The demographical profile was similar among the groups. Use of HES increased blood loss significantly (P < 0.05. Concomitant use of TA

  14. Operative strategies to reduce cerebral embolic events during on- and off-pump coronary artery bypass surgery: A stratified, prospective randomized trial.

    Science.gov (United States)

    Halkos, Michael E; Anderson, Aaron; Binongo, Jose Nilo G; Stringer, Anthony; Lasanajak, Yi; Thourani, Vinod H; Lattouf, Omar M; Guyton, Robert A; Baio, Kim T; Sarin, Eric; Keeling, William B; Cook, N Renee; Carssow, Katherine; Neill, Alexis; Glas, Kathryn E; Puskas, John D

    2017-10-01

    To determine the impact of different aortic clamping strategies on the incidence of cerebral embolic events during coronary artery bypass grafting (CABG). Between 2012 and 2015, 142 patients with low-grade aortic disease (epiaortic ultrasound grade I/II) undergoing primary isolated CABG were studied. Those undergoing off-pump CABG were randomized to a partial clamp (n = 36) or clampless facilitating device (CFD; n = 36) strategy. Those undergoing on-pump CABG were randomized to a single-clamp (n = 34) or double-clamp (n = 36) strategy. Transcranial Doppler ultrasonography (TCD) was performed to identify high-intensity transient signals (HITS) in the middle cerebral arteries during periods of aortic manipulation. Neurocognitive testing was performed at baseline and 30-days postoperatively. The primary endpoint was total number of HITS detected by TCD. Groups were compared using the Mann-Whitney U test. In the off-pump group, the median number of total HITS were higher in the CFD subgroup (30.0; interquartile range [IQR], 22-43) compared with the partial clamp subgroup (7.0; IQR, 0-16; P 1 CFD (12.5 [IQR, 4-19] vs 36.0 [IQR, 25-47]; P = .001). In the on-pump group, the median number of total HITS was 10.0 (IQR, 3-17) in the single-clamp group, compared with 16.0 (IQR, 4-49) in the double-clamp group (P = .10). There were no differences in neurocognitive outcomes across the groups. For patients with low-grade aortic disease, the use of CFDs was associated with an increased rate of cerebral embolic events compared with partial clamping during off-pump CABG. A single-clamp strategy during on-pump CABG did not significantly reduce embolic events compared with a double-clamp strategy. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  15. A methylene blue-assisted technique for harvesting lymph nodes after radical surgery for gastric cancer: a prospective, randomized, controlled study.

    Science.gov (United States)

    Aoyama, Toru; Fujikawa, Hirohito; Cho, Haruhiko; Ogata, Takashi; Shirai, Junya; Hayashi, Tsutomu; Rino, Yasushi; Masuda, Munetaka; Oba, Mari S; Morita, Satoshi; Yoshikawa, Takaki

    2015-02-01

    Harvesting lymph nodes (LNs) after gastrectomy is essential for accurate staging. This trial evaluated the efficiency and quality of a conventional method and a methylene blue-assisted method in a randomized manner. The key eligibility criteria were as follows: (i) histologically proven adenocarcinoma of the stomach; (ii) clinical stage I-III; (iii) R0 resection planned by gastrectomy with D1+ or D2 lymphadenectomy. The primary endpoint was the ratio of the pathologic number of harvested LNs per time (minutes) as an efficacy measure. The secondary endpoint was the number of harvested LNs, as a quality measure. Between August 2012 and December 2012, 60 patients were assigned to undergo treatment using the conventional method (n=29) and the methylene blue dye method (n=31). The baseline demographics were mostly well balanced between the 2 groups. The number of harvested LNs (mean±SD) was 33.6±11.9 in the conventional arm and 43.4±13.9 in the methylene blue arm (P=0.005). The ratio of the number of the harvested LNs per time was 1.12±0.46 LNs/min in the conventional arm and 1.49±0.59 LNs/min in the methylene blue arm (P=0.010). In the subgroup analyses, the quality and efficacy were both superior for the methylene blue dye method compared with the conventional method. The methylene blue technique is recommended for harvesting LNs during gastric cancer surgery on the basis of both the quality and efficacy.

  16. Off-pump versus On-pump Coronary Artery Surgery - Identification of Fibrinolysis using Rotation Thromboelastography. A Preliminary, Prospective, Randomized Study

    Czech Academy of Sciences Publication Activity Database

    Jareš, M.; Vaněk, T.; Bednář, F.; Malý, Marek; Šnircová, J.; Straka, Z.

    2007-01-01

    Roč. 48, č. 1 (2007), s. 57-67 ISSN 1349-2365 Source of funding: V - iné verejné zdroje Keywords : cardiopulmonary bypass * hemostasis * beating heart surgery * D-dimers * cardiac surgical procedures Subject RIV: FA - Cardiovascular Diseases incl. Cardiotharic Surgery Impact factor: 0.929, year: 2007

  17. Outcome of intraoperative goal-directed therapy using Vigileo/FloTrac in high-risk patients scheduled for major abdominal surgeries: A prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Mohammed A. Elgendy

    2017-07-01

    Conclusion: The applied protocol for intraoperative GDT provided significant reduction of PO morbidities, ICU and hospital LOS but couldn‘t significantly reduce mortality rates in high risk patients scheduled for major abdominal surgeries.

  18. 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.

  19. Hyaluronic acid-carboxymethylcellulose reduced postoperative bowel adhesions following laparoscopic urologic pelvic surgery: a prospective, randomized, controlled, single-blind study

    OpenAIRE

    Ha, U-Syn; Koh, Jun Sung; Cho, Kang Jun; Yoon, Byung Il; Lee, Kyu Won; Hong, Sung Hoo; Lee, Ji Youl

    2016-01-01

    Background To assess the anti-adhesive effect of treatment with hyaluronic acid-carboxymethylcellulose following laparoscopic radical prostatectomy. Methods This was a randomized, controlled, single-blind, parallel-group study using hyaluronic acid-carboxymethylcellulose in patients who underwent laparoscopic radical prostatectomy. Sixty patients were enrolled in the study. All patients were randomly assigned to either the hyaluronic acid-carboxymethylcellulose treatment group (n?=?30) or the...

  20. 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

  1. 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.

  2. 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.

  3. ICU sedation with haloperidol-propofol infusion versus midazolam-propofol infusion after coronary artery bypass graft surgery: A prospective, double-blind randomized study

    Directory of Open Access Journals (Sweden)

    Farhad Etezadi

    2012-01-01

    Full Text Available Combinations of hypnotics with or without opiates are commonly used in agitated patients. We hypothesized that combination of haloperidol-propofol in comparison with midazolam-propofol would lower consumption of propofol and lead to better hemodynamic and respiratory profile during sedation of agitated patients. Among 108 patients admitted in our ICU, 60 patients were agitated according to Ramsay Sedation Score (RSS and randomly divided into two groups. Morphine sulfate (0.05 mg/kg was administered to all patients for relief of postoperative pain. In one group, sedative infusion was started with 1 mg/h of haloperidol plus 25 μg/kg/min of propofol after bolus injection of 2 mg haloperidol. In the other group, midazolam1 mg/h and propofol 25 μg/kg/min were infused after a bolus injection of 2 mg midazolam. Propofol infusion was adjusted to keep bi-spectral index between 61-80 and the RSS between 3-5. Hourly propofol consumption was recorded during 24 h of sedation and compared statistically. We also compared SpO 2 , arterial blood gas variables, hemodynamic parameters and episodes of respiratory depression (SpO 2 ≤85% requiring respiratory support between the groups. Haloperidol, when added to propofol infusion, decreased its consumption at all the measured times (P = 0.001. There was no significant difference in hemodynamic variables between two groups, but the episodes of respiratory depression was significantly higher in propofol-midazolam group (P = 0.02. We conclude that haloperidol-propofol infusion decreases propofol requirements in the agitated patients. Besides, this combination showed a better profile in terms of occurrence of respiratory depression.

  4. A prospective non-randomized two-centre study of patients with passive faecal incontinence after birth trauma and patients with soiling after anal surgery, treated by elastomer implants versus rectal irrigation

    OpenAIRE

    van der Hagen, S. J.; van der Meer, W.; Soeters, P. B.; Baeten, C. G.; van Gemert, W. G.

    2012-01-01

    Aim This study is a prospective evaluation of patients with passive faecal incontinence and patients with soiling treated by elastomer implants and rectal irrigation. Patients and methods Patients with passive faecal incontinence after birth trauma resulting from a defect of the internal sphincter and patients with soiling after previous anal surgery were included. All patients underwent endo-anal ultrasound, magnetic resonance imaging, and anal manometry. The patients with passive faecal inc...

  5. Quality of life following aesthetic plastic surgery: a prospective study.

    Science.gov (United States)

    Papadopulos, N A; Kovacs, L; Krammer, S; Herschbach, P; Henrich, G; Biemer, E

    2007-01-01

    The objective of this study was the prospective evaluation of quality of life in patients undergoing aesthetic plastic surgery procedures. We examined pre- and postoperative changes in quality of life, and performed a comparison of our data with a representative random sample. 228 patients agreed to participate in the present study. Measurements were taken preoperatively as well as 3 and 6 months postoperatively. One hundred and thirty two patients completed the three months postoperative evaluation (T1), 82 answered the 6 months follow-up evaluation (T2). The testing instrument included a standardised self-assessment test on satisfaction and quality of life (FLZ(M)), consisting of three modules: satisfaction with general life, health and appearance. Further, a postoperative complication questionnaire was used in order to evaluate the satisfaction with the surgical outcome and to estimate postoperative complications and side effects. Significantly increasing values in two aspects of quality of life were found: health and appearance. Whereas the positive influence on health is persistent, there is a diminishing influence of appearance 6 months postoperatively. Although higher values for some of the individual items of the FLZ(M) modules of the norm data were found in comparison to our study group, a general preoperative lower level of quality of life of the aesthetic surgery patients could not be confirmed. Over 84% were satisfied or very satisfied with the aesthetic result. 85% would undergo the same treatment again and 94% of the patients would further recommend their operation. More than half of the study group did not report a decrease in physical fitness or reduced social contacts in the direct postoperative period. Our study reveals that aesthetic plastic surgery increases most aspects of quality of life, especially regarding body satisfaction and health. It is very well tolerated by the patients and is therefore a recommended option.

  6. Effect of a Perioperative Nutritional Supplementation with Oral Impact® in Patients undergoing Hepatic Surgery for Liver Cancer: A Prospective, Placebo-Controlled, Randomized, Double-Blind Study.

    Science.gov (United States)

    Seguin, Philippe; Locher, Clara; Boudjema, Karim; Hamon, Catherine; Mouchel, Catherine; Malledant, Yannick; Bellissant, Eric

    2016-01-01

    Perioperative nutrition with supplements containing L-arginine, ω3-polyunsaturated fatty acids, and nucleotides could boost liver function recovery, immune response, and resistance to infection after hepatic resection. We conducted a placebo-controlled, randomized, double-blind study to assess the effect of a perioperative nutritional supplementation with Oral Impact® in patients undergoing hepatic surgery for liver cancer. Treatment was given three times daily for 7 days before and 3 days after surgery. Primary outcome was factor V, 3 days after surgery. Thirty-five patients (placebo: 17; Oral Impact: 18) were included. Five patients (placebo: three; Oral Impact: two) were not operated and five (placebo: two; Oral Impact: three) did not undergo hepatic resection. Factor V (mean ± SD) was 70 ± 27% and 79 ± 25% (P = 0.409) 3 days after surgery and 90 ± 30% and 106 ± 16% (P = 0.066) 5 days after surgery, in placebo and Oral Impact groups, respectively. There were no significant differences between groups on other outcomes assessing liver function recovery (bile production, γ-glutamyl transferase, α-fetoprotein), immune response (CD3, CD4, CD8 cells, CD4/CD8 ratio, natural killer cells, B lymphocytes), number of infections, and tolerance. A 10-day perioperative nutritional supplementation with Oral Impact does not improve hepatic function, immune response, and resistance to infection in patients undergoing hepatic surgery for liver cancer.

  7. 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...

  8. The efficacy, safety and cost-effectiveness of intra-operative cell salvage in high-bleeding-risk cardiac surgery with cardiopulmonary bypass: a prospective randomized and controlled trial.

    Science.gov (United States)

    Xie, Yihong; Shen, Sheliang; Zhang, Jun; Wang, Wenyuan; Zheng, Jiayin

    2015-01-01

    Intra-operative cell salvage (CS) was reported to be ineffective, safe and not cost-effective in low-bleeding-risk cardiac surgery with cardiopulmonary bypass (CPB), but studies in high-bleeding-risk cardiac surgery are limited. The objective of this study is to evaluate the efficacy, safety and cost-effectiveness of intra-operative CS in high-bleeding-risk cardiac surgery with CPB. One hundred and fifty patients were randomly assigned to either with intra-operative CS group (Group CS) or without intra-operative CS group (Group C). Study endpoints were defined as perioperative allogeneic red blood cell (RBC) transfusion, perioperative impairment of blood coagulative function, postoperative adverse events and costs of transfusion-related. Both the proportion and quantity of perioperative allogeneic RBC transfusion were significantly lower in Group CS than that in Group C (p=0.0002, operative CS in high-bleeding-risk cardiac surgery with CPB is effective, generally safe, and cost-effective in developed countries but not in China.

  9. Micronutrient Levels and Supplement Intake in Pregnancy after Bariatric Surgery: A Prospective Cohort Study

    OpenAIRE

    Devlieger, Roland; Guelinckx, Isabelle; Jans, Goele; Voets, Willy; Vanholsbeke, Caroline; Vansant, Greet

    2014-01-01

    Background Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. Objective To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. Design A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened duri...

  10. Prospective observational study comparing traditional laparoscopy and three-dimensional laparoscopy in gynecologic surgery.

    Science.gov (United States)

    Lara-Domínguez, Maria D; López-Jiménez, Araceli; Grabowski, Jacek P; Arjona-Berral, Jose E; Zapardiel, Ignacio

    2017-03-01

    To compare perioperative details among patients who underwent gynecologic surgery between traditional laparoscopy and three-dimensional laparoscopy. The present prospective non-randomized study enrolled all consecutive patients diagnosed with gynecologic pathology who underwent laparoscopic surgery at Reina Sofia Hospital, Cordoba, Spain between January 1 and April 30, 2014. Perioperative data, adverse events, and patient satisfaction were compared between patients who underwent treatment with two-dimensional and three-dimensional laparoscopic surgery techniques. The study enrolled 60 consecutive patients; 31 (52%) patients who underwent three-dimensional surgery and 29 (48%) who underwent traditional two-dimensional surgery. No significant differences were observed in the adverse-event rate, operating time, or perioperative parameters. A higher use of sealing devices was recorded among patients who underwent three-dimensional laparoscopy (P=0.021). No difference was recorded in patient satisfaction between the two patient groups. Although there was no impact on surgical outcomes, three-dimensional surgery could give a more accurate view of the surgical field. Performing three-dimensional surgery could be beneficial for more complex procedures although further comparative studies are required to investigate this hypothesis. © 2016 International Federation of Gynecology and Obstetrics.

  11. Sexual satisfaction following bariatric surgery: A prospective exploratory study.

    Science.gov (United States)

    Ferrer-Márquez, Manuel; Pomares-Callejón, María Ángeles; Fernández-Agis, Inmaculada; Belda-Lozano, Ricardo; Vidaña-Márquez, Elisabet; Soriano-Maldonado, Alberto

    2017-11-01

    Bariatric surgery improves sexual function in obese individuals, although the extent to which sexual satisfaction is improved following surgery is unknown. The aims of this study were 1) to describe sexual satisfaction in severely/morbidly obese men and women candidates for bariatric surgery; 2) to assess the effects of bariatric surgery on sexual satisfaction at 12-months follow-up; and 3) to assess whether weight changes at follow-up following bariatric surgery are associated with changes in sexual satisfaction. We conducted a prospective observational study from February 2011 to June 2014. A total of 44 patients with severe/morbid obesity participated in the study. Sexual satisfaction was assessed (at baseline and 12-months follow-up) through the Index of Sexual Satisfaction (ISS) questionnaire. Of 44 patients who completed the ISS at baseline (mean age 40.3 [SD=9.4] years and BMI 46.9 [SD=6.2] kg/m 2 ), 17 were lost to follow-up. The baseline ISS total scores were 32.0 (SD=20.1) in women and 24.4 (SD=16.0) in men (P>0.05). The proportion of sexually satisfied men and women at baseline was 62.5% and 46.4%, respectively (P=0.360). At follow-up, sexual satisfaction improved significantly in women (average difference 13.7 units; P=0.032) but not in men (average difference 3.6 units; P=0.717). The percentage of women with sexual satisfaction problems was reduced by 33% at follow-up (P=0.038). A relatively large percentage of severely/morbidly obese women and men present clinically significant sexual satisfaction problems before undergoing bariatric surgery. Sexual satisfaction improves significantly 12 months following bariatric surgery, particularly in women. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  13. Immediate postoperative complications in transsphenoidal pituitary surgery: A prospective study

    Directory of Open Access Journals (Sweden)

    Tumul Chowdhury

    2014-01-01

    Full Text Available Background: Considering the important role of pituitary gland in regulating various endocrine axes and its unique anatomical location, various postoperative complications can be anticipated resulting from surgery on pituitary tumors. We examined and categorized the immediate postoperative complications according to various tumor pathologies. Materials and Methods: We carried out a prospective study in 152 consecutive patients and noted various postoperative complications during neurosurgical intensive care unit stay (within 48 hrs of hospital stay in patients undergoing transsphenoidal removal of pituitary tumors. Results: In our series, various groups showed different postoperative complications out of which, cerebrospinal fluid leak was the commonest followed by diabetes insipidus, postoperative nausea and vomiting, and hematoma at operation site. Conclusion: Various immediate postoperative complications can be anticipated in transsphenoidal pituitary surgery even though, it is considered to be relatively safe.

  14. Prospective Randomized Controlled Comparison of Caudal ...

    African Journals Online (AJOL)

    Background: Bupivacaine and ropivacaine are commonly used agents for caudal anesthesia in pediatric patients. Several ... only significant difference was the motor‑block score at 2, 3 and 4 h after surgery, although the score was same 1 h ... 2 = little movement of feet only, 3 = no movement of knees or feet. However ...

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

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

    2015-01-01

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

  17. [3-dimensional computer animation--a new medium for supporting patient education before surgery. Acceptance and assessment of patients based on a prospective randomized study--picture versus text].

    Science.gov (United States)

    Hermann, M

    2002-05-01

    The rigorous implementation of clear preoperative information is mandatory for the patient's understanding, acceptance and written informed consent to all diagnostic and surgical procedures. In the present study, I evaluated whether new media are suitable for conveying basic information to patients; I analysed the merits of computerized animation to illustrate a difficult treatment process, i.e., the progressive steps of a thyroid operation, in comparison to the use of conventional flyers. 3D animation software was employed to illustrate the basic anatomy of the thyroid and the larnyx; the principle of thyroidectomy was explained by visualizing the surgical procedure step by step. Finally, the possible complications that may result from the intraoperative manipulations were also visually explained. Eighty patients entered a prospective randomisation: on the day before surgery, group 1 watched the computer animation, whereas group 2 was given the identical information in a written text (= standard flyer). The evaluation included a questionnaire with scores of 1-5, rating the patients' understanding, subjective and objective knowledge, emotional factors like anxiety and trust, and the willingness to undergo an operation. Understanding of and subjective knowledge about the surgical procedure and possible complications, the degree of trust in professional treatment, the reduction in anxiety and readiness for the operation were significantly better after watching the computer animation than after reading the text. However, active knowledge did not improve significantly. The interest in the preoperative information was high in both groups. The benefit of computer animation was enhanced in a second inquiry; patients who had only read the text had a significant improvement in parameters after an additional exposure to the video animation. Preoperative surgical information can be optimized by presenting the operative procedure via computer animation. Nowadays, several types

  18. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

    2016-01-01

    To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  19. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Pascal H Colson

    Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  20. Reconstructive surgery after female genital mutilation: a prospective cohort study.

    Science.gov (United States)

    Foldès, Pierre; Cuzin, Béatrice; Andro, Armelle

    2012-07-14

    Women who have undergone female genital mutilation rarely have access to the reconstructive surgery that is now available. Our objective was to assess the immediate and long-term outcomes of this surgery. Between 1998 and 2009, we included consecutive patients with female genital mutilation aged 18 years or older who had consulted a urologist at Poissy-St Germain Hospital, France. We used the WHO classification to prospectively include patients with type II or type III mutilation. The skin covering the stump was resected to reveal the clitoris. The suspensory ligament was then sectioned to mobilise the stump, the scar tissue was removed from the exposed portion and the glans was brought into a normal position. All patients answered a questionnaire at entry about their characteristics, expectations, and preoperative clitoris pleasure and pain, measured on a 5-point scale. Those patients who returned at 1 year for follow-up were questioned about clitoris pain and functionality. We compared data from the 1-year group with the total group of patients who had surgery. We operated on 2938 women with a mean age of 29·2 (SD 7·77 years; age at excision 6·1, SD 3·5 years). Mali, Senegal, and Ivory Coast were the main countries of origin, but 564 patients had undergone female genital mutilation in France. The 1-year follow-up visit was attended by 866 patients (29%). Expectations before surgery were identity recovery for 2933 patients (99%), improved sex life for 2378 patients (81%), and pain reduction for 847 patients (29%). At 1-year follow-up, 363 women (42%) had a hoodless glans, 239 (28%) had a normal clitoris, 210 (24%) had a visible projection, 51 (6%) had a palpable projection, and three (0·4%) had no change. Most patients reported an improvement, or at least no worsening, in pain (821 of 840 patients) and clitoral pleasure (815 of 834 patients). At 1 year, 430 (51%) of 841 women experienced orgasms. Immediate complications after surgery (haematoma, suture

  1. 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:

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

    Science.gov (United States)

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

    2016-01-01

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

  3. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  4. Effects of a balanced energy and high protein formula diet (Vegestart complet®) vs. low-calorie regular diet in morbid obese patients prior to bariatric surgery (laparoscopic single anastomosis gastric bypass): a prospective, double-blind randomized study.

    Science.gov (United States)

    Carbajo, M A; Castro, Maria J; Kleinfinger, S; Gómez-Arenas, S; Ortiz-Solórzano, J; Wellman, R; García-Ianza, C; Luque, E

    2010-01-01

    Bariatric surgery is considered the only therapeutic alternative for morbid obesity and its comorbidities. High risks factors are usually linked with this kind of surgery. In order to reduce it, we consider that losing at least 10% of overweight in Morbid Obese (MO) and a minimum of 20% in Super- Obese patients (SO) before surgery, may reduce the morbidity of the procedure. The aim of our study is to demonstrate the effectiveness and tolerance of a balanced energy formula diet at the preoperative stage, comparing it against a low calorie regular diet. We studied 120 patients divided into two groups of 60 each, group A was treated 20 days prior to bariatric surgery with a balanced energy formula diet, based on 200 Kcal every 6 hours for 12 days and group B was treated with a low calorie regular diet with no carbs or fat. The last eight days prior to surgery both groups took only clear liquids. We studied the evolution of weight loss, the BMI, as well as behavior of co-morbidities as systolic blood pressure, diastolic blood pressure, glucose controls and tolerance at the protocol. The study shows that patients undergoing a balanced energy formula diet improved their comorbidities statistically significant in terms of decrease in weight and BMI loss, blood pressure and glucose, compared to the group that was treated before surgery with a low calorie regular diet. Nevertheless both groups improving the weight loss and co-morbidities with better surgical results and facilities. A correct preparation of the Morbid Obese patients prior of surgery can reduce the operative risks improving the results. Our study show that the preoperative treatment with a balanced energy formula diet as were included in our protocol in patients undergoing bariatric surgery improves statistical better their overall conditions, lowers cardiovascular risk and metabolic diseases that the patients with regular diet alone.

  5. [Prospects of hernia and abdominal wall surgery in China].

    Science.gov (United States)

    Tang, J X; Huang, L; Li, S J; Hu, X C

    2017-01-01

    In recent 20 years, hernia and abdominal wall surgery has made great progress in China. However, what we've done still leaves much to be desired. Related guidelines of hernia disease had been conducted, but China is short of multi-center, prospective, and large-sample research evidence. These guidelines are still with low evidence level, and contents need additional modified to well meet Chinese real situation. In terms of treatment of inguinal and abdominal wall incisional hernia, some consensus has been reached from certain key issues globally, but further exploration are still needed. To stand at top of the world, we are a long distance. We should not only strengthen training and quality control but also establish patient registration system and overall management process.

  6. 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 ...

  7. Prospective study of filtering blebs after XEN45 surgery.

    Science.gov (United States)

    Olate-Pérez, Á; Pérez-Torregrosa, V T; Gargallo-Benedicto, A; Neira-Ibáñez, P; Cerdà-Ibáñez, M; Osorio-Alayo, V; Barreiro-Rego, A; Duch-Samper, A

    2017-08-01

    To qualitatively analyse the evolution of filtering blebs after XEN surgery, by using anterior segment optical coherence tomography (AS-OCT). A prospective study was performed on filtering blebs of 30 eyes with cataracts and glaucoma, surgically operated on using phacoemulsification and XEN45 implantation (PHACO-XEN). AS-OCT was used to analyse bleb morphology and reflectivity at 3, 6, and 12 months after surgery. Functionality was studied considering an intraocular pressure (IOP)≤18mmHg without antihypertensive medication. The IOP enabled the blebs to be classified into non-functional: flat (6.67%) and encapsulated (3.33%); and functional (90%), which were then divide by their morphology into cystic (5/27), diffuse (2/27), and layered (20/27). Cystic types had a mean IOP of 12.8, 12.6, and 14.0mmHg at 3, 6 and 12 months, respectively. In the diffuse type, the mean IOP was 13.0, 11.5 and 13.0mmHg at 3, 6 and 12 months, respectively. In the layers pattern the mean IOP was 14.45, 14.55 and 14.8mmHg at 3, 6 and 12 months respectively. The percentage of blebs with high reflectivity was 48.15%, 62.96%, and 77.78%, at 3, 6 and 12 months, with a mean IOP of 14.23, 14.59, and 15.14mmHg in each time period, respectively. AS-OCT could be a good predictor of bleb functionality in PHACO-XEN surgery. Those with a cystic pattern or low reflectivity seem to have better post-operative success. Nevertheless, more long-term studies are required. Copyright © 2017 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. 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.

  9. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... H. pylori infection in Turkey. KEYWORDS: Duodenum, dyspepsia, Helicobacter pylori, gastritis, stomach. A Prospective, Randomized Study Comparing 7-day and 14-day. Quadruple Therapies as First-line Treatments for Helicobacter pylori. Infection in Patients with Functional Dyspepsia. A Yağbasan, DÖ ...

  10. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  11. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial.

    OpenAIRE

    Peterli Ralph; Steinert Robert E; Woelnerhanssen Bettina; Peters Thomas; Christoffel-Courtin Caroline; Gass Markus; Kern Beatrice; von Fluee Markus; Beglinger Christoph

    2012-01-01

    Background The mechanisms of amelioration of glycemic control early after laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) are not fully understood. Methods In this prospective, randomized 1-year trial, outcomes of LRYGB and LSG patients were compared, focusing on possibly responsible mechanisms. Twelve patients were randomized to LRYGB and 11 to LSG. These non-diabetic patients were investigated before and 1 week, 3 months, and 12 months after surgery. A...

  12. 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.

  13. 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).

  14. 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...

  15. 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.

  16. 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.

  17. 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.

  18. [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.

  19. 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...

  20. 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 ...

  1. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD......) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  2. 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

  3. Analgesia preemptiva nas cirurgias da coluna lombossacra: estudo prospectivo e randomizado Analgesia preventiva en las cirugías de la columna lumbosacra: estudio prospectivo y aleatorio Preemptive analgesia in lumbosacral spine surgeries: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Augustin Malzac

    2009-06-01

    recibieron alguna sustancia analgésica (control. Veinte y dos en el segundo (B que fueron sometidos a la inyección epidural, 20 minutos antes de la incisión quirúrgica, conteniendo 10 mL de marcaína y morfina. En el tercer grupo, y último (C, con 20 pacientes que fueron inyectados con auxilio de un catéter, en el espacio epidural, las mismas drogas del grupo B, por medio de la incisión antes de cerrar la herida operatoria. Los pacientes fueron examinados durante las primeras 24 horas, con auxilio de la escala verbal de dolor. RESULTADOS: los tres grupos fueron comparados según la edad, sexo, nivel y tiempo quirúrgico. Como los datos no obedecieron a una distribución Gausiana, el test paramétrico de Mann-Whitney fue entonces adoptado para análisis estadístico. De esta forma, los valores de la escala verbal de dolor, en todos los intervalos de tiempo fueron significativamente bajos (pOBJECTIVE: To analyze the efficacy of the preemptive analgesia with a method of epidural analgesic administration before and after the surgical painful stimulation, as comparing them. Its role in postoperative pain relief after lumbosacral spinal surgery, by the posterior approach, has not been fully investigated. METHODS: Sixty two patients who underwent microdiscectomy or microdecompression in a single level of the lumbosacral spine were divided into three groups: 20 patients that had not received any analgesic medication in the first one (A (control; 22 that had been submitted to the epidural injection containing 10 mL of marcaína and morphine 20 minutes before the surgical incision in the second one (B. In the third and last group (C, 20 patients received the same drugs of group B, with the aid of a catheter positioned in the epidural space, through the incision before the closing of the surgical wound. The patients were examined during the first 24 hours, with the use of the verbal scale of pain. RESULTS: The three groups were compared concerning age, sex, level and surgical

  4. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial.

    Science.gov (United States)

    Kubota, Go; Kamoda, Hiroto; Orita, Sumihisa; Yamauchi, Kazuyo; Sakuma, Yoshihiro; Oikawa, Yasuhiro; Inage, Kazuhide; Sainoh, Takeshi; Sato, Jun; Ito, Michihiro; Yamashita, Masaomi; Nakamura, Junichi; Suzuki, Takane; Takahashi, Kazuhisa; Ohtori, Seiji

    2017-07-20

    Platelet-rich plasma (PRP) accelerates bone union in vivo in a rodent model of spinal fusion surgery. However, PRP's effect on bone union after spinal surgery remains unclear. The objective of this study was to evaluate the efficacy of PRP after posterolateral lumbar fusion (PLF) surgery. Single-center prospective randomized controlled clinical trial with 2-year follow-up. The patient sample included a total 62 patients (31 patients in the PRP group or 31 patients in the control group). The outcome measures included the bone fusion rate, the area of bone fusion mass, the duration of bone fusion, and the clinical score using the visual analog scale (VAS). We randomized 62 patients who underwent one- or two-level instrumented PLF for lumbar degenerative spondylosis with instability to either the PRP (31 patients) or the control (31 patients) groups. Platelet-rich plasma-treated patients underwent surgery using an autograft bone chip (local bone), and PRP was prepared from patient blood samples immediately before surgery; patients from the control group underwent PLF without PRP treatment. We assessed platelet counts and growth factor concentrations in PRP prepared immediately before surgery. The duration of bone union, the postoperative bone fusion rate, and the area of fusion mass were assessed using plain radiography every 3 months after surgery and by computed tomography at 12 or 24 months. The duration of bone fusion and the clinical scores for low back pain, leg pain, and leg numbness before and 3, 6, 12, and 24 months after surgery were evaluated using VAS. Data from 50 patients with complete data were included. The bone union rate at the final follow-up was significantly higher in the PRP group (94%) than in the control group (74%) (p=.002). The area of fusion mass was significantly higher in the PRP group (572 mm 2 ) than in the control group (367 mm 2 ) (p=.02). The mean period necessary for union was 7.8 months in the PRP group and 9.8 months in the

  5. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared...... with surgical and histopathologic staging. RESULTS: A total of 104 patients underwent EUS; 36 had surgical resection of the tumor, 26 surgical exploration without resection, and 42 did not undergo surgery. Comparison of the TNM staging results for the two echoendoscopies gave high kappa values (T, 0.77; N, 0...

  6. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    Science.gov (United States)

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  7. 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.

  8. [Complications in gynecologic laparoscopic surgery--retrospective and prospective study].

    Science.gov (United States)

    Gocevska, S; Gortchev, G; Tomov, S

    2011-01-01

    Laparoscopic surgery is a surgical approach with proven advantages in the contemporary treatment of gynaecological diseases. It is applied with proven results in oncologic patients in order to respect certain rules. Mini-invasive approach has less complication and therefore is widely recommended. In this respect, the constantly increasing interest in this surgery and additional training and education. Risk factors must be taken into consideration and patients should be informed about possible complications during surgery.

  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. Prospective evaluation of quality of life in adolescent idiopathic scoliosis before and after surgery.

    Science.gov (United States)

    Pellegrino, Luciano N; Avanzi, Osmar

    2014-12-01

    Prospective observational study. To assess patient quality of life before and after surgical treatment of adolescent idiopathic scoliosis (AIS) and determine whether an association exists between quality of life and curve magnitude, curve correction, and type of instrumentation. Assessment of AIS surgery outcomes has always been based on analysis of radiographic measurements and postoperative curve correction. However, there is a current trend toward greater emphasis on patient-centered outcomes. Assessment of treatment success on the basis of these outcomes requires prospective use of quality-of-life surveys before and after AIS treatment. Prospective study of 33 patients undergoing surgical treatment of AIS. Mean age was 15.6 years and mean Cobb angle was 70.5 degrees. Patients were randomly allocated into one of 2 instrumentation groups (hybrid and pedicle screws alone), and the Scoliosis Research Society-30 questionnaire (SRS-30) and Short Form-36 Health Survey (SF-36) questionnaires were administered preoperatively and at 3-, 6-, and 12-month follow-up. Statistical testing was performed to determine whether survey scores correlated with Cobb angle, curve correction, or type of instrumentation. SRS-30 and SF-36 scores improved significantly. The greatest changes occurred in the self-image and satisfaction with management domains of the SRS-30 survey. SRS-30 and SF-36 scores showed worsening pain and decreased function at 3-month follow-up, but significant improvement from baseline at 12 months. Total SRS-30 scores were significantly improved at 6- and 12-month follow-up, as were subscores in the general health, vitality, and social functioning domains of SF-36. Curve magnitude, percent curve correction, and type of instrumentation had no significant influence on final SRS-30 and SF-36 scores. Surgical treatment of AIS improved patient quality of life, as shown by significant improvement on all SRS-30 and SF-36 domains. Questionnaire scores did not correlate

  11. 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.

  12. 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

  13. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Phuttharak Warinthorn

    2008-03-01

    Full Text Available Abstract Background An acute complication of thyroidectomy is fatal hematoma, which can produce an upper airway obstruction needing immediate intubation or tracheostomy. After neck surgery, we usually apply a pressure dressing with a non-woven, adhesive fabric to reduce bleeding and fluid collection at the operative bed. We conducted a prospective, randomized, controlled study to evaluate a pressure vs. a non-pressure dressing after thyroid surgery by monitoring blood and serum in the operative bed. Methods We studied 108 patients who underwent 116 thyroid surgeries at Srinagarind Hospital, Khon Kaen University, between December 2006 and September 2007. The patients were randomized to either the pressure dressing or non-pressure dressing group. Ultrasound of the neck was performed 24 ± 3 hours after surgery. The volume of fluid collection in the operative bed was calculated. All patients were observed for any post-operative respiratory distress, wound complications, tingling sensation or tetany. Results The distributions of age, sex, surgical indications and approaches were similar between the two groups. There was no statistically significant difference in the volume of fluid collection in the operative bed (p = 0.150 and the collected drained content (p = 0.798. The average time a drain was retained was 3 days. One patient in the pressure dressing group suffered cutaneous bruising while one patient in the non-pressure dressing group developed immediate hemorrhage after the skin sutures. Conclusion Pressure dressing after thyroidectomy does not have any significant impact on decreasing fluid collection at the operative bed. The use of pressure dressing after thyroidectomy may not therefore be justified. Trial Registration NCT00400465, ISRCTN52660978

  14. The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

    NARCIS (Netherlands)

    Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

    2005-01-01

    BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

  15. Nutritional assessment of bariatric surgery patients presenting for plastic surgery: a prospective analysis.

    Science.gov (United States)

    Naghshineh, Nima; O'Brien Coon, Devin; McTigue, Kathleen; Courcoulas, Anita P; Fernstrom, Madelyn; Rubin, J Peter

    2010-08-01

    Assessment of nutritional status in the growing postbariatric patient population remains controversial. Previous literature suggests that these patients have poor nutrition that may have adverse effects on surgical outcomes. The authors sought to determine the optimal method of nutritional assessment in postbariatric patients. One hundred patients presenting for body contouring after bariatric surgery were consecutively enrolled in an institutional review board-approved prospective study. A trained nutritionist assessed protein and calorie intake. All patients underwent baseline laboratory assessment. Eighteen percent of subjects had less than the recommended daily protein intake. Hypoalbuminemia was observed in 13.8 percent of subjects, with hypoprealbuminemia in 6.5 percent. Nearly forty percent of all patients had evidence of iron deficiency, with vitamin B12 deficiency present in 14.5 percent. Ten percent of subjects (all women) were confirmed to have iron deficiency anemia. Impaired fasting glucose was seen in 6.2 percent of subjects, whereas 3.6 percent had hemoglobin A1c levels greater than 6.5. Increasing age (odds ratio, 1.07) and greater change in body mass index (odds ratio, 1.11) were predictors of low protein intake. Dumping syndrome led to 13.3 times increased odds of low albumin levels. The results suggest that inadequate nutrition is common among postbariatric patients presenting for body contouring. The lack of correlation between methods of nutritional assessment supports the combination of multiple methods in determining overall nutritional status. The presence of dumping syndrome, a large change in body mass index, and advanced age may help to identify patients with an increased risk of nutritional deficiency.

  16. 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.

  17. 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.

  18. Bariatric Surgery in Moderately Obese Patients: A Prospective Study

    Directory of Open Access Journals (Sweden)

    M. Cerci

    2013-01-01

    Full Text Available Introduction. Moderate obesity (BMI 30–35 kg/m2 affects 25% of the western population. The role of bariatric surgery in this context is currently debated, reserved for patients with comorbidity, as an alternative to conservative medical treatment. We describe our experience in moderately obese patients treated with bariatric surgery. Materials and Methods. Between September 2011 and September 2012, 25 patients with grade I obesity and comorbidities underwent bariatric surgery: preoperative mean BMI 33.2 kg/m2, 10 males, mean age 42 years. In presence of type 2 diabetes mellitus (T2DM (56%, gastric bypass was performed; in cases with hypertension (64% and obstructive sleep apnea (OSA (12%, sleeve gastrectomy was performed. All operations were performed laparoscopically. Results. Mean follow-up was 12.4 months. A postoperative complication occurred: bleeding from the trocar site was resolved with surgery in local anesthesia. Reduction in average BMI was 6 points, with a value of 27.2 kg/m2. Of the 14 patients with T2DM, 12 (86% discontinued medical therapy because of a normalization of glycemia. Of the 16 patients with arterial hypertension, 14 (87% showed remission and 2 (13% improvement. Complete remission was observed in patients with OSAS. Conclusions. The results of our study support the validity of bariatric surgery in patients with BMI 30–35 kg/m2. Our opinion is that, in the future, bariatric surgery could be successful in selected cases of moderately obese patients.

  19. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    ) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included....... With larger patient samples, it is possible, however, that a significant difference might have been achieved. The running costs for APD treatment were US $75 per day and for CAPD treatment US $61 per day. CONCLUSION: If APD treatment can help to keep selected patients vocationally or socially active, paying...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  20. Intramedullary nailing of the femoral shaft: a prospective, randomized study.

    Science.gov (United States)

    Cameron, C D; Meek, R N; Blachut, P A; O'Brien, P J; Pate, G C

    2014-08-01

    We conducted a prospective, randomized study on 84 consecutive patients with 88 acute, traumatic femoral shaft fractures using 32 Grosse-Kempf nails, 29 Russell-Taylor nails, and 27 Synthes nails. Although total operative times and proximal and distal locking times were similar for the three groups, the procedure was faster with the Grosse-Kempf nail. Three proximal fractures could not be locked with the Synthes nail. At first follow-up, we found no significant difference in terms of pain, limp, range of motion, or time to union; however, we removed fewer Synthes nails to resolve patient complaints of pain. Three delayed unions were attributed to fracture distraction. We conclude that all three nails are suitable for the treatment of almost all femoral shaft fractures. A careful analysis of intraoperative technique and instrumentation indicates that all three nails can be used safely and easily once experience is gained. Clinical outcome is similar regardless of the nail chosen.

  1. One-day nasogastric tube decompression after distal gastrectomy: a prospective randomized study.

    Science.gov (United States)

    Kimura, Yutaka; Yano, Hiroshi; Iwazawa, Takashi; Fujita, Junya; Fujita, Shoichiro; Yamamoto, Kazuyoshi; Yasuda, Takushi

    2017-09-01

    Many surgeons in Japan use 1-day nasogastric tube (NGT) decompression after gastrectomy as a standard procedure. This prospective randomized study aimed to define whether 1-day NGT decompression is necessary after distal gastrectomy. The subjects were 233 patients with gastric cancer, randomized into two groups immediately after distal gastrectomy: one group received 1-day NGT decompression (NGT group, n = 119) and the other did not (no-NGT group, n = 114). The primary outcome measure was postoperative surgery-related and respiratory complications, whereas secondary measures were the postoperative course to recovery and patient complaints. The incidence of surgery-related complications did not differ significantly between the NGT and no-NGT groups (21.0 and 19.2%, respectively; p = 0.87). The rate of respiratory complications was 6.7% in the NGT group and 7.0% in the no-NGT group (p > 0.99). The time to passage of first flatus and the postoperative hospital stay did not differ between the groups. Twenty-five patients in the NGT group and none in the no-NGT group complained of nasopharyngeal discomfort (p < 0.0001). Considering the physical discomfort caused by the NGT, we believe that routine 1-day NGT decompression is unnecessary after distal gastrectomy.

  2. Aprotinin and classic wound drainage are unnecessary in total hip replacement - a prospective randomized trial.

    Science.gov (United States)

    Fleischmann, F; Matuschek, C; Orth, K; Gerber, P A; Mota, R; Knoefel, W T; Peiper, M; Schick, M; van Griensven, M; Bölke, Edwin; Fleischmann, W

    2011-01-27

    Classic wound drainage is still common in hip replacement but its benefit is doubtful. The role of systemic administration of proteinase inhibitors like aprotinin to avoid perioperative blood loss is still unclear. In a prospective randomized trial, the perioperative blood loss in alloplastic hip replacement under the influence of proteinase inhibitor (aprotinin, Trasylol®) using wound drainage as well as compression treatment alone were compared. 80 patients were prospectively randomized in 4 arms. Patients received either aprotinin or placebo during surgery as well as drainage or targeted external wound compression. Observing the "drug therapy" aprotinin had no effect on the intra- or postoperative blood loss (p>0.05), a trend to lower postoperative hemoglobin decline was found, but without significance. Thrombosis occurred in neither the aprotinin nor in the placebo group. Two patients had a severe allergic drug reaction and were excluded from the study. Under "non drug therapy" with compression therapy and wound drainage a significant difference in blood loss was found (pperioperative blood loss. Hence, costs and two severe allergic drug reactions in our study represent arguments against its use in regular treatment. Furthermore, it seems that wound drainage is neglectable in hip replacement and can be substituted by a sole compression treatment.

  3. Aprotinin and classic wound drainage are unnecessary in total hip replacement a prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Fleischmann F

    2011-01-01

    Full Text Available Abstract Background Classic wound drainage is still common in hip replacement but its benefit is doubtful. The role of systemic administration of proteinase inhibitors like aprotinin to avoid perioperative blood loss is still unclear. Patients and Methods In a prospective randomized trial, the perioperative blood loss in alloplastic hip replacement under the influence of proteinase inhibitor (aprotinin, Trasylol® using wound drainage as well as compression treatment alone were compared. 80 patients were prospectively randomized in 4 arms. Patients received either aprotinin or placebo during surgery as well as drainage or targeted external wound compression. Results Observing the "drug therapy" aprotinin had no effect on the intraor postoperative blood loss (p > 0.05, a trend to lower postoperative hemoglobin decline was found, but without significance. thrombosis occurred in neither the aprotinin nor in the placebo group. Two patients had a severe allergic drug reaction and were excluded from the study. Under "non drug therapy" with compression therapy and wound drainage a significant difference in blood loss was found (p Conclusion The administration of aprotinin did not achieve the desired reduction of perioperative blood loss. Hence, costs and two severe allergic drug reactions in our study represent arguments against its use in regular treatment. Furthermore, it seems that wound drainage is neglectable in hip replacement and can be substituted by a sole compression treatment.

  4. Precision of maxillary repositioning during orthognathic surgery: a prospective study.

    Science.gov (United States)

    Bouchard, Carl; Landry, Pierre-Éric

    2013-05-01

    The purpose of this study was to evaluate the accuracy of surgical splints and an external reference point to reposition the maxilla during orthognathic surgery. Before surgery, a radiological marker was inserted inside the orthodontic bracket of the first right maxillary molar. A surgical splint was utilized to reposition the maxilla in the sagittal and coronal planes after the osteotomy. The vertical position was established by measuring the distance between a Kirschner wire inserted at bony nasion and the orthodontic wire. Preoperative and postoperative cephalometric radiographs were obtained and manually traced. The radiological marker and the tip of the right maxillary incisor were used as specific landmarks. Their displacement on the pre- and postoperative radiographs was measured. The actual surgical movement of the maxilla was compared to the initial surgical planning. 23 patients met the inclusion criteria to participate in the study. The mean difference between the planned and executed movements of the maxilla was 0.1mm (p=0.71). The difference was not statistically significant for any given movements of the maxilla. The use of surgical splints made from model surgery combined with an external reference point at bony nasion is accurate methods for repositioning the maxilla during orthognathic surgery. Copyright © 2012 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  5. Vitamin K1 monitoring in pregnancies after bariatric surgery: a prospective cohort study.

    Science.gov (United States)

    Jans, Goele; Guelinckx, Isabelle; Voets, Willy; Galjaard, Sander; Van Haard, Paul M M; Vansant, Greet M; Devlieger, Roland

    2014-01-01

    Neonatal intracranial bleedings and birth defects have been reported, possibly related to maternal vitamin K1 deficiency during pregnancy after bariatric surgery. The objective of this study was to investigate the effects of screening and supplementation on K1 serum levels in pregnant women with bariatric surgery, and to compare K1 levels and prothrombin time (PT %) in the first trimester with pregnant women without bariatric surgery. A prospective cohort study including 49 pregnant women with bariatric surgery. Nutritional deficiencies were prospectively screened. In case of observed low K1 serum levels, supplementation was provided. K1 serum levels and PT (%) during the first trimester were compared with a nonsurgical control group of 27 women. During the first trimester, most women had low K1 serum levels (surgery group showed a higher mean PT compared to the controls (111.3 versus 98.9%; Pbariatric surgery. Supplementation during pregnancy can restore vitamin K1 in women with bariatric surgery, potentially protecting the fetus and newborn against intracranial hemorrhage. Copyright © 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  6. 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.

  7. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  8. [A prospective randomized controlled trial of laparoscopic repair versus open repair for perforated peptic ulcers].

    Science.gov (United States)

    Wang, Qiwei; Ge, Bujun; Huang, Qi

    2017-03-25

    To compared the clinical efficacy of laparoscopic repair (LR) versus open repair (OR) for perforated peptic ulcers. From January 2010 to June 2014, in Shanghai Tongji Hospital, 119 patients who were diagnosed as perforated peptic ulcers and planned to receive operation were prospectively enrolled. Patients were randomly divided into LR (58 patients) and OR(61 patients) group by computer. Intra-operative and postoperative parameters were compared between two groups. This study was registered as a randomized controlled trial by the China Clinical Trials Registry (registration No.ChiCTR-TRC-11001607). There was no significant difference in baseline data between two groups (all P>0.05). No significant differences of operation time, morbidity of postoperative complication, mortality, reoperation probability, decompression time, fluid diet recovery time and hospitalization cost were found between two groups (all P>0.05). As compared to OR group, LR group required less postoperative fentanyl [(0.74±0.33) mg vs. (1.04±0.39) mg, t=-4.519, P=0.000] and had shorter hospital stay [median 7(5 to 9) days vs. 8(7 to 10) days, U=-2.090, P=0.001]. In LR group, 3 patients(5.2%) had leakage in perforation site after surgery. One case received laparotomy on the second day after surgery for diffuse peritonitis. The other two received conservative treatment (total parenteral nutrition and enteral nutrition). There was no recurrence of perforation in OR group. One patient of each group died of multiple organ dysfunction syndrome (MODS) 22 days after surgery. LR may be preferable for treating perforated peptic ulcers than OR, however preventive measures during LR should be taken to avoid postopertive leak in perforation site.

  9. 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.

  10. 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.

  11. Objective and subjective outcomes of strabismus surgery in Graves' orbitopathy: a prospective multicentre study

    NARCIS (Netherlands)

    Jellema, Hinke Marijke; Saeed, Peerooz; Mombaerts, Ilse; Dolman, Peter J.; Garrity, Jim; Kazim, Mike; Dhrami-Gavazi, Elona; Lyons, Christopher; Nieuwkerk, Pythia; Mourits, Maarten P.

    2017-01-01

    To assess the change and interrelationship of the field of binocular single vision (BSV) and the quality of life (QoL), tested with two different tools, after one or two strabismus surgeries in patients with Graves' orbitopathy (GO). Prospectively, consecutive patients with GO who were scheduled for

  12. Prospective evaluation of psychosocial adaptation to stoma surgery: the role of self-efficacy.

    NARCIS (Netherlands)

    Bekkers, M.J.T.; Knippenberg, F.C.E. van; Borne, H.W. van den; Berge-Henegouwen, G.P. van

    1996-01-01

    Self-efficacy, one's expectations regarding the ability to perform some specific task, was studied prospectively in the adaptation process of stoma patients. One week after surgery, stoma-related self-efficacy was assessed in 59 patients (26 cancer patients and 33 patients with benign diseases) who

  13. Iodine Status After Bariatric Surgery-a Prospective 10-Year Report from the Swedish Obese Subjects (SOS) Study.

    Science.gov (United States)

    Manousou, Sofia; Carlsson, Lena M S; Eggertsen, Robert; Hulthén, Lena; Jacobson, Peter; Landin-Wilhelmsen, Kerstin; Trimpou, Penelope; Svensson, Per-Arne; Nyström, Helena Filipsson

    2018-02-01

    Bariatric surgery can lead to nutrient deficiencies. Gastric by-pass (GBP) entails restriction and malabsorption, whereas, vertical banded gastroplasty (VBG) is only restrictive. The objective of this study is to study whether GBP-patients develop iodine deficiency from malabsorption, and if GBP- and VBG-patients develop lower 24-h urinary iodine excretion (24-UIE) than obese non-operated controls (OB-controls) due to lower iodine intake. The Swedish Obese Subjects (SOS) study is a prospective, non-randomized study of 4047 obese patients included 1987-2001, who chose bariatric surgery or non-surgical treatment. SOS-groups were compared at baseline, after 2 and 10 years and with population-based subsamples (MONICA-controls). One hundred eighty-eight GBP-patients were matched with 188 VBG-patients and 188 OB-controls and with three subgroups from 412 MONICA-controls. Primary outcome was 24-UIE. Secondary outcomes were iodine intake, iodine supplementation, TSH, FT4, and thyroid morbidity. At baseline, median 24-UIE was higher in GBP-patients, VBG-patients and OB-controls than in MONICA-controls (214, 201, 203 and 137 μg/day, p surgery, GBP- and VBG-patients did not suffer from iodine deficiency, but both groups had lower iodine status than OB-controls. Dietary supplements recommended after bariatric surgery do not need to include iodine, in iodine sufficient countries. clinicaltrials.gov : NCT01479452.

  14. ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial.

    Science.gov (United States)

    Vespa, Paul; Hanley, Daniel; Betz, Joshua; Hoffer, Alan; Engh, Johnathan; Carter, Robert; Nakaji, Peter; Ogilvy, Chris; Jallo, Jack; Selman, Warren; Bistran-Hall, Amanda; Lane, Karen; McBee, Nichol; Saver, Jeffery; Thompson, Richard E; Martin, Neil

    2016-11-01

    Intracerebral hemorrhage (ICH) is a devastating disease without a proven therapy to improve long-term outcome. Considerable controversy about the role of surgery remains. Minimally invasive endoscopic surgery for ICH offers the potential of improved neurological outcome. We tested the hypothesis that intraoperative computerized tomographic image-guided endoscopic surgery is safe and effectively removes the majority of the hematoma rapidly. A prospective randomized controlled study was performed on 20 subjects (14 surgical and 4 medical) with primary ICH of >20 mL volume within 48 hours of ICH onset. We prospectively used a contemporaneous medical control cohort (n=36) from the MISTIE trial (Minimally Invasive Surgery and r-tPA for ICH Evacuation). We evaluated surgical safety and neurological outcomes at 6 months and 1 year. The intraoperative computerized tomographic image-guided endoscopic surgery procedure resulted in immediate reduction of hemorrhagic volume by 68±21.6% (interquartile range 59-84.5) within 29 hours of hemorrhage onset. Surgery was successfully completed in all cases, with a mean operative time of 1.9 hours (interquartile range 1.5-2.2 hours). One surgically related bleed occurred peri-operatively, but no patient met surgical safety stopping threshold end points for intraoperative hemorrhage, infection, or death. The surgical intervention group had a greater percentage of patients with good neurological outcome (modified Rankin scale score 0-3) at 180 and 365 days as compared with medical control subjects (42.9% versus 23.7%; P=0.19). Early computerized tomographic image-guided endoscopic surgery is a safe and effective method to remove acute intracerebral hematomas, with a potential to enhance neurological recovery. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00224770. © 2016 American Heart Association, Inc.

  15. 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

  16. 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

  17. A prospective, randomized trial for use of prednisolone in patients with facial nerve paralysis after parotidectomy.

    Science.gov (United States)

    Roh, Jong-Lyel; Park, Chan Il

    2008-11-01

    A high rate of facial nerve paralysis (FNP) develops after parotid surgery, but there have been few clinical trials on treatments to improve recovery times. This study evaluated the efficacy of prednisolone in these patients. A total of 123 patients who underwent parotidectomy without injury to the facial nerve were assessed prospectively for postoperative FNP. These patients were assigned randomly to treatment with prednisolone or placebo for 10 days. FNP was evaluated by House-Brackmann grades. Recovery rates and adverse effects were monitored regularly for 6 months after surgery. Of the 123 patients, 45 had postoperative FNP. All FNPs were grades II to IV, mostly on 1 or 2 facial areas. The incidence of FNP was increased significantly with malignant pathology, increased parotidectomy extent, and neck dissection (P FNP after 6 months, whereas 1 patient had permanent FNP. Recovery rates were equal in both groups, and there was no evidence of major adverse effects. Prednisolone was ineffective in early recovery from postparotidectomy FNP.

  18. Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

    International Nuclear Information System (INIS)

    EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

    2010-01-01

    Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

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

    Science.gov (United States)

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

    2016-02-01

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

  1. Prospective evaluation of outcome measures in free-flap surgery.

    LENUS (Irish Health Repository)

    Kelly, John L

    2004-08-01

    Free-flap failure is usually caused by venous or arterial thrombosis. In many cases, lack of experience and surgical delay also contribute to flap loss. The authors prospectively analyzed the outcome of 57 free flaps over a 28-month period (January, 1999 to April, 2001). The setting was a university hospital tertiary referral center. Anastomotic technique, ischemia time, choice of anticoagulant, and the grade of surgeon were recorded. The type of flap, medications, and co-morbidities, including preoperative radiotherapy, were also documented. Ten flaps were re-explored (17 percent). There were four cases of complete flap failure (6.7 percent) and five cases of partial failure (8.5 percent). In patients who received perioperative systemic heparin or dextran, there was no evidence of flap failure (p = .08). The mean ischemia time was similar in flaps that failed (95 +\\/- 29 min) and in those that survived (92 +\\/- 34 min). Also, the number of anastomoses performed by trainees in flaps that failed (22 percent), was similar to the number in flaps that survived (28 percent). Nine patients received preoperative radiotherapy, and there was complete flap survival in each case. This study reveals that closely supervised anastomoses performed by trainees may have a similar outcome to those performed by more senior surgeons. There was no adverse effect from radiotherapy or increased ischemia time on flap survival.

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

    Science.gov (United States)

    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.

  3. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study

    Directory of Open Access Journals (Sweden)

    Donmez T

    2016-10-01

    Full Text Available Turgut Donmez,1 Vuslat Muslu Erdem,2 Oguzhan Sunamak,3 Duygu Ayfer Erdem,2 Huseyin Imam Avaroglu1 1Department of General Surgery, 2Department of Anesthesiology and Reanimation, Lutfiye Nuri Burat State Hospital, 3Department of General Surgery, Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey Background: Laparoscopic total extraperitoneal (TEP inguinal hernia repair is a well-known approach to inguinal hernia repair that is usually performed under general anesthesia (GA. To date, no reports compare the efficacy of spinal anesthesia (SA with that of GA for laparoscopic hernia repairs. The purpose of this study was to compare the surgical outcome of TEP inguinal hernia repair performed when the patient was treated under SA with that performed under GA. Materials and methods: Between July 2015 and July 2016, 50 patients were prospectively randomized to either the GA TEP group (Group I or the SA TEP group (Group II. Propofol, fentanyl, rocuronium, sevoflurane, and tracheal intubation were used for GA. Hyperbaric bupivacaine (15 mg and fentanyl (10 µg were used for SA to achieve a sensorial level of T3. Intraoperative events related to SA, operative and anesthesia times, postoperative complications, and pain scores were recorded. Each patient was asked to evaluate the anesthetic technique by using a direct questionnaire filled in 3 months after the operation. Results: All the procedures were completed by the allocated method of anesthesia as there were no conversions from SA to GA. Pain was significantly less for 1 h (P<0.0001 and 4 h (P=0.002 after the procedure for the SA and GA groups, respectively. There was no difference between the two groups regarding complications, hospital stay, recovery, or surgery time. Generally, patients were more satisfied with SA than GA (P<0.020. Conclusion: TEP inguinal hernia repair can be safely performed under SA, and SA was associated with less postoperative pain, better recovery, and better

  4. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial.

    Science.gov (United States)

    Angioli, Roberto; De Cicco Nardone, Carlo; Plotti, Francesco; Cafà, Ester Valentina; Dugo, Nella; Damiani, Patrizio; Ricciardi, Roberto; Linciano, Francesca; Terranova, Corrado

    2014-01-01

    To investigate the effects of music on anxiety and perception of pain during office hysteroscopy. Prospective randomized trial (Canadian Task Force classification I). Major university medical center. Three hundred fifty-six patients were enrolled between July 2012 and January 2013. Hysteroscopy was performed in a dedicated ambulatory room, using vaginoscopy and without any type of anesthesia. A Bettocchi hysteroscope 5 mm in diameter was used. All procedures were performed by the same surgeon, a gynecologist with special interest in hysteroscopy. Data collected included age, body mass index, number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy). For each patient, vital parameters such as blood pressure, heart rate, and respiratory rate were recorded 15 minutes before the procedure and during hysteroscopy after traversing the cervix. Wait time before surgery and the duration of the procedure were also recorded. A completed Italian version of the state anxiety questionnaire (State-Trait Anxiety Inventory) and a visual analog scale (VAS) were administered to each patient before and after the procedure. The t test and Mann-Whitney U test was used when appropriate to compare the 2 groups. Statistical significance was accepted at p = .05. During surgery, systolic blood pressure and heart rate were significantly lower in the music group compared with the no music group. Women in the music group experienced significantly lower anxiety after hysteroscopy and less pain during the procedure, and a significant decrease in both anxiety and pain scores after hysteroscopy. Postoperative State-Trait Anxiety Inventory form Y1 and VAS scores were significantly lower in the music group. Music can be useful as a complementary method to control anxiety and reduce perception of pain. The patient is more relaxed and experiences less discomfort. Copyright © 2014. Published by Elsevier Inc.

  5. 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

  6. Pang-Rotenberg sign--snoring surgery prognosticator: A prospective clinical trial of 153 patients.

    Science.gov (United States)

    Pang, Kenny P; Kishore, Srivinas; Kit, Joseph Chung Chun; Pang, Edward B; Chan, Yiong Huak; Keat, Siow Jin; Rotenberg, Brian

    2016-01-01

    To illustrate the reliability of the Pang-Rotenberg (PR) sign as a prognosticator of snoring surgery. Our hypothesis was that patients who are PR-positive have better snoring reduction scores and outcomes than PR-negative patients after nose and palate surgery. A multicenter prospective series of 153 patients with snoring. All patients graded the snoring intensity on a visual analog scale (VAS). All 137 patients enrolled had both the nose surgery and palate surgery. The control group consisted of 16 patients who underwent nasal surgery alone. There were 122 men and 15 women, the mean age was 44.6 years old, and mean body mass index was 26.1. There were 15 simple snorers and 122 obstructive sleep apnea patients. Patients who were PR-positive showed significantly better postoperative snoring VAS reduction (from 9.04 to 1.02) compared to those patients who were PR-negative (from 8.91 to 3.14) (P snoring VAS reduction from 9.21 to 6.72. After adjusting for covariates that influence the snoring VAS change due to surgery, we found that PR-negative patients achieved an average of 5.78 improvement in snoring VAS, whereas PR-positive patients achieved an average of 8.02 improvement in snoring VAS (P snoring reduction, after combined nose and palate surgery, for patients with troublesome snoring. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  7. [Single event multilevel surgery to improve gait in diplegic cerebral palsy - a prospective controlled trial].

    Science.gov (United States)

    Zwick, E B; Saraph, V; Strobl, W; Steinwender, G

    2001-01-01

    To evaluate prospectively the outcome of gait-improvement surgery in children with spastic diplegia. Three-dimensional gait analysis was performed in twenty children with spastic diplegia. Ten children underwent single event multilevel surgery for gait improvement. Indications for individual procedures followed a fixed set of selection criteria. The other ten children continued with their physiotherapy programme and served as a control group. A second gait analysis was performed in all children after 1.5 years. Time-distance parameters and kinematics of the pelvis, hip, knee and ankle joints in the sagittal plane served as main outcome measures The patients walked faster with an increased stride length after surgery in comparison to the conservatively treated controls. The average pelvic tilt increased slightly and the range of motion of the knee joint increased considerably after multilevel surgery. The motion at the ankle remained unchanged over the study period in both the groups. An improved knee extension during the stance phase of gait served to improve stance limb stability and facilitated an unhindered swing phase of the opposite limb. This prospective trial showed favourable changes in gait function after multilevel surgery in spastic diplegic children.

  8. Micronutrient Levels and Supplement Intake in Pregnancy after Bariatric Surgery: A Prospective Cohort Study

    Science.gov (United States)

    Devlieger, Roland; Guelinckx, Isabelle; Jans, Goele; Voets, Willy; Vanholsbeke, Caroline; Vansant, Greet

    2014-01-01

    Background Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. Objective To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. Design A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy. Results The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002). The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030). Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%). In the second and third trimester, the majority took additional supplements (69.4 and 73.5%). No associations were found between supplement intake and micronutrient deficiencies. Conclusion Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients. PMID:25470614

  9. Micronutrient levels and supplement intake in pregnancy after bariatric surgery: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Roland Devlieger

    Full Text Available Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery.To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery.A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy.The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002. The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030. Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%. In the second and third trimester, the majority took additional supplements (69.4 and 73.5%. No associations were found between supplement intake and micronutrient deficiencies.Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients.

  10. Micronutrient levels and supplement intake in pregnancy after bariatric surgery: a prospective cohort study.

    Science.gov (United States)

    Devlieger, Roland; Guelinckx, Isabelle; Jans, Goele; Voets, Willy; Vanholsbeke, Caroline; Vansant, Greet

    2014-01-01

    Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy. The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002). The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030). Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%). In the second and third trimester, the majority took additional supplements (69.4 and 73.5%). No associations were found between supplement intake and micronutrient deficiencies. Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients.

  11. 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.

  12. Early symptoms in the prodromal phase of delirium: a prospective cohort study in elderly patients undergoing hip surgery.

    Science.gov (United States)

    de Jonghe, Jos F M; Kalisvaart, Kees J; Dijkstra, Marty; van Dis, Huib; Vreeswijk, Ralph; Kat, Martin G; Eikelenboom, Piet; van der Ploeg, Tjeerd; van Gool, Willem A

    2007-02-01

    The authors investigated prodromal delirium symptoms in elderly patients undergoing hip surgery. This was a prospective cohort study in the setting of a large medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants were patients undergoing hip surgery aged 70 and older at risk for delirium. Before surgery, patients were randomized to low-dose prophylactic haloperidol treatment or placebo. Daily assessments were based on patient interviews with the Mini-Mental State Examination and Digit Span test. The Delirium Rating Scale-Revised (DRS-R-98) was used to measure early symptoms during the prodromal phase before the onset of delirium. Data of 66 patients with delirium were compared with those of 35 at-risk patients who did not develop delirium: 14 of 66 patients (21%) had delirium on the day of surgery or early the day after, 32 of 66 (48%) on the second day, 14 of 66 on the third, and six of 66 (9%) on the fourth. The average DRS-R-98 total scores on day -4 to day -1 before delirium were 1.9 for the comparison group patients and 5.0, 4.3, 5.8, and 10.7 for patients with postoperative delirium. Multivariate analysis showed that the early symptoms memory impairments, incoherence, disorientation, and underlying somatic illness predict delirium. Most elderly patients undergoing hip surgery with postoperative delirium already have early symptoms in the prodromal phase of delirium. These findings are potentially useful for screening purposes and for optimizing prevention strategies targeted at reducing the incidence of postoperative delirium.

  13. 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®

  14. 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.

  15. 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

  16. Nationwide prospective audit of pancreatic surgery: design, accuracy, and outcomes of the Dutch Pancreatic Cancer Audit

    NARCIS (Netherlands)

    van Rijssen, L. Bengt; Koerkamp, Bas G.; Zwart, Maurice J.; Bonsing, Bert A.; Bosscha, Koop; van Dam, Ronald M.; van Eijck, Casper H.; Gerhards, Michael F.; van der Harst, Erwin; de Hingh, Ignace H.; de Jong, Koert P.; Kazemier, Geert; Klaase, Joost; van Laarhoven, Cornelis J.; Molenaar, I. Quintus; Patijn, Gijs A.; Rupert, Coen G.; van Santvoort, Hjalmar C.; Scheepers, Joris J.; van der Schelling, George P.; Busch, Olivier R.; Besselink, Marc G.; Bollen, Thomas L.; Bruno, Marco J.; van Tienhoven, Geert-Jan; Norduyn, Arnold; Berry, David P.; Tingstedt, Bobby; Tseng, Jennifer F.; Wolfgang, Christopher L.

    2017-01-01

    Background: Auditing is an important tool to identify practice variation and 'best practices'. The Dutch Pancreatic Cancer Audit is mandatory in all 18 Dutch centers for pancreatic surgery. Methods: Performance indicators and case-mix factors were identified by a PubMed search for randomized

  17. Routine calcium measurement is not necessary after most thyroid surgeries: a prospective clinical study.

    LENUS (Irish Health Repository)

    Quinn, E M

    2010-12-01

    Calcium levels are often measured to diagnose postoperative hypocalcaemia following thyroidectomy. The aims of this study were to (i) prospectively determine the incidence of symptomatic and biochemical hypocalcaemia following thyroidectomy, (ii) to identify if any associations exist between hypocalcaemia, type of surgery, histological diagnosis, specimen size\\/weight and the presence of histological parathyroid tissue and (iii) to evaluate the necessity of routine measurement of calcium levels following all thyroidectomies.

  18. Predicting complication risk in spine surgery: a prospective analysis of a novel risk assessment tool.

    Science.gov (United States)

    Veeravagu, Anand; Li, Amy; Swinney, Christian; Tian, Lu; Moraff, Adrienne; Azad, Tej D; Cheng, Ivan; Alamin, Todd; Hu, Serena S; Anderson, Robert L; Shuer, Lawrence; Desai, Atman; Park, Jon; Olshen, Richard A; Ratliff, John K

    2017-07-01

    OBJECTIVE The ability to assess the risk of adverse events based on known patient factors and comorbidities would provide more effective preoperative risk stratification. Present risk assessment in spine surgery is limited. An adverse event prediction tool was developed to predict the risk of complications after spine surgery and tested on a prospective patient cohort. METHODS The spinal Risk Assessment Tool (RAT), a novel instrument for the assessment of risk for patients undergoing spine surgery that was developed based on an administrative claims database, was prospectively applied to 246 patients undergoing 257 spinal procedures over a 3-month period. Prospectively collected data were used to compare the RAT to the Charlson Comorbidity Index (CCI) and the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator. Study end point was occurrence and type of complication after spine surgery. RESULTS The authors identified 69 patients (73 procedures) who experienced a complication over the prospective study period. Cardiac complications were most common (10.2%). Receiver operating characteristic (ROC) curves were calculated to compare complication outcomes using the different assessment tools. Area under the curve (AUC) analysis showed comparable predictive accuracy between the RAT and the ACS NSQIP calculator (0.670 [95% CI 0.60-0.74] in RAT, 0.669 [95% CI 0.60-0.74] in NSQIP). The CCI was not accurate in predicting complication occurrence (0.55 [95% CI 0.48-0.62]). The RAT produced mean probabilities of 34.6% for patients who had a complication and 24% for patients who did not (p = 0.0003). The generated predicted values were stratified into low, medium, and high rates. For the RAT, the predicted complication rate was 10.1% in the low-risk group (observed rate 12.8%), 21.9% in the medium-risk group (observed 31.8%), and 49.7% in the high-risk group (observed 41.2%). The ACS NSQIP calculator consistently

  19. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial.

    NARCIS (Netherlands)

    K.T. Tran; C.H.J. van Eijck (Casper); V. di Carlo (Valerio); W.C.J. Hop (Wim); A. Zerbi (Alessandro); G. Balzano (Gianpaolo); J. Jeekel (Hans)

    2002-01-01

    textabstractOBJECTIVE: Using a prospective randomized study to assess postoperative morbidity and pancreatic function after pancreaticoduodenectomy with pancreaticojejunostomy and duct occlusion without pancreaticojejunostomy. SUMMARY BACKGROUND DATA: Postoperative complications

  20. Endoscopic versus laparoscopic treatment for choledocholithiasis: a prospective randomized controlled trial

    Science.gov (United States)

    Barreras González, Javier Ernesto; Torres Peña, Rafael; Ruiz Torres, Julián; Martínez Alfonso, Miguel Ángel; Brizuela Quintanilla, Raúl; Morera Pérez, Maricela

    2016-01-01

    Background and study aims: Overall, 5 % to 15 % of patients undergoing cholecystectomy for cholelithiasis have concomitant bile duct stones, and the incidence of choledocholithiasis increases with age. There is no clear consensus on the best therapeutic approach (endoscopic versus surgical). Patients and methods: A prospective randomized controlled clinical trial was performed to compare three treatment options for patients with choledocholithiasis at the National Center for Minimally Invasive Surgery in Havana, Cuba from November 2007 to November 2011. The patients were randomized in three groups. Group I: patients who underwent intraoperative cholangiography (IOC) to confirm the choledocholithiasis followed by laparoscopic cholecystectomy (LC) associated with intraoperative endoscopic retrograde cholangiopancreatography (ERCP), group II: patients who underwent preoperative ERCP followed by LC during the same hospital admission and group III: patients who underwent IOC to confirm the choledocholithiasis followed by LC associated with laparoscopic common bile duct exploration (LCBDE). Results: A total of 300 patients with suspected choledocholithiasis were included in the trial and were randomized. As a result, a total of 134 patients were diagnosed with the presence of choledocholithiasis and treated during the study period. There were no significant differences in success rates of ductal stone clearance, but retained stone, postoperative complications and length of hospital stay were better in group I. Conclusions: Intraoperative ERCP/ES shows a higher rate of common bile duct stones clearance, a shorter hospital stay, and lower morbidity, but further research with a larger study population is necessary to determine the additional benefits of this procedure. The results to date suggests that in appropriate patients, single-stage treatments are the best options. PMID:27857966

  1. Does Zoledronate Prevent Femoral Head Collapse from Osteonecrosis? A Prospective, Randomized, Open-Label, Multicenter Study.

    Science.gov (United States)

    Lee, Young-Kyun; Ha, Yong-Chan; Cho, Yoon Je; Suh, Kuen Tak; Kim, Shin-Yoon; Won, Ye-Yeon; Min, Byung-Woo; Yoon, Taek Rim; Kim, Hee Joong; Koo, Kyung-Hoi

    2015-07-15

    Osteonecrosis of the femoral head frequently leads to collapse of the necrotic portion and subsequent degenerative joint disease of the hip, which is the most common diagnosis leading to total hip arthroplasty in young adults. Bisphosphonate therapy has been reported to potentially retard the collapse. We conducted a two-year prospective, randomized, open-label, multicenter study to determine whether zoledronate prevents the collapse and reduces the need for total hip arthroplasty. We randomly assigned patients who had Steinberg stage-I or II nontraumatic osteonecrosis of the femoral head with a necrotic area of ≥30% to either the zoledronate group or the control group. Patients in the zoledronate group received 5 mg of zoledronate intravenously per year for two years, while patients in the control group did not receive this medication. The primary efficacy outcome was the survival rate in terms of the occurrence of collapse (≥2 mm). The patients were observed for a minimum of two years after enrollment. A total of 110 patients (110 hips) underwent randomization; fifty-five patients were assigned to the zoledronate group and fifty-five, to the control group. During the two-year follow-up, twenty-nine femoral heads in the zoledronate group and twenty-two in the control group collapsed (p > 0.05). Nineteen hips in the zoledronate group and twenty in the control group underwent total hip arthroplasty (p > 0.05). Zoledronate for Steinberg stage-I or II osteonecrosis of the femoral head, with a medium to large necrotic area, did not prevent the collapse of the femoral head or reduce the need for total hip arthroplasty. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  2. Outpatient Latarjet surgery for gleno-humeral instability: Prospective comparative assessment of feasibility and safety.

    Science.gov (United States)

    Bohu, Y; Klouche, S; Gerometta, A; Herman, S; Lefevre, N

    2016-06-01

    Some surgical procedures are rarely done on an outpatient basis. The primary objective of this study was to assess the safety of outpatient surgical shoulder stabilisation using the Latarjet procedure. The Latarjet procedure is safe when performed on an outpatient basis provided the patients are managed according to a specifically designed programme starting at the decision to undergo surgery and ending at the end of the early postoperative period. Consecutive patients with unidirectional anterior shoulder instability managed in 2013-2014 by primary open, minimally invasive surgery involving coracoid process transfer as described by Latarjet was included prospectively. One of the surgeons routinely offered outpatient surgery to patients who met none of the usual exclusion criteria (age>60years, ASA 3-4, and long distance from home to hospital). Standardised protocols were applied for anaesthesia and analgesia. The primary evaluation criterion was failure of the admission modality, defined as inpatient admission of a patient after outpatient surgery either without prior discharge or within 1week after discharge. Secondary evaluation criteria were early postoperative symptoms and functional outcomes after at least 1year. All self-reported criteria were entered online by the patients. Of 46 included patients, 17 had outpatient surgery and 29 inpatient surgery. There were 41 males and 5 females, with a mean age of 25.3±6.4years. No significant baseline differences were found between the two groups. None of the outpatients required inpatient admission or readmission. No postoperative complications were recorded. After a mean follow-up of 18.5±5.2months, the two groups showed no significant differences for return to sports, apprehension, avoidance behaviours, or functional outcomes. Most patients were satisfied with their management and outcomes. No serious adverse events were recorded in this first French prospective evaluation of the safety of open, minimally

  3. Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

    Science.gov (United States)

    Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

    2015-12-01

    To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  4. A prospective, multi-site investigation of patient satisfaction and psychosocial status following cosmetic surgery.

    Science.gov (United States)

    Sarwer, David B; Gibbons, Lauren M; Magee, Leanne; Baker, James L; Casas, Laurie A; Glat, Paul M; Gold, Alan H; Jewell, Mark L; Larossa, Don; Nahai, Foad; Young, V Leroy

    2005-01-01

    Although several studies have investigated patient satisfaction and changes in body image following aesthetic plastic surgery, few have investigated more specific dimensions of body image, including dysphoric emotions that occur in specific social situations or body image quality of life. In addition, few studies have investigated changes in body image that may occur in concert with changes in more general areas of psychosocial functioning, such as depressive symptoms and self-esteem. This prospective, multi-site study investigated postoperative satisfaction and changes in psychosocial status following cosmetic surgery. One hundred patients recruited from 8 geographically diverse surgical practices completed psychometric measures of body image, depressive symptoms, and self-esteem prior to surgery. Seventy-two patients completed the 3-month postoperative assessment, 67 completed the 6-month assessment, and 63 completed the 12-month assessment. All statistical tests on changes after surgery were conducted using the sample of 72 patients who completed the 3-month assessment. A Last Observation Carried Forward analysis was used to account for patients who did not complete the subsequent follow-up assessments. In addition, they reported their postoperative satisfaction as well as self-rated attractiveness at the 3 postoperative assessment points. Eighty-seven percent of patients reported satisfaction with their postoperative outcomes. Patients also reported significant improvements in their overall appearance, as well as the appearance of the feature altered by surgery, at each of the postoperative assessment points. Patients experienced significant improvements in their overall body image, their degree of dissatisfaction with the feature altered by surgery, and the frequency of negative body image emotions in specific social situations. All of these improvements were maintained 12 months after surgery. These results add to a growing body of literature documenting

  5. Multisite prospective investigation of psychological outcomes following cataract surgery in Vietnam.

    Science.gov (United States)

    Berle, David; Steel, Zachary; Essue, Beverley M; Keay, Lisa; Jan, Stephen; Tan Phuc, Huynh; Hackett, Maree L

    2017-01-01

    Cataract surgery is a low-cost and effective intervention. There is increasing evidence to suggest that cataract surgery is associated with improvements in mobility, overall functioning and reductions in psychological distress. Within low-income and middle-income countries, cataract surgery has also been documented to lead to reductions in psychological distress; however, differences in economic activity and engagement in paid and domestic work in these countries may moderate such reductions. We aimed to examine the psychological outcomes following cataract surgery among a diverse Vietnamese sample. We report findings from the VISIONARY study, a 12-month multisite prospective study of cataract surgery outcomes conducted in Vietnam (N=462). Generalised estimating equations (GEEs) were used to identify the variables which were associated with reduced psychological distress. A high proportion of participants (56.6%) reported psychological distress before surgery and severity of psychological distress had decreased by 12 months following surgery (95% CI (4.13 to 4.95)). There were regional differences in the extent of improvement in psychological distress and change in paid and unpaid work. The extent of improvement in visual acuity, male gender, and increase in paid and unpaid work hours were significant predictors of reductions in psychological distress. Cataract surgery appears to result in the greatest reductions in psychological distress in communities where work engagement is highest. The VISIONARY study was funded by a grant provided by the Fred Hollows Foundation, Australia. During the course of this work, BME was in receipt of an Ian Potter Foundation Fellowship and a National Health and Medical Research Council (NHMRC) fellowship (1072148), SJ received an NHMRC Senior Research Fellowship, MLH was in receipt of a National Heart Foundation Future Leader Fellowship 100034.

  6. Pain control in laparoscopic gynecologic surgery with/without preoperative (preemptive) parecoxib sodium injection: a randomized study.

    Science.gov (United States)

    Ratchanon, Sarwinee; Phaloprakarn, Chadakarn; Traipak, Khanitta

    2011-10-01

    To determine the effectiveness of preoperative parecoxib sodium injection for pain relief after laparoscopic gynecologic surgery. A prospective double-blind, randomized study was conducted in 268 patients who underwent laparoscopic gynecologic surgery at Vajira Hospital between November 1, 2010 and March 31, 2011. The patients were randomly allocated into two groups to receive either single intravenous 40 mg parecoxib (treatment group; n = 133) or normal saline (control group; n = 135) 30 min before surgery. The degree of postoperative pain was assessed every 2 h in the first 8 h postoperation, then every 4 h until completion of 24 h by using a verbal rating scale. Total consumption of meperidine over a 24-h period and the adverse events relevant to parecoxib sodium were also recorded. Mean pain scores at all measured times in the treatment group were insignificantly lower than those in the control group (p = 0.106). The mean 24-h postoperative meperidine consumption in the treatment group was significantly lower compared to that in the control group (26.3 +/- 28.1 mg and 39.1 +/- 34.6 mg, respectively, p = 0.001). The proportion of patients requiring meperidine in the treatment group was significantly lower than that in the control group (58.6% and 70.3%, respectively, p = 0. 045). No serious adverse events were observed in both groups. Preoperative parecoxib sodium significantly reduced postoperative meperidine requirement and consumption, while insignificantly declined the pain scores. Serious adverse events were not encountered

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

    Science.gov (United States)

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

    2015-02-01

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

  8. The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study.

    Science.gov (United States)

    Yurtlu, S; Hanci, V; Kargi, E; Erdoğan, G; Köksal, B G; Gül, Ş; Okyay, R D; Ayoğlu, H; Turan, I Ö

    2011-01-01

    This prospective, randomized, placebo-controlled study evaluated the effects of dexketoprofen as an adjunct to lidocaine in intravenous regional anaesthesia (IVRA) or as a supplemental intravenous (i.v.) analgesic. Patients scheduled for elective hand or forearm soft-tissue surgery were randomly divided into three groups. All 45 patients received 0.5% lidocaine as IVRA. Dexketoprofen was given either i.v. or added into the IVRA solution and the control group received an equal volume of saline both i.v. and as part of the IVRA. The times of sensory and motor block onset, recovery time and postoperative analgesic consumption were recorded. Compared with controls, the addition of dexketoprofen to the IVRA solution resulted in more rapid onset of sensory and motor block, longer recovery time, decreased intra- and postoperative pain scores and decreased paracetamol use. It is concluded that coadministration of dexketoprofen with lidocaine in IVRA improves anaesthetic block and decreases postoperative analgesic requirements.

  9. Random forest predictive modeling of mineral prospectivity with small number of prospects and data with missing values in Abra (Philippines)

    Science.gov (United States)

    Carranza, Emmanuel John M.; Laborte, Alice G.

    2015-01-01

    Machine learning methods that have been used in data-driven predictive modeling of mineral prospectivity (e.g., artificial neural networks) invariably require large number of training prospect/locations and are unable to handle missing values in certain evidential data. The Random Forests (RF) algorithm, which is a machine learning method, has recently been applied to data-driven predictive mapping of mineral prospectivity, and so it is instructive to further study its efficacy in this particular field. This case study, carried out using data from Abra (Philippines), examines (a) if RF modeling can be used for data-driven modeling of mineral prospectivity in areas with a few (i.e., individual layers of evidential data. Furthermore, RF modeling can handle missing values in evidential data through an RF-based imputation technique whereas in WofE modeling values are simply represented by zero weights. Therefore, the RF algorithm is potentially more useful than existing methods that are currently used for data-driven predictive mapping of mineral prospectivity. In particular, it is not a purely black-box method like artificial neural networks in the context of data-driven predictive modeling of mineral prospectivity. However, further testing of the method in other areas with a few mineral occurrences is needed to fully investigate its usefulness in data-driven predictive modeling of mineral prospectivity.

  10. A prospective cohort study comparing early opioid requirement between Chinese from Hong Kong and Caucasian Australians after major abdominal surgery

    DEFF Research Database (Denmark)

    Konstantatos, A H; Imberger, G; Angliss, M

    2012-01-01

    The relationship between ethnicity and early opioid consumption is not well understood. Our prospective cohort study tested whether Chinese patients in Hong Kong require less opioid after major abdominal surgery compared with Caucasian patients in Australia.......The relationship between ethnicity and early opioid consumption is not well understood. Our prospective cohort study tested whether Chinese patients in Hong Kong require less opioid after major abdominal surgery compared with Caucasian patients in Australia....

  11. Do we at all need surgery to treat thrombosed external hemorrhoids? Results of a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Ole Gebbensleben

    2009-06-01

    Full Text Available Ole Gebbensleben1, York Hilger2, Henning Rohde31Park-Klinik Berlin-Weissensee, Berlin, Germany; 2Institut für Biostatistik, Freiburg im Breisgau, Germany; 3Praxis für Endoskopie und Proktologie, Berlin, GermanyBackground: It is unknown whether surgery is the gold standard for therapy of thrombosed external hemorrhoids (TEH.Methods: A prospective cohort study of 72 adults with TEH was conducted: no surgery, no sitz baths but gentle dry cleaning with smooth toilet paper after defecation. Follow-up information was collected six months after admission by questionnaire.Results: Despite our strict conservative management policy 62.5% (45/72 of patients (95% confidence interval [CI]: 51.0–74.0 described themselves as “healed” or “ameliorated”, and 61.1% (44/72, 95% CI: 49.6–72.6 found our management policy as “valuable to test” or “impracticable”. 13.9% (10/72, 95% CI: 5.7–22.1 of patients suspected to have recurrences. 4.2% did not know. Twenty-two of the 48 responding patients reported symptoms such as itching (18.8%, soiling (12.5%, pricking (10.4%, or a sore bottom (8.3% once a month (59.1%, 13/22, once a week (27.3%, 6/22, or every day (13.6%, 3/22. Conclusions: The dictum that surgery is the gold standard for therapy for TEH should be checked by randomized controlled trials.Keywords: hemorrhoids, acute hemorrhoidal disease, thrombosed external hemorrhoid, perianal thrombosis, conservative therapy, surgery

  12. Prospective, randomized comparative study between single-port laparoscopic appendectomy and conventional laparoscopic appendectomy.

    Science.gov (United States)

    Villalobos Mori, Rafael; Escoll Rufino, Jordi; Herrerías González, Fernando; Mias Carballal, M Carmen; Escartin Arias, Alfredo; Olsina Kissler, Jorge Juan

    2014-01-01

    Laparoscopic appendectomy is probably the technique of choice in acute appendicitis. Single port laparoscopic surgery (SILS) has been proposed as an alternative technique. The objective of this study is to compare the safety and efficacy of SILS against conventional laparoscopic appendectomy (LA). From January 2011 to September 2012, 120 patients with acute appendicitis were prospectively randomized; 60 for SILS and 60 for LA. Patients between 15 to 65 years were selected, with onset of symptoms less than 48h. We compared BMI, surgery time, start of oral intake, hospital stay, postoperative pain, pathology and costs. The median age, BMI, sex and time of onset of symptoms to diagnosis were similar. There were no statistically significant differences in the operative time, start of oral intake or hospital stay. There was a significant difference in postoperative pain being higher in SILS (4±1.3) than in LA (3.3±0.5) with a P=.004. Flemonous appendicitis predominated in both groups in a similar percentage. A total of 3 cases with intra-abdominal abscess (SILS 2, LA 1) required readmission and resolved spontaneously with intravenous antibiotic treatment. One case of SILS required assistance by a 5mm trocar in the RLC for drainage placement. The cost was higher in SILS due the single port device. SILS appendectomy is safe, effective and has similar results to LA in selected patients, and although the cost is greater, the long term results will determine the future of this technique. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  13. 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.

  14. 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.

  15. Prospective audit of ptosis surgery at the Singapore National Eye Centre: two-year results.

    Science.gov (United States)

    Young, Stephanie M; Lim, Lee-Hooi; Seah, Lay-Leng; Choo, Chai-Teck; Chee, Elaine W L; Shen, Sunny Y; Lang, Stephanie S; Looi, Audrey L G

    2013-01-01

    To evaluate the demographics, presentation, and surgical outcomes of patients undergoing ptosis surgery in an Asian population in a prospective manner. A prospective ptosis audit was conducted over a 2-year period from January 2010 to December 2011 in a tertiary eye hospital in Singapore. All patients undergoing ptosis surgery by, or under the supervision of, an oculoplastic-trained consultant in the institution were included. Institutional Review Board approval was obtained for the study. This study comprises 302 patients, of which 236 were acquired and 66 were congenital ptosis cases. Levator repair (77.2%) was the most commonly performed procedure, followed by levator resection (13.9%) and brow suspension (8.9%). Forty-seven (10.1%) eyes had readjustment within 2 weeks, the reasons for readjustment being eyelid height undercorrection (n = 35), eyelid height overcorrection (n = 9), and unsatisfactory eyelid contour (n = 4). Postoperatively, 93.8% of patients showed an increase in marginal reflex distance-1 (MRD1), 91.3% achieved symmetry or MRD1, 98.5% had good eyelid contour, and 74.3% had symmetric eyelid crease. On a scale of 1 to 10, 83.1% of patients gave a subjective grade of 7 or better. This study is the first prospective ptosis surgery audit in an Asian population and takes a leading step in assessing both subjective and objective surgical outcomes in a prospective manner. With the continuation of this audit in years to come, it will allow us to generate clinical outcomes in a robust manner and allow for more reliable benchmarking with major centers elsewhere.

  16. Prevalence of acute neuropathic pain after cancer surgery: A prospective study

    Directory of Open Access Journals (Sweden)

    P N Jain

    2014-01-01

    Full Text Available Background and Aims: Acute neuropathic pain (ANP is an under-recognised and under-diagnosed condition and often difficult to treat. If left untreated, it may further transform into persistent post-operative chronic pain leading to a disability. Aims: This prospective study was undertaken on 300 patients to identify the prevalence of ANP in the post-operative period by using a neuropathic pain detection questionnaire tool. Methods: This is an open-label study in which patients with six different types of cancer surgeries (Thoracic, gastro-intestinal, gynae/urology, bone/soft-tissue, head and neck and breast subgroups-50 each were included for painDETECT questionnaire tool on the 2 nd and 7 th day surgery. Results: This study found a 10% point prevalence of ANP. Analysis showed that 25 patients had ′possible′ ANP, the maximum from urological cancer surgery (6 followed by thoracic surgery (5. Five patients were found to have ′positive′ ANP including 2 groin node dissection, 2 hemipelvectomy and 1 oesophagectomy. Conclusion: Significant relationship between severity of post-operative pain was found with the occurrence of ANP in the post-operative period requiring a special attention to neuropathic pain assessment. Larger studies are required with longer follow-up to identify accurately the true prevalence and causative factors of ANP after surgery.

  17. 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

  18. [Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej

    2014-01-01

    Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

  19. [Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

    Science.gov (United States)

    Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

    2016-02-01

    Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. A prospective randomized trial of transnasal ileus tube vs nasogastric tube for adhesive small bowel obstruction

    Science.gov (United States)

    Chen, Xiao-Li; Ji, Feng; Lin, Qi; Chen, Yi-Peng; Lin, Jian-Jiang; Ye, Feng; Yu, Ji-Ren; Wu, Yi-Jun

    2012-01-01

    AIM: To study the therapeutic efficacy of a new transnasal ileus tube advanced endoscopically for adhesive small bowel obstruction. METHODS: A total of 186 patients with adhesive small bowel obstruction treated from September 2007 to February 2011 were enrolled into this prospective randomized controlled study. The endoscopically advanced new ileus tube was used for gastrointestinal decompression in 96 patients and ordinary nasogastric tube (NGT) was used in 90 patients. The therapeutic efficacy was compared between the two groups. RESULTS: Compared with the NGT group, the ileus tube group experienced significantly shorter time for relief of clinical symptoms and improvement in the findings of abdominal radiograph (4.1 ± 2.3 d vs 8.5 ± 5.0 d) and laboratory tests (P tube group and 46.7% in the NGT group (P tube group and 53.3% of the NGT group underwent surgery. For recurrent adhesive bowel obstruction, ileus tube was also significantly more effective than NGT (95.8% vs 31.6%). In the ileus tube group, the drainage output on the first day and the length of hospital stay were significantly different depending on the treatment success or failure (P tube can be used for adhesive small bowel obstruction. Endoscopic placement of the ileus tube is convenient and worthy to be promoted despite the potential risks. PMID:22563179

  1. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Kowey, Peter R; Dorian, Paul; Mitchell, L Brent

    2009-01-01

    BACKGROUND: Postoperative atrial arrhythmias are common and are associated with considerable morbidity. This study was designed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation (AF) or atrial flutter (AFL) after cardiac surgery. METHODS AND RESULTS...... and complete atrioventricular block). There were no cases of torsades de pointes, sustained ventricular tachycardia, or ventricular fibrillation. There were no deaths. CONCLUSIONS: Vernakalant was safe and effective in the rapid conversion of AF to sinus rhythm in patients who had AF after cardiac surgery......: This was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both. Patients were randomly assigned 2:1 to receive a 10-minute infusion of 3 mg/kg vernakalant or placebo. If AF or AFL was present after...

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

    African Journals Online (AJOL)

    complete wound healing is achieved and contamination from the ... mean age of 24.7 ± 4.9 years (range 19‑33 years) for Group A ... clean wounds.[16]. The use of single suture and sutureless techniques to achieve secondary closure following third molar surgery have been reported.[10,17] These emerging techniques ...

  3. Is LMWH Sufficient for Anticoagulant Prophylaxis in Bariatric Surgery? Prospective Study.

    Science.gov (United States)

    Moaad, Farraj; Zakhar, Bramnik; Anton, Kvasha; Moner, Merie; Wisam, Sbeit; Safy, Farraj; Igor, Waksman

    2017-09-01

    The objective of this study was to evaluate the coagulation profile by thromboelastography in morbidly obese patients who undergo bariatric surgery. Morbid obesity entails increased risk for thromboembolic events. There is no clear protocol for thromboembolic prophylaxis, regarding timing and length of treatment, in bariatric surgery. Thromboelastography provides data on a coagulation process from creation of the clot until the fibrinolysis. Ninety-three morbidly obese patients were prospectively recruited within a 2-year period. Coagulation profile was measured by thromboelastography before surgery, in the immediate postoperative period, within 3 h from surgery, and in the late postoperative period, within 10-14 days after surgery. Venous thromboembolic prophylaxis was achieved by giving low molecular weight heparin (LMWH), once a day. Of the eligible patients, 67 underwent sleeve gastrectomy while 23 underwent Roux-en-Y gastric bypass. Normal values of coagulation factor function, clotting time, and fibrin function, as measured by R, K, and α (angle), were demonstrated in addition to higher maximal amplitude (MA) values, reflecting increased function of platelets. The average MA value before the surgery was above normal and continued rising consistently in the immediate postoperative as well as in the early postoperative period. Morbidly obese patients have a strong tendency toward thrombosis, as demonstrated by pathologically elevated MA values. Altered coagulation profiles were demonstrated 2 weeks postoperatively; thus, prophylaxis that continued at least for 2 weeks after bariatric surgery should be considered. Since LMW heparin is not sufficient alone as thromboembolic prophylaxis, we recommend adding antiplatelet therapy. Further evaluation of appropriate thromboprophylaxis is warranted.

  4. 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

  5. Day case shoulder surgery: satisfactory pain control without regional anaesthesia. A prospective analysis of a perioperative protocol.

    LENUS (Irish Health Repository)

    Daruwalla, Z J

    2009-03-01

    Pain control is an issue which may limit patients\\' acceptance of day case shoulder surgery. This study prospectively examined the outcome of a protocol for day case shoulder surgery to determine if satisfactory pain relief could be achieved without regional anaesthesia.

  6. The efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery. A double blind randomized multicentre trail with venographic assesment

    DEFF Research Database (Denmark)

    Bergkvist, A; Eldor, A; Thorlacius-Ussing, O.

    1997-01-01

    three times daily. METHODS: Patients included were over 40 years of age and undergoing planned elective curative abdominal or pelvic surgery for cancer. The study was designed as a prospective double-blind randomized multicentre trial with participating departments from ten countries. Primary outcome...... severe thrombocytopenia. There were no differences in mortality at either 30 days or 3 months. CONCLUSION: Enoxaparin, 40 mg once daily, is as safe and effective as unfractionated heparin three times daily in preventing venous thromboembolism in patients undergoing major elective surgery for abdominal......BACKGROUND: Surgery for malignant disease carries a high risk of deep vein thrombosis. The aim of this study was to evaluate the prophylactic effect of a low molecular weight heparin, enoxaparin, 40 mg once daily, beginning 2 h before surgery, compared with that of unfractionated low-dose heparin...

  7. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial.

    Science.gov (United States)

    Steingrimsson, S; Thimour-Bergström, L; Roman-Emanuel, C; Scherstén, H; Friberg, Ö; Gudbjartsson, T; Jeppsson, A

    2015-12-01

    Surgical site infection is a common complication following cardiac surgery. Triclosan-coated sutures have been shown to reduce the rate of infections in various surgical wounds, including wounds after vein harvesting in coronary artery bypass grafting patients. Our purpose was to compare the rate of infections in sternotomy wounds closed with triclosan-coated or conventional sutures. A total of 357 patients that underwent coronary artery bypass grafting were included in a prospective randomized double-blind single-center study. The patients were randomized to closure of the sternal wound with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Inc., Somerville, NJ, USA) (n = 179) or identical sutures without triclosan (n = 178). Patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). The primary endpoint was the prevalence of sternal wound infection according to the Centers for Disease Control and Prevention (CDC) criteria. The demographics in both groups were comparable, including age, gender, body mass index, and rate of diabetes and smoking. Sternal wound infection was diagnosed in 43 patients; 23 (12.8%) sutured with triclosan-coated sutures compared to 20 (11.2%) sutured without triclosan (p = 0.640). Most infections were superficial (n = 36, 10.1%), while 7 (2.0%) were deep sternal wound infections. There were 16 positive cultures in the triclosan group and 17 in the non-coated suture group (p = 0.842). The most commonly identified main pathogens were Staphylococcus aureus (45.4%) and coagulase-negative staphylococci (36.4%). Skin closure with triclosan-coated sutures did not reduce the rate of sternal wound infection after coronary artery bypass grafting. (clinicaltrials.gov: NCT01212315).

  8. Anesthesia management with ultrasound-guided thoracic paravertebral block for donor nephrectomy: A prospective randomized study.

    Science.gov (United States)

    Yenidünya, Ozlem; Bircan, Huseyin Yuce; Altun, Dilek; Caymaz, Ismail; Demirag, Alp; Turkoz, Ayda

    2017-02-01

    To determine the efficacy of ultrasound-guided thoracic paravertebral block intraoperatively and 24 hours postoperatively in patients undergoing donor nephrectomy. Prospective randomized controlled study. Private foundation university hospital; November 2014 to June 2015. Thirty-two patients undergoing donor nephrectomy (exclusion criteria: coagulation disorders, allergy to local anesthetics, and unwillingness to participate). The final study population comprised 30 patients (15 male, 15 female) randomly assigned to either Group P (paravertebral block, n=14) or Group M (morphine, n=16). In Group P, a unilateral paravertebral catheter was inserted 1 day preoperatively; on the day of surgery, a single-level unilateral paravertebral block was administered through the catheter before general anesthesia. Infusion of bupivacaine continued intraoperatively and postoperatively. Patients in Group M received only general anesthesia, and morphine patient-controlled analgesia was begun postoperatively. Intraoperative analgesic and anesthetic requirement, postoperative numerical rating scale pain scores, additional analgesic consumption during the postoperative period, and incidence of complications related to thoracic paravertebral block (TPVB) like pleural puncture, pneumothorax, epidural spread, injection into the subarachnoid space, intravascular injection, and Horner's syndrome and rate of opioid related adverse reactions like nausea and vomiting, itching, constipation, and respiratory depression. Intraoperative remifentanil consumption was significantly higher in Group M, and postoperative morphine consumption was significantly lower in Group P (P<.001). During the first 24 hours postoperatively, the mean numerical rating scale pain scores were similar and there were no significant differences between the 2 groups. There were no statistically significant differences in the additional analgesic consumption and rate of adverse reactions between the 2 groups. We didn

  9. Randomized, Prospective Comparison of Bioabsorbable and Steel Screw Fixation of Lisfranc Injuries.

    Science.gov (United States)

    Ahmad, Jamal; Jones, Kennis

    2016-12-01

    This study's objective is to compare outcomes of bioabsorbable versus steel screws for treating Lisfranc injuries. This research was conducted in a prospective and randomized manner between September 2008 and December 2013. This study was performed in the outpatient setting at a tertiary-level care center in a single surgeon's practice. Forty patients with acute Lisfranc injuries, amenable to open reduction and screw fixation, enrolled and presented for final follow-up. Through randomization, 20 and 20 patients received bioabsorbable versus steel screws, respectively. Function and pain were graded using the Foot and Ankle Ability Measures (FAAM) and a visual analog scale of pain. Radiographs were assessed for joint stability and degeneration. For those with steel screws, the mean FAAM score increased from 24.9 to 89.6 of 100 and pain score decreased from 6.5 to 1.9 of 10 by latest follow-up. For those with absorbable screws, the mean FAAM score increased from 32.5 to 91.2 and pain score decreased from 4.7 to 1.3 by latest follow-up. These differences in final mean function (P = 0.4) and pain (P = 0.25) between the study groups were not statistically significant. Final radiographs showed no Lisfranc instability in any study patients, but rather midfoot arthritis in 4 and 2 patients with steel versus bioabsorbable screws, respectively. None of the patients who received steel screws had hardware-related problems, but 1 patient who received absorbable fixation developed an inflammatory reaction at a nonresorbed screw head at 2 years after surgery. Bioabsorbable screws provide short-term results that are comparable and not significantly different from steel screws for treating unstable Lisfranc injuries. Both methods are predictable in improving function and pain, but using absorbable screws eliminates the need for hardware removal after such trauma. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  10. Does preoperative orientation and education alleviate anxiety in posterior spinal fusion patients? A prospective, randomized study.

    Science.gov (United States)

    Rhodes, Leslie; Nash, Cassie; Moisan, Alice; Scott, Donna C; Barkoh, Kaku; Warner, William C; Sawyer, Jeffrey R; Kelly, Derek M

    2015-01-01

    A prospective, randomized study examined the effect of interventional preoperative education and orientation for scoliosis surgery (PEOSS) on anxiety levels of patients undergoing posterior spinal fusion (PSF). Secondary outcomes analyzed were caregiver anxiety, length of stay, morphine equivalent usage, and patient/caregiver satisfaction. Patients undergoing PSF were randomly distributed into a control group (N=39) or interventional group (N=26). All subjects and caregivers completed the State (current)-Trait (typical) Anxiety Inventory (STAI) at different intervals: preoperative appointment, preoperative holding area, postoperative orthopaedic unit, and discharge. At discharge, patients and caregivers completed a satisfaction survey. Significantly higher state anxiety scores were found compared with baseline at all time intervals in both the control group and PEOSS group. The PEOSS group had higher state anxiety scores than the control group at the postoperative interval (P=0.024). There were no significant differences in the caregiver state anxiety scores between the groups at any time interval. Trait anxiety scores for both groups remained stable over time, establishing that the measurement tool accurately reflected baseline anxiety. No significant differences were found in length of stay or morphine equivalent use. Patient satisfaction scores were higher in the PEOSS group than in the control group (P=0.0005). PSF was associated with increased anxiety at all time intervals in adolescents in both groups. In the PEOSS group, PSF was associated with increased anxiety in the immediate postoperative period. Despite the increase in anxiety, patient satisfaction was higher in the intervention group. It is likely that patients need age-appropriate information and educational strategies to minimize anxiety during PSF. Further work is underway to study and develop more effective interventional strategies. Level I study.

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

    Science.gov (United States)

    2014-01-01

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

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

    Science.gov (United States)

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

    2009-06-01

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

  13. Predictors of red blood cell transfusion after cardiac surgery: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Camila Takao Lopes

    2015-12-01

    Full Text Available Abstract OBJECTIVE To identify predictors of red blood cell transfusion (RBCT after cardiac surgery. METHOD A prospective cohort study performed with 323 adults after cardiac surgery, from April to December of 2013. A data collection instrument was constructed by the researchers containing factors associated with excessive bleeding after cardiac surgery, as found in the literature, for investigation in the immediate postoperative period. The relationship between risk factors and the outcome was assessed by univariate analysis and logistic regression. RESULTS The factors associated with RBCT in the immediate postoperative period included lower height and weight, decreased platelet count, lower hemoglobin level, higher prevalence of platelet count <150x10 3/mm3, lower volume of protamine, longer duration of anesthesia, higher prevalence of intraoperative RBCT, lower body temperature, higher heart rate and higher positive end-expiratory pressure. The independent predictor was weight <66.5Kg. CONCLUSION Factors associated with RBCT in the immediate postoperative period of cardiac surgery were found. The independent predictor was weight.

  14. Hemostatic function to regulate perioperative bleeding in patients undergoing spinal surgery: A prospective observational study.

    Directory of Open Access Journals (Sweden)

    Atsushi Kimura

    Full Text Available Although bleeding is a common complication of surgery, routine laboratory tests have been demonstrated to have a low ability to predict perioperative bleeding. Better understanding of hemostatic function during surgery would lead to identification of high-risk patients for bleeding. Here, we aimed to elucidate hemostatic mechanisms to determine perioperative bleeding. We prospectively enrolled 104 patients undergoing cervical spinal surgery without bleeding diathesis. Blood sampling was performed just before the operation. Volumes of perioperative blood loss were compared with the results of detailed laboratory tests assessing primary hemostasis, secondary hemostasis, and fibrinolysis. Platelet aggregations induced by several agonists correlated with each other, and only two latent factors determined inter-individual difference. Platelet aggregability independently determined perioperative bleeding. We also identified low levels of plasminogen-activator inhibitor-1 (PAI-1 and α2-plasmin inhibitor to be independent risk factors for intraoperative and postoperative bleeding, respectively. Most important independent factor to determine postoperative bleeding was body weight. Of note, obese patients with low levels of PAI-1 became high-risk patients for bleeding during surgery. Our data suggest that bleeding after surgical procedure may be influenced by inter-individual differences of hemostatic function including platelet function and fibrinolysis, even in the patients without bleeding diathesis.

  15. Prospective evaluation of dermatologic surgery complications including patients on multiple antiplatelet and anticoagulant medications.

    Science.gov (United States)

    Bordeaux, Jeremy S; Martires, Kathryn J; Goldberg, Dori; Pattee, Sean F; Fu, Pingfu; Maloney, Mary E

    2011-09-01

    Few prospective studies have evaluated the safety of dermatologic surgery. We sought to determine rates of bleeding, infection, flap and graft necrosis, and dehiscence in outpatient dermatologic surgery, and to examine their relationship to type of repair, anatomic location of repair, antibiotic use, antiplatelet use, or anticoagulant use. Patients presenting to University of Massachusetts Medical School Dermatology Clinic for surgery during a 15-month period were prospectively entered. Medications, procedures, and complications were recorded. Of the 1911 patients, 38% were on one anticoagulant or antiplatelet medication, and 8.0% were on two or more. Risk of hemorrhage was 0.89%. Complex repair (odds ratio [OR] = 5.80), graft repair (OR = 7.58), flap repair (OR = 11.93), and partial repair (OR = 43.13) were more likely to result in bleeding than intermediate repair. Patients on both clopidogrel and warfarin were 40 times more likely to have bleeding complications than all others (P = .03). Risk of infection was 1.3%, but was greater than 3% on the genitalia, scalp, back, and leg. Partial flap necrosis occurred in 1.7% of flaps, and partial graft necrosis occurred in 8.6% of grafts. Partial graft necrosis occurred in 20% of grafts on the scalp and 10% of grafts on the nose. All complications resolved without sequelae. The study was limited to one academic dermatology practice. The rate of complications in dermatologic surgery is low, even when multiple oral anticoagulant and antiplatelet medications are continued, and prophylactic antibiotics are not used. Closure type and use of warfarin or clopidogrel increase bleeding risk. However, these medications should be continued to avoid adverse thrombotic events. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  16. 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.

  17. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  18. Analysis of bedside entertainment services' effect on post cardiac surgery physical activity: a prospective, randomised clinical trial.

    Science.gov (United States)

    Papaspyros, Sotiris; Uppal, Shitansu; Khan, Shakeeb A; Paul, Sanjoy; O'Regan, David J

    2008-11-01

    A rising number of acute hospitals in the UK have been providing patients with bedside entertainment services (BES) since 1995. However, their effect on postoperative patient mobility has not been explored. The aim of this prospective randomised clinical trial was to compare the level of postoperative physical activity and length of in-hospital stay of patients undergoing cardiac surgery depending on whether they had access to BES or not. One hundred patients requiring elective cardiac surgery were randomised to receive access to BES (52 patients) or not (48 patients). Pedometers were used to quantify postoperative physical activity for 5 days. To assess the significance of the effect of intervention (TV off or on) on the pedometer counts over time a mixed effect Poisson regression model is used, with the time varying aspect as random component. The potential influence of gender difference and age on pedometer counts were assessed by incorporating these two factors as covariates in the Poisson model. On average, patients with no access to BES walked more than those with BES access. This difference ranged between 192 and 609 steps in favour of the first group for each individual postoperative day. Patients with no access to BES were 84% more likely (risk ratio: 1.84, 95% CI: 1.29-2.63) to walk higher number of steps than patients with access to BES. On average, participants with access to BES were likely to stay longer in hospital (median of 7 days with interquartile range 6-7 days), than participants with no access to BES (median of 6 days with interquartile range 5-7 days), however the difference did not reach statistical significance. We have demonstrated that the bedside entertainment systems may have an adverse effect on post cardiac surgery patient ambulation and may contribute to an increase in hospital stay.

  19. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion.

    Science.gov (United States)

    Foley, Kevin T; Mroz, Thomas E; Arnold, Paul M; Chandler, Howard C; Dixon, Robert A; Girasole, Gerard J; Renkens, Kenneth L; Riew, K Daniel; Sasso, Rick C; Smith, Richard C; Tung, Howard; Wecht, Daniel A; Whiting, Donald M

    2008-01-01

    Multilevel fusions, the use of allograft bone, and smoking have been associated with an increased risk of nonunion after anterior cervical discectomy and fusion (ACDF) procedures. Pulsed electromagnetic field (PEMF) stimulation has been shown to increase arthrodesis rates after lumbar spine fusion surgery, but there are minimal data concerning the effect of PEMF stimulation on cervical spine fusion. To determine the efficacy and safety of PEMF stimulation as an adjunct to arthrodesis after ACDF in patients with potential risk factors for nonunion. A randomized, controlled, prospective multicenter clinical trial. Three hundred and twenty-three patients with radiographic evidence (computed tomography-myelogram [CT-myelo] or magnetic resonance imaging [MRI]) of a compressed cervical nerve root and symptomatic radiculopathy appropriate to the compressed root that had failed to respond to nonoperative management were enrolled in the study. The patients were either smokers (more than one pack per day) and/or were undergoing multilevel fusions. All patients underwent ACDF using the Smith-Robinson technique. Allograft bone and an anterior cervical plate were used in all cases. Measurements were obtained preoperatively and at each postoperative interval and included neurologic assessment, visual analog scale (VAS) scores for shoulder/arm pain at rest and with activity, SF-12 scores, the neck disability index (NDI), and radiographs (anteroposterior, lateral, and flexion-extension views). Two orthopedic surgeons not otherwise affiliated with the study and blinded to treatment group evaluated the radiographs, as did a blinded radiologist. Adverse events were reported by all patients throughout the study to determine device safety. Patients were randomly assigned to one of two groups: those receiving PEMF stimulation after surgery (PEMF group, 163 patients) and those not receiving PEMF stimulation (control group, 160 patients). Postoperative care was otherwise identical. Follow

  20. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma.

    LENUS (Irish Health Repository)

    Walsh, T N

    1996-08-15

    Uncontrolled studies suggest that a combination of chemotherapy and radiotherapy improves the survival of patients with esophageal adenocarcinoma. We conducted a prospective, randomized trial comparing surgery alone with combined chemotherapy, radiotherapy, and surgery.

  1. Lifestyle after bariatric surgery: a multicenter, prospective cohort study in pregnant women.

    Science.gov (United States)

    Guelinckx, I; Devlieger, R; Donceel, P; Bel, S; Pauwels, S; Bogaerts, A; Thijs, I; Schurmans, K; Deschilder, P; Vansant, G

    2012-09-01

    To ensure a good pregnancy outcome after bariatric surgery, a healthy life-style and a multidisciplinary prenatal follow-up is recommended. The aim of this prospective multicenter trial was to compare diet quality and physical activity (PA) of pregnant women with bariatric surgery with current lifestyle recommendations. Pregnant women (>18 years, prepregnancy BMI 28 ± 6 kg/m², 39 % nulliparae, 25 % smokers) with a history of bariatric surgery were recruited and allocated to two groups according to surgery type: restrictive (N = 18) and bypass group (N = 31). One 7-day dietary record and one Kaiser questionnaire on PA were collected during the first and second trimester. Dietary quality was assessed using the Healthy Eating Index. The diet quality did not change during pregnancy (restrictive group p = 0.050; bypass group p = 0.975) and was comparable between groups (first trimester p = 0.426; second trimester p = 0.937). During the first trimester, 15 % of the pregnant women had a healthy diet quality, 82 % had a diet that needed improvement, and 3 % had a poor diet quality. This was independent of surgery type and was comparable in the second trimester (p = 0.525). No difference between groups was observed for the PA level, but the PA level in the bypass group significantly decreased from the first to the second trimester (p = 0.033). Nutritional advice and lifestyle coaching in this high-risk population seems recommendable since only 15 % of the pregnant women had a healthy diet quality, 25 % was smoking at the beginning of pregnancy, and the reported PA levels were low.

  2. Nosocomial infection and related risk factors in a general surgery service: a prospective study.

    Science.gov (United States)

    Vazquez-Aragon, P; Lizan-Garcia, M; Cascales-Sanchez, P; Villar-Canovas, M T; Garcia-Olmo, D

    2003-01-01

    The aim of this study was to quantify the frequency of nosocomial infection in the general surgery service of a tertiary-care hospital and to identify associated risk factors. A prospective, longitudinal, descriptive and analytical study was made from January 1995 to December 1998 of a clinical cohort of 2794 patients who underwent a surgical procedure with a post-surgery stay of more than 48 h. The criteria for infection were those defined by the Center for Disease Control and Prevention (CDC) of the USA. The most frequent nosocomial infection was surgical infection (SI), with a global cumulative incidence (CI) of 7.7%, ranging from 3.4% for clean surgery to 23.7% for dirty surgery. The next most frequent were urinary tract infection (UTI) and bacteremia (1.5%) and nosocomial pneumonia (NP) (0.5%). The global CI of SI decreased from 11.7% in 1995 to 4% in 1998. An ASA classification higher than 2 multiplied the risk of SI by 1.76; with respect to UTI multiplied the risk by 2.13; the risk of NP by 5.93 and multiplied the risk of B by 4.72. The most frequent nosocomial infection was surgical infection. An ASA higher than 2, the stay prior to surgery; the number of days with a urinary catheter, with a central venous catheter and with mechanical ventilation; as well as the improvement in the use of antimicrobial prophylaxis, were all factors that influenced the frequency of nosocomial infection.

  3. [Laparoscopic versus conventional appendectomy: a prospective randomized study].

    Science.gov (United States)

    Henle, K P; Beller, S; Rechner, J; Zerz, A; Szinicz, G; Klingler, A

    1996-05-01

    The discussion about laparoscopic appendectomy has increased since the introduction of this method. Randomized comparisons are still feasible, whereas this cannot be stated for other laparoscopic procedures (e.g., laparoscopic cholecystectomy). This randomized controlled trial included 170 patients. Open appendectomy was employed in 83 patients, and 87 were treated laparoscopically. The treatment groups were comparable regarding age, sex, Broca index, ASA classification, preliminary operations, and preoperative leucocytes. No statistically significant differences could be found with respect to surgical and general complications, operating time, consumption of analgesics and antibiotics, and return to work. The analysis revealed a statistically significant shorter hospital stay, a shorter time until return to normal physical activity, and a shorter duration of complaints for the laparoscopic group. We were unable to demonstrate any statistically significant advantage in using the open procedure.

  4. 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

  5. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    Science.gov (United States)

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  6. Continuous postoperative blood glucose monitoring and control by artificial pancreas in patients having pancreatic resection: a prospective randomized clinical trial.

    Science.gov (United States)

    Okabayashi, Takehiro; Nishimori, Isao; Yamashita, Koichi; Sugimoto, Takeki; Maeda, Hiromichi; Yatabe, Tomoaki; Kohsaki, Takuhiro; Kobayashi, Michiya; Hanazaki, Kazuhiro

    2009-10-01

    To evaluate a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection. Prospective, randomized clinical trial. Thirty patients who had pancreatic resection for pancreatic neoplasm. Patients were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method (sliding scale group, n = 13) or the artificial pancreas (artificial pancreas group, n = 17). Incidence of severe hypoglycemia (artificial pancreas. The secondary outcome measure was the total amount of insulin required for glycemic control in the first 18 hours after pancreatic resection in each patient group. In the sliding scale group, postoperative blood glucose levels rose initially before reaching a plateau of approximately 200 mg/dL between 4 and 6 hours after pancreatectomy. The levels remained high for 18 hours postoperatively. In the artificial pancreas group, blood glucose levels reduced steadily, reaching the target zone (80-110 mg/dL) by 6 hours after surgery. The total insulin dose administered per patient during the first postoperative 18 hours was significantly higher in the artificial pancreas group (mean [SD], 107 [109] IU) than the sliding scale group (8 [6] IU; P artificial endocrine pancreas to control pancreatogenic diabetes after pancreatic resection is an easy and effective way to maintain near-normal blood glucose levels. The artificial pancreas shows promise for use as insulin treatment for patients with pancreatogenic diabetes after pancreatic resection.

  7. Facial nerve injury following surgery for temporomandibular joint ankylosis: A prospective clinical study

    Directory of Open Access Journals (Sweden)

    S Gokkulakrishnan

    2013-01-01

    Full Text Available Objective: The purpose of this prospective study was to evaluate the incidence and degree of facial nerve damage and time taken for its recovery following surgery for temporomandibular joint (TMJ ankylosis. Materials and Methods: A total of 30 subjects with the TMJ ankylosis with or without history of previous surgery were included in this prospective study. House-Brackmann grading system was used to assess the function of the facial nerve post-operatively. Results: Most of the subjects were in the age range of 13-15 years. Eight subjects had bilateral ankylosis and remaining 22 had unilateral ankylosis. Out of 32 joints in which gap arthroplasty was performed, 4 had Grade 1 injury, 14 had Grade 2 injury, 12 had Grade 3, and 2 with the Grade 4 injury 24 h post-operatively. Whereas, out of 6 cases of interpositional arthroplasty 4 had Grade 1 injury and 2 had Grade 4 injury. According to House-Brackmann grading system, at 24 h, 78.9% patients had different grades of facial nerve injury, which gradually improved and came to normal limits within 1-3 months post-operatively. Comparison of change in the Grade of injury at 3 months follow-up as compared to baseline (24 h showed full recovery in all the cases (100% showing a statistically significant difference from baseline (P < 0.001. Conclusion: When proper care is taken during surgery for TMJ ankylosis, permanent facial nerve injury is rare. However, the incidence and degree of temporary nerve injury could be either due to the heavy retraction causing compression and or stretching of nerve fiber resulting in neuropraxia.

  8. Revisiting acute normovolemic hemodilution and blood transfusion during pediatric cardiac surgery: a prospective observational study.

    Science.gov (United States)

    Sebastian, Roby; Ratliff, Todd; Winch, Peter D; Tumin, Dmitry; Gomez, Daniel; Tobias, Joseph; Galantowicz, Mark; Naguib, Aymen N

    2017-01-01

    The majority of allogeneic transfusions occur in the perioperative setting, especially during cardiac surgery. In addition to the economic implications, there is emerging evidence that blood transfusion may increase both morbidity and mortality. Acute normovolemic hemodilution (ANH) may limit the need for blood products. The primary objective of this study was to determine if the method of blood collection (syringe or bag) during the ANH process impacted the platelet count and function. The secondary objectives included the need for perioperative blood transfusions during the procedure and in the intensive care unit. In addition, we assessed these outcomes' associations with ANH parameters including the method of collection, time of storage, and volume removed. Data were collected prospectively from 50 patients undergoing cardiac surgery on cardiopulmonary bypass over a 6-month period. Platelet count and function were measured for the ANH blood immediately after collection and again prior to transfusing to the patient at the end of cardiopulmonary bypass. Other data collected included ANH volume, length of storage, and the quantity of all blood products given throughout the perioperative period. No change in platelet count or function was noted regardless of the length of time or collection method for the ANH blood. Twenty-three patients received blood or blood products in the operating room or the intensive care unit, while 27 patients received no blood transfusion during their entire hospitalization. Higher ANH volume (ml·kg -1 ) and longer storage time were associated with a greater need for intraoperative transfusions. Acute normovolemic hemodilution protects the platelets from the untoward effects of cardiopulmonary bypass and offers an important autologous blood product that improves hemostasis at the conclusion of surgery. Platelet count and function are preserved regardless of the method of collection or the length of storage. The volume of ANH removed

  9. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial.

    Science.gov (United States)

    Cherian, Jeffrey J; Bhave, Anil; Kapadia, Bhaveen H; Starr, Roland; McElroy, Mark J; Mont, Michael A

    2015-05-01

    Pneumatic unloader bracing with extension assists have been proposed as a non-operative modality that may delay the need for knee surgery by reducing pain and improving function. This prospective, randomized trial evaluated 52 patients who had knee osteoarthritis for changes in: (1) muscle strength; (2) objective functional improvements; (3); subjective functional improvements; (4) pain; (5) quality of life; and (6) conversion to total knee arthroplasty (TKA) compared to standard of care. Patient outcomes were evaluated at a minimum 3 months. Braced patient's demonstrated significant improvements in muscle strength, several functional tests, and patient reported outcomes when compared to the matched cohort. These results are encouraging and suggest that this device may represent a promising alternative to standard treatment methods for knee osteoarthritis. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. Circulating histones for predicting prognosis after cardiac surgery: a prospective study.

    Science.gov (United States)

    Gao, Hongxiang; Zhang, Naipu; Lu, Fangfang; Yu, Xindi; Zhu, Limin; Mo, Xi; Wang, Wei

    2016-11-01

    The objective of this study was to assess the perioperative changes in circulating histones and their relationships with other biomarkers and clinical outcomes after cardiac surgery with cardiopulmonary bypass (CPB) in patients. Forty-eight patients with congenital cardiac diseases undergoing corrective procedure with CPB were prospectively enrolled in this study. Circulating histones, N-terminal pro-brain natriuretic peptide (NT-proBNP), procalcitonin (PCT) and C-reactive protein (CRP) were measured preoperatively (T0) and at 0 (T1), 24 (T2), 48 (T3) and 72 (T4) h postoperatively. The relationships between biomarkers and clinical outcomes were analysed. Circulating histones, NT-proBNP, PCT and CRP increased significantly postoperatively, with histones reaching the peak value earliest at T1. Circulating histone levels were higher in patients with adverse events. Receiver operating characteristic curve analysis showed that peak histone levels had a better predictive value for adverse events postoperatively. Peak histone levels correlated with the peak level of NT-proBNP (r = 0.563, P histones reached peak levels faster than NT-proBNP, PCT and CRP. Furthermore, peak histone levels correlated with biomarkers and postoperative clinical outcomes. Circulating histones may be used as a prognostic indicator for patients after cardiac surgery with CPB. ClinicalTrials.gov (ID: NCT02325765). © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  11. Very low-carbohydrate ketogenic diet before bariatric surgery: prospective evaluation of a sequential diet.

    Science.gov (United States)

    Leonetti, Frida; Campanile, Fabio Cesare; Coccia, Federica; Capoccia, Danila; Alessandroni, Laura; Puzziello, Alessandro; Coluzzi, Ilenia; Silecchia, Gianfranco

    2015-01-01

    We evaluated the effectiveness of a sequential diet regimen termed the obese preoperative diet (OPOD) in morbidly obese patients with and without type 2 diabetes mellitus (T2DM) scheduled for laparoscopic bariatric surgery. Fifty patients (body mass index 53.5 ± 8.4 kg/m(2)) scheduled for bariatric surgery, including 14 with T2DM, were prospectively enrolled and followed the OPOD regimen: a very low-calorie ketogenic diet for 10 days, followed by a very low-calorie diet for 10 days, and then a low-calorie diet for 10 days. Patients were evaluated at baseline (T0) and after 10 days (T1), 20 days (T2), and 30 days (T3). Body weight, body mass index, waist circumference, and neck circumference were significantly lower at T1, T2, and T3 than at T0 in the 48 patients who completed the OPOD. Two patients discontinued the OPOD after 4-7 days. In patients with T2DM, fasting plasma glucose levels decreased significantly, enabling reduction of diabetic medications. Plasma and urine ketone levels increased at T1 but were all diet period. OPOD, including 10 days of a VLCKD, was safe and effective in morbidly obese patients, and it seems to be promising in morbidly obese patients with and without T2DM scheduled for laparoscopic bariatric surgery.

  12. Rhabdomyolysis following Cardiac Surgery: A Prospective, Descriptive, Single-Center Study

    Directory of Open Access Journals (Sweden)

    Amr S. Omar

    2016-01-01

    Full Text Available Purpose. Rhabdomyolysis (RML following cardiac surgery and its relationship with acute kidney injury (AKI require investigation. Patients and Methods. All patients undergoing cardiac surgery in our hospital were enrolled in this prospective study during a 1-year period. To investigate the occurrence of RML and its association with AKI, all patients in the study underwent serial assessment of serum creatine kinase (CK and myoglobin levels. Serial renal function, prior statin treatment, and outcome variables were recorded. Results. In total, 201 patients were included in the study: 185 men and 16 women with a mean age of 52.0±12.4 years. According to the presence of RML (CK of ≥2,500 U/L, the patients were divided into Group I (RML present in 17 patients and Group II (RML absent in 184 patients. Seven patients in Group I had AKI (41% where 34 patients in group II had AKI (18.4%, P=0.025. We observed a significantly longer duration of ventilation, length of stay in the ICU, and hospitalization in Group I (P<0.001 for all observations. Conclusions. An early elevation of serum CK above 2500 U/L postoperatively in high-risk cardiac surgery could be used to diagnose RML that may predict the concomitance of early AKI.

  13. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium.

    Science.gov (United States)

    Evans, Joanna L; Nadler, Jacob W; Preud'homme, Xavier A; Fang, Eric; Daughtry, Rommie L; Chapman, Joseph B; Attarian, David; Wellman, Samuel; Krystal, Andrew D

    2017-08-01

    Delirium is a common post-operative complication associated with significant costs, morbidity, and mortality. We sought sleep/EEG predictors of delirium present prior to delirium symptoms to facilitate developing and targeting therapies. Continuous EEG data were obtained in 12 patients post-orthopedic surgery from the day of surgery until delirium assessment on post-operative day 2 (POD2). Diminished total sleep time (r=-0.68; pdelirium severity. Patients experiencing delirium slept 2.4h less and took 2h longer to fall asleep. Greater waking EEG delta power (r=0.84; pdelirium severity. Loss of sleep on night1 post-surgery is an early predictor of subsequent delirium. EEG Delta Power alterations in waking and sleep appear to be later indicators of impending delirium. Further work is needed to evaluate reproducibility/generalizability and assess whether sleep loss contributes to causing delirium. This first study to prospectively collect continuous EEG data for an extended period prior to delirium onset identified EEG-derived indices that predict subsequent delirium that could aid in developing and targeting therapies. Copyright © 2017. Published by Elsevier B.V.

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

    Science.gov (United States)

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

    2015-12-01

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

  15. 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

  16. 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

  17. 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.

  18. Laparoscopic Surgery for Severe Rectovaginal Endometriosis Compromising the Bowel: A Prospective Cohort Study.

    Science.gov (United States)

    Kent, Andrew; Shakir, Fevzi; Rockall, Tim; Haines, Pat; Pearson, Carol; Rae-Mitchell, Wendy; Jan, Haider

    2016-01-01

    Endometriosis can affect 10% of women at reproductive age. Of those, 5.3% to 12% will have endometriosis affecting the bowel. Although outcomes after surgery for severe endometriosis affecting the bowel have previously been studied and have shown improvement in generic quality of life indices and sexual function, few studies have evaluated bowel function or symptoms specific to endometriosis. Our aim was to determine the quality of life after radical excision of rectovagina endometriosis compromising the bowel. Single-center prospective cohort study (Canadian Task Force classification II-2). Specialist referral center for the management of advanced endometriosis. Women with severe rectovaginal endometriosis compromising the bowel. Comparison of preoperative data with a 2-, 6-, and 12-month follow-up was made for consecutive patients who underwent surgery for endometriosis with bowel involvement. The main outcome measures were quality of life using the Endometriosis Health Profile 30 and EuroQol-5 dimension questionnaires. Bowel symptoms were measured using the Gastrointestinal Quality of Life Index. Dysmenorrhea, dyspareunia, dyschezia, and chronic pain were measured using a visual analogue scale. To compare preoperative and postoperative scores, a Freidman test was performed followed by a preoperative and 12-month postoperative Wilcoxon signed-rank test. A Mann-Whitney U test was used to compare the results between those who had pelvic clearance and those who did not. In total, 137 patients had surgery, of which 100 completed follow-up to 12 months. The serious perioperative and postoperative complication rate was 7.3%. The results show significant improvement in almost all variables measured (p < .01). At 12 months patients who had a pelvic clearance (hysterectomy with bilateral salpingo-oophorectomy) had significantly less pain with better bowel function. Additionally, they had higher quality of life scores and greater satisfaction with their treatment

  19. 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.

  20. Radiotherapy confined to the tumor bed following breast conserving surgery. Current status, controversies, and future prospects

    Energy Technology Data Exchange (ETDEWEB)

    Polgar, C.; Fodor, J.; Major, T.; Takacsi-Nagy, Z.; Nemeth, G. [National Institut of Oncology, Department of Radiotherapy, Budapest (Hungary); Kasler, M. [Semmelweis University Budapest, Chair of Oncology, Budapest (Hungary); Hammer, J. [Barmherzige Schwestern Hospital, Department of Radiation Oncology, Linz (Austria); Limbergen, E. van [University Ziekenhuizen, Department of Radiation Oncology, Leuven (Belgium)

    2002-11-01

    The aim of this study was to review the current status, controversies, and future prospects of tumor bed irradiation alone after breast conserving surgery. Material and Methods: Published prospective trials evaluating the feasibility and efficacy of radiotherapy confined to the tumor bed following breast conserving surgery were reviewed in order to analyze treatment results. Results: In three earlier studies, using tumor bed radiotherapy for unselected patients, the incidence of intra-breast relapse was reported in the range of 15.6-37%. However, in nine prospective phase I-II trials, sole brachytherapy (BT) with different dose rates, strict patients selection, and meticulous quality assurance, resulted in 95.6-100% local control rates. To date, only one phase III protocol has been initiated comparing the efficacy of tumor bed brachytherapy alone with conventional whole breast radiotherapy. The ideal extent of the planning target volume (PTV) for tumor bed radiotherapy alone has not been established yet. In most series, PTV was defined as the excision cavity with generous (1-3 cm) safety margins. Minimal requirement for PTV localization is the use of titanium clips to mark the walls of the excision cavity intraoperatively, but the combination of clip demarcation and three-dimensional (3-D) visual information obtained from cross-sectional images seems to be the best method to determine the target volume. 3-D virtual brachytherapy is also a promising method to minimize the chance of geographic miss. Recently developed techniques, such as intraoperative radiotherapy (IORT), as well as accelerated 3-D conformal external beam radiation therapy (3-D-CRT) were also found to be feasible for tumor bed radiotherapy alone. Conclusions: In spite of the existing arguments against limiting radiotherapy to the tumor bed after breast conserving surgery, results of phase I-II studies suggest that tumor bed radiotherapy alone might be an appropriate treatment option for selected

  1. Surgical treatment of displaced middle-third clavicular fractures: a prospective, randomized trial in a working compensation population.

    Science.gov (United States)

    Melean, Patricio A; Zuniga, Adrian; Marsalli, Michael; Fritis, Nelson A; Cook, Erik R; Zilleruelo, Matías; Alvarez, Cristian

    2015-04-01

    Surgical treatment with open reduction and internal fixation (ORIF) of displaced middle-third clavicular fractures resulted in shorter complete return to work periods with earlier consolidation documented on computed tomography (CT) scans in this prospective, randomized controlled trial. The study randomized 76 consecutive patients with displaced fractures (2B1-2B2 according to Robinson) to conservative (C, n = 42) and surgical (S, n = 34) treatment with plates and screws. Bone union was documented with CT scans at 6 and 12 weeks. Risk factors known to increase the risk of nonunion were similar between groups. Time until discharge for complete return to work was 3.7 ± 1.1 months for C and 2.9 ± 0.8 months for S (P = .003). On the CT scan at 6 weeks, 24.1% of the patients presented advanced bone union in S vs 5.3% in C (P = .05). At 12 weeks, 81% of the patients presented advanced bone union in S vs 16.7% in C (P = .005). At final follow-up, 4 nonunions were present in the C group that required surgery; in the S group, 4 patients underwent revision surgery for plate removal. At 6 and 12 months of follow-up, Constant scores were higher for the S group. Surgical treatment with ORIF of displaced middle-third clavicular fractures achieved good and excellent functional results, shorter time to complete return to work, earlier bone union, and fewer cases of nonunions in a working population under injury compensation. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  2. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    Science.gov (United States)

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  3. Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial

    NARCIS (Netherlands)

    Brans, J. W.; Lindeboom, R.; Snoek, J. W.; Zwarts, M. J.; van Weerden, T. W.; Brunt, E. R.; van Hilten, J. J.; van der Kamp, W.; Prins, M. H.; Speelman, J. D.

    1996-01-01

    Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study. This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind

  4. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    A prospective, randomized, double-blind clinical trial of one nano-hybrid and one high-viscosity bulk-fill composite restorative systems in class II cavities: 12 ... composites (RCs) perform just as well as nano‑hybrid RCs with the 2 mm RC layering technique, therefore could be alternative to conventional nano‑hybrid RCs.

  5. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  6. Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

    NARCIS (Netherlands)

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

    Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

  7. Immediate placement of implants in periapical infected sites: a prospective randomized study in 50 patients

    NARCIS (Netherlands)

    Lindeboom, Jérôme A. H.; Tjiook, Yang; Kroon, Frans H. M.

    2006-01-01

    OBJECTIVE: To determine clinical success when implants are placed in chronic periapical infected sites. STUDY DESIGN: Fifty patients (25 females, 25 males, mean age 39.7 +/- 14.5 years) were included in this prospective controlled study. After randomization, 25 Frialit-2 Synchro implants were

  8. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    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.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  9. TVT versus TOT, 2-year prospective randomized study.

    Science.gov (United States)

    Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

    2013-06-01

    To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

  10. A randomized, prospective study of adjunctive Ampicillin in preterm labor

    Directory of Open Access Journals (Sweden)

    Tehranian A

    1999-09-01

    Full Text Available Acute amniotic fluid infection has emerged as a possible cause of many heretofore unexplained preterm births. Our purpose was to determine the effect of ampicillin in the prolongation of pregnancies receiving tocolysis for preterm labor. A blinded, placebo-controlled, randomized trial was conducted to study ampicillin in women hospitalized for preterm labor between 24 and 37 weeks' gestation. A total of 60 patients with intact membranes and without chorioamnionitis who were receiving magnesium sulfate were screened. Thirty women with preterm labor received ampicillin, and 30 received placebos. The primary end point was prolongation of gestation. There was no difference in age of delivery (37.6±9.7 days vs 36.08±3.9 days, P=0.085 and no difference in retardation of delivery (4.7±3.1 vs 4.1±2.1, P=0.39. The mean degree of preterm delivery were 0.62±1.93 and 1.8±3.3 weeks in ampicillin and placebo groups, respectively (not significant, P>0.1. Conclusions: Ampicillin had no effect on interval to delivery or duration of pregnancy in women treated for preterm labor. So rotine clinical use of ampicillin during tocolysis should not be recommended.

  11. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  12. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  13. A prospective study of conservative surgery without radiation therapy in select patients with Stage I breast cancer

    International Nuclear Information System (INIS)

    Lim, May; Bellon, Jennifer R.; Gelman, Rebecca; Silver, Barbara B.A.; Recht, Abram; Schnitt, Stuart J.; Harris, Jay R.

    2006-01-01

    Purpose: The effectiveness of radiation therapy (RT) in reducing local recurrence after breast-conserving surgery (BCS) in unselected patients with early stage invasive breast cancer has been demonstrated in multiple randomized trials. Whether a subset of women can achieve local control without RT is unknown. In 1986, we initiated a prospective one-arm trial of BCS alone for highly selected breast-cancer patients. This report updates those results. Methods and Materials: Eighty-seven (of 90 planned) patients enrolled from 1986 until closure in 1992, when a predefined stopping boundary was crossed. Patients were required to have a unicentric, T1, pathologic node-negative invasive ductal, mucinous, or tubular carcinoma without an extensive intraductal component or lymphatic-vessel invasion. Surgery included local excision with margins of at least 1 cm or a negative re-excision. No RT or systemic therapy was given. Results: Results are available on 81 patients (median follow-up, 86 months). Nineteen patients (23%) had local recurrence (LR) as a first site of failure (average annual LR: 3.5 per 100 patient-years of follow-up). Other sites of first failure included 1 ipsilateral axilla, 2 contralateral breast cancers, and 4 distant metastases. Six patients developed other (nonbreast) malignancies. Nine patients have died, 4 of metastatic breast cancer and 5 of unrelated causes. Conclusions: Even in this highly selected cohort, a substantial risk of local recurrence occurred after BCS alone with margins of 1.0 cm or more. These results suggest that with the possible exception of elderly women with comorbid conditions, radiation therapy after BCS remains standard treatment

  14. 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.

  15. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

    2017-02-01

    Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Continuous versus cyclic use of oral contraceptives after surgery for symptomatic endometriosis: a prospective cohort study.

    Science.gov (United States)

    Vlahos, Nikos; Vlachos, Athanasios; Triantafyllidou, Olga; Vitoratos, Nikolaos; Creatsas, George

    2013-11-01

    To evaluate the efficacy of continuous oral contraceptive (OC) use versus the usual cyclic fashion in the recurrence of endometriosis-related symptoms after surgery. Prospective cohort trial involving patients in two tertiary care units. Academic institution in collaboration with a private hospital. 356 patients underwent surgical treatment by laparoscopy for symptomatic endometriosis. After surgical treatment for endometriosis, patients offered 6-month course of cyclic OC (including a 7-day pill-free period) or continuous OC. Recurrence rate of endometriosis-related symptoms and endometriomas after fertility-sparing surgery. Out of 356 patients, 167 were placed on the usual cyclic OC course and 85 on continuous OC for a minimum of 6 months. The continuous OC group experienced a statistically significant reduction in recurrence rates for endometrioma, dysmenorrhea, and non-menstrual pelvic pain as compared with the cyclic OC group. There was no reduction in the recurrence of dyspareunia between the two groups. After surgical treatment of endometriosis, the use of both cyclic and continuous OC improves pain symptoms when compared with preoperative scores. Continuous OC appears to be associated with a reduced recurrence rate for dysmenorrhea, non-menstrual pelvic pain, and endometrioma but not for dyspareunia as compared with cyclic OC. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  17. Correlates of non-technical skills in surgery: a prospective study.

    Science.gov (United States)

    Gillespie, Brigid M; Harbeck, Emma; Kang, Evelyn; Steel, Catherine; Fairweather, Nicole; Chaboyer, Wendy

    2017-01-30

    Communication and teamwork failures have frequently been identified as the root cause of adverse events and complications in surgery. Few studies have examined contextual factors that influence teams' non-technical skills (NTS) in surgery. The purpose of this prospective study was to identify and describe correlates of NTS. We assessed NTS of teams and professional role at 2 hospitals using the revised 23-item Non-TECHnical Skills (NOTECHS) and its subscales (communication, situational awareness, team skills, leadership and decision-making). Over 6 months, 2 trained observers evaluated teams' NTS using a structured form. Interobserver agreement across hospitals ranged from 86% to 95%. Multiple regression models were developed to describe associations between operative time, team membership, miscommunications, interruptions, and total NOTECHS and subscale scores. We observed 161 surgical procedures across 8 teams. The total amount of explained variance in NOTECHS and its 5 subscales ranged from 14% (adjusted R 2 0.12, p<0.001) to 24% (adjusted R 2 0.22, p<0.001). In all models, inverse relationships between the total number of miscommunications and total number of interruptions and teams' NTS were observed. Miscommunications and interruptions impact on team NTS performance. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  18. Bone-anchored hearing device surgery: Linear incision without soft tissue reduction. A prospective study.

    Science.gov (United States)

    Altuna, Xabier; Navarro, Juan José; Palicio, Idoia; Álvarez, Leire

    2015-01-01

    The classic surgical procedure for percutaneous bone-anchored hearing devices involves removal of a large area of subcutaneous tissue down to the periosteum. This leads to alopecia and raises the risk of devascularization of the overlying skin with the potential for infection and scarring. The objective of this study was to determine the results of implant placement using a single, linear incision with no underlying soft tissue reduction. A prospective study was conducted in our hospital over a period of 14 months in all consecutive surgeries performed using this technique in adults. Patients were reviewed regularly (week 1, week 3, weeks 4-6 and months 3, 6 and 12) to assess wound healing including evaluation with the Holgers scale. Corresponding to 34 patients, 34 cases were consecutively enrolled in this study. We found that 15% of the patients had minor skin reactions during the first visit (Holgers grade 1 or 2); this number raised to 20% in week 3, but at week 4 only 1 patient had a reaction score of 1 (which was solved by week 6). None of the cases required revision surgery and all skin reactions were treated topically. Our results suggest that the tissue preservation technique is a simple and effective insertion technique with a favourable healing process and cosmesis. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

  19. Prospective study of use of perioperative antimicrobial therapy in general surgery.

    LENUS (Irish Health Repository)

    Fennessy, Brendan G

    2012-02-03

    BACKGROUND: Perioperative antimicrobial therapy has demonstrated efficacy in reducing the rate of surgical site infections in clinical trials. With the emergence of antibiotic resistance, the risk of reaction, and the inevitable financial repercussions, use of prophylactic antibiotics is not a panacea, and their misuse may have considerable implications. The aim of this study was to assess the use of antibiotics in the perioperative period in both general and vascular surgery procedures. METHODS: A prospective study was undertaken of 131 patients with a mean age of 43 years (range one month-88 years), of whom 68 (51%) were male, who underwent twenty-seven different general or vascular surgery procedures over a four-week period. Each patient was evaluated from the time of antibiotic commencement through their operative procedure until the treatment was discontinued. RESULTS: A total of 73 patients (54%) received ten antibiotics, with 71 (97%) of these uses being prophylactic. Of the 15 appendectomies performed for uncomplicated appendicitis, the mean number of prophylactic antibiotic doses was 5.3 (range 1-12). Where they were documented, written postoperative directives were not adhered to in 18\\/27 prescriptions (66%). CONCLUSION: This study has demonstrated a lack of adherence to guidelines in the perioperative administration of antimicrobial agents. In addition, it calls attention to the economic implications of unnecessary prophylaxis.

  20. Influence of preoperative skin sealing with cyanoacrylate on microbial contamination of surgical wounds following trauma surgery: a prospective, blinded, controlled observational study.

    Science.gov (United States)

    Daeschlein, Georg; Napp, Matthias; Assadian, Ojan; Bluhm, Jessica; Krueger, Colin; von Podewils, Sebastian; Gümbel, Denis; Hinz, Peter; Haase, Hermann; Dohmen, Pascal M; Koburger, Torsten; Ekkernkamp, Axel; Kramer, Axel

    2014-12-01

    Intraoperative bacterial contamination is a risk factor for surgical site infections (SSIs). This prospective, randomized, blinded, controlled trial (Reg. No. BB08/12) investigated the effect of a cyanoacrylate-based skin sealant (InteguSeal) on intraoperative wound contamination during trauma surgery. A total of 128 patients undergoing trauma surgery were assigned randomly to an intervention (n=62) or a control group (n=66). Surgical sites were investigated at three locations: maximum incision depth (base), wound margin prior to wound closure (margin), and the surgical sutures (suture). Colony-forming units (CFU) were counted after 48h of incubation. Overall, significantly lower CFU counts were obtained for samples from the intervention group at all three sample sites compared to the control group. The difference, however, was only significant for the suture site (p=0.040). Preoperative sealing reduced microbial contamination on sutures during surgery, while the overall wound contamination remained unchanged. Hence, prevention of the clinically more relevant deep SSIs may not be expected. However, this study was not designed to detect differences in the rate of SSI. The role of the reduction in suture contamination with regard to the prevention of SSI remains to be evaluated. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Percutaneous forefoot surgery for treatment of hallux valgus deformity: an intermediate prospective study.

    Science.gov (United States)

    Crespo Romero, E; Peñuela Candel, R; Gómez Gómez, S; Arias Arias, A; Arcas Ordoño, A; Gálvez González, J; Crespo Romero, R

    2017-08-01

    This study aims to illustrate the results of percutaneous forefoot surgery (PFS) for correction of hallux valgus. A prospective study of 108 patients, with hallux valgus deformity, who underwent PFS was conducted. The minimum clinical and radiological follow-up was two years (mean 57.3 months, range 22-112). Preoperative mean visual analog scale was 6.3 ± 1.5 points, and AOFAS scores were 50.6 ± 11 points. At the last follow-up, both scores improved to 1.9 ± 2.4 points and 85.9 ± 1.83 points, respectively. Mean hallux valgus angle changed from 34.3° ± 9.3° preoperatively to 22.5° ± 11.1° at follow-up. At follow-up, 76.5% of the subjects were satisfied or very satisfied. Recurrence of medial 1st MT head pain happened in 22 cases (16.7%). PFS, in our study, does not improve the radiological and patient satisfaction rate results compared with conventional procedures. The main advantage is a low postoperative pain level, but with an insufficient HVA correction. II, prospective study.

  2. 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.

  3. Comparison of commercial fibrin sealants in facelift surgery: a prospective study

    Directory of Open Access Journals (Sweden)

    Botti G

    2013-11-01

    Full Text Available Giovanni Botti,1 Michele Pascali,2 Chiara Botti,1 Florian Bodog,3 Pietro Gentile,2 Valerio Cervelli2 1Villa Bella Clinic, Salò, 2Department of Plastic and Reconstructive Surgery, University of Rome Tor Vergata, Italy; 3University of Oradea, Oradea, Romania Background: The aim of this study was to compare the effects of two types of fibrin glue in patients undergoing facelift surgery. Methods: A prospective, controlled "right-left side" study was carried out in 20 patients. The two fibrin sealants used were Quixil® and Tissucol®. The two sealants were used at the same time, ie, one on one side of the face and the other on the contralateral side. Comparisons were made with regard to rates of hematoma and seroma, degree of induration, edema, ecchymosis, pain levels, and patient satisfaction. Results: The results were almost equivalent. The only exception was a significant (40 mL hematoma in a patient treated with Quixil. Bleeding was most likely due to a sudden rise in blood pressure during the immediate postoperative period. However, it must be emphasized that, while Tissucol actually seals the undermined area, thus virtually eliminating the dead space, Quixil acts differently, in that its effectiveness in preventing hematoma is linked mainly to its hemostatic effect. Conclusion: The two fibrin sealants used were nearly identical with regard to patient safety and quality of the result. Nevertheless, it is noted that, while Tissucol has both hemostatic and "gluing" effects, Quixil is mainly effective in securing hemostasis. Keywords: facelift surgery, rhytidectomy, fibrin sealants, hematoma

  4. Anterior or posterior surgery for right thoracic adolescent idiopathic scoliosis (AIS)? A prospective cohorts' comparison using radiologic and functional outcomes.

    Science.gov (United States)

    Rushton, Paul R P; Grevitt, Michael P; Sell, Philip J

    2015-04-01

    Prospective cohort study. Prospectively compare patient-reported as well as clinical and radiologic outcomes after anterior or posterior surgery for right thoracic adolescent idiopathic scoliosis (AIS) in a single center by the same surgeons. Anterior and posterior spinal instrumentation and arthrodesis are both well-established treatments of thoracic AIS. The majority of studies comparing the 2 approaches have focused on radiographic outcomes. There remains a paucity of prospectively gathered patient-reported outcomes comparing surgical approaches. Forty-two consecutive patients with right thoracic AIS were treated in a single center by one of 2 surgeons with either anterior (n=18) or posterior (n=24) approaches and followed up for over 2 years. Radiographic, clinical, and patient-reported outcomes of the Modified Scoliosis Research Society Outcome Instrument were gathered and analyzed by an independent surgeon. Patients reported significant improvements in all areas of the Modified Scoliosis Research Society Outcome Instrument, especially pain and self-image domains. There were no significant differences in the degree of improvement in any domains between the groups. Posterior and anterior surgery corrected rib hump by 53% and 61%, respectively (P=0.4). The Main thoracic curve Cobb angle was corrected from 69 to 26 degrees (62%) by posterior surgery and 61 to 23 degrees (64%) by anterior surgery (P=0.6). Posterior surgery significantly reduced kyphosis and lumbosacral lordosis. Anterior surgery had no overall affect of sagittal alignment but seemed able to correct those hypokyphotic preoperatively. Complications differed and were largely approach-related--intrathoracic in anterior and wound-related in posterior surgery. Patients with right thoracic AIS of differing curve types but otherwise similar preoperatively demonstrated that anterior and posterior surgery are largely equivalent. Patient-reported outcomes are improved similarly by either approach. Both offer

  5. Early symptoms in the prodromal phase of delirium: a prospective cohort study in elderly patients undergoing hip surgery

    NARCIS (Netherlands)

    de Jonghe, Jos F. M.; Kalisvaart, Kees J.; Dijkstra, Marty; van Dis, Huib; Vreeswijk, Ralph; Kat, Martin G.; Eikelenboom, Piet; van der Ploeg, Tjeerd; van Goo, Willem A.

    2007-01-01

    OBJECTIVES: The authors investigated prodromal delirium symptoms in elderly patients undergoing hip surgery. METHODS: This was a prospective cohort study in the setting of a large medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants were patients undergoing hip

  6. Evaluation of clinical safety and beneficial effects of a fish oil containing lipid emulsion (Lipoplus, MLF541): data from a prospective, randomized, multicenter trial.

    Science.gov (United States)

    Wichmann, Matthias W; Thul, Paul; Czarnetzki, Hans-Dieter; Morlion, Bart J; Kemen, Matthias; Jauch, Karl-Walter

    2007-03-01

    To prove safety and effectiveness of a lipid emulsion enriched with n-3 fatty acids from fish oil (Lipoplus) within the setting of parenteral nutrition of patients after major abdominal surgery and to determine whether there are effects on outcome parameters. Prospective, randomized, double-blind, multicenter trial. University and surgical teaching hospitals. After obtaining informed consent, 256 patients undergoing major abdominal surgery were randomized. Parameters of safety, effectiveness, and outcome were routine laboratory parameters, complication rates, length of stay in the intensive care unit, and length of hospital stay. In addition we determined in patient subgroups of 30 patients each, the changes of the content of selected long-chain polyunsaturated fatty acids, the leukotriene synthetic capacity and the antioxidant alpha-tocopherol. Participating patients were randomized to receive either Lipoplus (group I; n = 127 patients) or Intralipid (group II; n = 129 patients). Parenteral nutrition was initiated immediately after surgery and ended on day 5 after surgery. No significant differences between groups I and II were observed when comparing routine laboratory parameters during the perioperative period. Plasma levels of eicosapentaenoic acid, leukotriene B5, and antioxidant content were significantly increased in group I. Furthermore, there was a significantly shorter length of hospital stay of approximately 21% (17.2 vs. 21.9 days; p = .0061) in group I. Our findings indicate that the administration of Lipoplus in the postoperative period after major abdominal surgery is safe and results in a significantly shorter length of hospital stay. Administration of n-3 polyunsaturated fatty acids in the postoperative period can be considered a valuable choice for patients requiring parenteral nutrition after major abdominal surgery.

  7. 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.

  8. 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.

  9. 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.

  10. Prospective, randomized evaluation of endoscopic versus open carpal tunnel release in bilateral carpal tunnel syndrome: an interim analysis.

    Science.gov (United States)

    Michelotti, Brett; Romanowsky, Diane; Hauck, Randy M

    2014-12-01

    Most randomized trials have shown similar results with endoscopic carpal tunnel release (ECTR) and open carpal tunnel release (OCTR); however, there are studies suggesting less postoperative pain, faster improvement in grip and pinch strength, and earlier return to work with the endoscopic technique. The goal of this study was to prospectively examine subjective and functional outcomes, satisfaction, and complications after both ECTR and OCTR in the opposite hands of the same patient, serving as their own control. This was a prospective, randomized study in which patients underwent surgery for bilateral carpal tunnel syndrome. The first carpal tunnel release was performed on the most symptomatic hand-determined by the patient. Operative approach was randomly assigned and, approximately 1 month later, the alternative technique was performed on the contralateral side. Demographic data were obtained, and functional outcomes were recorded preoperatively and postoperatively, including pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, and overall grip strength. The carpal tunnel syndrome-functional status score and carpal tunnel syndrome-symptom severity score were recorded before surgery and at 2, 4, 8, 12, and 24 weeks postoperatively. Overall satisfaction with each technique was recorded at the conclusion of the study. Currently, 25 subjects have completed final visit testing. There were no differences in pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, or overall grip strength at any of the postoperative time points. Carpal tunnel syndrome-symptom severity score and carpal tunnel syndrome-functional status score were not significantly different between groups at any of the evaluations. Overall satisfaction, where patients recorded a number from 0 to 100, was significantly greater in the ECTR group (95.95 vs 91.60, P = 0.04). There were no complications with either technique. This

  11. 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.

  12. 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.

  13. Dexmedetomidine attenuates tourniquet-induced hyperdynamic response in patients undergoing lower limb surgeries: a randomized controlled study.

    Science.gov (United States)

    Lao, Hsuan-Chih; Tsai, Pei-Shan; Su, Jung-Yuan; Kwok, Tiew-Guan; Huang, Chun-Jen

    2013-01-01

    Activation of sympathetic nervous system has a crucial role in mediating the pneumatic tourniquet inflation induced hyperdynamic response. Dexmedetomidine, a selective α(2)-adrenergic receptor agonist, has potent sympatholytic effects. We conducted this prospective, randomized, placebo-controlled, double-blinded study to elucidate the effects of dexmedetomidine on attenuating the tourniquet-induced hyperdynamic response during general anesthesia. We included a total of 72 healthy adult patients undergoing elective lower limb surgery. Under general anesthesia, patients were randomized to the dexmedetomidine or the control group (n = 36 in each group). The dexmedetomidine group received a loading dose of dexmedetomidine (0.8 μg·kg(-1) over 10 min) followed by continuous infusion of dexmedetomidine (0.4 μg·kg(-1).h(-1)) until tourniquet deflation. The control group received normal saline instead. We compared tourniquet-induced changes in hemodynamic parameters between groups to elucidate the effects of dexmedetomidine. Tourniquet inflation induced significant increases in hemodynamic parameters, including heart rate, systolic arterial pressure, mean arterial pressure, diastolic arterial pressure, rate pressure product, cardiac output, and stroke volume in the control group. The effects of tourniquet inflation on increasing hemodynamic parameters were significantly attenuated by dexmedetomidine: heart rate (P product (P < 0.001), and cardiac output (P = 0.001) of the dexmedetomidine group were significantly lower than those of the control group. However, the stroke volume of these groups was comparable. Dexmedetomidine attenuates tourniquet-induced hyperdynamic response in general anesthesia patients undergoing lower limb surgeries. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. 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.

  15. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

    Science.gov (United States)

    Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

    2015-01-01

    To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

  16. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  17. A comparison of a single or triple injection technique for ultrasound-guided infraclavicular block: a prospective randomized controlled study.

    Science.gov (United States)

    Desgagnés, Marie-Christine; Lévesque, Simon; Dion, Nicolas; Nadeau, Marie-Josée; Coté, Dany; Brassard, Jean; Nicole, Pierre C; Turgeon, Alexis F

    2009-08-01

    Good success rates have been reported with ultrasound-guided infraclavicular block using one or multiple injections of local anesthetic. We hypothesized that a separate injection of local anesthetics on each cord enhances the onset of complete sensory block. We designed this prospective randomized study to compare the rate of complete sensory block using one or three injections of local anesthetic. Patients scheduled for hand, wrist, or elbow surgery were included in this study. All blocks were performed under ultrasound guidance. In Group S (single injection), 30 mL of mepivacaine 1.5% was injected posterior to the axillary artery. In Group T (triple injections), 10 mL of mepivacaine 1.5% was injected on the posterior, medial, and lateral aspects of the axillary artery. Sensory block was evaluated every 3 min up to 30 min. The primary end point was the rate of complete sensory block at 15 min. Forty-nine and 51 patients were randomized in Groups S and T, respectively. The rate of complete sensory block was comparable at 15 min (Group S: 84%, Group T: 78%, P = 0.61) and at each time interval up to 30 min. There was no statistically significant difference in the rate of complications between the two groups. The success rate and the onset of complete sensory block after ultrasound-guided infraclavicular block are not enhanced by a triple injection of local anesthetic compared with a single injection posterior to the axillary artery.

  18. Ultrasound-guided regional anesthesia for pediatric burn reconstructive surgery; a prospective study

    Science.gov (United States)

    Shank, Erik S.; Martyn, Jeevendra A.; Donelan, Mathias B.; Perrone, Anthony; Firth, Paul G.; Driscoll, Daniel N.

    2014-01-01

    Pediatric patients face multiple reconstructive surgeries to re-establish function and aesthetics post burn injury. Often, the site of the harvested graft for these reconstructions is reported to be the most painful part of the procedure and a common reason for deferring these reconstructive procedures. This study in pediatric burn patients undergoing reconstructive procedures examined the analgesia response to local anesthetic infiltration versus either a single ultrasound guided regional nerve block of the lateral femoral cutaneous nerve, or a fascia-iliaca compartment block with catheter placement and continuous infusion. Methods 19 patients were randomized to one of three groups (infiltration, single shot nerve block, or compartment block with catheter) and received intraoperative analgesia intervention. Post-operatively, visual analog scale pain scores were recorded –for pain at the donor site—every four hours while awake—for forty-eight hours. Results This non-parametric data was analyzed using a two way ANOVA, Friedman's test, and Kruskal-Walllis test, with significance determined at panesthetic block of the lateral femoral cutaneous nerve, with or without catheter placement, provides an improved postoperative experience for the pediatric patient undergoing reconstructive surgery with lateral/anterolateral skin graft versus local anesthesia infiltration of donor site. For optimal comfort throughout the postoperative period, an ultrasound guided block with continuous catheter may be beneficial. PMID:25412051

  19. Prospective comparative study of cefotetan with piperacillin for prophylaxis against infection in elective colorectal surgery.

    Science.gov (United States)

    Hershman, M J; Swift, R I; Reilly, D T; Logan, W A; Sackier, J M; Gompertz, H; Horner, J; Baker, N W; Wood, C B

    1990-02-01

    This study compared one dose of cefotetan with three doses of piperacillin as prophylaxis against wound infection in 153 patients undergoing elective colorectal surgery. The patients were randomized into two groups: the first received 2 g cefotetan intravenously with induction of anaesthesia (n = 75), and the second received three doses of 2 g piperacillin (n = 78). Wound infection was defined as the presence of an abscess or discharging pus from the wound. In the cefotetan group there were 14 (19%) wound infections and 13 (17%) in the piperacillin group. There were three septic deaths, one in the cefotetan group and two in the piperacillin group. Both groups were comparable with regard to age, sex, nature of pathology and pre- and perioperative risk factors. No significant haematological or biochemical abnormalities were detected. The only adverse reaction was one patient who had an allergic reaction (rash) to piperacillin. These data suggest that single-dose cefotetan is as effective as triple-dose piperacillin in prophylaxis against infection in elective colorectal surgery.

  20. Comparison of digital and traditional thoracic drainage systems for postoperative chest tube management after pulmonary resection: A prospective randomized trial.

    Science.gov (United States)

    Takamochi, Kazuya; Nojiri, Shuko; Oh, Shiaki; Matsunaga, Takeshi; Imashimizu, Kota; Fukui, Mariko; Suzuki, Kenji

    2017-11-13

    The objective of this study was to evaluate whether a digital thoracic drainage system (group D) is clinically useful compared with a traditional thoracic drainage system (group T) in chest tube management following anatomic lung resection. Patients scheduled to undergo segmentectomy or lobectomy were prospectively randomized before surgery to group D or T. A stratification randomization was performed according to the following air leak risk factors: age, sex, smoking status, and presence of emphysema and/or chronic obstructive pulmonary disease. The primary end point was the duration of chest tube placement. No statistically significant differences were found between groups D (n = 135) and T (n = 164) with regard to the duration of chest tube placement (median, 2.0 vs 3.0 days; P = .149), duration of hospitalization (median, 6.0 vs 7.0 days; P = .548), or frequency of postoperative adverse events (25.1% vs 20.7%; P = .361). In subgroup analyses of the 64 patients with postoperative air leak (20 in group D and 44 in group T), the duration of chest tube placement (median, 4.5 vs 4.0 days; P = .225) and duration of postoperative air leak (median, 3.0 vs 3.0 days; P = .226) were not significantly different between subgroups. The use of a digital thoracic drainage system did not shorten the duration of chest tube placement in comparison to a traditional thoracic drainage system after anatomic lung resection. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  1. Aprotinin and classic wound drainage are unnecessary in total hip replacement a prospective randomized trial

    OpenAIRE

    Fleischmann, F; Matuschek, C; Orth, K; Gerber, PA; Mota, R; Knoefel, WT; Peiper, M; Schick, M; van Griensven, M; Bdlke, E; Fleischmann, W

    2011-01-01

    Abstract Background Classic wound drainage is still common in hip replacement but its benefit is doubtful. The role of systemic administration of proteinase inhibitors like aprotinin to avoid perioperative blood loss is still unclear. Patients and Methods In a prospective randomized trial, the perioperative blood loss in alloplastic hip replacement under the influence of proteinase inhibitor (aprotinin, Trasylol®) using wound drainage as well as compression treatment alone were compared. 80 p...

  2. A prospective randomized trial comparing traditional and fast-track patient care in elective open infrarenal aneurysm repair.

    Science.gov (United States)

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

    2009-03-01

    Fast-track recovery programs have led to reduced patient morbidity and mortality after major surgery. In terms of elective open infrarenal aneurysm repair, no evidence is available about such programs. To address this issue, we have conducted a randomized prospective pilot study. The study involved prospective randomization of 101 patients with the indication for elective open aneurysm repair in a traditional and a fast-track treatment arm. The basic fast-track elements were no bowel preparation, reduced preoperative fasting, patient-controlled epidural analgesia (PCEA), enhanced postoperative feeding, and postoperative mobilization. Morbidity and mortality, need for postoperative mechanical ventilation, length of stay (LOS) in the intensive care unit (ICU) and total length of postoperative hospital stay were analyzed in terms of an intention to treat. Demographic data for the two groups were similar. In the fast-track group the need for postoperative ventilation was significantly lower (6.1% versus 32%; p = 0.002), the median LOS on ICU did not significantly differ (20 h versus 32 h; p = 0.183), full enteral feeding was achieved significantly earlier (5 versus 7 days; p < 0.0001), and the rate of postoperative medical complications-gastrointestinal, cardiac, pulmonary, renal, and infective-was significantly lower (16% versus 36%; p = 0.039). The postoperative hospital stay was significantly shorter in the fast-track group (10 days versus 11 days; p = 0.016); the mortality rate in both groups was 0%. An optimized patient care program in open infrarenal aortic aneurysm repair shows favorable results concerning need for postoperative assisted mechanical ventilation, time to full enteral feeding, and incidence of medical complications. Further ranomized multicentric trials are necessary to justify broad implementation (clinical trials. gov identifier NCT 00615888).

  3. Big Five Personality Characteristics and Adherence to Clinic-Based Rehabilitation Activities after ACL Surgery: A Prospective Analysis.

    Science.gov (United States)

    Hilliard, Robert C; Brewer, Britton W; Cornelius, Allen E; Van Raalte, Judy L

    2014-05-30

    A prospective, longitudinal study was conducted to examine Big Five personality characteristics as predictors of adherence to clinic-based rehabilitation activities following anterior cruciate ligament (ACL) reconstruction surgery. Participants (72 men, 36 women) completed a questionnaire assessing Big Five personality dimensions prior to surgery. For the first 7 weeks after surgery, participants' rehabilitation session attendance was recorded and rehabilitation professionals rated participants' adherence during rehabilitation sessions.. Results of multiple regression analyses indicated that the 5 personality factors explained 11 percent of the variance in attendance and 17 percent of the variance in adherence ratings, that agreeableness was a significant positive predictor of attendance, and that conscientiousness and openness to experience were significant positive predictors of adherence ratings. As a potential contributor to adherence, personality warrants consideration when implementing rehabilitation programs after ACL surgery.

  4. Is after-hours orthopaedic surgery associated with adverse outcomes? A prospective comparative study.

    Science.gov (United States)

    Ricci, William M; Gallagher, Bethany; Brandt, Angel; Schwappach, John; Tucker, Michael; Leighton, Ross

    2009-09-01

    Treatment of fractures is sometimes performed after normal daytime operating hours and in such instances may be performed under less than ideal conditions. The consequence of performing operations under such conditions is largely unknown and was therefore studied in the context of intramedullary nail fixation of tibial and femoral shaft fractures. Two hundred and three consecutive patients with either a femoral or tibial shaft fracture (Orthopaedic Trauma Association classification 32 or 42) treated with intramedullary nail fixation were included in a prospective, multicenter, nonrandomized study. Patients were divided into an after-hours group defined as an operation beginning from 4:00 P.M. to 6:00 A.M. or a daytime group defined as an operation beginning from 6:00 A.M. to 4:00 P.M. These groups were further divided on the basis of the injured bone into the following subgroups: after-hours femoral fracture (fifty-five patients), daytime femoral fracture (forty-four patients), after-hours tibial fracture (forty-eight patients), and daytime tibial fracture (fifty-six patients). The demographic and fracture characteristics were similar among the subgroups. All patients were treated with the same type of femoral antegrade, femoral retrograde, or tibial nail fixation with reaming. Data for fracture-healing, complications, operative time, and fluoroscopy time were collected prospectively. The healing rates were similar between daytime and after-hours surgery groups for both the tibial and femoral nailing. On the basis of univariate analysis, operative times were shorter in the after-hours group compared with the daytime group for both the tibial and femoral nail fixation groups (p tibial and femoral nail fixation (p > 0.05). The after-hours group had more unplanned reoperations than the daytime group (p fracture group (27%) than in the daytime femoral fracture group (3%) (p fracture hardware (p intramedullary nail fixation of both femoral and tibial fractures. After

  5. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery.

    Science.gov (United States)

    Cottam, J; Richards, K; Hasted, A; Blackman, A

    2007-11-01

    Actuarial analysis of stoma complications (problematic stomas) is lacking. The objectives of this audit were: to identify the incidence of stoma complications within the UK; to highlight any dissimilarity of incidence from centre to centre; to ascertain if the height of the stoma (distance of stoma lumen from the skin) at the time of fashioning is a predisposing factor to problems; and finally to initiate much needed research. Commencing 1st January 2005, stoma care services nationwide (256) were invited to audit prospectively their next 50 enteric stomas or for a period of 1 year which ever came first. The definition of a problematic stoma being one, which needed one or more accessories to keep the patient clean and dry for a minimum period of 24 h. The incident is to have happened within 3 weeks of surgery. Factors taken into account were: type of stoma, height of stoma within 48 h of surgery; emergency or elective procedure, problem identified, BMI, gender and underlying diagnosis of the patient. The identities of the participating centres are confidential. Of the 256 hospital-based stoma care services within the UK, 93 (36%) participated. A total of 3970 stomas were recorded, of which 1329 (34%) were identified as problematic. Sixty-two centres reported 45-50 stomas with a range of complications 6-96%. The loop ileostomy was found to be the stoma which causes most problems. A stoma of stomas formed, but have significantly fewer problems and there is no significant difference between underlying diagnoses. The stoma height, stoma type and gender of the patient are significant risk factors identified in this audit. The BMI of patient did not affect the outcome. Patients undergoing an emergency procedure are more likely to have a problematic stoma. The significant variation of complications from centre to centre indicates surgical technique as being the key factor in stoma formation and subsequent quality of life for the patient.

  6. 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.

  7. 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.

  8. 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

  9. Intermittent claudication--surgical reconstruction or physical training? A prospective randomized trial of treatment efficiency.

    Science.gov (United States)

    Lundgren, F; Dahllöf, A G; Lundholm, K; Scherstén, T; Volkmann, R

    1989-01-01

    This study reports the initial evaluation of treatment efficiency in 75 patients with intermittent claudication who were randomized to three treatment groups: 1) reconstructive surgery, 2) reconstructive surgery with subsequent physical training, and 3) physical training alone. Before treatment, there were no statistically significant differences between the groups in age, sex, smoking habits, symptom duration of claudication, ankle-arm blood pressure quotient (ankle-index), maximal plethysmographic calf blood flow, symptom-free and maximal walking distance, the history of other atherosclerotic manifestations or in the medical treatment. The walking performance was improved in all three groups at follow-up 13 +/- 0.5 months after randomization. Surgery was most effective, but the addition of training to surgery improved the symptom-free walking distance even further. In pooled observations of the three groups, age, symptom duration, and a history of myocardial ischemic disease correlated negatively with walking performance after treatment. In the operated group, the duration of claudication and a history of myocardial ischemic disease correlated negatively with the walking performance. This was not the case when patients were censored if limited by other symptoms than intermittent claudication after treatment. In the trained group, the duration of claudication correlated negatively to symptom-free and maximal walking distance. Ankle-index and maximal plethysmographic calf blood flow after treatment and the change of these variables with treatment correlated positively with both symptom-free and maximal walking distance when results were pooled for all patients. Although this mainly was a consequence of the improved blood flow after surgery, the change of maximal plethysmographic calf blood flow also correlated with symptom-free but not with maximal walking distance in the trained group. The results demonstrate that, compared with physical training alone, operation

  10. Assessment of cosmetic outcome of oncoplastic breast conservation surgery in women with early breast cancer: a prospective cohort study.

    Science.gov (United States)

    Adimulam, G; Challa, V R; Dhar, A; Chumber, S; Seenu, V; Srivastava, A

    2014-01-01

    The aim of this study was to assess the cosmetic outcome of patients undergoing oncoplastic breast conserving surgery in Indian population. A prospective cohort of 35 patients who were eligible for breast conservation surgery was included in the study from year 2007 to 2009. Patients with central quadrant tumors were excluded from the study. A double - blind cosmetic assessment was done by a plastic surgeon and a senior nurse not involved in the management of patients. Moreover, self-assessment was carried out by the patient regarding the satisfaction of surgery, comfort with brasserie, social and sexual life after oncoplastic surgery. In this study, 35 patients underwent oncoplastic breast conservation surgery by various techniques. The cosmetic outcome scores of the surgeon and nurse were analyzed for inter rater agreement using inter-class Correlation Coefficients. There was a good association between them. The risk factors for poor cosmetic outcome was studied by univariate analysis and significant correlation was obtained with age, volume of breast tissue excised and estimated percentage of breast volume excised (P surgery. Patients were offered an option for cosmetic correction of contralateral breast by mastopexy or reduction mammoplasty however, none of them agreed for another procedure. Oncoplastic breast surgery helps to resect larger volume of tissue with wider margins around the tumor. It helps to achieve better cosmesis and extends the indications for breast conservation. Most of the patients were satisfied with mere preservation of the breast mound rather than a symmetrical contralateral breast.

  11. Cutaneous and Labyrinthine Tolerance of Bioactive Glass S53P4 in Mastoid and Epitympanic Obliteration Surgery: Prospective Clinical Study

    Directory of Open Access Journals (Sweden)

    Daniele Bernardeschi

    2015-01-01

    Full Text Available Objective. To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery. Material and Methods. Forty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance. Results. All surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study. Conclusion. The bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications.

  12. 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

  13. 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

  14. 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).

  15. 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

  16. A prospective evaluation of short-term health-related quality of life in patients undergoing anterior skull base surgery.

    Science.gov (United States)

    Abergel, Abraham; Fliss, Dan M; Margalit, Nevo; Gil, Ziv

    2010-01-01

    We evaluated the health-related quality of life (QOL) of patients undergoing anterior skull base tumor resection. The Anterior Skull Base Surgery QOL questionnaire, a disease-specific multidimensional instrument dedicated to this population, was used to collect and prospectively analyze demographic, medical, and QOL data on 48 patients. Thirty-nine patients completed the questionnaire preoperatively and at 6 and 12 months postoperatively. Seventeen patients (44%) had malignant histology and 22 (56%) had benign tumors. The overall QOL score decreased significantly at 6 months postoperatively (p base tumor resection returns to baseline by 1 year after surgery. Histology and radiotherapy are significant predictors of health-related QOL in this population.

  17. Prospective assessment of positioning-related pain in robotic urologic surgery.

    Science.gov (United States)

    Ginsburg, Kevin B; Pape, Kelsey; Heilbronn, Chase; Levin, Michael; Cher, Michael L

    2018-03-01

    This was a prospective study to assess positioning-related pain in 20 awake volunteers in the dorsal lithotomy (DL) and lateral decubitus (LD) positions. Each volunteer was put through the series of discrete, sequential steps used to achieve a final position; each step had two options. The Wong-Baker scale (WB) was used to rate pain for each option and the preferred option and ad lib comments were recorded. We found that awake volunteers could clearly and immediately distinguish differences in pain levels between position options. For the DL position, volunteers favored having the arms slightly flexed and pronated as opposed to being straight and supinated reflected by statistically less painful WB scores and option preference. Volunteers preferred having the neck flexed as opposed to being flat. For the LD position, volunteers reported statistically lower pain scores and preference for a foam roll for axilla support as opposed to a rolled blanket, the table flexed without the kidney rest as opposed to a raised kidney rest, and the over arm board as oppose to stacked blankets for contralateral arm support. Ad lib comments from the volunteers supported the above findings. To our knowledge, ours is the first study to demonstrate objective preferences for variations in surgical positioning using awake volunteers. This exercise with awake volunteers resulted in immediate changes in positioning for real robotic surgery patients in our practice.

  18. Prospective comparison of single port versus conventional laparoscopic surgery for ectopic pregnancy.

    Science.gov (United States)

    Kim, Min Kyung; Kim, Jeong Jin; Choi, Joong Sub; Eom, Jeong Min; Lee, Jung Hun

    2015-04-01

    To investigate the feasibility and safety of single port laparoscopic surgery (SP-LS) for ectopic pregnancy, irrespective of type of ectopic pregnancy and hemodynamic stability. A prospective case-control study of 106 women who underwent SP-LS or conventional LS for a suspected ectopic pregnancy was performed at a university teaching hospital from January 2009 to March 2012. Twenty-six women underwent SP-LS (SP-LS group) and 80 women underwent conventional LS (conventional LS group). There were no statistical differences between the groups in terms of demographic characteristics, operating time, hemoglobin change, return of bowel activity, hospital stay or complication rate. There were no cases of additional trocar use or conversion to laparotomy. Of five women with heterotopic pregnancy, one underwent SP-LS, and three underwent conventional LS for tubal pregnancy, which all resulted in vaginal delivery without obstetric complication; one woman received SP-LS for cornual pregnancy and had an ongoing pregnancy. SP-LS for ectopic pregnancy is feasible and safe regardless of the type of ectopic pregnancy and hemodynamic stability. However, further work is needed to confirm this conclusion and to demonstrate any advantage of SP-LS for ectopic pregnancy. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

  19. A prospective study on the risk of glove fingertip contamination during draping in joint replacement surgery.

    Science.gov (United States)

    Makki, D; Deierl, K; Pandit, A; Trakru, S

    2014-09-01

    The aim of this prospective study was to investigate the risk of contamination of surgical gloves during preparation and draping in joint replacement surgery. During 46 hip and knee replacement procedures, the gloves of orthopaedic consultants (n=5) and registrars (n=3) were assessed for contamination immediately after draping by impression of gloved fingers on blood agar. Contamination was evaluated by the surgeon's grade, the type of procedure, the role of the assistant and the dominance of the hand. A total of 125 pairs of top gloves were examined (79 pairs from registrars and 46 pairs from consultants). Bacterial contamination was isolated on 19 pairs (15.2%) (16 pairs from registrars and 3 pairs from consultants, p=0.04). Coagulase negative staphylococci were the main isolates and contamination was considered low in all cases (1-5 colonies). Contamination was seen more on the dominant hand (16 gloves from dominant hands and 6 from non-dominant hands, p=0.04), on the index finger and thumb. More contaminated gloves were seen in hip arthroplasty procedures (16 pairs from total hip replacements vs 3 pairs from total knee replacements, p=0.02). Contamination of glove fingertips during draping in joint replacement procedures is more likely to occur among junior surgeons, in hip rather than knee arthroplasty procedures and on the dominant hand. It is therefore essential that surgeons of different grades replace gloves used in draping to avoid exposing patients to the risk of infection.

  20. 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

  1. 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....

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

    Science.gov (United States)

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

    2017-02-01

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

  3. 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.

  4. Multi-modal-analgesia for pain management after Hallux Valgus surgery: a prospective randomised study on the effect of ankle block

    Directory of Open Access Journals (Sweden)

    Rolf Christer

    2007-12-01

    Full Text Available Abstract Background Pain and emesis are the two major complaints after day case surgery. Local anaesthesia has become an important part of optimizing intra and post-operative pain treatment, but is sometimes not entirely sufficient. The aim of the present study was to study the effect of adding an ankle block to a multi-modal analgesic approach on the first 24-hour-need for rescue analgesia in patients undergoing elective Hallux Valgus surgery. Type of study Prospective, randomized patient-blind study comparing ankle block with levo-bupivacaine, lidocaine and Saline placebo control. Methods Ninety patients were studied comparing ankle block (15 cc using levo-bupivacaine 2.5 mg/ml, lidocaine 10 mg/ml or placebo (saline on day-case elective Hallux Valgus surgery, supported by general anaesthesia in all cases. Primary study endpoint was number of patient's requiring oral analgesics during the first 24 post-operative hours. Results Ankle block had no effect on need for rescue analgesia and pain ratings during the 1st 24 postoperative hours, there was no difference seen between placebo and any of the two active local anaesthesia studied. The only differences seen was that both lidocaine and levo-bupivacaine reduced the intra-operative need for anaesthetic (sevoflurane and that levo-bupivacaine patients had a lower need as compared to the lidocaine patients for oral analgesics during the afternoon of surgery. Conclusion Adding a single shot ankle block to a multi-modal pain management strategy reduces the need for intra-operative anaesthesia but has no major impact of need of rescue analgesics or pain during the first 24-hour after surgery.

  5. Multi-modal-analgesia for pain management after Hallux Valgus surgery: a prospective randomised study on the effect of ankle block

    Science.gov (United States)

    Turan, Ibrahim; Assareh, Hamid; Rolf, Christer; Jakobsson, Jan

    2007-01-01

    Background Pain and emesis are the two major complaints after day case surgery. Local anaesthesia has become an important part of optimizing intra and post-operative pain treatment, but is sometimes not entirely sufficient. The aim of the present study was to study the effect of adding an ankle block to a multi-modal analgesic approach on the first 24-hour-need for rescue analgesia in patients undergoing elective Hallux Valgus surgery. Type of study Prospective, randomized patient-blind study comparing ankle block with levo-bupivacaine, lidocaine and Saline placebo control. Methods Ninety patients were studied comparing ankle block (15 cc) using levo-bupivacaine 2.5 mg/ml, lidocaine 10 mg/ml or placebo (saline) on day-case elective Hallux Valgus surgery, supported by general anaesthesia in all cases. Primary study endpoint was number of patient's requiring oral analgesics during the first 24 post-operative hours. Results Ankle block had no effect on need for rescue analgesia and pain ratings during the 1st 24 postoperative hours, there was no difference seen between placebo and any of the two active local anaesthesia studied. The only differences seen was that both lidocaine and levo-bupivacaine reduced the intra-operative need for anaesthetic (sevoflurane) and that levo-bupivacaine patients had a lower need as compared to the lidocaine patients for oral analgesics during the afternoon of surgery. Conclusion Adding a single shot ankle block to a multi-modal pain management strategy reduces the need for intra-operative anaesthesia but has no major impact of need of rescue analgesics or pain during the first 24-hour after surgery. PMID:18088436

  6. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  7. 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.

  8. 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

  9. Methylprednisolone pulse therapy for patients with moderately severe Graves' orbitopathy: a prospective, randomized, placebo-controlled study

    NARCIS (Netherlands)

    van Geest, Rob J.; Sasim, Inna V.; Koppeschaar, Hans P. F.; Kalmann, Rachel; Stravers, Simone N.; Bijlsma, Ward R.; Mourits, Maarten P.

    2008-01-01

    Objective: To assess whether methylprednisolone (MP) pulse therapy is efficacious in the treatment of moderately severe Graves' orbitopathy (GO). Design: Prospective, placebo (PL)-controlled, double-blind, randomized study. Methods: Fifteen previously untreated patients with active, moderately

  10. 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.

  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. Training With Curved Laparoscopic Instruments in Single-Port Setting Improves Performance Using Straight Instruments: A Prospective Randomized Simulation Study.

    Science.gov (United States)

    Lukovich, Peter; Sionov, Valery Ben; Kakucs, Timea

    2016-01-01

    Lately single-port surgery is becoming a widespread procedure, but it is more difficult than conventional laparoscopy owing to the lack of triangulation. Although, these operations are also possible with standard laparoscopic instruments, curved instruments are being developed. The aims of the study were to identify the effect of training on a box trainer in single-port setting on the quality of acquired skills, and transferred with the straight and curved instruments for the basic laparoscopic tasks, and highlight the importance of a special laparoscopic training curriculum. A prospective study on a box trainer in single-port setting was conducted using 2 groups. Each group performed 2 tasks on the box trainer in single-port setting. Group-S used conventional straight laparoscopic instruments, and Group-C used curved laparoscopic instruments. Learning curves were obtained by daily measurements recorded in 7-day sessions. On the last day, the 2 groups changed instruments between each other. 1st Department of Surgery, Semmelweis University of Medicine from Budapest, Hungary, a university teaching hospital. In all, 20 fifth-year medical students were randomized into 2 groups. None of them had any laparoscopic or endoscopic experience. Participation was voluntary. Although Group-S performed all tasks significantly faster than Group-C on the first day, the difference proved to be nonsignificant on the last day. All participants achieved significantly shorter task completion time on the last day than on the first day, regardless of the instrument they used. Group-S showed improvement of 63.5%, and Group-C 69.0% improvement by the end of the session. After swapping the instruments, Group-S reached significantly higher task completion time with curved instruments, whereas Group-C showed further progression of 8.9% with straight instruments. Training with curved instruments in a single-port setting allows for a better acquisition of skills in a shorter period. For this

  13. Two-year results of a prospective, multi-site investigation of patient satisfaction and psychosocial status following cosmetic surgery.

    Science.gov (United States)

    Sarwer, David B; Infield, Alison L; Baker, James L; Casas, Laurie A; Glat, Paul M; Gold, Alan H; Jewell, Mark L; Larossa, Don; Nahai, Foad; Young, V Leroy

    2008-01-01

    The number of cosmetic surgical and nonsurgical procedures performed in the United States has increased by 500% over the past 10 years. Most studies of psychosocial functioning following aesthetic procedures have reported high levels of patient satisfaction and improved functioning; however, nearly all these studies focused only on changes during the first posttreatment year. This paper reports on the 2-year results of a prospective, multi-site investigation of postoperative satisfaction and changes in psychosocial status following cosmetic surgery. One hundred patients from 8 surgical practices completed psychometric measures of body image, depressive symptoms, and self-esteem before surgery. Patients completed the same measures again at 3, 6, 12, and 24 months postoperatively. In addition, they reported their postoperative satisfaction as well as self-rated attractiveness at the 4 postoperative assessment points. Patients reported improvements in their overall appearance and body image, the appearance of and their degree of dissatisfaction with the feature altered by surgery, and the frequency of negative body image emotions in specific social situations through 24 months after surgery. These improvements were first evident at 3 months postoperatively and were maintained, without deterioration, through 2 years following surgery. Patients reported high rates of satisfaction and improvements in body image within the first 3 months of cosmetic surgery. These improvements were well maintained through the first 2 postoperative years.

  14. 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.

  15. Resistance training in the early postoperative phase reduces hospitalization and leads to muscle hypertrophy in elderly hip surgery patients--a controlled, randomized study

    DEFF Research Database (Denmark)

    Suetta, Charlotte; Magnusson, S Peter; Rosted, Anna

    2004-01-01

    OBJECTIVES: To better understand how immobilization and surgery affect muscle size and function in the elderly and to identify effective training regimes. DESIGN: A prospective randomized, controlled study. SETTING: Bispebjerg University Hospital, Copenhagen, Denmark. PARTICIPANTS: Thirty......-six patients (aged 60-86) scheduled for unilateral hip replacement due to primary hip osteoarthrosis. INTERVENTION: Patients were randomized to standard home-based rehabilitation (1 h/d x 12 weeks), unilateral neuromuscular electrical stimulation of the operated side (1 h/d x 12 weeks), or unilateral...... resistance training of the operated side (3/wk x 12 weeks). MEASUREMENTS: Hospital length of stay (LOS), quadriceps muscle cross-sectional area (CSA), isokinetic muscle strength, and functional performance. Patients were tested presurgery and 5 and 12 weeks postsurgery. RESULTS: Mean+/-standard error LOS...

  16. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2017-06-01

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

  17. An evaluation of biodegradable synthetic polyurethane foam in patients following septoplasty: a prospective randomized trial.

    Science.gov (United States)

    Yilmaz, Mahmut Sinan; Guven, Mehmet; Elicora, Sultan Sevik; Kaymaz, Recep

    2013-01-01

    The purpose of this study is to examine the usability of biodegradable synthetic polyurethane foam (BSPF) after septoplasty by comparing it with Merocel and silicone intranasal splints as packing materials in terms of patient comfort and efficiency. A prospective, unmasked, randomized trial. A tertiary referral center. This study was designed to be a prospective, randomized clinical trial. Sixty-eight patients who underwent septoplasty were included in this study. The patients were randomized to receive Merocel, silicone intranasal septal splint (INS), or BSPF after septoplasty. Clinical efficacy on bleeding, pain, and subjective symptoms related to packing materials was evaluated. There was a statistically significant difference between the Merocel group and the other 2 groups in terms of bleeding and adhesion. The average score on the pain scale was 2.47 ± 1.01 for BSPF, 3.68 ± 1.27 for INS, and 6 ± 2.21 for Merocel. Scores on general satisfaction scales were 6.95 ± 1.42 for Merocel, 8.44 ± 2.12 for INS, and 8.28 ± 1.88 for BSPF. The efficacy of BSPF was comparable with that of Merocel and INS. Biodegradable synthetic polyurethane foam significantly reduced pain and patient discomfort during packing and removal, followed by INS, compared with Merocel.

  18. Prospective randomized trial of sclerotherapy vs standard treatment for epistaxis due to hereditary hemorrhagic telangiectasia.

    Science.gov (United States)

    Boyer, Holly; Fernandes, Patricia; Le, Chap; Yueh, Bevan

    2015-05-01

    Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT. © 2015 ARS-AAOA, LLC.

  19. 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.

  20. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared...... with surgical and histopathologic staging. RESULTS: A total of 104 patients underwent EUS; 36 had surgical resection of the tumor, 26 surgical exploration without resection, and 42 did not undergo surgery. Comparison of the TNM staging results for the two echoendoscopies gave high kappa values (T, 0.77; N, 0...

  1. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    Directory of Open Access Journals (Sweden)

    Andrzej Kotela

    2015-01-01

    Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

  2. Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial.

    Science.gov (United States)

    Abildgaard, Jeffrey T; Lonergan, Keith T; Tolan, Stefan J; Kissenberth, Michael J; Hawkins, Richard J; Washburn, Richard; Adams, Kyle J; Long, Catherine D; Shealy, E Carlisle; Motley, Jay R; Tokish, John M

    2017-07-01

    Pain management strategies following shoulder arthroplasty vary significantly. Liposomal bupivacaine (LB) is an extended-release delivery of a phospholipid bilayer encapsulating bupivacaine that can result in drug delivery up to 72 hours. Prior studies in lower extremity surgery demonstrated efficacy of LB in comparison to a single-shot peripheral nerve block; however, no study has investigated LB in a total shoulder arthroplasty population. Therefore, this study compared LB vs. an indwelling interscalene nerve block (IINB). This is a prospective, randomized study of 83 consecutive shoulder arthroplasty patients; 36 patients received LB and a "bridge" of 30 mL of 0.5% bupivacaine, and 47 patients received an IINB. Postoperative visual analog scale pain levels, opiate consumption measured with oral morphine equivalents, length of hospital stay, and postoperative complications were recorded. Continuous variables were compared using an analysis of variance with significance set at P < .05. Visual analog scale pain scores were statistically higher in the LB cohort immediately postoperatively in the postanesthesia care unit (7.25 vs. 1.91; P = .000) as well as for the remainder of postoperative day 0 (4.99 vs. 3.20; P = .005) but not for the remainder of admission. Opiate consumption was significantly higher among the LB cohort in the postanesthesia care unit (31.79 vs. 7.47; P = .000), on postoperative day 0 (32.64 vs. 15.04; P = .000), and for the total hospital admission (189.50 vs. 91.70, P = .000). Complication numbers and length of stay were not statistically different. Use of an IINB provides superior pain management in the immediate postoperative setting as demonstrated by decreased narcotic medication consumption and lower subjective pain scores. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  3. ANALGESIC EFFICACY OF EPIDURAL MORPHINE AND CLONIDINEIN PATIENTS UNDERGOING DECOMPRESSION OF THE LUMBAR CANAL: A PROSPECTIVE RANDOMIZED TRIAL

    Directory of Open Access Journals (Sweden)

    BRUNO RONCAGLIO

    Full Text Available ABSTRACT Objective: To evaluate the postoperative analgesic efficacy in patients undergoing lumbar canal decompression using epidural morphine and clonidine at the Hospital Santa Casa de Vitória - ES, Brazil. Methods: Prospective, randomized study of 60 patients with stenosis of the lumbar canal up to two levels with surgical indication, in which decompression of the canal was performed in association with lumbar arthrodesis. In group 1 we performed conventional postoperative analgesia and in group 2, in addition to conventional analgesia, we associated epidural morphine and clonidine. We used VAS as a means of analyzing pain intensity at 1, 12, and 36 hours after surgery. The statistical analysis was performed using Microsoft Office/Excel and the software GraphPad Prism (San Diego, CA, USA. Results: The mean age of patients was 47 years, and 52% were female. The mean VAS in the first hour, 12th, and 36th hours after surgery in the control group was 5.44, 2.13, and 0.55 respectively. In the morphine-clonidine group it was 6.96; 2.21 and 0.60. Comparing one group with another in its absolute values through the Mann-Whitney test, as well as comparing the pain variations between the 1st and 12th hour (1h X 12h and between the 12th hour and 36th hour (12h x 36h through Student’s t test it became clear that there was no statistical difference between groups (p > 0.05. Conclusions: The addition of epidural morphine and clonidine to conventional analgesia is not beneficial to reduce postoperative pain in patients undergoing lumbar canal decompression.

  4. 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.

  5. 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.

  6. Gonadotrophin-releasing hormone analogue or dienogest plus estradiol valerate to prevent pain recurrence after laparoscopic surgery for endometriosis: a multi-center randomized trial.

    Science.gov (United States)

    Granese, Roberta; Perino, Antonino; Calagna, Gloria; Saitta, Salvatore; De Franciscis, Pasquale; Colacurci, Nicola; Triolo, Onofrio; Cucinella, Gaspare

    2015-06-01

    To evaluate the efficacy of dienogest + estradiol valerate (E2V) and gonadotrophin-releasing hormone analogue (GnRH-a) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis. Multi-center, prospective, randomized study. Three university departments of obstetrics and gynecology in Italy. Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain. Post-operative administration of dienogest + E2V for 9 months (group 1) or GnRH-a monthly for 6 months (group 2). A visual analogue scale was used to test intensity of pain before laparoscopic surgery at 3, 6 and 9 months of follow up. A questionnaire to investigate quality of life was administered before surgery and at 9 months of follow up. The visual analogue scale score did not show any significant differences between the two groups (p = 0.417). The questionnaire showed an increase of scores for all women compared with pre-surgery values, demonstrating a marked improvement in quality of life and health-related satisfaction with both treatments. No significant differences were found between the groups. The rate of apparent endometriosis recurrence was 10.8% in group 1 and 13.7% in group 2 (p = 0.962). Both therapies seemed equally efficacious in preventing endometriosis-related chronic pelvic pain recurrence in the first 9 months of follow-up. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  7. A randomized, double-blind, placebo-controlled trial of oral pregabalin for relief of shoulder pain after laparoscopic gynecologic surgery.

    Science.gov (United States)

    Nutthachote, Pattiya; Sirayapiwat, Porntip; Wisawasukmongchol, Wirach; Charuluxananan, Somrat

    2014-01-01

    To investigate the efficacy of pregabalin for the relief of postoperative shoulder pain after laparoscopic gynecologic surgery. Prospective, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). Tertiary referral center, university hospital. Fifty-six women undergoing elective laparoscopic gynecologic surgery between June 2012 and March 2013. Women in the study group received 75 mg pregabalin 2 hours before surgery and then every 12 hours for 2 doses, and women in the control group received an identical capsule and the same dosage of placebo. Visual analog scale (VAS) scores for shoulder pain and surgical pain at 24 and 48 hours after surgery were evaluated as primary outcome. Postoperative analgesics used and drug-related adverse events were also monitored. Patients in the pregabalin group had significantly lower postoperative VAS scores for shoulder pain at 24 hours, compared with the placebo group (median, 23.14 [range, 13.67-32.61] vs. 37.22 [27.75-46.64]; p = .04), and required less analgesic (p = .01). There were no significant differences in VAS scores for surgical pain and adverse events between the 2 groups (p = .56). Perioperative administration of 75 mg pregabalin significantly reduced postoperative laparoscopic shoulder pain and amount of analgesic used. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

  8. The position of a written document in preoperative information for pediatric surgery: A randomized controlled trial on parental anxiety, knowledge, and satisfaction.

    Science.gov (United States)

    Landier, M; Villemagne, T; Le Touze, A; Braïk, K; Meignan, P; Cook, A R; Morel, B; Lardy, H; Binet, A

    2018-03-01

    Preoperative information is a legal and ethical obligation. Very little studies have evaluated the preoperative information method in pediatrics. Having a child operated on is stressful for the parents. Improving information is a way to lower their anxiety. Our study aims to measure the impact of a leaflet, which supports spoken information on parental anxiety, the comprehension-memorization of the information and their satisfaction. Prospective study including 178 patients of outpatient surgery, randomized in two groups: spoken information versus spoken information supported by a leaflet, which is then handed out to the parents. The messages were identical: physiopathology, risks without treatment, surgical technique and its possible complications, description of the hospitalization day, and postoperative care. Parental evaluation was made with self-questionnaires after the preoperative consultation, then on the day of surgery. At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data. Written information significantly improves the scores of comprehension-memorization, parental satisfaction and significantly decreases the level of anxiety. Significant impact of the written document as communication support in pediatric surgery, validating the method and encouraging it to be generalized to other pediatric surgery acts. Level I. Prognosis study. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Determinants of operative time in thyroid surgery: A prospective multicenter study of 3454 thyroidectomies.

    Directory of Open Access Journals (Sweden)

    Arnaud Patoir

    Full Text Available To identify the determinants of operative time for thyroidectomy and quantify the relative influence of preoperative and intra-operative factors.Anticipation of operative time is key to avoid both waste of hospital resources and dissatisfaction of the surgical staff. Having an accurate and anticipated planning would allow a rationalized operating room use and may improve patient flow and staffing level.We conducted a prospective, cross-sectional study between April 2008 and December 2009. The operative time of 3454 patients who underwent thyroidectomy performed by 28 surgeons in five academic hospitals was monitored. We used multilevel linear regression to model determinants of operative time while accounting for the interplay of characteristics specific to surgeons, patients, and surgical procedures. The relative impact of each variable on operative time was estimated.Overall, 86% (99% CI 83 to 89 of operative time variation was related to preoperative variables. Surgeon characteristics accounted for 32% (99% CI 29 to 35 of variation, center location for 29% (99% CI 25 to 33, and surgical procedure or patient variables for 24% (99% CI 20 to 27. Operative time was significantly lower among experienced surgeons having practiced from 5-19 years (-21.8 min, P<0.05, performing at least 300 thyroidectomies per year (-28.8 min, P<0.05, and with increasing number of thyroidectomies performed the same day (-11.7min, P<0.001. Conversely, operative time increased in cases of procedure supervision by a more experienced surgeon (+20.0 min, P<0.001. The remaining 13.0% of variability was attributable to unanticipated technical difficulties at the time of surgery.Variation in thyroidectomy duration is largely explained by preoperative factors, suggesting that it can be accurately anticipated. Prediction tools allowing better regulation of patient flow in operating rooms appears feasible for both working conditions and cost management.

  10. Outcomes of anterior lumbar interbody fusion surgery based on indication: a prospective study.

    Science.gov (United States)

    Rao, Prashanth J; Loganathan, Ajanthan; Yeung, Vivian; Mobbs, Ralph J

    2015-01-01

    There is limited information on clinical outcomes after anterior lumbar interbody fusion (ALIF) based on the indications for surgery. To compare the clinical and radiological outcomes of ALIF for each surgical indication. This prospective clinical study included 125 patients who underwent ALIF over a 2-year period. The patients were evaluated preoperatively and postoperatively. Outcome measures included the Short Form-12, Oswestry Disability Index, Visual Analog Scale, and Patient Satisfaction Index. After a mean follow-up of 20 months, the clinical condition of the patients was significantly better than their preoperative status across all indications. A total of 108 patients had a Patient Satisfaction Index score of 1 or 2, indicating a successful clinical outcome in 86%. Patients with degenerative disk disease (with and without radiculopathy), spondylolisthesis, and scoliosis had the best clinical response to ALIF, with statistically significant improvement in the Short Form-12, Oswestry Disability Index, and Visual Analog Scale. Failed posterior fusion and adjacent segment disease showed statistically significant improvement in all of these clinical outcome scores, although the mean changes in the Short Form-12 Mental Component Summary, Oswestry Disability Index, and Visual Analog Scale (back pain) were lower. The overall radiological fusion rate was 94.4%. Superior radiological outcomes (fusion >90%) were observed in patients with degenerative disk disease (with and without radiculopathy), spondylolisthesis, and failed posterior fusion, whereas in adjacent segment disease, it was 80%. ALIF is an effective treatment for degenerative disk disease (with and without radiculopathy) and spondylolisthesis. Although results were promising for scoliosis, failed posterior fusion, and adjacent segment disease, further studies are necessary to establish the effectiveness of ALIF in these conditions.

  11. Prospective evaluation of CO2 laser-assisted sclerectomy surgery (CLASS) with Mitomycin C.

    Science.gov (United States)

    Cutolo, Carlo Alberto; Bagnis, Alessandro; Scotto, Riccardo; Bonzano, Chiara; Traverso, Carlo Enrico

    2018-01-01

    Our purpose was to evaluate the clinical safety and efficacy of CO 2 laser-assisted sclerectomy surgery (CLASS) with Mitomycin C (MMC) in open angle glaucoma (OAG). This was a prospective, uncontrolled, interventional case series. All subjects underwent CLASS procedure by a single surgeon. After the dissection of a partial thickness scleral flap, topical MMC 0.2 mg/ml was applied to the sclera and the conjunctiva for 3 min. The CO 2 laser with a beam-manipulating system was used to ablate the scleral tissue and expose the Schlemm's canal area. Primary outcomes: intraocular pressure (IOP) change, number of IOP-lowering medicaments change. Adverse events were evaluated as secondary outcomes. Twenty-one eyes of 21 patients underwent the CLASS procedure. Thirteen were primary OAG (62%), two normal pressure glaucoma (10%), three exfoliative glaucoma (14%) and three others secondary OAG. With a mean (SD) follow-up of 15.3 (5.9) months, the IOP changed from 25.4 (6.7) mmHg at baseline to 10.9 (3.4) mmHg al the last visit. Mean reduction of IOP was -14.5 mmHg (95% CI, -17.7 to -11.2, P filtration area that was successfully managed with office-based procedures. In one case (5%), CLASS was converted to trabeculectomy due to intraoperative perforation of the ablated area. There was one case of hypotony maculopathy successfully treated with placement of additional transconjunctival scleral flap sutures. The CLASS procedure with MMC is clinically safe and effective maintaining a large reduction in IOP and in the number of IOP-lowering medications with a mean follow-up of 15 months. Iris adhesion at the filtrating area warrants further evaluation and possibly reflects the surgeon's learning curve.

  12. Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery.

    Science.gov (United States)

    Dick, H Burkhard; Piovella, Matteo; Vukich, John; Vilupuru, Srividhya; Lin, Ling

    2017-07-01

    To evaluate the clinical acceptability of monocular implantation of the small-aperture (IC-8) intraocular lens (IOL) in 1 eye and an aspheric monofocal IOL in the fellow eye of bilateral cataract patients over 6 months postoperatively. Twelve clinics in Austria, Belgium, Germany, Italy, Spain, and Norway. Prospective case series. The visual acuity, depth of focus, contrast sensitivity, patient satisfaction, visual symptoms, and adverse events were assessed in patients who had bilateral cataract surgery followed by implantation of the small-aperture IOL in 1 eye and an aspheric monofocal IOL in the fellow eye. Uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuities were reported in Snellen notation. The study comprised 105 patients. At 6 months, the UDVA, UIVA, and UNVA in eyes with the small-aperture IOL were 20/23, 20/24, and 20/30, respectively. Ninety-nine percent, 95%, and 79% of patients achieved 20/32 or better binocular UDVA, UIVA, and UNVA, respectively. Ninety-three patients (95.9%) reported they would have the procedure again versus 4 patients (4.1%) who reported they would not have the procedure again. In eyes with the small-aperture IOL, the target-corrected defocus curve measured with 0.75 diopter (D) of myopia extended the range of functional near vision by an additional diopter without loss of distance vision compared with the distance-corrected defocus curves. The mean UIVA and UNVA remained at 20/25 and 20/32, respectively, for up to 1.5 D of residual astigmatism in eyes with the small-aperture IOL. The small-aperture IOL showed excellent visual performance, safety, patient satisfaction, and tolerance to residual astigmatism 6 months after implantation. Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  13. [Factors involved in the development of vasoplegia after cardiac surgery with extracorporeal circulation. A prospective observational study].

    Science.gov (United States)

    Durán Bruce, M; Gomar Sancho, C; Holguera, J C; Muliterno Español, E

    2014-05-01

    The incidence and risk factors for vasoplegia in the early postoperative period and at 24h are investigated in patients subjected to cardiopulmonary bypass surgery. Vasoplegia following cardiac surgery with cardiopulmonary bypass is associated with a high morbimortality. The risk factors described emerged from retrospective, non-controlled studies. Observational prospective study of 188 consecutive patients subjected to cardiac surgery with cardiopulmonary bypass in a single hospital between November 2011 and May 2012. Emergency surgery or complex procedures were excluded. Vasoplegia was assessed during the immediate postoperative period, and at 24h after surgery, and was defined as a mean arterial pressure below 50mmHg, and the need for a noradrenaline perfusion of more than 0.08μg/kg/min, monitored by cardiac output and systemic vascular resistances. The anaesthetic and cardiopulmonary bypass protocols, as well as haemodynamic management, were the same in all patients. Almost half (48%) of patients had vasoplegia in the immediate postoperative period, and 34% at 24h. Risk factors for immediate vasoplegia development were preoperative use of angiotensin converting enzyme inhibitor drugs, a mean arterial pressure<50mmHg immediately after beginning cardiopulmonary bypass, duration of aortic clamping as well as the cardiopulmonary bypass, and minimum temperature in cardiopulmonary bypass. Vasoplegia at 24h after surgery was correlated to preoperative angiotensin converting enzyme inhibitor drug treatment and cardiopulmonary bypass duration. The incidence of vasoplegia after cardiac surgery with cardiopulmonary bypass is high during the first 24 postoperative hours. Preoperative treatment with angiotensin converting enzyme inhibitor and the mean arterial pressure at the beginning of cardiopulmonary bypass are the more easily controllable risk factors. In patients arriving to surgery with those drugs, treatment or prevention of vasoplejia should be planned. Copyright

  14. Could application of epinephrine improve hemostatic efficacy of hemoclips for bleeding peptic ulcers? A prospective randomized study.

    Science.gov (United States)

    Grgov, Sasa; Radovanović-Dinić, Biljana; Tasić, Tomislav

    2013-09-01

    Bleeding from peptic ulcers can be effectively and safely treated with endoscopic hemoclips therapy. However, due to certain limiting factors of hemoclips, application of combination with another endoscopic method may give better results. The aim of this study was to examine the efficacy and safety of endoscopic hemoclips therapy and to evaluate potential benefits of this therapy combined with epinephrine in the treatment of bleeding peptic ulcers. This prospective randomized study included 70 patients with bleeding gastric or duodenal ulcer. In 34 of the patients endoscopic hemoclips therapy was applied (group I), and in 36 of them a combined therapy of hemoclips and epinephrine (group II). Initial hemostasis was achieved in most patients treated with endoscopic hemoclips therapy (94.1%) as well as in the patients treated with combination therapy (97.2%). After initial hemostasis achieved rebleeding occurred in 3 (9.3%) patients treated with hemoclips and in 2 (5.7%) patients treated with combination therapy, but this difference was not statistically significant (p > 0.05). The difference in the achieved final hemostasis between the group I (91.1%) and the group II (94.4%) was not statistically significant. Also, the differences between the two groups of patients in the need for blood transfusions, length of hospital stay, need for surgery and mortality were not statistically significant (p > 0.05). Endoscopic hemoclips therapy is effective and safe in treatment of bleeding peptic ulcers. Combination therapy of hemoclips and epinephrine has no advantage over hemoclips monotherapy.

  15. Effect of warming bupivacaine 0.5% on ultrasound-guided axillary plexus block. Randomized prospective double-blind study.

    Science.gov (United States)

    Trabelsi, W; Ben Gabsia, A; Lebbi, A; Sammoud, W; Labbène, I; Kchelfi, S; Ferjani, M

    2017-02-01

    To evaluate the effect of warming bupivacaine 0.5% on ultrasound-guided axillary brachial plexus block. Prospective, randomized, double-blind. Eighty patients undergoing elective or emergency surgery beyond the distal third of the upper limb were divided into two groups of 40 patients: the warm group received 15mL bupivacaine 0.5% heated to 37°C; the cold group received 15mL 0.5% bupivacaine stored for at least 24hours in the lower compartment of a refrigerator at 13-15°C. Onset and duration of sensory and motor blocks were evaluated every 5minutes for 40minutes. Postoperative pain was evaluated at 1, 3, 6, 12 and 24hours. Effective analgesia time was recorded as the interval between anesthetic injection and the first analgesia requirement (VAS>30mm). Time to onset of sensory and motor block was significantly shorter in the warm group, and mean duration of sensory and motor block and of postoperative analgesia significantly longer. Warming bupivacaine 0.5% to 37°C accelerated onset of sensory and motor block and extended action duration. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  16. A prospective randomized study comparing polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and ulcer.

    Science.gov (United States)

    Campos, Walter; Torres, Inez Ohashi; da Silva, Erasmo Simão; Casella, Ivan Benaduce; Puech-Leão, Pedro

    2015-08-01

    To compare polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and active ulcer treated at a single vascular center. Fifty-eight limbs of 56 patients with active ulcers were prospectively randomized to undergo either surgical treatment or foam sclerotherapy. Patients completed the Aberdeen Varicose Veins Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and Venous Disability Score (VDS). The follow-up was 502 ± 220 days. The ulcer healed in 100% and 91.3% of patients treated with surgery or foam sclerotherapy, respectively (P > 0.05). There were no significant differences in AVVQ, VCSS, and VDS between the 2 groups after the procedures (P = 0.45, 0.58, and 0.66, respectively; Mann-Whitney U test). Complications occurred in 14.2% and 13.0% in the surgical and foam sclerotherapy groups, respectively. Surgical treatment and foam sclerotherapy achieved high rates of ulcer healing, without a statistically significant difference. Both treatments led to significant improvements in VCSS, VDS, AVVQ scores, demonstrating improvements in clinical outcomes and quality of life. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  17. Strict versus liberal target range for perioperative glucose in patients undergoing coronary artery bypass grafting: a prospective randomized controlled trial.

    Science.gov (United States)

    Desai, Shalin P; Henry, Linda L; Holmes, Sari D; Hunt, Sharon L; Martin, Chidima T; Hebsur, Shrinivas; Ad, Niv

    2012-02-01

    The purpose of this study was to test the hypothesis that a liberal blood glucose strategy (121-180 mg/dL) is not inferior to a strict blood glucose strategy (90-120 mg/dL) for outcomes in patients after first-time isolated coronary artery bypass grafting and is superior for glucose control and target blood glucose management. A total of 189 patients undergoing coronary artery bypass grafting were investigated in this prospective randomized study to compare 2 glucose control strategies on patient perioperative outcomes. Three methods of analyses (intention to treat, completer, and per protocol) were conducted. Observed power was robust (>80%) for significant results. The groups were similar on preoperative hemoglobin A(1c) and number of diabetic patients. The liberal group was found to be noninferior to the strict group for perioperative complications and superior on glucose control and target range management. The liberal group had significantly fewer patients with hypoglycemic events (liberal range after coronary artery bypass grafting led to similar outcomes compared with a strict target range and was superior in glucose control and target range management. On the basis of the results of this study, a target blood glucose range of 121 to 180 mg/dL is recommended for patients after coronary artery bypass grafting as advocated by the Society of Thoracic Surgeons. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  18. [Surgery for degenerative spondylolisthesis of the lumbar spine using intra-articular fusion. A prospective study].

    Science.gov (United States)

    Hrabálek, L; Wanek, T; Adamus, M; Cecháková, E; Buřval, S; Langová, K; Vaverka, M

    2014-01-01

    The aim of the study is to present our surgical method of treating degenerative spondylolisthesis, which includes radical bilateral laminectomy to relieve compression on the spinal cord, transpedicular fixation of the segment and arthrodesis by bilateral intra-articular fusion. This surgery was indicated in patients with grade I or grade II of degenerative sponylolisthesis with a 4-mm or more slippage. Our prospectively studied group consisted of 46 patients (17 men, 29 women; average age, 64.2 years; range, 39-84 years). Before surgery and at 1 year after the procedure, the intensity of axial pain and that of radicular pain were each assessed using the visual Analogue Scale (VAS). Difficulty in performing daily living activities was measured by the Oswestry Disability Index (ODI). The surgical procedure included laminectomy, partial medial facetectomy, foraminotomy to relieve pressure on the spinal nerve roots and transpedicular fixation to provide stability. Using a cutter, cartilage was separated off the cortical bone and, in order to facilitate fusion, bone cavities thus produced were filed with corticospongious grafts harvested from the removed vertebral arch with Kerrison forceps. At 1-year follow-up, dynamic X-ray was used to evaluate spine alignment and, on a CT scan, the degree of intra-articular fusion was assessed. Fusion was achieved when bone density measurement showed more than 350 Hounsfield Units (HU). For the measurements, the authors used their own modified method by means of a Region of Interest (ROI) analysis. The clinical and radiographic results were statistically evaluated. At 1 year after surgery, lumbar flexion-extension bending X-ray films revealed stability of the treated segments in all patients (100%). CT examination showed bone density higher than 350 HU at both joints, i.e., complete bone fusion, also in all 46 patients. The mean post-operative ODI score was significantly lower than its mean pre-operative value (23.6 vs 55.4), which

  19. [Current Status and Future Prospect of Robot-assisted Thoracoscopic Surgery].

    Science.gov (United States)

    Nakamura, Hiroshige; Haruki, Tomohiro

    2018-01-01

    As surgical robots have widely spread, verification of their usefulness in the general thoracic surgery field is required. The most favorable advantage of robot-assisted surgery is the markedly free movement of joint-equipped robotic forceps under 3-dimensional high-vision. Accurate operation makes complex procedures straightforward and may overcome weak points of previous thoracoscopic surgery. Robot-assisted surgery for lung cancer and mediastinal disease have been safely introduced and initial results have shown favorable. It is still at the stage of clinical research, but recently a lot of merits of robot-assisted thoracic surgery are proved. Although safety management, education and significant cost are also important issues, the robotic-assisted thoracoscopic surgery will become one of the surgical options in minimally invasive surgery.

  20. 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.

  1. 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.

  2. The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

    NARCIS (Netherlands)

    de Jong, Leo A. M. S.

    2009-01-01

    The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

  3. 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.

  4. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial.

    Science.gov (United States)

    Jeschke, Marc G; Kulp, Gabriela A; Kraft, Robert; Finnerty, Celeste C; Mlcak, Ron; Lee, Jong O; Herndon, David N

    2010-08-01

    Hyperglycemia and insulin resistance have been shown to increase morbidity and mortality in severely burned patients, and glycemic control appears essential to improve clinical outcomes. However, to date no prospective randomized study exists that determines whether intensive insulin therapy is associated with improved post-burn morbidity and mortality. To determine whether intensive insulin therapy is associated with improved post-burn morbidity. A total of 239 severely burned pediatric patients with burns over greater than 30% of their total body surface area were randomized (block randomization 1:3) to intensive insulin treatment (n = 60) or control (n = 179). Demographics, clinical outcomes, sepsis, glucose metabolism, organ function, and inflammatory, acute-phase, and hypermetabolic responses were determined. Demographics were similar in both groups. Intensive insulin treatment significantly decreased the incidence of infections and sepsis compared with controls (P < 0.05). Furthermore, intensive insulin therapy improved organ function as indicated by improved serum markers, DENVER2 scores, and ultrasound (P < 0.05). Intensive insulin therapy alleviated post-burn insulin resistance and the vast catabolic response of the body (P < 0.05). Intensive insulin treatment dampened inflammatory and acute-phase responses by deceasing IL-6 and acute-phase proteins compared with controls (P < 0.05). Mortality was 4% in the intensive insulin therapy group and 11% in the control group (P = 0.14). In this prospective randomized clinical trial, we showed that intensive insulin therapy improves post-burn morbidity. Clinical trial registered with www.clinicaltrials.gov (NCT00673309).

  5. PROSPECTIVE RANDOMIZED TRIAL ASSESSING THE IMPACT OF FEEDBACK MECHANISMS ON PATIENT POSITIONING.

    Science.gov (United States)

    Dimopoulos, Spyridon; Vivell, Julian; Ziemssen, Focke; Bende, Thomas; Bartz-Schmidt, Karl Ulrich; Leitritz, Martin Alexander

    2017-12-20

    To investigate the use of a head-fixed feedback sensor to improve good positioning times after macular hole or retinal detachment surgery. The instructional methods, macular hole closure rates, and questionnaire responses were also evaluated. After randomization, sensor devices with different feedback types (none/acoustic/vibration) were fixed on the patients' heads. Two positioning recommendations (verbal/illustrated) were used. The posturing data were logged every 500 ms for 24 hours. Forty-eight data sets (24 per group) were evaluated. Using sensory feedback, the median time for face-down positioning after macular hole surgery (Group 1) was significantly boosted from 463 minutes (range: 61-1,168) to 1,257 minutes (range: 1,024-1,327). The side positioning time after retinal detachment surgery (Group 2) increased from a median of 1,032 minutes (range: 520-1,165) to 1,284 minutes (range: 1,231-1,437). The night-time alarm records were reduced; however, the instructional methods exhibited no noteworthy effects. The questionnaires indicated positive acceptance of the sensors. Sensory feedback may help in cases where face-down or side positioning is recommended. These constant reminders were superior to verbal or written reminders; however, further studies are required to assess the clinical impact of sensory feedback on patient positioning.

  6. 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.

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

    Science.gov (United States)

    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.

  8. 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.

  9. A prospective comparison of postoperative pain and quality of life in robotic assisted vs conventional laparoscopic gynecologic surgery.

    Science.gov (United States)

    Zechmeister, Jenna R; Pua, Tarah L; Boyd, Leslie R; Blank, Stephanie V; Curtin, John P; Pothuri, Bhavana

    2015-02-01

    We sought to compare robotic vs laparoscopic surgery in regards to patient reported postoperative pain and quality of life. This was a prospective study of patients who presented for treatment of a new gynecologic disease requiring minimally invasive surgical intervention. All subjects were asked to take the validated Brief Pain Inventory-Short Form at 3 time points to assess pain and its effect on quality of life. Statistical analyses were performed using Pearson x(2) and Student's t test. One hundred eleven were included in the analysis of which 56 patients underwent robotic assisted surgery and 55 patients underwent laparoscopic surgery. There was no difference in postoperative pain between conventional laparoscopy and robotic assisted surgery for gynecologic procedures. There was a statistically significant difference found at the delayed postoperative period when evaluating interference of sleep, favoring laparoscopy (ROB 2.0 vs LSC 1.0; P = .03). There were no differences found between the robotic and laparoscopic groups of patients receiving narcotics (56 vs 53, P = .24, respectively), route of administration of narcotics (47 vs 45, P > .99, respectively), or administration of nonsteroidal antiinflammatory medications (27 vs 21, P = .33, respectively). Our results demonstrate no difference in postoperative pain between conventional laparoscopy and robotic assisted surgery for gynecologic procedures. Furthermore, pain did not appear to interfere consistently with any daily activity of living. Interference of sleep needs to be further evaluated after controlling for bilateral salpingo-oophorectomy. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Incidence and risk factors for hospital-acquired pneumonia after surgery for gastric cancer: results of prospective surveillance.

    Science.gov (United States)

    Mohri, Yasuhiko; Tonouchi, Hitoshi; Miki, Chikao; Kobayashi, Minako; Kusunoki, Masato

    2008-06-01

    Postoperative hospital-acquired pneumonia (HAP) is recognized as a major risk associated with surgery. Although upper abdominal surgery is known to have the highest incidence of postoperative HAP, little is known about the risk factors that contribute to HAP after gastric cancer surgery. The aim of this study was to determine the incidence and risk factors for HAP after elective surgery for gastric cancer. We conducted prospective surveillance of all elective gastric resections by surgeons in ten affiliated hospitals, including ours, from May 2001 to May 2005. The outcome of interest was postoperative HAP. Univariate and multivariate analyses were performed to determine the predictive significance of variables in gastric cancer surgery. A total of 529 patients undergoing elective operations for gastric cancer were admitted to the program. Postoperative HAP was identified in 20 patients (3.6%). Univariate and multivariate analyses showed that male gender and intra- and/or postoperative blood transfusion were independently predictive of postoperative HAP. Male gender and intra- and/or postoperative blood transfusion were independent risk factors for the development of HAP after elective resection of gastric cancer. Surgeons should keep these risk factors in mind when managing postoperative patients.

  11. Effects of preventive surgery for unruptured intracranial aneurysms on attention, executive function, learning and memory: a prospective cohort study.

    Science.gov (United States)

    Chung, Joonho; Seok, Jeong-Ho; Kwon, Min A; Kim, Yong Bae; Joo, Jin-Yang; Hong, Chang-Ki

    2016-01-01

    We prospectively evaluated the effects of preventive surgery for unruptured intracranial aneurysms on attention, executive function, learning and memory. Between March 2012 and June 2013, 56 patients were recruited for this study. Fifty-one patients met the inclusion criteria and were enrolled. Inclusion criteria were as follows: (1) age ≤65 years and (2) planned microsurgery or endovascular surgery for unruptured intracranial aneurysm. Exclusion criteria were as follows: (1) preoperative intelligence quotient color test (WCT) and verbal learning test (VLT) were performed before and after (6 months) preventive surgery. ACCPT (attention), WCT (executive function) and VLT (learning and memory) scores did not change significantly between the pre- and postoperative evaluations. The ACCPT, WCT, total VLT scores (verbal learning) and delayed VLT scores (memory) did not differ significantly between patients undergoing microsurgery and those undergoing endovascular surgery. However, ACCPT, WCT and delayed VLT scores decreased postoperatively in patients with leukoaraiosis on preoperative FLAIR images (OR 9.899, p = 0.041; OR 11.421, p = 0.006; OR 2.952, p = 0.024, respectively). Preventive surgery for unruptured intracranial aneurysms did not affect attention, executive function, learning or memory. However, patients with leukoaraiosis on FLAIR images might be prone to deficits in attention, executive function and memory postoperatively, whereas learning might not be affected.

  12. A prospective randomized study of operative treatment for noncomminuted humeral shaft fractures: conventional open plating versus minimal invasive plate osteosynthesis.

    Science.gov (United States)

    Kim, Ji Wan; Oh, Chang-Wug; Byun, Young-Soo; Kim, Jung Jae; Park, Ki Chul

    2015-04-01

    To compare the clinical and radiologic results of conventional open plating (COP) and minimally invasive plate osteosynthesis (MIPO) in the treatment of noncomminuted humeral shaft fractures. Randomized prospective study. Five level 1 trauma centers. Sixty-eight consecutive patients were randomized into 2 study groups: those treated by COP (COP group; n = 32) and those treated by MIPO (MIPO group; n = 36). Simple humeral shaft fractures (AO/OTA classification types A and B) were reduced by open reduction or closed reduction and fixed with a narrow 4.5/5.0 locking compression plate, metaphyseal locking compression plate, or proximal humeral internal locking system plate to the anterior lateral aspect of the humerus. Fracture healing time, operative time, radiation exposure time, and intraoperative nerve injury. To assess shoulder and elbow function, we used the University of California, Los Angeles (UCLA) scoring system and the Mayo elbow performance index, including the range of motion and pain. Radiographic measurements included fracture alignment, delayed union, and nonunion. Thirty-one fractures (97%) healed in the COP group within 16 weeks, whereas 36 fractures (100%) were healed in the MIPO group by 15 weeks. No significant difference was observed in the operative time or complication rates. In both groups, all fractures achieved union without malunion and with excellent functional outcomes by definition of the Mayo elbow performance index and UCLA scoring system. This study confirmed a high overall rate of union and excellent functional outcomes in both MIPO and COP groups. MIPO is equivalent to COP as a safe and effective method for simple types of humeral shaft fractures when surgery is indicated, and the surgeon is experienced in the technique. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  13. Prospective Randomized Evaluation of Intraoperative Application of Autologous Platelet-Rich Plasma on Surgical Site Infection or Delayed Wound Healing.

    Science.gov (United States)

    SanGiovanni, Thomas P; Kiebzak, Gary M

    2016-05-01

    Prevention of surgical site infections and the reduction of wound-related complication rates have become increasingly emphasized by hospital task groups and government agencies given the degree of economic burden it places on the health care system. Platelet-rich plasma (PRP) contains growth factors and other biomolecules that promote endogenous microbicidal activity. We hypothesized that PRP would help prevent postoperative infection and delayed wound healing (DWH). We randomized patients having foot or ankle surgery to the treatment group receiving intraoperative PRP (applied to operative field) and platelet-poor plasma at closing (PPP, on the sutured skin) or the control group (no PRP/PPP). The incidence of deep surgical site infection and DWH (collectively called endpoints) was compared between groups (n = 250/group). PRP had a mean 5.3-fold platelet concentration compared to whole blood, with concentrated white blood cells. Mean age (±SD) of patients was 52 years (±15), 65% were women. Minor and major operative procedures were included. Patients were followed for 60 days. Seventy controls had PRP prepared for assay of growth factors. Procedure mix, ASA scores, mean operative times, and comorbidity mix were similar between groups. The primary result was no difference in number of endpoints between groups: 19 patients in the PRP group (7.6%) versus 18 controls (7.2%). Endpoints were deep surgical site infections in 2 PRP/PPP patients and 1 control, and DWH in 17 PRP/PPP patients and 17 controls. Analysis of PRP samples revealed a large variation in growth factor concentrations between patients. Intraoperative application of PRP/PPP did not reduce the incidence of postoperative infection or DWH. Growth factor profiles varied greatly between patients, suggesting that the potentially therapeutic treatment delivered was not consistent from patient-to-patient. Level I, prospective randomized trial. © The Author(s) 2015.

  14. A Prospective Randomized Clinical Trial Comparing 3D and Standard Miniplates in Treatment of Mandibular Symphysis and Parasymphysis Fractures.

    Science.gov (United States)

    Agarwal, Mohit; Meena, Balram; Gupta, D K; Tiwari, Anjali Dave; Jakhar, Sunil Kumar

    2014-06-01

    To compare the efficacy of the 3D miniplates to standard miniplates in the osteosynthesis of mandibular symphysis and parasymphysis fractures on the basis of clinical parameters and radiographic evaluation. A prospective randomized clinical trial was conducted to treat consecutive mandibular symphysis and parasymphysis fractures. The patients were randomly divided into 2 groups. The patients underwent osteosynthesis in group A with 3D titanium miniplates and in group B with conventional titanium miniplates. The cause of trauma, the number of days from injury to surgery, average age and gender were all reviewed. The assessment of the patients was done at 1, 3, and 6 weeks and 3 months using the clinical parameters and radiographic evaluation. Eighty patients with isolated symphysis or parasymphysis fracture met the inclusion criteria. In our study, a statistically significant difference was not found in the clinical parameters such as pain, swelling, infection, paresthesia, hardware failure, and mobility between the fracture segments. Similarly Radiological evaluation did not show any statistically significant difference in reduction between the 2 groups. 3D plates are difficult to adapt and use sometimes, but operative time is less with them in treatment of symphysis and parasymphysis fractures. The use of 3D miniplates for symphysis and parasymphysis fracture fixation was efficacious enough to bear the masticatory load during osteosynthesis of the fracture. Although 3D miniplate system is difficult to adapt and difficult to use in cases of fractures involving the mental nerve, they provide the advantage of less operative time and less implant material in treatment of symphysis and parasymphysis fracture, with clinical results almost similar to those seen with conventional miniplate osteosynthesis.

  15. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  16. The effect of colorectal surgery in female sexual function, body image, self-esteem and general health: a prospective study.

    Science.gov (United States)

    da Silva, Giovanna M; Hull, Tracy; Roberts, Patricia L; Ruiz, Dan E; Wexner, Steven D; Weiss, Eric G; Nogueras, Juan J; Daniel, Norma; Bast, Jane; Hammel, Jeff; Sands, Dana

    2008-08-01

    To evaluate women's sexual function, self-esteem, body image, and health-related quality of life after colorectal surgery. Current literature lacks prospective studies that evaluate female sexuality/quality of life after colorectal surgery using validated instruments. Sexual function, self-esteem, body image, and general health of female patients undergoing colorectal surgery were evaluated preoperatively, at 6 and 12 months after surgery, using the Female Sexual Function Index, Rosenberg Self-Esteem scale, Body Image scale and SF-36, respectively. Ninety-three women with a mean age of 43.0 +/- 11.6 years old were enrolled in the study. Fifty-seven (61.3%) patients underwent pelvic and 36 (38.7%) underwent abdominal procedures. There was a significant deterioration in overall sexual function at 6 months after surgery, with a partial recovery at 12 months (P = 0.02). Self-esteem did not change significantly after surgery. Body image improved, with slight changes at 6 months and significant improvement at 12 months, compared with baseline (P = 0.05). Similarly, mental status improved over time with significant improvement at 12 months, with values superior than baseline (P = 0.007). Physical recovery was significantly better than baseline in the first 6 months after surgery with no significant further improvement between 6 and 12 months. Overall, there were no differences between patients who had abdominal procedures and those who underwent pelvic dissection, except that patients from the former group had faster physical recovery than patients in the latter (P = 0.031). When asked about the importance of discussing sexual issues, 81.4% of the woman stated it to be extremely or somewhat important. Surgical treatment of colorectal diseases leads to improvement in global quality of life. There is, however, a significant decline in sexual function postoperatively. Preoperative counseling is desired by most of the patients.

  17. The effects of prolapse surgery on vaginal wall sensibility, vaginal vasocongestion, and sexual function: a prospective single centre study.

    Science.gov (United States)

    Lakeman, Marielle M E; Laan, Ellen; Roovers, Jan-Paul W R

    2014-11-01

    Prolapse surgery has been shown to positively alter body image and decrease pelvic floor symptoms, hereby possibly improving sexual function. However, the surgical trauma itself may adversely affect sexual function, by damaging vaginal innervation and vascularization. The aim of this study is to evaluate the effects of vaginal prolapse surgery on vaginal vasocongestion, vaginal wall sensibility, and sexual function. A prospective study was performed, including patients scheduled for vaginal prolapse surgery. Participants underwent measurements before and 6 months after surgery, during non-erotic and erotic visual stimuli. Measurements were performed using a vaginal combi-probe which includes vaginal photoplethysmography to assess vaginal pulse amplitude (VPA) (representing vaginal vasocongestion), and four pulse-generating electrodes to measure vaginal wall sensibility (representing vaginal innervation). Sexual function was assessed using validated questionnaires (FSFI, FSDS-R, SSAQ). Twenty-nine women were included, 24 (83%) completed the 6 months follow-up. VPA analysis showed a significant reduction in vaginal vasocongestion during sexual stimulation post-operatively (pre-op 2.4 mV (SD 2.5) vs. post-op 1.7 mV (SD 2.4), P = 0.05). Vaginal wall sensibility in the cranial posterior vaginal wall was significantly reduced after surgery (pre-op 13.3 mA vs. post-op 17.5 mA, P sensibility in the other three locations was not affected by surgery. Sexual function as assessed with questionnaires, was not significantly affected. Prolapse surgery negatively impacted levels of vaginal vasocongestion during erotic stimuli as well as vaginal wall sensibility in the cranial posterior wall. Future studies are needed to tease out if these changes in physiological factors are relevant for subjective sexual function. © 2013 Wiley Periodicals, Inc.

  18. Systemic, intratympanic and combined administration of steroids for sudden hearing loss. A prospective randomized multicenter trial.

    Science.gov (United States)

    Tsounis, Michael; Psillas, George; Tsalighopoulos, Miltiadis; Vital, Victor; Maroudias, Nicolas; Markou, Konstantinos

    2018-01-01

    The purpose of this prospective, randomized, multicenter clinical trial was to compare the therapeutic efficacy of systemic versus intratympanic versus combined administration of steroids in the treatment of idiopathic sudden sensorineural hearing loss. 102 patients with an up to 14 days history of idiopathic sudden sensorineural hearing loss were randomized to 1 of 3 arms and followed prospectively. Group A (35 patients) received prednisolone intravenously followed by methylprednisolone orally, whereas Group B (34 patients) were administered intratympanic methylprednisolone. Patients in Group C (33 patients) were administered the combination of the above-mentioned treatment modalities. The patients were followed-up with pure tone audiograms on days 1 (initiation of treatment), 3, 5, 10, 30 and 90. The final mean hearing gain was 29.0 dB HL for Group A, 27.0 dB HL for Group B and 29.8 dB HL for Group C. The differences between the three groups were not statistically significant. When hearing improvement was assessed according to Siegel's criteria, no statistically significant difference was recorded either. Furthermore, patients younger than 60 years old achieved significantly better hearing outcomes. The results demonstrated that systemic, intratympanic and combined steroid administration have similar results in the primary treatment of idiopathic sudden hearing loss. Younger patients are more likely to achieve better hearing outcomes.

  19. Prospective Randomized Study of the Effect of Music on the Efficiency of Surgical Closures.

    Science.gov (United States)

    Lies, Shelby R; Zhang, Andrew Y

    2015-09-01

    Music is commonly played in operating theaters. Some surgeons believe music reduces stress and operative time, while others think music is a distraction and should be avoided. There is limited published evidence evaluating the effects of music on surgical performance. The goal of this study is to evaluate the effect of music on simple wound closure. Plastic surgery residents were asked to perform layered closures on pigs' feet with and without their preferred music playing. Simple randomization was used to assign residents to the music playing first or music playing second group. The time to complete the repair was measured and repairs were graded by blinded faculty. Results were analyzed to determine significant differences in time to complete the task and quality of repair. Participants were retested in a second session with music played in the opposite order to evaluate consistency. Listening to preferred music decreased repair time by 8% for all plastic surgery residents (p = 0.009). Subgroup analysis demonstrated even more significant improvement in speed for senior residents (PGY 4-6), resulting in a 10% decrease in repair time (p = 0.006). The quality of repair was also better in the music group, at 3.3 versus 3.1 (p = 0.047). Retesting revealed results remained significant whether music was played first or second. Playing preferred music made plastic surgery residents faster in completing wound closure with a 10% improvement in senior residents. Music also improved quality of repair as judged by blinded faculty. Our study showed that music improves efficiency of wound closure, which may translate to healthcare cost savings. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  20. Multisite prospective investigation of psychological outcomes following cataract surgery in Vietnam

    OpenAIRE

    Berle, David; Steel, Zachary; Essue, Beverley M; Keay, Lisa; Jan, Stephen; Tan Phuc, Huynh; Hackett, Maree L

    2017-01-01

    Background Cataract surgery is a low-cost and effective intervention. There is increasing evidence to suggest that cataract surgery is associated with improvements in mobility, overall functioning and reductions in psychological distress. Within low-income and middle-income countries, cataract surgery has also been documented to lead to reductions in psychological distress; however, differences in economic activity and engagement in paid and domestic work in these countries may moderate such ...

  1. Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study.

    Science.gov (United States)

    Turchetti, Giuseppe; Pierotti, Francesca; Palla, Ilaria; Manetti, Stefania; Freschi, Cinzia; Ferrari, Vincenzo; Cuschieri, Alfred

    2017-02-01

    Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA). The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches. The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p hospital stay of RAS approach (p hospitalization and after discharge. The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

  2. A prospective, randomized, double-blind comparison of ultrasound-guided axillary brachial plexus blocks using 2 versus 4 injections.

    Science.gov (United States)

    Imasogie, Ngozi; Ganapathy, Sugantha; Singh, Sudha; Armstrong, Kevin; Armstrong, Paidrig

    2010-04-01

    In this prospective, randomized, double-blind study, we compared the effectiveness and time efficiency of perioperative axillary blocks performed via 2 different techniques, 1 involving 2 and the other 4 separate skin punctures. One hundred twenty patients undergoing upper limb surgery were randomized to receive either (1) an axillary brachial plexus block involving 2 injections, with 30 mL local anesthetic injected posterior to the axillary artery (with redirection, as needed, to achieve circumferential spread), plus 10 mL local anesthetic to the musculocutaneous nerve, guided by ultrasound (group 1, n = 56); or (2) 4 separate 10-mL injections to the median, ulnar, radial, and musculocutaneous nerves, using a combined ultrasound and neurostimulation technique (group 2, n = 58). All patients received 40 mL of 0.5% ropivacaine with 1:400,000 epinephrine. The primary outcome was the success rate of the block, defined as anesthesia adequate for surgery. Secondary outcomes were the time to administer the block, time to the onset of motor-sensory block, time to surgical readiness, and incidence of adverse events. The 2-injection technique was slightly faster to administer (8 vs 11 minutes, P = 0.003). The mean nerve block score was slightly higher for the 4-injection group at the 10-, 15-, 20-, and 30-minute time points, but the cumulative percentages of blocks having taken effect were not significantly different over these time points, at 0.0%, 5.4%, 12.5%, and 37.5% among those who had received a 2-injection block versus 6.9%, 10.4%, 19.0%, and 48.3%, respectively, with the 4-injection block (P = 0.20). There was no difference in the percentage of patients with complete block by 30 minutes (32.1% vs 37.5%, P = 0.55) or in final block success rates (89.3% vs 87.9%, P = 0.99). An ultrasound-guided 2-injection axillary block may be as effective as, and more time efficient than, a 4-injection technique.

  3. 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...

  4. 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...

  5. A prospective, randomized study addressing the need for physical simulation following virtual simulation

    International Nuclear Information System (INIS)

    Valicenti, Richard K.; Waterman, Frank M.; Corn, Benjamin W.; Curran, Walter J.

    1997-01-01

    Purpose: To accurately implement a treatment plan obtained by virtual or CT simulation, conventional or physical simulation is still widely used. To evaluate the need for physical simulation, we prospectively randomized patients to undergo physical simulation or no additional simulation after virtual simulation. Methods and Materials: From July 1995 to September 1996, 75 patients underwent conformal four-field radiation therapy planning for prostate cancer with a commercial grade CT simulator. The patients were randomized to undergo either port filming immediately following physical simulation or port filming alone. The precision of implementing the devised plan was evaluated by comparing simulator radiographs and/or port films against the digitally reconstructed radiographs (DRRs) for x, y, and z displacements of the isocenter. Changes in beam aperture were also prospectively evaluated. Results: Thirty-seven patients were randomized to undergo physical simulation and first day port filming, and 38 had first day treatment verification films only without a physical simulation. Seventy-eight simulator radiographs and 195 first day treatment port films were reviewed. There was no statistically significant reduction in treatment setup error (>5 mm) if patients underwent physical simulation following virtual simulation. No patient required a resimulation, and there was no significant difference in changes of beam aperture. Conclusions: Following virtual simulation, physical simulation may not be necessary to accurately implement the conformal four-field technique. Because port filming appears to be sufficient to assure precise and reliable execution of a devised treatment plan, physical simulation may be eliminated from the process of CT based planning when virtual simulation is available

  6. Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial.

    Science.gov (United States)

    Romanò, Carlo L; Monti, Lorenzo; Logoluso, Nicola; Romanò, Delia; Drago, Lorenzo

    2015-11-01

    The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient's group allocation. Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0-4) vs. 1.9 ± 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. II.

  7. 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.

  8. ORGAN-SPARING SURGERY FOR RECTAL CANCER: EVOLUTION, CURRENT TRENDS, AND PROSPECTS

    Directory of Open Access Journals (Sweden)

    R. I. Tamrazov

    2013-01-01

    Full Text Available The article describes the main stages of the development of sphincter-saving surgery for rectal cancer. An historical look at this issue from the standpoint of research of past years in our country and abroad, as well as analysis of current sphincter-preserving surgery and future directions in this area.

  9. 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

  10. 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.

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

    Science.gov (United States)

    2011-01-01

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

  12. Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing three different techniques.

    Science.gov (United States)

    Dapri, Giovanni; Cadière, Guy Bernard; Himpens, Jacques

    2010-04-01

    Gastric leak and hemorrhage are the most important challenges after laparoscopic sleeve gastrectomy (LSG). In order to reduce these complications, the staple line can be reinforced by absorbable sutures or by the use of glycolide trimethylene carbonate copolymer onto the linear stapler (Gore Seamguard; W.L. Gore & Associates, Inc, Flagstaff, AZ). To our knowledge, there are no randomized studies showing the utility of staple line reinforcement during LSG. The purpose of this study was to randomly compare three techniques in LSG: no staple line reinforcement (group 1), buttressing of the staple line with Gore Seamguard (group 2), and staple line suturing (group 3). Between January 2008 and February 2009, 75 patients were prospectively and randomly enrolled in the three different techniques of handling the staple line during LSG. The patient groups were similar (NS). Mean operative time to perform the stomach sectioning was 15.9 +/- 5.9 min (group 1), 20.8 +/- 8.1 min (group 2), and 30.8 +/- 10.1 min (group 3) (p Gore Seamguard statistically reduces blood loss during stomach sectioning as well as overall blood loss. No staple line reinforcement statistically decreases the time to perform stomach sectioning and the total operative time. No significant difference is evidenced in terms of postoperative leak between the three techniques of LSG.

  13. Methadone versus morphine for treatment of neonatal abstinence syndrome: a prospective randomized clinical trial.

    Science.gov (United States)

    Brown, M S; Hayes, M J; Thornton, L M

    2015-04-01

    Compare duration of treatment of neonatal abstinence syndrome between methadone and morphine. A prospective, double-masked, randomized trial at a single site. Randomization of methadone or morphine was stratified for maternal treatment with methadone or buprenorphine. Inclusion criteria were (i) maternal treatment with prescribed methadone or buprenorphine, (ii) withdrawal treatment criteria, (iii) adjusted gestational age ⩾35(0/7) weeks and (iv) medically stable. Primary outcome was length of opioid treatment. From January 2011 through October 2012, 78 infants were eligible for the study: 41 methadone-exposed and 37 buprenorphine-exposed. Consent was obtained from 31 mothers, 13/41 (32%) methadone-treated and 18/37 (49%) buprenorphine-treated. Length of opioid treatment was significantly shorter for methadone than morphine treatment, median 14 versus 21 days (P=0.008). Methadone had a shorter length of neonatal withdrawal treatment compared with morphine. Owing to the smaller sample size and single site, a larger randomized study is needed.

  14. A Prospective Study of the Conservative Management of Asymptomatic Preoperative and Postoperative Gallbladder Disease in Bariatric Surgery.

    Science.gov (United States)

    Pineda, Omar; Maydón, Hernán G; Amado, Mónica; Sepúlveda, Elisa M; Guilbert, Lizbeth; Espinosa, Omar; Zerrweck, Carlos

    2017-01-01

    Bariatric surgery is the most effective therapy for weight loss in patients with morbid obesity. One of the most common long-term complications includes cholelithiasis. There is not a clear consensus in how to treat an asymptomatic gallbladder disease before and after bariatric surgery. Prospective study with every patient submitted to bariatric surgery from 2012 to 2014. The gallbladder status was assessed with an ultrasound before and after surgery (12 months), and a conservative management was conducted for patients with asymptomatic disease (preoperative and de novo); the need for delayed cholecystectomy was reported. Secondarily, an analysis of weight loss (%EWL) and gallbladder status was performed. Two-hundred and two bariatric surgeries were performed. The global incidence of preoperative gallbladder disease was 34.3 %, with 14.2 % presenting sludge, 20.1 % asymptomatic gallstones, and 2.3 % symptomatic gallstones. The final analysis was based on 146 patients; female sex comprised 81.1 % of cases with a mean age of 38.5 years. After 12 months, de novo gallbladder disease was observed in 21.2 %. The overall rate of cholecystectomy because of symptomatic disease after 12 months was 3.4 % (2 % developed acute cholecystitis). There were no differences in %EWL between patients with de novo gallbladder disease and those without. Conservative management of asymptomatic gallbladder disease in candidates to bariatric surgery is safe and can be offered in every case, based on the low percentage of patients requiring further cholecystectomy after 12 months. Also, a conservative management can be offered to patients developing de novo sludge/cholelithiasis without related symptoms.

  15. Factors associated to post-operative nausea and vomiting following oral and maxillofacial surgery: a prospective study.

    Science.gov (United States)

    Albuquerque, Assis Filipe Medeiros; Queiroz, Salomão Israel Monteiro Lourenço; Germano, Adriano Rocha; da Silva, José Sandro Pereira

    2017-03-01

    This study aims to address and assess possible factors associated with nausea and vomiting (NV) following oral and maxillofacial surgery. A prospective study was carried out in the period from December 2013 to January 2016 targeting all attended cases in that period. For statistical analysis, Pearson chi-square and Fisher tests were used to verify association and ANOVA and Student's t tests to test for significant difference, p was defined as ≤0.05. The sample group consisted of 207 patients with an average age of 33.56 years (±13.23), and 70.5% of subjects were male. Calculations based on the predictive model showed that a female patient with prior history of nausea and vomiting who used opioids and had intra-oral surgical access would have a 96% chance of experiencing a nausea and vomiting episode. Other factors like age, being overweight, anesthesia, surgery duration, and duration of hospital stay also contribute so that these aspects must be paid careful attention prior to surgery to ensure a suitably orientated treatment that will avoid disturbances caused by post-operative nausea and vomiting. The occurrence of post-operative nausea and vomiting after oral and maxillofacial surgery was found to be more higher incidence associated to female patients who used opioids, who had a prior history of NV, whose surgery involved intra-oral access, who were in the second or third decades of their lives, who have above average weight, and who have long anesthesia when undergoing surgery, resulting in a long hospital stays.

  16. A prospective study in children: Pre- and post-surgery use of vitamin E in surgical incisions.

    Science.gov (United States)

    Zampieri, Nicola; Zuin, Veronica; Burro, Roberto; Ottolenghi, Alberto; Camoglio, Francesco Saverio

    2010-09-01

    One of the main problems of elective surgery is the cosmetic result. This prospective controlled study aims to determine the effects of topical vitamin E on cosmetic results in children. A single-blind study was carried out. Topical vitamin E was used on the intended incision site for at least 15 days, thrice daily, before surgery and for at least 30 days, twice daily, after surgery (group A). The control group received topical petrolatum-based ointment (group B). No patients in group A developed keloids. A total of 96% of patients (or parents) considered the cosmetic results very good. No patients had wound infection. In the control group, only 78% of patients (or parents) considered the cosmetic results very good and 13 (6.5%) patients developed keloids after 6 months. There were no cases of wound infection. Topical vitamin E before and after surgery improved surgical wound healing and improved cosmetic results. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  17. Comparison of Effectiveness of Laminaria versus Vaginal Misoprostol for Cervical Preparation Before Operative Hysteroscopy in Women of Reproductive Age: A Prospective Randomized Trial.

    Science.gov (United States)

    Karakus, Savas; Akkar, Ozlem Bozoklu; Yildiz, Caglar; Yenicesu, Gonca Imir; Cetin, Meral; Cetin, Ali

    2016-01-01

    To compare the effectiveness and safety of intracervical laminaria dilator versus intravaginal misoprostol administered before surgery to facilitate cervical dilation before operative hysteroscopy. A prospective randomized study (Canadian Task Force classification 1). A university hospital. A total of 150 women were assigned at random to the following groups: laminaria dilation (n = 50), misoprostol dilation (n = 50), and mechanical dilation (n = 50). Hysteroscopic surgery of intrauterine lesions. In this study, 150 women were assigned at random to receive cervical priming with an intracervical laminaria dilator, 200 μg of intravaginal misoprostol, or a mechanical dilator before operative hysteroscopy. Cervical response, surgical outcome, and complications of operative hysteroscopy were assessed. Visual analog scale (VAS) pain scores were recorded in the misoprostol and laminaria dilation groups. Demographic variables of the study groups were comparable (p = .278-.988). The duration of cervical pretreatment was similar with the intracervical laminaria dilator and intravaginal misoprostol (p = .803); however, intravaginal misoprostol was associated with more adverse effects (p = .031). Compared with the misoprostol dilation group, in which all patients required additional cervical dilation, notably fewer patients in the laminaria dilation group required additional cervical dilation after cervical preparation (p = .001). VAS pain scores were significantly higher in the laminaria dilation group, however (p = .001). Cervical priming with an intracervical laminaria dilator before operative hysteroscopy reduces the need for cervical dilation and better facilitates hysteroscopic surgery compared with intravaginal misoprostol. Oral analgesic use may be required before the use of this device. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    Shiv Akshat

    2014-01-01

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

  6. 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.

  7. Gynecomastia Surgery-Impact on Life Quality: A Prospective Case-Control Study.

    Science.gov (United States)

    Kasielska-Trojan, Anna; Antoszewski, Bogusław

    2017-03-01

    To evaluate the results of surgical treatment of gynecomastia in the context of quality of life and satisfaction after the surgery. Fifty male patients (mean age, 25.1 years [SD = 8 years]) who underwent surgery for gynecomastia and completed both (preoperative and postoperative) stages of the study were included in the analysis. The quality-of-life evaluation instrument was The Short Form-36 Health Survey Questionnaire. Additionally, we used a short questionnaire including 2 questions about patient satisfaction with gynecomastia surgery. The overall change in life satisfaction after gynecomastia surgery was 1 point on Likert scale (sign test, P gynecomastia surgery scored significantly higher than before the procedure in all Short Form-36 Health Survey Questionnaire domains as well as in 2 main scales Psychical and Physical Health. The changes were especially visible for the domain social functioning and a scale Psychical Health (P Gynecomastia surgery significantly improved men's life quality in all aspects and especially in the social aspect and psychical health. This indicates that adult men with gynecomastia are a specific group of patients, in which surgery may result in life quality improvement even over the average scores.

  8. A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

    Science.gov (United States)

    Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

    2014-02-01

    Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P aromatherapy was significantly higher in the treatment group (P Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

  9. Immediate loading of mandibular dental implants in partially edentulous patients: a prospective randomized comparative study.

    Science.gov (United States)

    Margossian, Patrice; Mariani, Paul; Stephan, Grégory; Margerit, Jacques; Jorgensen, Christian

    2012-04-01

    While immediate loading in the edentulous mandible is a well-documented procedure, there are limited scientific data on immediate loading in the partially edentulous mandible. Two-year success rates of immediate loading and conventional delayed loading of dental implants in partially dentate mandibles were compared. Patients were randomized into three groups: group A (n = 40), immediate provisionalization with nonocclusal loading; group B (n = 40), immediate provisionalization with occlusal loading; and group C (n = 37), delayed loading with single-stage surgery. Baseline and 2-year measurements included implant stability quotient, insertion torque, and peri-implant bone crest radiography. Two hundred nine implants were immediately loaded in 80 patients. The 2-year success rates were 93.3% for group B and 100% for groups A and C. Immediate provisionalization provided success rates similar to those for delayed loading only when not loaded in occlusion.

  10. Single port laparoscopic surgery

    DEFF Research Database (Denmark)

    Springborg, Henrik; Istre, Olav

    2012-01-01

    potential benefits. Theoretically, cosmetic outcomes, postoperative pain and complication rates could be improved with use of single site surgery. This study describes introduction of the method in a private hospital in Denmark, in which 40 patients have been treated for benign gynecologic conditions......LESS, or laparo-endoscopic single site surgery, is a promising new method in minimally invasive surgery. An increasing number of surgical procedures are being performed using this technique, however, its large-scale adoption awaits results of prospective randomized controlled studies confirming...

  11. 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.

  12. 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.

  13. Effect of Mechanical Ventilation Mode Type on Intra- and Postoperative Blood Loss in Patients Undergoing Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Kang, Woon-Seok; Oh, Chung-Sik; Kwon, Won-Kyoung; Rhee, Ka Young; Lee, Yun Gu; Kim, Tae-Hoon; Lee, Suk Ha; Kim, Seong-Hyop

    2016-07-01

    The aim of study was to evaluate the effect of mechanical ventilation mode type, pressure-controlled ventilation (PCV), or volume-controlled ventilation (VCV) on intra- and postoperative surgical bleeding in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. This was a prospective, randomized, single-blinded, and parallel study that included 56 patients undergoing PLIF and who were mechanically ventilated using PCV or VCV. A permuted block randomization was used with a computer-generated list. The hemodynamic and respiratory parameters were measured after anesthesia induction in supine position, 5 min after patients were changed from supine to prone position, at the time of skin closure, and 5 min after the patients were changed from prone to supine position. The amount of intraoperative surgical bleeding, fluid administration, urine output, and transfusion requirement were measured at the end of surgery. The amount of postoperative bleeding and transfusion requirement were recorded every 24 h for 72 h. The primary outcome was the amount of intraoperative surgical bleeding, and 56 patients were analyzed. The amount of intraoperative surgical bleeding was significantly less in the PCV group than that in the VCV group (median, 253.0 [interquartile range, 179.0 to 316.5] ml in PCV group vs. 382.5 [328.0 to 489.5] ml in VCV group; P patients undergoing PLIF, which may be related to lower intraoperative peak inspiratory pressure.

  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. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  16. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Launonen Antti P

    2012-09-01

    Full Text Available Abstract Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. Methods/Design The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH score and the secondary outcome measures will be the EuroQol-5D (EQ-5D value, OSS, Constant-Murley Score, VAS, and 15D. Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. Discussion This publication

  17. Goal directed fluid therapy decreases postoperative morbidity but not mortality in major non-cardiac surgery: a meta-analysis and trial sequential analysis of randomized controlled trials.

    Science.gov (United States)

    Som, Anirban; Maitra, Souvik; Bhattacharjee, Sulagna; Baidya, Dalim K

    2017-02-01

    Optimum perioperative fluid administration may improve postoperative outcome after major surgery. This meta-analysis and systematic review has been aimed to determine the effect of dynamic goal directed fluid therapy (GDFT) on postoperative morbidity and mortality in non-cardiac surgical patients. Meta-analysis of published prospective randomized controlled trials where GDFT based on non-invasive flow based hemodynamic measurement has been compared with a standard care. Data from 41 prospective randomized trials have been included in this study. Use of GDFT in major surgical patients does not decrease postoperative hospital/30-day mortality (OR 0.70, 95 % CI 0.46-1.08, p = 0.11) length of post-operative hospital stay (SMD -0.14; 95 % CI -0.28, 0.00; p = 0.05) and length of ICU stay (SMD -0.12; 95 % CI -0.28, 0.04; p = 0.14). However, number of patients having at least one postoperative complication is significantly lower with use of GDFT (OR 0.57; 95 % CI 0.43, 0.75; p infection (p = 0.002) and postoperative hypotension (p = 0.04) are also decreased with used of GDFT as opposed to a standard care. Though patients who received GDFT were infused more colloid (p infection, abdominal complications and postoperative hypotension is reduced.

  18. A Prospective, Comparative Study of the Pain of Local Anesthesia Using 2% Lidocaine, 2% Lidocaine With Epinephrine, and 2% Lidocaine With Epinephrine-Bupivicaine Mixture for Eyelid Surgery.

    Science.gov (United States)

    Han, Jung-Woo; Nah, Seung Kwan; Lee, Sang Yeul; Kim, Chang Yeom; Yoon, Jin Sook; Jang, Sun Young

    A mixture of 2% lidocaine with epinephrine and bupivacaine was developed to achieve the fast-onset anesthetic effect of lidocaine and the long-lasting effect of bupivacaine. The authors compared pain scores between 2% lidocaine, 2% lidocaine with epinephrine, and 2% lidocaine with epinephrine-bupivicaine mixture during local anesthesia for eyelid surgeries. This was a double-blind, randomized, prospective, comparative study. In total, 120 consecutive patients (43 males, 77 females, mean age = 47.2 ± 21.2) who underwent bilateral eyelid surgery under subcutaneous anesthesia were asked to report pain scores for each eye during the first injection of anesthesia. Each patient was randomly assigned to receive 1 of the 3 anesthetic agents in 1 eyelid, and 1 of the remaining 2 agents in the other. The pH values of the 2% lidocaine, 2% lidocaine with epinephrine, and 2% lidocaine with epinephrine-bupivicaine mixture were 6.23 ± 0.21, 4.21 ± 0.37, and 3.87 ± 0.19, respectively. The pain scores of each were 4.3 ± 1.8, 5.1 ± 1.8, and 5.7 ± 1.9, respectively. The 2% lidocaine with epinephrine produced a statistically significantly higher pain score than 2% lidocaine (p = 0.044, generalized estimating equation method). The mixture also showed a significantly higher pain score than 2% lidocaine (p = 0.003, generalized estimating equation method). Epinephrine seemed to increase subjective pain scores. Compared with 2% lidocaine with epinephrine, 2% lidocaine with epinephrine-bupivicaine mixture was not significantly different in terms of subjective symptoms or pH.

  19. 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 ...

  20. Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization

    Science.gov (United States)

    Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J.; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K.; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M.; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J.; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E.; Nordestgaard, Børge G.; Nielsen, Sune F.; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K.; Rookus, Matti A.; van den Hurk, Katja; de Kort, Wim L. A. M.; Couch, Fergus J.; Olson, Janet E.; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M. Pilar; Perez, Jose I. A.; Cox, Angela; Cross, Simon S.; Reed, Malcolm W. R.; Andrulis, Irene L.; Knight, Julia A.; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J.; Tomlinson, Ian; Kerin, Michael J.; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A.; Henderson, Brian E.; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J.; Martens, John W. M.; Tilanus-Linthorst, Madeleine M. A.; Collée, J. Margriet; Hopper, John L.; Southey, Melissa C.; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E.; Ambrosone, Christine B.; Yannoukakos, Drakoulis; Giles, Graham G.; Milne, Roger L.; McLean, Catriona; Fasching, Peter A.; Haeberle, Lothar; Ekici, Arif B.; Beckmann, Matthias W.; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J.; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M.; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J.; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K.; Neuhausen, Susan L.; Anton-Culver, Hoda; Kristensen, Vessela N.; Grenaker Alnæs, Grethe I.; Pierce, Brandon L.; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S.; John, Esther M.; Gammon, Marilie D.; Malone, Kathleen E.; Tessier, Daniel C.; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S.; González-Neira, Anna; Pita, Guillermo; Alonso, M. Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D. P.; Simard, Jacques; Hall, Per; Hunter, David J.; Easton, Douglas F.

    2015-01-01

    Background: Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. Methods: We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control subjects, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control subjects. Results: The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor–positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. PMID:26296642

  1. Variable impact of complications in general surgery : A prospective cohort study

    NARCIS (Netherlands)

    Bosma, E.; Veen, E.J.; de Jongh, M.A.; Roukema, J.A.

    2012-01-01

    Background: Registering complications is important in surgery, since complications serve as outcome measures and indicators of quality of care. Few studies have addressed the variation in severity and consequences of complications. We hypothesized that complications show much variation in

  2. 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

  3. 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.

  4. 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.

  5. Changes in retinal nerve fiber layer thickness after spinal surgery in the prone position: a prospective study

    Directory of Open Access Journals (Sweden)

    Baran Gencer

    2015-02-01

    Full Text Available BACKGROUND AND OBJECTIVES: Changes in ocular perfusion play an important role in the pathogenesis of ischemic optic neuropathy. Ocular perfusion pressure is equal to mean arterial pressure minus intraocular pressure. The aim of this study was to evaluate the changes in the intraocular pressure and the retinal nerve fiber layer thickness in patients undergoing spinal surgery in the prone position. METHODS: This prospective study included 30 patients undergoing spinal surgery. Retinal nerve fiber layer thickness were measured one day before and after the surgery by using optical coherence tomography. Intraocular pressure was measured by tonopen six times at different position and time-duration: supine position (baseline; 10 min after intubation (Supine 1; 10 (Prone 1, 60 (Prone 2, 120 (Prone 3 min after prone position; and just after postoperative supine position (Supine 2. RESULTS: Our study involved 10 male and 20 female patients with the median age of 57 years. When postoperative retinal nerve fiber layer thickness measurements were compared with preoperative values, a statistically significant thinning was observed in inferior and nasal quadrants (p = 0.009 and p = 0.003, respectively. We observed a statistically significant intraocular pressure decrease in Supine 1 and an increase in both Prone 2 and Prone 3 when compared to the baseline. Mean arterial pressure and ocular perfusion pressure were found to be significantly lower in Prone 1, Prone 2 and Prone 3, when compared with the baseline. CONCLUSIONS: Our study has shown increase in intraocular pressure during spinal surgery in prone position. A statistically significant retinal nerve fiber layer thickness thinning was seen in inferior and nasal quadrants one day after the spinal surgery.

  6. Comparative assessment between eyelet wiring and direct interdental wiring for achieving intermaxillary fixation: a prospective randomized clinical study.

    Science.gov (United States)

    Rai, Anshul; Datarkar, Abhay; Borle, Rajeev; Rai, Monika

    2012-08-01

    The intention of this study was to compare the efficacy of eyelet wiring and direct interdental (Gilmer) wiring for achieving intermaxillary fixation (IMF). This study was a prospective randomized clinical trial. The study sample was derived from the population of patients who underwent IMF at the Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Wardha, India, between October 2008 and September 2010. The time required for placement and removal (in minutes) was compared between the eyelet wiring and direct interdental wiring techniques. Postoperative stability after achieving IMF was analyzed in the 2 groups. The plaque accumulation in both groups was evaluated using the Turesky-Gilmore-Glickman modification of the Quigley-Hein plaque index. Complications in the form of soft tissue injury, glove puncture, and trauma to the operator's finger were also recorded. Statistical analysis was performed with SPSS statistical software for Windows, version 8.0 (SPSS, Chicago, IL) using the χ(2) test and Student t test. The mean working time for placement and removal of eyelet wiring (group I) was 18.00 minutes and 9.67 minutes, respectively. For direct interdental wiring (group II), it was 30.50 minutes and 23.12 minutes, respectively. The mean plaque index values were 1.78 and 2.54 for groups I and II, respectively, which signifies a higher plaque deposition in group II. No occlusal disturbance was seen in either group. The incidences of glove perforation, soft tissue trauma, and trauma to the operator's finger were higher in group II. Eyelet wiring is preferable to direct interdental wiring as evidenced by fewer complications, and requires a shorter operating time in patients with minimally displaced fractures. Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Could application of epinephrine improve hemostatic efficacy of hemoclips for bleeding peptic ulcers? A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Grgov Saša

    2013-01-01

    Full Text Available Background/Aim. Bleeding from peptic ulcers can be effectively and safely treated with endoscopic hemoclips therapy. However, due to certain limiting factors of hemoclips, application of combination with another endoscopic method may give better results. The aim of this study was to examine the efficacy and safety of endoscopic hemoclips therapy and to evaluate potential benefits of this therapy combined with epinephrine in the treatment of bleeding peptic ulcers. Methods. This prospective randomized study included 70 patients with bleeding gastric or duodenal ulcer. In 34 of the patients endoscopic hemoclips therapy was applied (group I, and in 36 of them a combined therapy of hemoclips and epinephrine (group II. Results. Initial hemostasis was achieved in most patients treated with endoscopic hemoclips therapy (94.1% as well as in the patients treated with combination therapy (97.2%. After initial hemostasis achieved rebleeding occurred in 3 (9.3% patients treated with hemoclips and in 2 (5.7% patients treated with combination therapy, but this difference was not statistically significant (p > 0.05. The difference in the achieved final hemostasis between the group I (91.1% and the group II (94.4% was not statistically significant. Also, the differences between the two groups of patients in the need for blood transfusions, length of hospital stay, need for surgery and mortality were not statistically significant (p > 0.05. Conclusion. Endoscopic hemoclips therapy is effective and safe in treatment of bleeding peptic ulcers. Combination therapy of hemoclips and epinephrine has no advantage over hemoclips monotherapy.

  8. Mini-flared Kelman tip, reverse tip, and sidewinder tip with torsional phaco: a prospective randomized comparative study

    Directory of Open Access Journals (Sweden)

    Wilson Takashi Hida

    2015-02-01

    Full Text Available Purpose: To compare the efficiency of surgical procedures using three phaco tip designs in torsional phacoemulsification using the bevel-down technique. Methods: In this prospective, comparative, masked study, patients were randomly assigned to have torsional coaxial microincision cataract surgery using the mini-flared 45-degree Kelman tip, reversed mini-flared 30-degree Kelman tip, or Sidewinder 30-degree Kelman tip. Clinical measurements included preoperative and 3-month postoperative corrected distance visual acuity (CDVA, endothelial cell counts (ECC, and preoperative and 1-day postoperative central corneal thickness (CCT. Intraoperative measurements included phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE, and balanced salt solution volume (BSS. Results: The study evaluated 150 eyes of 150 patients. Intraoperatively, there was no statistically significant difference in cumulative dissipated energy, case time, torsional time, and aspiration time between the three tip configurations. However, less phaco time was used with the mini-flared 45-degree Kelman tip (p=0.02 than that with the Sidewinder 30-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. The mini-flared 45-degree Kelman tip and the reversed mini-flared 30-degree Kelman tip required significantly less balanced salt solution volume than that required by the Sidewinder 30-degree Kelman tip (p=0.009. There was no statistically significant difference in corrected distance visual acuity and endothelial cell counts between tips 3 months postoperatively (p>0.05. Conclusion: All three tips were effective with no intraoperative complications. When using torsional phacoemulsification through microincisions and the prefracture technique with the bevel-down technique, the mini-flared 45-degree Kelman tip required a lower mean phaco time than the reversed mini-flared 30-degree Kelman tip and the Sidewinder 30-degree Kelman tip.

  9. A Prospective Randomized Peri- and Post-Operative Comparison of the Minimally Invasive Anterolateral Approach Versus the Lateral Approach

    Science.gov (United States)

    Landgraeber, Stefan; Quitmann, Henning; Güth, Sebastian; Haversath, Marcel; Kowalczyk, Wojciech; Kecskeméthy, Andrés; Heep, Hansjörg; Jäger, Marcus

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and McMaster Universities Osteoarthritis Index and Harris Hip score (HHS) were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045). But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study. PMID:24191179

  10. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    Directory of Open Access Journals (Sweden)

    Stefan Landgraeber

    2013-07-01

    Full Text Available There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS or a conventional lateral approach (CON. We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36 or CON (n=39 approach. The Western Ontario\tand\tMcMaster\tUniversities Osteoarthritis Index and Harris Hip score (HHS were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045. But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study.

  11. Clindamycin vs. first-generation cephalosporins for acute osteoarticular infections of childhood--a prospective quasi-randomized controlled trial.

    Science.gov (United States)

    Peltola, H; Pääkkönen, M; Kallio, P; Kallio, M J T

    2012-06-01

    No sufficiently powered trial has examined two antimicrobials in acute osteoarticular infections of childhood. We conducted a prospective, multicentre, quasi-randomized trial in Finland, comparing clindamycin with first-generation cephalosporins. The age of patients ranged between 3 months and 15 years, and all cases were culture-positive. We assigned antibiotic treatment intravenously for the first 2-4 days, and continued oral treatment with clindamycin 40 mg/kg/24 h or first-generation cephalosporin 150 mg/kg/24 h in four doses. Surgery was kept to a minimum. Subsiding symptoms and signs and normalization of C-reactive protein (CRP) level were preconditions for the discontinuation of antimicrobials. The main outcome was full recovery without further antimicrobials because of an osteoarticular indication during 12 months after therapy. The intention-to-treat analysis comprised 252 children, 169 of whom were analysed per-protocol: 82 cases of osteomyelitis, 80 of septic arthritis, and seven of osteomyelitis-arthritis. Staphylococcus aureus strains (all methicillin-sensitive) caused 84% of the cases. Except for one non-serious sequela during convalescence in both groups, and two late infections caused by dissimilar agents in one child, all patients recovered. The entire courses (medians) of clindamycin and cephalosporin lasted for 23 and 24 days, respectively. CRP normalized in both groups in 9 days. The patients were discharged, on average, on day 10. Loose stools were reported less often (1%) in the clindamycin group than in the cephalosporin group (7%), but two clindamycin recipients developed rash. Clindamycin or a first-generation cephalosporin, administered mostly orally, perform equally well in childhood osteoarticular infections, provided that high doses and administration four times daily are used. As most methicillin-resistant staphylococci remain clindamycin-sensitive, clindamycin remains an option instead of costly alternatives. © 2011 The Authors

  12. Immediate and early loading of chemically modified implants in posterior jaws: 3-year results from a prospective randomized multicenter study.

    Science.gov (United States)

    Nicolau, Pedro; Korostoff, Jonathan; Ganeles, Jeffrey; Jackowski, Jochen; Krafft, Tim; Neves, Manuel; Divi, Jose; Rasse, Michael; Guerra, Fernando; Fischer, Kerstin

    2013-08-01

    There is a lack of well-designed prospective, randomized clinical trials evaluating the efficacy of immediate and early loading of implants placed in the partially edentulous posterior maxilla or mandible. The aim of this study was to evaluate crestal bone level changes over 3 years following immediate or early loading of Straumann implants with a chemically modified surface (SLActive®, Institut Straumann AG, Basel, Switzerland) placed in the posterior maxilla and mandible. Subjects received temporary restorations immediately or 28 to 34 days after surgery, with permanent restorations placed at 20 to 23 weeks. Bone level changes were measured by comparison of standardized radiographs taken on the day of implant placement and 5, 12, 24, and 36 months thereafter. Two hundred thirty-nine of two hundred sixty-six patients (89.9%) completed the trial. Implant survival rates were 97.4% and 96.7% in the immediate and early loading groups, respectively (p = not significant). Over 36 months, the mean bone level change for immediately loaded implants was 0.88 ± 0.81 mm versus 0.57 ± 0.83 mm for the early-loaded group (p loading had no significant influence on bone level change. Changes in crestal bone level occurred mostly during the first 5 months postloading. After this bone remodeling period, crestal bone level was stable up to 36 months. Implants with a chemically modified surface are safe and predictable for immediate and early loading in the posterior maxilla and mandible. © 2011 Wiley Periodicals, Inc.

  13. Effect of Continuous Motion Parameter Feedback on Laparoscopic Simulation Training: A Prospective Randomized Controlled Trial on Skill Acquisition and Retention.

    Science.gov (United States)

    Buescher, Julian Frederik; Mehdorn, Anne-Sophie; Neumann, Philipp-Alexander; Becker, Felix; Eichelmann, Ann-Kathrin; Pankratius, Ulrich; Bahde, Ralf; Foell, Daniel; Senninger, Norbert; Rijcken, Emile

    To investigate the effect of motion parameter feedback on laparoscopic basic skill acquisition and retention during a standardized box training curriculum. A Lap-X Hybrid laparoscopic simulator was designed to provide individual and continuous motion parameter feedback in a dry box trainer setting. In a prospective controlled trial, surgical novices were randomized into 2 groups (regular box group, n = 18, and Hybrid group, n = 18) to undergo an identical 5-day training program. In each group, 7 standardized tasks on laparoscopic basic skills were completed twice a day on 4 consecutive days in fixed pairs. Additionally, each participant performed a simulated standard laparoscopic cholecystectomy before (day 1) and after training (day 5) on a LAP Mentor II virtual reality (VR) trainer, allowing an independent control of skill progress in both groups. A follow-up assessment of skill retention was performed after 6 weeks with repetition of both the box tasks and VR cholecystectomy. Muenster University Hospital Training Center, Muenster, Germany. Medical students without previous surgical experience. Laparoscopic skills in both groups improved significantly during the training period, measured by the overall task performance time. The 6 week follow-up showed comparable skill retention in both groups. Evaluation of the VR cholecystectomies demonstrated significant decrease of operation time (p Simulation training on both trainers enables reliable acquisition of laparoscopic basic skills. Furthermore, individual and continuous motion feedback improves laparoscopic skill enhancement significantly in several aspects. Thus, training systems with feedback of motion parameters should be considered to achieve long-term improvement of motion economy among surgical trainees. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  14. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial

    International Nuclear Information System (INIS)

    Xiaobin, Feng; Shuguang, Wang; Ping, Bie; Jiahong, Dong; Shuguo, Zheng; Jian, Zhou; Yudong, Qiu; Lijian, Liang; Kuansheng, Ma; Xiaowu, Li; Feng, Xia; Dong, Yi

    2012-01-01

    Hepatic resection is currently still the best choice of therapeutic strategies for liver cancer, but the long-term survival rate after surgery is unsatisfactory. Most patients develop intra- and/or extrahepatic recurrence. The reasons for this high recurrence rate are not entirely clear. Recent studies have indicated that ischemia-reperfusion injury to the liver may be a significant factor promoting tumor recurrence and metastasis in animal models. If this is also true in humans, the effects of the Pringle maneuver, which has been widely used in hepatectomy for the past century, should be examined. To date, there are no reported data or randomized controlled studies examining the relationship between use of the Pringle maneuver and local tumor recurrence. We hypothesize that the long-term prognosis of patients with liver cancer could be worsened by use of the Pringle maneuver due to an increase in the rate of tumor recurrence in the liver remnant. We designed a multicenter, prospective, randomized surgical trial to test this hypothesis. At least 498 eligible patients from five participating centers will be enrolled and randomized into either the Pringle group or the non-Pringle group in a ratio of 1:1 using a permuted-blocks randomization protocol. After the completion of surgical intervention, patients will be included in a 3-year follow-up program. This multicenter surgical trial will examine whether the Pringle maneuver has a negative effect on the long-term outcome of hepatocellular carcinoma patients. The trial will also provide information about prognostic differences, safety, advantages and disadvantages between Pringle and non-Pringle surgical procedures. Ultimately, the results will increase the available information about the effects of ischemia-reperfusion injury on tumor recurrence, which will be of immense benefit to general surgery.

  15. 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

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

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    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.

  17. 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.

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

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    Ernesto Crisafulli

    2013-01-01

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

  19. Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

    Science.gov (United States)

    Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

    2012-01-01

    This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

  20. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

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    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  1. Methylergometrine during the early puerperium; a prospective randomized double blind study.

    Science.gov (United States)

    Andersen, B; Andersen, L L; Sørensen, T

    1998-01-01

    The purpose of the study was to determine the efficacy of 72-hour prophylactic oral methylergometrine in reducing postpartum hemorrhage and endometritis during the early puerperium, and the effect of methylergometrine on lochia and requests for analgesics. A prospective randomized double-blind study was undertaken; a total of 217 women received 0.2 mg methylergometrine intravenously after delivery of the placenta and randomized to either tabl. Methergin 0.125 mg or placebo three times a day for three days. The main measures were weight of sanitary towels, temperature, consumptions of analgesics and length of hospital stay. We found no significant difference in the median amount of lochia, the need for analgesics or length of hospital stay between the two groups. Incidence of infection and postpartum hemorrhage were low in both groups. We conclude that prophylactic use of methylergometrine during early puerperium has no effect on lochia. Endometritis and postpartum hemorrhage were rare in both groups. There was no increase in requests for analgesics among women given oral methylergometrine.

  2. Randomized prospective trial comparing ultrasonography and pelvic examination for preterm labor surveillance.

    Science.gov (United States)

    Lorenz, R P; Comstock, C H; Bottoms, S F; Marx, S R

    1990-06-01

    This study was designed to compare the effectiveness of cervical assessment by either ultrasonography or bimanual pelvic examination in a program for preterm labor surveillance. Patients (n = 57) at risk for preterm birth were seen once a week for patient education, review of symptoms, and cervical evaluation. Cervical evaluation was assigned randomly to either ultrasonographic evaluation or pelvic examination. The groups did not differ in demographic or obstetric factors. The overall rate of prematurity was 18%. Preterm labor was more frequent with ultrasonographic evaluation (52%) than with pelvic examination (25%) (p less than 0.05). The group evaluated by ultrasonography received oral tocolytic agents (55%) more than the group that had pelvic examinations (21%) (p less than 0.02). The groups did not differ in infant birth weights, length of gestation, or neonatal mortality or morbidity. In this prospective randomized study of patients at risk for preterm birth, patients under surveillance by ultrasonographic assessment of the cervix did not fare better than those assigned to bimanual examination.

  3. A prospective randomized evaluation of topical gatifloxacin on conjunctival flora in patients undergoing intravitreal injections.

    Science.gov (United States)

    Moss, Jason M; Sanislo, Steven R; Ta, Christopher N

    2009-08-01

    We sought to assess the efficacy of 3-day topical gatifloxacin use in combination with povidone-iodine (PVI) versus PVI alone in eliminating conjunctival bacterial flora in patients scheduled to undergo intravitreal (IVT) injection. Prospective, randomized single-blind clinical trial. We included 129 patients scheduled to undergo 273 IVT injections at California Vitreoretinal Center at Stanford University. Study patients were randomized to self-administration of gatifloxacin drops for 3 days before injection, or no pretreatment antibiotics. Cultures were collected from the bulbar conjunctiva at the injection site and at the corresponding location in the fellow eye before PVI preparation. After topical PVI treatment and immediately before injection, a third culture was obtained at the injection site. Additionally, the injection needle was also cultured after the procedure. Incidence of positive bacterial samples collected from injection site conjunctiva and injection needles. Three-day gatifloxacin use resulted in a significantly lower rate of SeptiChek (Becton Dickinson, Franklin Lakes, NJ) positive cultures compared with untreated controls (21% vs 48% respectively, P = 0.005). After topical PVI, the rate of positive bacterial cultures in gatifloxacin-treated and control eyes were similar (8% and 4%, respectively; P = 0.324). Although 3-day topical gatifloxacin use is effective in reducing the frequency of conjunctival bacterial growth relative to untreated eyes, antibiotic use confers no additional benefit in combination with PVI than eyes receiving PVI alone. This supports that topical PVI is an effective preinjection monotherapy for infection prophylaxis in the setting of IVT injections.

  4. Instructional authenticity and clinical reasoning in undergraduate medical education: a 2-year, prospective, randomized trial.

    Science.gov (United States)

    Durning, Steven J; Dong, Ting; Artino, Anthony R; LaRochelle, Jeffery; Pangaro, Louis N; van der Vleuten, Cees; Schuwirth, Lambert

    2012-09-01

    The purpose of the study was to investigate the relationship between authenticity (how close to actual practice) of preclerkship instructional formats and preclerkship and clerkship outcome measures. A secondary purpose was to investigate the effect of student's small-group assignment during preclerkship period on instructional formats and preclerkship and clerkship outcome measurements. A prospective, randomized, crossover study was carried out with preclerkship students taking a clinical reasoning course. Students were randomized to small groups and exposed to three formats of differing instructional authenticity across three subject areas. Three student cohorts were taught using one instructional format per subject area with each cohort receiving a different instructional format for each of the three areas. Outcome measures at the end of the preclerkship year and the clerkship year were selected to determine the effect of each instructional format. Hierarchical linear modeling was performed to assess impact of format on outcomes and to assess potential group effect on outcomes. Increasingly authentic instructional formats did not significantly improve clinical reasoning performance. Small-group assignment did not significantly contribute to the outcomes providing evidence that teacher training was successful. Increasing authenticity of instructional formats does not appear to significantly improve clinical reasoning performance. Faculty can be successfully trained to teach consistently in a clinical reasoning course. Medical educators should balance increasing authenticity with factors such as cognitive load and learner experience as well as engaging in frame-of-reference training to minimize group effects with designing new instructional formats.

  5. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

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    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  6. Prospective randomized controlled trial to evaluate "fast-track" elective open infrarenal aneurysm repair.

    Science.gov (United States)

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

    2008-05-01

    Fast-track programs have been introduced in many surgical fields to minimize postoperative morbidity and mortality. Morbidity after elective open infrarenal aneurysm repair is as high as 30%; mortality ranges up to 10%. In terms of open infrarenal aneurysm repair, no randomized controlled trials exist to introduce and evaluate such patient care programs. This study involved prospective randomization of 82 patients in a "traditional" and a "fast-track" treatment arm. Main differences consisted in preoperative bowel washout (none vs. 3 l cleaning solution) and analgesia (patient controlled analgesia vs. patient controlled epidural analgesia). Study endpoints were morbidity and mortality, need for postoperative mechanical ventilation, and length of stay (LOS) on intensive care unit (ICU). The need for assisted postoperative ventilation was significantly higher in the traditional group (33.3% vs. 5.4%; p = 0.011). Median LOS on ICU was shorter in the fast-track group, 41 vs. 20 h. The rate of postoperative medical complications was significantly lower in the fast-track group, 16.2% vs. 35.7% (p = 0.045). We introduced and evaluated an optimized patient care program for patients undergoing open infrarenal aortic aneurysm repair which showed a significant advantage for "fast-track" patients in terms of postoperative morbidity.

  7. Protocol versus ad libitum feeds after laparoscopic pyloromyotomy: a prospective randomized trial.

    Science.gov (United States)

    Adibe, Obinna O; Iqbal, Corey W; Sharp, Susan W; Juang, David; Snyder, Charles L; Holcomb, George W; Ostlie, Daniel J; St Peter, Shawn D

    2014-01-01

    We conducted a prospective, randomized trial comparing protocol to ad libitum (ad lib) feeding after laparoscopic pyloromyotomy. Infants undergoing laparoscopic pyloromyotomy were randomized to protocol versus ad lib feeding strategies. The protocol started with Pedialyte® two hours post-operative. This was repeated by another round of Pedialyte®, then two rounds of half-strength formula or breast milk, followed by two rounds of full strength formula or breast milk, followed by the home feeding regimen, at which time the patient was discharged if feeding well. The ad lib group was allowed formula or breast milk two hours after the operation and considered for discharge after tolerating three consecutive feeds. The primary outcome variable was the length of postoperative hospitalization. One hundred fifty infants were enrolled between January 2010 and December 2011. There were no differences in patient characteristics at presentation. While the ad lib group reached goal feeds sooner than the protocol group, this did not translate into a difference in duration of postoperative hospitalization. There were more patients with emesis in the ad lib group after goal feeding was reached, but no difference in readmissions. Ad lib feeding allows patients to reach goal feeds more rapidly than protocol feeding following laparoscopic pyloromyotomy. However, this goal is usually reached beyond discharge hours, resulting in a similar duration of hospitalization. © 2014.

  8. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necess