BACKGROUND:Transvaginal cholecystectomy (TVC) is regarded as a model operation in the newly developed field of natural orifice transluminal endoscopic surgery (NOTES). Randomized, controlled trials to assess TVC as a surgical strategy are largely missing. MATERIALS AND METHODS: The study was a double blind, randomized, controlled, single center trial in female patients > 18 years with symptomatic cholecystolithiasis comparinglaparoscopic cholecystectomy (CLC) and TVC. The study investigated pain reduction of ≥ 1 point on a visual-numeric rating scale with a follow-up after 7 days. Secondary endpoints were complications and patient reported outcome. Groups were established using computer-generated randomization and sealed envelopes in the operating theatre. At the end of the surgical procedure all patients received a standard 4-trocar dressing as for CLC and a vaginal tamponade. RESULTS:A total of 426 patients were asked to participate, of which 97 were randomized, 51 in the CLC, 41 in the TVC groups and 5 were excluded from the study. Patients were comparable regarding age, body mass index (BMI) and American Society of Anesthesiologists (ASA) grade. Surgical and anesthesia times were significantly different. There was no difference in postoperative pain. The majority of patients were satisfied with both procedures and TVC was recommended to other patients by 93 % of patients in the TVC group. CONCLUSION: The results did not show superiority of TVC over CLC with regards to postoperative pain. With no differences in postoperative pain and high patient satisfaction, TVC can be recommended to future patients as an alternative method. For confirmation of this evaluation of TVC further randomized trials are needed.
RCT Entities:
BACKGROUND: Transvaginal cholecystectomy (TVC) is regarded as a model operation in the newly developed field of natural orifice transluminal endoscopic surgery (NOTES). Randomized, controlled trials to assess TVC as a surgical strategy are largely missing. MATERIALS AND METHODS: The study was a double blind, randomized, controlled, single center trial in female patients > 18 years with symptomatic cholecystolithiasis comparing laparoscopic cholecystectomy (CLC) and TVC. The study investigated pain reduction of ≥ 1 point on a visual-numeric rating scale with a follow-up after 7 days. Secondary endpoints were complications and patient reported outcome. Groups were established using computer-generated randomization and sealed envelopes in the operating theatre. At the end of the surgical procedure all patients received a standard 4-trocar dressing as for CLC and a vaginal tamponade. RESULTS: A total of 426 patients were asked to participate, of which 97 were randomized, 51 in the CLC, 41 in the TVC groups and 5 were excluded from the study. Patients were comparable regarding age, body mass index (BMI) and American Society of Anesthesiologists (ASA) grade. Surgical and anesthesia times were significantly different. There was no difference in postoperative pain. The majority of patients were satisfied with both procedures and TVC was recommended to other patients by 93 % of patients in the TVC group. CONCLUSION: The results did not show superiority of TVC over CLC with regards to postoperative pain. With no differences in postoperative pain and high patient satisfaction, TVC can be recommended to future patients as an alternative method. For confirmation of this evaluation of TVC further randomized trials are needed.
Authors: Dirk Rolf Bulian; Linda Trump; Jürgen Knuth; Robert Siegel; Axel Sauerwald; Michael A Ströhlein; Markus Maria Heiss Journal: Surg Endosc Date: 2012-08-28 Impact factor: 4.584
Authors: Alberto Arezzo; Carsten Zornig; Hamid Mofid; Karl-Hermann Fuchs; Wolfram Breithaupt; José Noguera; Georg Kaehler; Richard Magdeburg; Silvana Perretta; Bernard Dallemagne; Jacques Marescaux; Catalin Copaescu; Florin Graur; Andrei Szasz; Antonello Forgione; Raffaele Pugliese; Gerhard Buess; Hemanga K Bhattacharjee; Giuseppe Navarra; Mario Godina; Kirill Shishin; Mario Morino Journal: Surg Endosc Date: 2013-03-22 Impact factor: 4.584
Authors: Dirk Rolf Bulian; Jürgen Knuth; Nicola Cerasani; Axel Sauerwald; Rolf Lefering; Markus Maria Heiss Journal: Ann Surg Date: 2015-03 Impact factor: 12.969