BACKGROUND:Laparoscopic appendectomy through a single umbilical incision is an emerging approach supported by several case series. However, to date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing single site umbilical laparoscopic appendectomy to 3-port laparoscopic appendectomy. METHODS: After Internal Review Board approval, patients were randomized to laparoscopic appendectomy via a single umbilical incision or standard 3-port access. The primary outcome variable was postoperative wound infection. Using a power of 0.9 and an alpha of 0.05, 180 patients were calculated for each arm. Patients with perforated appendicitis were excluded. The technique of ligation/division of the appendix and mesoappendix was left to the surgeon's discretion. There were 7 participating surgeons dictated by the call schedule. All patients received the same preoperative antibiotics and postoperative management was controlled. RESULTS: There were 360 patients were enrolled between August 2009 and November 2010. There were no differences in patient characteristics at presentation. There was no difference in wound infection rate, time to regular diet, length of hospitalization, or time to return to full activity. Operative time, doses of narcotics, surgical difficultly and hospital charges were greater with the single site approach. Also, the mean operative time was 5 minutes longer for the single site group. CONCLUSION: The single site umbilical laparoscopic approach to appendectomy produces longer operative times resulting in greater charges. However, these small differences are likely of marginal clinical relevance. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).
RCT Entities:
BACKGROUND: Laparoscopic appendectomy through a single umbilical incision is an emerging approach supported by several case series. However, to date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing single site umbilical laparoscopic appendectomy to 3-port laparoscopic appendectomy. METHODS: After Internal Review Board approval, patients were randomized to laparoscopic appendectomy via a single umbilical incision or standard 3-port access. The primary outcome variable was postoperative wound infection. Using a power of 0.9 and an alpha of 0.05, 180 patients were calculated for each arm. Patients with perforated appendicitis were excluded. The technique of ligation/division of the appendix and mesoappendix was left to the surgeon's discretion. There were 7 participating surgeons dictated by the call schedule. All patients received the same preoperative antibiotics and postoperative management was controlled. RESULTS: There were 360 patients were enrolled between August 2009 and November 2010. There were no differences in patient characteristics at presentation. There was no difference in wound infection rate, time to regular diet, length of hospitalization, or time to return to full activity. Operative time, doses of narcotics, surgical difficultly and hospital charges were greater with the single site approach. Also, the mean operative time was 5 minutes longer for the single site group. CONCLUSION: The single site umbilical laparoscopic approach to appendectomy produces longer operative times resulting in greater charges. However, these small differences are likely of marginal clinical relevance. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).
Authors: Michael Clerveus; Antonio Morandeira-Rivas; Carlos Moreno-Sanz; Maria Luz Herrero-Bogajo; Joaquin Salvelio Picazo-Yeste; Gloria Tadeo-Ruiz Journal: World J Surg Date: 2014-08 Impact factor: 3.352
Authors: F Paul Buckley; Hannah Vassaur; Sharon Monsivais; Daniel Jupiter; Rob Watson; John Eckford Journal: Surg Endosc Date: 2013-10-04 Impact factor: 4.584