OBJECTIVE: : We report a multicentered randomized controlled trial across Australia and New Zealand comparing laparoscopic-assisted colon resection (LCR) with open colon resection (OCR) for colon cancer. BACKGROUND: : Colon cancer is a significant worldwide health issue. This trial investigated whether the short-term benefits associated with LCR for colon cancer could be achieved safely, without survival disadvantages, in our region. METHODS: : A total of 601 patients with potentially curable colon cancer were randomized to receive LCR or OCR. Primary endpoints were 5-year overall survival, recurrence-free survival, and freedom from recurrence rates, compared using an intention-to-treat analysis. RESULTS: : On April 5, 2010, 587 eligible patients were followed for a median of 5.2 years (range, 1 week-11.4 years) with 5-year confirmed follow-up data for survival and recurrence on 567 (96.6%). Significant differences between the 2 trial groups were as follows: LCR patients were older at randomization, and their pathology specimens showed smaller distal resection margins; OCR patients had some worse pathology parameters, but there were no differences in disease stages. There were no significant differences between the LCR and OCR groups in 5-year follow-up of overall survival (77.7% vs 76.0%, P = 0.64), recurrence-free survival (72.7% vs 71.2%, P = 0.70), or freedom from recurrence (86.2% vs 85.6%, P = 0.85). CONCLUSIONS: : In spite of some differences in short-term surrogate oncological markers, LCR was not inferior to OCR in direct measures of survival and disease recurrence. These findings emphasize the importance of long-term data in formulating evidence-based practice guidelines.
RCT Entities:
OBJECTIVE: : We report a multicentered randomized controlled trial across Australia and New Zealand comparing laparoscopic-assisted colon resection (LCR) with open colon resection (OCR) for colon cancer. BACKGROUND: : Colon cancer is a significant worldwide health issue. This trial investigated whether the short-term benefits associated with LCR for colon cancer could be achieved safely, without survival disadvantages, in our region. METHODS: : A total of 601 patients with potentially curable colon cancer were randomized to receive LCR or OCR. Primary endpoints were 5-year overall survival, recurrence-free survival, and freedom from recurrence rates, compared using an intention-to-treat analysis. RESULTS: : On April 5, 2010, 587 eligible patients were followed for a median of 5.2 years (range, 1 week-11.4 years) with 5-year confirmed follow-up data for survival and recurrence on 567 (96.6%). Significant differences between the 2 trial groups were as follows: LCR patients were older at randomization, and their pathology specimens showed smaller distal resection margins; OCR patients had some worse pathology parameters, but there were no differences in disease stages. There were no significant differences between the LCR and OCR groups in 5-year follow-up of overall survival (77.7% vs 76.0%, P = 0.64), recurrence-free survival (72.7% vs 71.2%, P = 0.70), or freedom from recurrence (86.2% vs 85.6%, P = 0.85). CONCLUSIONS: : In spite of some differences in short-term surrogate oncological markers, LCR was not inferior to OCR in direct measures of survival and disease recurrence. These findings emphasize the importance of long-term data in formulating evidence-based practice guidelines.
Authors: Anne F Peery; Nicholas J Shaheen; Katherine S Cools; Todd H Baron; Mark Koruda; Joseph A Galanko; Ian S Grimm Journal: Gastrointest Endosc Date: 2017-04-10 Impact factor: 9.427
Authors: Kjartan Stormark; Kjetil Søreide; Jon Arne Søreide; Jan Terje Kvaløy; Frank Pfeffer; Morten T Eriksen; Bjørn S Nedrebø; Hartwig Kørner Journal: Surg Endosc Date: 2016-02-23 Impact factor: 4.584
Authors: Stefano Ferretti; Hadrien Tranchart; Joseph F Buell; Constantino Eretta; Alberto Patriti; Marcello Giuseppe Spampinato; Jung Wook Huh; Luca Vigano; Ho Seong Han; Giuseppe Maria Ettorre; Elio Jovine; Thomas Clark Gamblin; Giulio Belli; Go Wakabayashi; Brice Gayet; Ibrahim Dagher Journal: World J Surg Date: 2015-08 Impact factor: 3.352
Authors: Daniel P Nussbaum; Paul J Speicher; Asvin M Ganapathi; Brian R Englum; Jeffrey E Keenan; Christopher R Mantyh; John Migaly Journal: J Gastrointest Surg Date: 2014-08-05 Impact factor: 3.452