A randomized trial of laparoscopic versus open surgery for rectal cancer

H Jaap Bonjer, Charlotte L Deijen, Gabor A Abis, Miguel A Cuesta, Martijn H G M van der Pas, Elly S M de Lange-de Klerk, Antonio M Lacy, Willem A Bemelman, John Andersson, Eva Angenete, Jacob Rosenberg, Alois Fuerst, Eva Haglind, Color II Study Group

646 Citationer (Scopus)

Abstract

Background: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). Conclusions: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery.

OriginalsprogEngelsk
TidsskriftNew England Journal of Medicine
Vol/bind372
Udgave nummer14
Sider (fra-til)1324-32
Antal sider9
ISSN0028-4793
DOI
StatusUdgivet - 2 apr. 2015

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