Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/112376
Title: A randomized trial of laparoscopic versus open surgery for rectal cancer.
Author: Bonjer, H.Jaap
Deijen, Charlotte L.
Abis, Gabor A.
Cuesta, Miguel A.
van der Pas, Martijn H.
de Lange-de Klerk, Elly S.
Lacy Fortuny, Antonio Ma. de
Bemelman, Willem A.
Andersson, John
Angenete, Eva
Rosenberg, Jacob
Fuerst, Alois
Haglind, Eva
COLOR II Study Group
Keywords: Laparoscòpia
Cirurgia colorectal
Càncer colorectal
Laparoscopy
Colorectal surgery
Colorectal cancer
Issue Date: 2-Apr-2015
Publisher: Massachusetts Medical Society
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. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.)
Note: Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1414882
It is part of: New England Journal of Medicine, 2015, vol. 372, p. 1324-1332
Related resource: https://doi.org/10.1056/NEJMoa1414882
URI: http://hdl.handle.net/2445/112376
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)

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