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N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.

A randomized trial of laparoscopic versus open surgery for rectal cancer.

Author information

1
From VU University Medical Center (H.J.B., C.L.D., G.A.A., M.A.C., M.H.G.M.P., E.S.M.L.-K.) and Amsterdam Medical Center (W.A.B.) - both in Amsterdam; Hospital Clinic I Provincial de Barcelona, Barcelona (A.M.L.); the Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital-Ă–stra, Gothenburg, Sweden (J.A., E.A., E.H.); Herlev Hospital, Department of Surgery, University of Copenhagen, Copenhagen (J.R.); and Caritas Krankenhaus St. Josef, Regensburg, Germany (A.F.).

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.).

PMID:
25830422
DOI:
10.1056/NEJMoa1414882
[Indexed for MEDLINE]
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