A randomized trial of laparoscopic versus open surgery for rectal cancer
Research output: Contribution to journal › Journal article › Research › peer-review
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.).
Original language | English |
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Journal | New England Journal of Medicine |
Volume | 372 |
Issue number | 14 |
Pages (from-to) | 1324-32 |
Number of pages | 9 |
ISSN | 0028-4793 |
DOIs | |
Publication status | Published - 2 Apr 2015 |
- Adenocarcinoma, Aged, Digestive System Surgical Procedures, Disease-Free Survival, Female, Humans, Laparoscopy, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Rectal Neoplasms, Survival Rate
Research areas
ID: 162370763