A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer
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Résumé
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.).
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La notice
- Revue
- New England Journal of Medicine
- Thématique
- Colorectal Cancer Surgical Treatments
- Domaine
- Medicine
- Établissements canadiens
- —
- Organismes subventionnaires
- Ethicon Endo-SurgeryErasmus Universitair Medisch Centrum RotterdamSahlgrenska UniversitetssjukhusetDalhousie UniversityVrije Universiteit AmsterdamHealth and Medical Care Committee of the Regional Executive Board, Region Västra GötalandCancerfondenVästra Götalandsregionen
- Mots-clés
- MedicineColorectal cancerLaparoscopic surgeryOpen surgeryRandomized controlled trialLaparoscopySurgeryGeneral surgeryCancerInternal medicine
- Résumé présent dans OpenAlex
- oui