COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy.

If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%.

Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.

Inclusion criteria

• solitary rectal cancer observed at colonoscopy or on barium X-ray
• no evidence of distant metastases
• distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
• suitable for elective surgical resection
• informed consent

Exclusion criteria

• T1 tumors treated by locl excision
• T4 tumors
• patients under 18 years of age
• signs of acute intestinal obstruction
• more than one colorectal tumor
• Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
• active crohn's or active ulcerative colitis
• scheduled need for other synchronous colon surgery
• preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
• preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
• other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
• absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
• pregnancy