ArticlesLaparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial
Introduction
Rectal cancer afflicts more than 50 women and men per 100 000 individuals per year in Europe and accounts for more than 80 000 deaths per year.1, 2 The outcome of surgery for this cancer has improved substantially during the past two decades because of the introduction of total mesorectal excision (TME),3 which entails complete removal of the mesorectum—adipose lymphatic tissue surrounding the rectum—with preservation of the pelvic autonomic nerves. Local recurrence rates of rectal cancer have fallen sharply because radially spread cancer cells in the mesorectum are removed by complete resection of this tissue. Radiotherapy and chemotherapy are important components of multimodal treatment in patients with more advanced rectal cancer.4
The introduction of TME in the early 1990s coincided with the progressive use of laparoscopic surgery in patients with colorectal disease. Laparoscopic resection of colonic cancer has proven to be safe, causing less postoperative pain, allowing earlier recovery, and is associated with cancer survival similar to that obtained with traditional open colectomy.5, 6
Although the findings of various reports have shown that laparoscopic TME is safe, studies with sufficient numbers of patients allowing clinical acceptance of laparoscopic surgery in rectal cancer are lacking.7, 8 We compared laparoscopic and open surgery in patients with rectal cancer in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial and report the short-term (secondary) outcomes.
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Patients
COLOR II, a non-inferiority, open-label, randomised trial, was undertaken in 30 centres and hospitals in eight countries (Belgium, Canada, Denmark, Germany, the Netherlands, Spain, South Korea, and Sweden). Patients with a single rectal cancer within 15 cm from the anal verge at colonoscopy, rigid rectoscopy, or barium enema without evidence of distant metastases who were candidates for elective surgery were eligible for participation in this study. The localisation of the tumour was
Results
Between Jan 20, 2004, and May 4, 2010, 1103 patients with rectal cancer were randomly assigned to either laparoscopic or open surgery. 260 patients were from Dutch hospitals, 475 from Scandinavian hospitals, 138 from Spanish hospitals, and 230 from other European, Canadian, and Asian centres. The median number of patients per centre was 32 (range 1–113). 59 patients were excluded after randomisation; reasons for exclusion included distant metastases, no malignant tumour, or a T4 tumour (figure
Discussion
The short-term outcomes of the COLOR II trial show that the radicality of laparoscopic resection (as assessed by pathology report) in patients with rectal cancer is no different to that of open surgery, and that laparoscopic surgery was associated with similar rates of intra-operative complications, morbidity, and mortality. Complete removal of the primary tumour and tumour deposits in the mesorectum is the goal of surgery in patients with rectal cancer. A resection is judged radical when the
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