Elsevier

The Lancet Oncology

Volume 14, Issue 3, March 2013, Pages 210-218
The Lancet Oncology

Articles
Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial

https://doi.org/10.1016/S1470-2045(13)70016-0Get rights and content

Summary

Background

Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer.

Methods

A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes—including operative findings, complications, mortality, and results at pathological examination—are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791.

Findings

The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100–400] vs 400 mL [200–700], p<0·0001); however, laparoscopic procedures took longer (240 min [184–300] vs 188 min [150–240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0–3·0] vs 3·0 days [2·0–4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0–13·0] vs 9·0 days [7·0–14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0–4·8] vs 3·0 cm [1·8–5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar.

Interpretation

In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint—locoregional recurrence—are expected by the end of 2013.

Funding

Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.

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.

Section snippets

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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