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.
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.
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.
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.
Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska
University Hospital.
Copyright © 2013 Elsevier Ltd. All rights reserved.