Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial
- PMID: 23395398
- DOI: 10.1016/S1470-2045(13)70016-0
Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial
Abstract
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.
Copyright © 2013 Elsevier Ltd. All rights reserved.
Comment in
-
Another laparoscopic trial report: what have we learned?Lancet Oncol. 2013 Mar;14(3):179-80. doi: 10.1016/S1470-2045(13)70044-5. Epub 2013 Feb 6. Lancet Oncol. 2013. PMID: 23395399 No abstract available.
-
[Laparoscopic vs open rectal carcinoma surgery: short-term results of the COLOR II trial].Chirurg. 2013 Jun;84(6):526. doi: 10.1007/s00104-013-2521-0. Chirurg. 2013. PMID: 23681368 German. No abstract available.
Similar articles
-
Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial.Lancet Oncol. 2010 Jul;11(7):637-45. doi: 10.1016/S1470-2045(10)70131-5. Epub 2010 Jun 16. Lancet Oncol. 2010. PMID: 20610322 Clinical Trial.
-
Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial.Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004. doi: 10.1016/S2468-1253(22)00248-5. Epub 2022 Sep 8. Lancet Gastroenterol Hepatol. 2022. PMID: 36087608 Clinical Trial.
-
Laparoscopic resection of rectal cancer results in higher lymph node yield and better short-term outcomes than open surgery: a large single-center comparative study.Dis Colon Rectum. 2013 Jun;56(6):679-88. doi: 10.1097/DCR.0b013e318287c594. Dis Colon Rectum. 2013. PMID: 23652740
-
Laparoscopic abdominoperineal resection for anorectal cancer.Am Surg. 1998 Jan;64(1):12-8. Am Surg. 1998. PMID: 9457031 Review.
-
There is no difference in outcome between laparoscopic and open surgery for rectal cancer: a systematic review and meta-analysis on short- and long-term oncologic outcomes.Tech Coloproctol. 2017 Aug;21(8):595-604. doi: 10.1007/s10151-017-1662-4. Epub 2017 Aug 9. Tech Coloproctol. 2017. PMID: 28795243 Free PMC article. Review.
Cited by
-
Short- and long-term outcomes of robotic and laparoscopic surgery in rectal cancer: a propensity score-matched analysis.Surg Endosc. 2024 Nov 1. doi: 10.1007/s00464-024-11374-w. Online ahead of print. Surg Endosc. 2024. PMID: 39485536
-
Robotic right colectomy versus laparoscopic right colectomy in patients with right colon cancer: a comparative study.BMC Surg. 2024 Oct 25;24(1):332. doi: 10.1186/s12893-024-02593-y. BMC Surg. 2024. PMID: 39455989 Free PMC article.
-
Short-Term Postoperative Outcomes after Resective Colorectal Surgery in Elderly vs. Nonelderly Patients: A Single Centre Retrospective Analysis.Cancers (Basel). 2024 Sep 30;16(19):3358. doi: 10.3390/cancers16193358. Cancers (Basel). 2024. PMID: 39409978 Free PMC article.
-
Rectal stenosis after circular mechanical anastomosis; the influence of stapler size.Surg Endosc. 2024 Oct 14. doi: 10.1007/s00464-024-11306-8. Online ahead of print. Surg Endosc. 2024. PMID: 39402229
-
Evaluation of the da Vinci single-port system in colorectal cancer surgery: a scoping review.Updates Surg. 2024 Oct 5. doi: 10.1007/s13304-024-02014-y. Online ahead of print. Updates Surg. 2024. PMID: 39369142 Review.
Publication types
MeSH terms
Associated data
LinkOut - more resources
Full Text Sources
Other Literature Sources