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Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer.

ABSTRACT: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up.Between March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842).In total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) -10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI -10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI -11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4).Laparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery at 10-year follow-up.

SUBMITTER: Deijen CL

PROVIDER: S-EPMC5443846 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer.

Deijen Charlotte L CL Vasmel Jeanine E JE de Lange-de Klerk Elly S M ESM Cuesta Miguel A MA Coene Peter-Paul L O PLO Lange Johan F JF Meijerink W J H Jeroen WJHJ Jakimowicz Jack J JJ Jeekel Johannes J Kazemier Geert G Janssen Ignace M C IMC Påhlman Lars L Haglind Eva E Bonjer H Jaap HJ

Surgical endoscopy 20161012 6

<h4>Background</h4>Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up.<h4>Methods</h4>Between March 1997 and March 2003, patients with non-metastatic colon cancer were recru ...[more]

PMID: 27734203

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Project description:Studies evaluating the outcomes after laparoscopic resections of transverse colon cancers are scant. This manuscript aimed to compare surgical and oncological outcomes after laparoscopic (Lap) and open procedures for transverse colon carcinomas. All consecutive patients who underwent resection for a cancer located in the transverse colon between 2003 and 2019 were reviewed. Patients were categorized according to the surgical approach (Lap versus open) and groups were compared. Outcome measures were the short-term results, complications and functional recovery; moreover, recurrence-free survival (RFS) and overall survival (OS) rates were compared overall and after propensity score matching (PSM) based on age, sex, ASA classification, BMI, carcinoembryonic antigen (CEA) level, use of postoperative chemotherapy, location of tumour, stage and grading, operation time, blood loss and complications. Of 248 transverse resections reviewed, 146 (81 Lap and 65 open) were selected for data analysis. Blood loss, fluid intake and the incidence of wound infection were significantly lower and the hospital stay was significantly shorter in the Lap group (P < 0.001). The operation time and incidence of complications (Clavien-Dindo classification grade 3 or above) did not differ significantly between the two groups. Mean follow-up was of 75.4 months in the Lap group and 78.6 months in the open group. Regression analyses showed that OS was associated with the postoperative carcinoembryonic antigen (CEA) level (hazard ratio 1.18 (95 per cent c.i. 1.10 to 1.27); P < 0.001), BMI (hazard ratio 0.81 (95 per cent c.i. 0.68 to 0.96); P = 0.017), operation time (hazard ratio 0.99 (95 per cent c.i. 0.97 to 1.00; P = 0.010), and postoperative chemotherapy (hazard ratio 0.27 (95 per cent c.i. 0.08 to 0.96); P = 0.042), while RFS was associated with the postoperative CEA level (hazard ratio 1.13 (95 per cent c.i. 1.07 to 1.20); P < 0.001). PSM selected 42 patients for data comparison of long-term results, and showed no significant differences between groups (RFS: P = 0.530; OS: P = 0.561). Lap and open resections for transverse colon cancer provided similar outcomes in terms of severe post-operative complication and long-term results.

Project description:IntroductionAcute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection.Methods and analysisThe LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes.Ethics and disseminationThe LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals.Trial registration numberISRCTN15681041; Pre-results.

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Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer.

Publications

Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer.

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