Fast track — ArticlesSurvival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial
Introduction
Cancer of the colon is the third most common cancer in men and women in the developed world,1 and resection is the only curative treatment. Traditionally, cancers of the colon were removed through large abdominal incisions. More than a decade ago, the first report on laparoscopic resection of colon cancer was published.2 Laparoscopic colectomy is associated with improved convalescence and decreased morbidity compared with open resection.3, 4, 5, 6 However, reports of tumour recurrence at the port sites after laparoscopic resection of colon cancer have questioned the oncological safety of laparoscopic surgery in patients with bowel cancer.7 Thus, disease-free survival after laparoscopic colectomy for cancer needs to be proven non-inferior to that after open resection of bowel cancer.
The European multicentre COlon cancer Laparoscopic or Open Resection (COLOR) trial aimed to assess disease-free survival and overall survival 3 years after laparoscopic surgery or open surgery for colon cancer. The short-term outcomes of the COLOR trial have been published previously.6 Here, we present the data for long-term outcome.
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Patients and procedures
Patients with colon cancer presenting at 29 participating hospitals in Europe were considered for inclusion in the trial. Patients with a solitary adenocarcinoma, localised in the caecum, ascending colon, descending colon, or sigmoid colon above the peritoneal deflection, who were aged 18 years or more, and who provided written informed consent, were eligible for random assignment to either laparoscopic or open surgery. Exclusion criteria included: a body-mass index (BMI) greater than 30 kg/m2;
Results
Between March 7, 1997, and March 6, 2003, 1248 patients were randomly assigned to either laparoscopic or open surgery. 153 patients were excluded after randomisation for various reasons (figure 1) and 19 patients were lost to follow-up. Of the 1076 patients who were available for analysis, 542 had an open colectomy and 534 had a laparoscopic colectomy. The average number of patients included per centre was 37, with a median follow-up in the laparoscopic group of 52 months (SD 17·0; range
Discussion
Data from the COLOR trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy, because the upper limit of the 95% CI for the difference just passed the predetermined non-inferiority boundary of 7%. However, in a per-protocol analysis, done as per CONSORT guidelines to prevent a false conclusion of non-inferiority,11 in which those patients who were randomly assigned to laparoscopic surgery but were switched pre-operatively to receive open surgery were
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