Fast track — ArticlesOpen versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial
Introduction
Laparoscopic resection for rectal cancer does not have level 1 evidence in surgical practice, although laparoscopic surgery for colon cancer has been growing in popularity based on oncological evidence.1, 2, 3, 4, 5 Subset analysis of the UK Medical Research Council (MRC) Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) trial reported a 34% conversion rate with 59% morbidity for 30 days after laparoscopic surgery for rectal cancer.6 Although a randomised trial of sigmoid colon cancer, including upper rectal cancer, showed that laparoscopic surgery had short-term benefits with similar oncological outcomes to open surgery,3 the results were difficult to interpret because of the heterogeneity of tumour locations.3, 4 Laparoscopic procedures for rectal cancer are regarded as technically demanding7 because total mesorectal excision (TME) and autonomic nerve preservation are prerequisites for functional and oncological safety. Several studies have shown that laparoscopic surgery has technical benefits, such as a magnified view, over open surgery.8, 9, 10 A few randomised trials involving patients with mid or low rectal cancer have shown that laparoscopic surgery does not compromise oncological outcomes compared with open types of surgery,8, 10, 11 but these trials were based on small samples and did not control for preoperative chemoradiotherapy.
There have been no randomised trials demonstrating the safety of laparoscopic surgery after preoperative chemoradiotherapy for mid and low rectal cancer. The German Rectal Cancer Study Group trial12 showed that preoperative chemoradiotherapy improves 5-year locoregional recurrence and sphincter preservation compared with postoperative chemoradiotherapy in patients with stage T3, T4, or node-positive disease. The National Comprehensive Cancer Network recommends that resectable cT3N0 or any cTN1–2 lesions should be initially treated with preoperative chemoradiation.13 Only a single case-matched study has compared short-term outcomes of laparoscopy versus open surgery after preoperative chemoradiotherapy in mid or low rectal cancer.14 The COREAN (Comparison of Open versus laparoscopic surgery for mid and low REctal cancer After Neoadjuvant chemoradiotherapy) randomised controlled trial was designed to assess the safety and efficacy of laparoscopic surgery compared with that of open surgery for mid or low rectal cancer after preoperative chemoradiotherapy. Here, we report the short-term outcomes of this trial.
Section snippets
Patients
This randomised, controlled, open-label, parallel group trial compared open versus laparoscopic surgery after preoperative chemoradiotherapy in patients with mid or low rectal cancer. Patients were recruited at three tertiary-referral hospitals in South Korea: the National Cancer Center, the Seoul National University Hospital, and the Seoul National University Bundang Hospital. The primary endpoint is 3-year disease-free survival (DFS); patients continue to be followed up for this endpoint.
Results
Between April 4, 2006, and Aug 26, 2009, 340 patients were randomly assigned to receive laparoscopic or open surgery (figure 1). None of the patients had a metastatic lesion detected before or during surgery. Two patients in the laparoscopic group were converted to open surgery because of a difficult dissection in a narrow pelvis and intraoperative bleeding; for the purposes of the analyses presented here, these patients were included in the laparoscopic surgery group. There were no deaths
Discussion
To our knowledge, this is the first randomised trial comparing open and laparoscopic surgery after preoperative chemoradiotherapy for mid or low rectal cancer. The study shows that laparoscopic surgery for rectal cancer after preoperative chemoradiotherapy does not jeopardise short-term surgical outcomes such as CRM positivity, macroscopic quality of the TME specimen, or the number of harvested lymph nodes, which are associated with long-term oncological outcomes, and does not increase
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