Compared with open resection, laparoscopic resection of rectal cancers is associated with improved short-term outcomes, but high-level evidence showing similar long-term outcomes is scarce.
The trial has compared survival outcomes of laparoscopic surgery with open surgery for patients with mid-rectal or low-rectal cancer.
The Comparison of Open versus laparoscopic surgery for mid or low REctal cancer After Neoadjuvant chemoradiotherapy ( COREAN ) trial was an open-label, non-inferiority, randomised controlled trial done between April 4, 2006, and Aug 26, 2009, at three centres in Korea.
Patients ( aged 18-80 years ) with cT3N0-2M0 mid-rectal or low-rectal cancer who had received preoperative chemoradiotherapy were randomly assigned ( 1:1 ) to receive either open or laparoscopic surgery.
Randomisation was stratified by sex and preoperative chemotherapy regimen. Investigators were masked to the randomisation sequence; patients and clinicians were not masked to the treatment assignments.
The primary endpoint was 3 year disease-free survival, with a non-inferiority margin of 15%. Analysis was by intention to treat.
340 patients were randomly assigned to receive either open surgery ( n=170 ) or laparoscopic surgery ( n=170 ).
3 year disease-free survival was 72.5% for the open surgery group and 79.2% for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin ( -6.7%; p less than 0.0001 ).
25 ( 15% ) patients died in the open group and 20 ( 12% ) died in the laparoscopic group. No deaths were treatment related.
The results have shown that laparoscopic resection for locally advanced rectal cancer after preoperative chemoradiotherapy provides similar outcomes for disease-free survival as open resection, thus justifying its use. ( Xagena )
Jeong SY et al, The Lancet Oncology 2014; 15: 767-774