Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial.
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. We aimed to compare 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. This trial is registered with ClinicalTrials.gov, number NCT00470951.



We randomly assigned 340 patients to receive either open surgery (n=170) or laparoscopic surgery (n=170). 3 year disease-free survival was 72·5% (95% CI 65·0-78·6) for the open surgery group and 79·2% (72·3-84·6) for the laparoscopic surgery group, with a difference that was lower than the prespecified non-inferiority margin (-6·7%, 95% CI -15·8 to 2·4; p<0·0001). 25 (15%) patients died in the open group and 20 (12%) died in the laparoscopic group. No deaths were treatment related.



Our results show 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.



National Cancer Center, South Korea.
Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University, Seoul, South Korea.
Seung-Yong
SY
Jeong
Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, South Korea; Cancer Research Institute, Seoul National University, Seoul, South Korea.
Ji Won
JW
Park
Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Byung Ho
BH
Nam
Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Sohee
S
Kim
Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Sung-Bum
SB
Kang
Department of Colon and Rectal Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Seok-Byung
SB
Lim
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Hyo Seong
HS
Choi
Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Duck-Woo
DW
Kim
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Hee Jin
HJ
Chang
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Dae Yong
DY
Kim
Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Kyung Hae
KH
Jung
Division of Medical Oncology and Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Tae-You
TY
Kim
Department of Pathology, Seoul National University Hospital, Seoul, South Korea.
Gyeong Hoon
GH
Kang
Department of Radiation Oncology, Seoul National University Hospital, Seoul, South Korea.
Eui Kyu
EK
Chie
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Sun Young
SY
Kim
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Dae Kyung
DK
Sohn
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.
Dae-Hyun
DH
Kim
Department of Radiation Oncology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Jae-Sung
JS
Kim
Department of Pathology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Hye Seung
HS
Lee
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Jee Hyun
JH
Kim
Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea. Electronic address: jayoh@ncc.re.kr.
Jae Hwan
JH
Oh
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059248:Chemoradiotherapy; D005260:Female; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome