In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.
This study was a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon adenocarcinoma;(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate hematological, hepatic and renal function. Patients operated on as an emergency, or with tumours in the transverse colon, or with other previous malignancy within 5 years were excluded. All particapants were recruited and randomly assigned to receive laproscopic or open right hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was the incidence of postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification. The secondary end-points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
602
patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Zhongshan Hospital, Fudan University
Shanghai, China
incidence of postoperative complications
The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification
Time frame: 30 days from surgery
overall survival
Time from randomization to deaths resulting from any reason
Time frame: 3 years
disease-free survival
Time from randomization to recurrence at any site or deaths resulting from any reason
Time frame: 3 years
operative mortality
Deaths related to surgery within 30 days from surgery
Time frame: 30 days post operatively
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