NCT02944188

Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer

Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Xu jianmin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic right hemicolectomy plus ERAS	patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
PROCEDURE	Open right hemicolectomy plus ERAS	patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-30
• Completion: 2020-12-30
• First posted: 2016-10-25
• Last updated: 2022-03-22

Locations

1 site across 1 country: China