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

Not Applicable

Completed

• Conditions: Colon Cancer
• Interventions: Procedure: Laparoscopic right hemicolectomy plus ERAS; Procedure: Open right hemicolectomy plus ERAS

• Registration Number: NCT02944188
• Lead Sponsor: Xu jianmin

Brief 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.

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2016-10-23
• Study First Posted: 2016-10-25
• Primary Completion: 2017-12-30
• Study Completion: 2020-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years;
2. Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
3. Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
4. Performance status (ECOG) 0~1
5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
7. Written informed consent for participation in the trial.

Exclusion Criteria

1. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
2. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
3. Known drug abuse/ alcohol abuse
4. Legal incapacity or limited legal capacity
5. Pre-existing peripheral neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LRH plus ERAS	Laparoscopic right hemicolectomy plus ERAS	patients undergo Laparoscopic right hemicolectomy plus ERAS
ORH plus ERAS	Open right hemicolectomy plus ERAS	patients undergo open right hemicolectomy plus ERAS

Primary Outcome Measures

Name	Time	Method
incidence of postoperative complications	30 days from surgery	The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification

Secondary Outcome Measures

Name	Time	Method
disease-free survival	3 years	Time from randomization to recurrence at any site or deaths resulting from any reason
overall survival	3 years	Time from randomization to deaths resulting from any reason
operative mortality	30 days post operatively	Deaths related to surgery within 30 days from surgery

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China