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

NCT ID: NCT02944188

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 602 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2020-12-30

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LRH plus ERAS

patients undergo Laparoscopic right hemicolectomy plus ERAS

Group Type: EXPERIMENTAL

Laparoscopic right hemicolectomy plus ERAS

Intervention Type: PROCEDURE

patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

ORH plus ERAS

patients undergo open right hemicolectomy plus ERAS

Group Type: ACTIVE_COMPARATOR

Open right hemicolectomy plus ERAS

Intervention Type: PROCEDURE

patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

Interventions

Laparoscopic right hemicolectomy plus ERAS

patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

Intervention Type: PROCEDURE

Open right hemicolectomy plus ERAS

patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

Intervention Type: PROCEDURE

Other Intervention Names

LRH ERAS

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xu jianmin

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Deputy director of the colorectal cancer center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hong Jiang, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Countries

China

Other Identifiers

82345432

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ERAS-02

Identifier Type: -

Identifier Source: org_study_id