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

Xu jianmin

Status: Completed

Conditions: Colon Cancer

Treatments: Procedure: Open right hemicolectomy plus ERAS; Procedure: Laparoscopic right hemicolectomy plus ERAS

Study type: Interventional

Funder types: Other

Identifiers

NCT02944188

ERAS-02

82345432 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 602 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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602 participants in 2 patient groups

LRH plus ERAS

Experimental group

Description:

patients undergo Laparoscopic right hemicolectomy plus ERAS

Treatment:

Procedure: Laparoscopic right hemicolectomy plus ERAS

ORH plus ERAS

Active Comparator group

Description:

patients undergo open right hemicolectomy plus ERAS

Treatment:

Procedure: Open right hemicolectomy plus ERAS