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

Overview

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 Title of Study: “3D-Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

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 3D-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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: LRH plus ERAS
    • patients undergo Laparoscopic right hemicolectomy plus ERAS
  • Active Comparator: ORH plus ERAS
    • patients undergo open right hemicolectomy plus ERAS

Clinical Trial Outcome Measures

Primary Measures

  • incidence of postoperative complications
    • Time Frame: 30 days from surgery
    • The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xu jianmin
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Xu jianmin, Deputy director of the colorectal cancer center – Fudan University
  • Overall Official(s)
    • Hong Jiang, MD, Study Director, Fudan University
  • Overall Contact(s)
    • Jianmin Xu, MD, 86-18917982975, xujmin@aliyun.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.