Robotic-assisted Left Hemicolectomy for Left Colon Cancer

Overview

The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection. Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated

Full Title of Study: “Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2020

Detailed Description

Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.

Interventions

  • Procedure: robotic assisted surgery
    • robotic assisted surgery was benefit to operation
  • Procedure: laparoscopic
    • conventional laparoscopic surgery

Arms, Groups and Cohorts

  • Experimental: robotic-assisted left colonic resection
    • Standard left colonic resection assisted by Davinci Robotic
  • Active Comparator: laparoscopic left colonic resection
    • Standard laparoscopic left colonic resection

Clinical Trial Outcome Measures

Primary Measures

  • 5-years overall survival rate
    • Time Frame: 5 years

Secondary Measures

  • Short-term morbidity rate
    • Time Frame: 30 days
  • Anastomosis leakage rate
    • Time Frame: 6 months
  • Operation Time
    • Time Frame: 1 day
  • Blood loss during operation
    • Time Frame: 1 day
  • Complication incident rate of surgery
    • Time Frame: 1 day
  • C-reaction protein level
    • Time Frame: 7 days
  • Recovery time after surgery
    • Time Frame: 60 days

Participating in This Clinical Trial

Inclusion Criteria

Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2 Exclusion Criteria:

With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Southwest Hospital, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Li Chuan, Secretary of General Surgery – Southwest Hospital, China
  • Overall Contact(s)
    • Li Chuan, M.D, +862368754167, lee_tran@126.com

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