Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients

Overview

Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study,no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.

Full Title of Study: “Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients”

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 2018

Detailed Description

It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications. So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.

Interventions

  • Procedure: circular stapler-assisted colostomy
    • procedure:circular stapler-assisted colostomy device:circular stapler
  • Procedure: conventional hand-stitching colostomy
    • procedure:hand-stitching colostomy

Arms, Groups and Cohorts

  • Experimental: Circular Stapler-assisted Colostomy
    • Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
  • Experimental: Hand-stitching Colostomy
    • Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.

Clinical Trial Outcome Measures

Primary Measures

  • colostomy associated complications
    • Time Frame: 2 year
    • measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.

Participating in This Clinical Trial

Inclusion Criteria

  • Receiving permanent colostomy because of colorectal cancer – Age of ≥18 and ≤80 Exclusion Criteria:

  • Not willing or incapable to comply with all study visits and assessments – Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ding Ke-Feng, Principal Investigator – Zhejiang University

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