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

Phase 2

Terminated

• Conditions: Colorectal Carcinoma
• Interventions: Procedure: circular stapler-assisted colostomy; Procedure: conventional hand-stitching colostomy

• Registration Number: NCT02652702
• Lead Sponsor: Zhejiang University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2016-01-09
• Study First Posted: 2016-01-12
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2020-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circular Stapler-assisted Colostomy	circular stapler-assisted colostomy	Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.
Hand-stitching Colostomy	conventional hand-stitching colostomy	Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Second Affiliated Hospital Zhejiang University College of Medicine; 🇨🇳 Hangzhou, Zhejiang, China