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

NCT ID: NCT02652702

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-01-31

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.

Conditions

Colorectal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Circular Stapler-assisted Colostomy

Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.

Group Type: EXPERIMENTAL

circular stapler-assisted colostomy

Intervention Type: PROCEDURE

procedure:circular stapler-assisted colostomy device:circular stapler

Hand-stitching Colostomy

Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.

Group Type: EXPERIMENTAL

conventional hand-stitching colostomy

Intervention Type: PROCEDURE

procedure:hand-stitching colostomy

Interventions

circular stapler-assisted colostomy

procedure:circular stapler-assisted colostomy device:circular stapler

Intervention Type: PROCEDURE

conventional hand-stitching colostomy

procedure:hand-stitching colostomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Ding Ke-Feng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CRCCZ-D01

Identifier Type: -

Identifier Source: org_study_id