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NCT02652702 Clinical Trial

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

Colorectal Carcinoma Clinical Trial

— STAPLER  

Official title:
Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02652702
Other study ID # CRCCZ-D01
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 2016
Est. completion date January 2020

Study information
Verified date July 2020
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date January 2020
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Second Affiliated Hospital Zhejiang University College of Medicine Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary colostomy associated complications measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia. 2 year
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