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

Sponsor

Zhejiang University (Other)

Overall Status

Terminated

CT.gov ID

NCT02652702

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Carcinoma	Procedure: circular stapler-assisted colostomy Procedure: conventional hand-stitching colostomy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circular Stapler-assisted Colostomy Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.	Procedure: circular stapler-assisted colostomy procedure:circular stapler-assisted colostomy device:circular stapler
Experimental: Hand-stitching Colostomy Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma.	Procedure: conventional hand-stitching colostomy procedure:hand-stitching colostomy

Arm

Intervention/Treatment

Experimental: Circular Stapler-assisted Colostomy

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

Procedure: circular stapler-assisted colostomy

procedure:circular stapler-assisted colostomy device:circular stapler

Experimental: Hand-stitching Colostomy

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

Procedure: conventional hand-stitching colostomy

procedure:hand-stitching colostomy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital Zhejiang University College of Medicine	Hangzhou	Zhejiang	China	310999

Sponsors and Collaborators

Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ding Ke-Feng, Principal Investigator, Zhejiang University

ClinicalTrials.gov Identifier:

NCT02652702

Other Study ID Numbers:

CRCCZ-D01

First Posted:

Jan 12, 2016

Last Update Posted:

Jul 7, 2020

Last Verified:

Jul 1, 2020

Keywords provided by Ding Ke-Feng, Principal Investigator, Zhejiang University

circular stapler-assisted colostomy

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Jul 7, 2020