Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Reverse Stoma (GSICT1126)

September 6, 2019 updated by: Zhen Jun Wang, Beijing Chao Yang Hospital

Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Eliminate the Risk of Wound Infection

The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs "gunsight" skin incision and closure technique closure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Beijing Chaoyang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • loop colostomy
  • end colostomy

Exclusion Criteria:

  • other stomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pursestring Wound Closure group
use Pursestring Wound Closure technique to close the stoma
Procedure: Pursestring Wound Closure
EXPERIMENTAL: Gunsight Skin Incision and Closure group
use Gunsight Skin Incision and Closure Technique to close the stoma
Procedure: Gunsight Skin Incision and Closure Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
superficial wound infection of stoma site
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Healing time after stoma reversal
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Patient's satisfaction about the wound after stoma reversal
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Collaborators

Peking University People's Hospital
Beijing Friendship Hospital
Peking Union Medical College Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese PLA General Hospital
Shengjing Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Hebei Medical University Fourth Hospital
First Hospital of China Medical University
Jinling Hospital, China

Investigators

  • Principal Investigator: Jiagang Han, Professor, Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 30, 2013

Primary Completion (ACTUAL)

December 30, 2017

Study Completion (ACTUAL)

December 30, 2017

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

February 3, 2014

First Posted (ESTIMATE)

February 4, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSICT1126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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