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

Primary Purpose

Colostomy

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pursestring Wound Closure

Gunsight Skin Incision and Closure Technique

About this trial

This is an interventional treatment trial for Colostomy focused on measuring Reversal, Surgical technique, Pursestring Wound Closure, Gunsight Skin Incision and Closure Technique

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

loop colostomy
end colostomy

Exclusion Criteria:

other stomy

Sites / Locations

Beijing Chaoyang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pursestring Wound Closure group

Gunsight Skin Incision and Closure group

Arm Description

use Pursestring Wound Closure technique to close the stoma

use Gunsight Skin Incision and Closure Technique to close the stoma

Outcomes

Primary Outcome Measures

superficial wound infection of stoma site

Secondary Outcome Measures

Healing time after stoma reversal

Full Information

NCT ID

NCT02053948

First Posted

November 26, 2013

Last Updated

September 6, 2019

Sponsor

Beijing Chao Yang Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02053948

Brief Title

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

Acronym

GSICT1126

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 30, 2013 (undefined)

Primary Completion Date

December 30, 2017 (Actual)

Study Completion Date

December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Chao Yang Hospital

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colostomy

Keywords

Reversal, Surgical technique, Pursestring Wound Closure, Gunsight Skin Incision and Closure Technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pursestring Wound Closure group

Arm Type

Experimental

Arm Description

use Pursestring Wound Closure technique to close the stoma

Arm Title

Gunsight Skin Incision and Closure group

Arm Type

Experimental

Arm Description

use Gunsight Skin Incision and Closure Technique to close the stoma

Intervention Type

Procedure

Intervention Name(s)

Pursestring Wound Closure

Intervention Type

Procedure

Intervention Name(s)

Gunsight Skin Incision and Closure Technique

Primary Outcome Measure Information:

Title

superficial wound infection of stoma site

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Healing time after stoma reversal

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Patient's satisfaction about the wound after stoma reversal

Time Frame

1 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: loop colostomy end colostomy Exclusion Criteria: other stomy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiagang Han, Professor

Organizational Affiliation

Beijing Chao Yang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Chaoyang Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23303149

Citation

Camacho-Mauries D, Rodriguez-Diaz JL, Salgado-Nesme N, Gonzalez QH, Vergara-Fernandez O. Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection. Dis Colon Rectum. 2013 Feb;56(2):205-11. doi: 10.1097/DCR.0b013e31827888f6.

Results Reference

background

PubMed Identifier

20940608

Citation

Lim JT, Shedda SM, Hayes IP. "Gunsight" skin incision and closure technique for stoma reversal. Dis Colon Rectum. 2010 Nov;53(11):1569-75. doi: 10.1007/DCR.0b013e3181f0535a.

Results Reference

background

PubMed Identifier

32969884

Citation

Han JG, Yao HW, Zhou JP, Zhang H, Wang GY, Shen ZL, Gong JF, Wang ZJ; Colorectal Surgery Group of Chinese Academic Society of Young Surgeons. Gunsight Procedure Versus the Purse-String Procedure for Closing Wounds After Stoma Reversal: A Multicenter Prospective Randomized Trial. Dis Colon Rectum. 2020 Oct;63(10):1411-1418. doi: 10.1097/DCR.0000000000001755.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/

Description

the Technique used in this trial

Learn more about this trial

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

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