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

NCT ID: NCT02053948

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pursestring Wound Closure group

use Pursestring Wound Closure technique to close the stoma

Group Type EXPERIMENTAL

Pursestring Wound Closure

Intervention Type PROCEDURE

Gunsight Skin Incision and Closure group

use Gunsight Skin Incision and Closure Technique to close the stoma

Group Type EXPERIMENTAL

Gunsight Skin Incision and Closure Technique

Intervention Type PROCEDURE

Interventions

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Pursestring Wound Closure

Intervention Type PROCEDURE

Gunsight Skin Incision and Closure Technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* loop colostomy
* end colostomy

Exclusion Criteria

* other stomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Jinling Hospital, China

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhen Jun Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiagang Han, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23303149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20940608 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32969884 (View on PubMed)

Related Links

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

the Technique used in this trial

Other Identifiers

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GSICT1126

Identifier Type: -

Identifier Source: org_study_id

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