NCT02053948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

November 30, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

4.1 years

First QC Date

November 26, 2013

Last Update Submit

September 6, 2019

Conditions

Colostomy

Keywords

ReversalSurgical techniquePursestring Wound ClosureGunsight Skin Incision and Closure Technique

Outcome Measures

Primary Outcomes (1)

  • superficial wound infection of stoma site

    1 year

Secondary Outcomes (1)

  • Healing time after stoma reversal

    1 year

Other Outcomes (1)

  • Patient's satisfaction about the wound after stoma reversal

    1 year

Study Arms (2)

Pursestring Wound Closure group

EXPERIMENTAL

use Pursestring Wound Closure technique to close the stoma

Procedure: Pursestring Wound Closure

Gunsight Skin Incision and Closure group

EXPERIMENTAL

use Gunsight Skin Incision and Closure Technique to close the stoma

Procedure: Gunsight Skin Incision and Closure Technique

Interventions

Pursestring Wound ClosurePROCEDURE
Pursestring Wound Closure group
Gunsight Skin Incision and Closure TechniquePROCEDURE
Gunsight Skin Incision and Closure group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • loop colostomy
  • end colostomy

You may not qualify if:

  • other stomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (3)

  • 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.

    PMID: 23303149BACKGROUND

  • 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.

    PMID: 20940608BACKGROUND

  • 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.

    PMID: 32969884DERIVED

Related Links

Study Officials

  • Jiagang Han, Professor

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2013

First Posted

February 4, 2014

Study Start

November 30, 2013

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

CN(1)