NCT07605403

Brief Summary

To compare outcomes of purse-string skin closure and conventional linear skin closure techniques in patients undergoing stoma reversal

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

16 days

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Stoma Reversal Procedure

Outcome Measures

Primary Outcomes (3)

  • Surgical Site Infections

    The presence of infection at the wound site, identified by clinical signs (e.g., redness, swelling, pus)

    7 days

  • Time for wound healing

    The duration from the surgical procedure until the wound is fully healed. It will be assessed on clinical examination of wound closure, including inspection for signs of epithelialization and the absence of gaps or dehiscence.

    6 weeks

  • Length of stay

    The total number of days a patient in a hospital from admission till discharge date.

    10 days

Study Arms (2)

Purse-string closure group

EXPERIMENTAL

Patients undergoing stoma reversal in whom wound closure will be performed using the purse-string closure technique.

Procedure: Purse-string wound closure

Conventional linear closure group

ACTIVE COMPARATOR

Patients undergoing stoma reversal in whom wound closure will be performed using the conventional linear closure technique

Procedure: Conventional linear wound closure

Interventions

Purse-string wound closurePROCEDURE

Closure of stoma reversal wound using purse-string approximation technique

Purse-string closure group
Conventional linear wound closurePROCEDURE

Closure of stoma reversal wound using conventional linear skin closure technique.

Conventional linear closure group

Eligibility Criteria

Age8 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children of both genders
  • months to 12 years
  • Undergoing ileostomy or colostomy reversal will be include

You may not qualify if:

  • Patients with Re-current stoma prolapse
  • Patients with Re-do stomas
  • Patients with underlying chronic inflammatory and neoplastic conditions (Tuberculosis, Maligency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children hospital Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

Central Study Contacts

Sayed Elyas

CONTACT

+923194440578elyas.sadat100@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator department of Pediatric Surgery

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

June 15, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations

PA(1)