Stoma Reversal ProcedureNCT07605403
Comparison of Outcome of Purse-string Versus Conventional Linear Wound Closure Techniques in Patients Undergoing Stoma Reversal
A study testing Purse-string wound closure and Conventional linear wound closure in people with Stoma Reversal Procedure, run by Children Hospital Faisalabad at 1 site in Pakistan.
Trial summary
To compare outcomes of purse-string skin closure and conventional linear skin closure techniques in patients undergoing stoma reversal Read more about this study
- Who is it for?
- Ages 8 months to 12 years
- Conditions the study is for
- Stoma Reversal Procedure
- What is being tested?
- Purse-string wound closure and Conventional linear wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both genders
- 8 months to 12 years
- Undergoing ileostomy or colostomy reversal will be include
Who cannot join
- • Patients with Re-current stoma prolapse
- Patients with Re-do stomas
- Patients with underlying chronic inflammatory and neoplastic conditions (Tuberculosis, Maligency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Children hospital Faisalabad
Faisalābad, Punjab Province, 38000
Sayed Elyas, FCPS Pediatric Surgery, +923194440578, elyas.sadat100@gmail.com
About this study
To compare outcomes of purse-string skin closure and conventional linear skin closure techniques in patients undergoing stoma reversal
Read the detailed description
Upon receiving permission from the ERC, children who fulfill the operational definitions and inclusion criteria will be enrolled in the research after informed consent. Children of both genders, age 8 months to 12 years, undergoing ileostomy or colostomy reversal will be included. All patients will be divided into two groups by lottery method by offering them to pick up slip. In group A patients, skin wound closure after stoma reversal will be done with technique of purse-string closure. In group B patients, skin closure after reversal will be done with technique of conventional linear closure. All procedures will be performed by the same. Outcome of surgery will be noted in every patient of both groups as per operational definition. This all data will be recorded on a specially designed proforma
- Conditions
- Stoma Reversal Procedure
- Being tested
- Purse-string wound closure, Conventional linear wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse-string wound closureProcedure or surgery
Closure of stoma reversal wound using purse-string approximation technique
Conventional linear wound closureProcedure or surgery
Closure of stoma reversal wound using conventional linear skin closure technique.
| Study group | Role | What they receive |
|---|---|---|
| Purse-string closure group | Experimental | Patients undergoing stoma reversal in whom wound closure will be performed using the purse-string closure technique. Receives: 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 Receives: Procedure: Conventional linear wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infections
The presence of infection at the wound site, identified by clinical signs (e.g., redness, swelling, pus)
Measured: 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.
Measured: 6 weeks
Length of stay
The total number of days a patient in a hospital from admission till discharge date.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma Reversal ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sayed Elyas, Children Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605403
- Sponsor's protocol ID
- CH-FSD-RCT-2026-01
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Purse-string Versus Conventional Linear Wound Closure Techniques in Patients Undergoing Stoma Reversal
- ClinicalTrials.gov ID
- NCT07605403
- Acronym / sponsor ID
- CH-FSD-RCT-2026-01
- Conditions
- Stoma Reversal Procedure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Children Hospital FaisalabadUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare outcomes of purse-string skin closure and conventional linear skin closure techniques in patients undergoing stoma reversal
Detailed description
Upon receiving permission from the ERC, children who fulfill the operational definitions and inclusion criteria will be enrolled in the research after informed consent. Children of both genders, age 8 months to 12 years, undergoing ileostomy or colostomy reversal will be included. All patients will be divided into two groups by lottery method by offering them to pick up slip. In group A patients, skin wound closure after stoma reversal will be done with technique of purse-string closure. In group B patients, skin closure after reversal will be done with technique of conventional linear closure. All procedures will be performed by the same. Outcome of surgery will be noted in every patient of both groups as per operational definition. This all data will be recorded on a specially designed proforma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purse-string closure group | Experimental | Procedure: Purse-string wound closurePatients undergoing stoma reversal in whom wound closure will be performed using the purse-string closure technique. |
| Conventional linear closure group | Active comparator | Procedure: Conventional linear wound closurePatients undergoing stoma reversal in whom wound closure will be performed using the conventional linear closure technique |
Who may qualify
- Ages
- 8 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of both genders
- 8 months to 12 years
- Undergoing ileostomy or colostomy reversal will be include
Key exclusion criteria (3 listed)
- • Patients with Re-current stoma prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purse-string wound closureClosure of stoma reversal wound using purse-string approximation technique | Procedure or surgery | Purse-string closure group |
| Conventional linear wound closureClosure of stoma reversal wound using conventional linear skin closure technique. | Procedure or surgery | Conventional linear closure group |
Primary outcome
Surgical Site Infections
Time frame: 7 days
The presence of infection at the wound site, identified by clinical signs (e.g., redness, swelling, pus)
Time for wound healing
Time frame: 6 weeks
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.
Length of stay
Time frame: 10 days
The total number of days a patient in a hospital from admission till discharge date.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stoma Reversal Procedure
Not yet recruiting
Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal
Purse-String Suture, Wound Closure Technique
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Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery
Colostomy - Stoma, Stoma Reversal Procedure
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Post Operative Hospital at Home After Colorectal Surgery
Colo-rectal Cancer, Colo-rectal Surgery
Not yet recruitingObservational study
Laparoscopic Hartmann's Reversal Procedure: In the Absence of Standardized Guidelines, we Started a Database of Patient Submitted Reversal Hartman With Standard Technique and Laparoscopic Technique, Prospectively for One Year and a Follow-up Period of 6 Months
Colostomy - Stoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purse-string wound closure and Conventional linear wound closure in people with Stoma Reversal Procedure, run by Children Hospital Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sayed Elyas (+923194440578, elyas.sadat100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.