IleostomyNCT07601594
Early vs Standard Ileostomy Reversal
A study testing Ileostomy reversal in people with Ileostomy and Colorectal Surgery, run by Gulab Devi Hospital at 1 site in Pakistan.
Trial summary
This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Ileostomy, Colorectal Surgery
- What is being tested?
- Ileostomy reversal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing
Who cannot join
- Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gulab Devi Teaching Hospital, Lahore, Pakistan
Lahore, Punjab Province, 54000
About this study
Official title: Early Ileostomy Reversal at Two Months Versus Three Months: A Randomized Controlled Trial
This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.
Read the detailed description
This open-label randomized controlled trial was conducted at Gulab Devi Teaching Hospital, Lahore, Pakistan, between August 2025 and January 2026 to compare early versus standard timing of ileostomy reversal. Patients aged 14 to 55 years with a protective loop ileostomy following colorectal surgery and radiologically confirmed anastomotic healing were enrolled. Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at approximately 8 weeks (early group) or 12 weeks (standard group).
The primary outcome was the rate of postoperative complications occurring during the index hospital admission following ileostomy reversal. Secondary outcomes included length of hospital stay, time to first oral intake, time to return to normal activities, patient-reported comfort using a visual analogue scale, and 30-day readmission rates.
All procedures were performed using a standardized surgical technique by experienced surgeons within the same unit. Statistical analysis was performed using appropriate tests for continuous and categorical variables, with a significance threshold of p<0.05.
The study aimed to evaluate whether earlier ileostomy reversal is safe and associated with improved recovery outcomes in a resource-limited tertiary care setting.
- Conditions
- Ileostomy, Colorectal Surgery
- Being tested
- Ileostomy reversal
- Keywords
- Ileostomy reversal, Loop ileostomy, Early stoma closure, Colorectal surgery, Stoma closure timing, Anastomotic healing, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileostomy reversalProcedure or surgery
Surgical closure of loop ileostomy
| Study group | Role | What they receive |
|---|---|---|
| Early Reversal | Experimental | Ileostomy reversal performed at approximately 8 weeks Receives: Procedure: Ileostomy reversal |
| Standard Reversal | Active comparator | Ileostomy reversal performed at approximately 12 weeks Receives: Procedure: Ileostomy reversal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate
Measured: From enrollment to end of study at 6 months
Secondary outcomes (4)
Length of hospital stay
Measured: From enrollment to the end of study at 6 months
Time to oral intake
Measured: From enrollment to the discharge of patient which was upto 2 weeks
Return to normal activities
Measured: From enrollment to end of study at 6 months
Patient comfort score
Measured: From enrollment to the discharge of patient which was upto 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Aug 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomyStudies 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
- Model description
- Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at 8 weeks (early group) or 12 weeks (standard group), with outcomes compared between the two parallel groups.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulab Devi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamza Akhtar, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601594
- Sponsor's protocol ID
- GDTH-IR-2025-01
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ileostomy Reversal at Two Months Versus Three Months: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07601594
- Acronym / sponsor ID
- GDTH-IR-2025-01
- Conditions
- Ileostomy, Colorectal Surgery
- Keywords
- Ileostomy reversal, Loop ileostomy, Early stoma closure, Colorectal surgery, Stoma closure timing, Anastomotic healing, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gulab Devi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 22 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.
This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.
Detailed description
This open-label randomized controlled trial was conducted at Gulab Devi Teaching Hospital, Lahore, Pakistan, between August 2025 and January 2026 to compare early versus standard timing of ileostomy reversal. Patients aged 14 to 55 years with a protective loop ileostomy following colorectal surgery and radiologically confirmed anastomotic healing were enrolled. Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at approximately 8 weeks (early group) or 12 weeks (standard group).
The primary outcome was the rate of postoperative complications occurring during the index hospital admission following ileostomy reversal. Secondary outcomes included length of hospital stay, time to first oral intake, time to return to normal activities, patient-reported comfort using a visual analogue scale, and 30-day readmission rates.
All procedures were performed using a standardized surgical technique by experienced surgeons within the same unit. Statistical analysis was performed using appropriate tests for continuous and categorical variables, with a significance threshold of p<0.05.
The study aimed to evaluate whether earlier ileostomy reversal is safe and associated with improved recovery outcomes in a resource-limited tertiary care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at 8 weeks (early group) or 12 weeks (standard group), with outcomes compared between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Early Reversal | Experimental | Procedure: Ileostomy reversalIleostomy reversal performed at approximately 8 weeks |
| Standard Reversal | Active comparator | Procedure: Ileostomy reversalIleostomy reversal performed at approximately 12 weeks |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing
Key exclusion criteria (1 listed)
- Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia
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 |
|---|---|---|
| Ileostomy reversalSurgical closure of loop ileostomy | Procedure or surgery | Early Reversal, Standard Reversal |
Primary outcome
Postoperative complication rate
Time frame: From enrollment to end of study at 6 months
4 secondary outcomes
Length of hospital stay
Time frame: From enrollment to the end of study at 6 months
Time to oral intake
Time frame: From enrollment to the discharge of patient which was upto 2 weeks
Return to normal activities
Time frame: From enrollment to end of study at 6 months
Patient comfort score
Time frame: From enrollment to the discharge of patient which was upto 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileostomy reversal in people with Ileostomy and Colorectal Surgery, run by Gulab Devi Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rate (time frame: From enrollment to end of study at 6 months). 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 22 May 2026.