Colorectal DiseasesEDICNCT07754227
Early Versus Delayed Ileostomy Closure Following Bowel Surgery
A study testing Early Ileostomy Closure and Delayed Ileostomy Closure in people with Colorectal Diseases and Intestinal Diseases, run by Dr. Waseem Ullah at 1 site in Pakistan.
Trial summary
Temporary ileostomy is commonly created following bowel surgery to protect distal anastomoses and reduce the consequences of anastomotic leakage. However, the optimal timing for ileostomy closure remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Diseases, Intestinal Diseases, Ileostomy
- What is being tested?
- Early Ileostomy Closure and Delayed Ileostomy Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2026to 8 Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Male or female participants.
- Patients with a temporary ileostomy following bowel surgery.
- Patients scheduled for elective ileostomy closure.
- Participants willing to provide written informed consent.
Who cannot join
- Abdominal wall dehiscence.
- Tubercular perforation.
- Peritoneal contamination.
- Patients medically unfit for surgery.
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mean Post-Operative Hospital Stay in Early and Delayed Ileostomy Closure Following Bowel Surgery: A Randomized Controlled Trial
Temporary ileostomy is commonly created following bowel surgery to protect distal anastomoses and reduce the consequences of anastomotic leakage. However, the optimal timing for ileostomy closure remains controversial. Early closure may improve quality of life and reduce stoma-related complications, whereas delayed closure may allow better recovery but prolong stoma-related morbidity and hospital care. This randomized controlled trial aims to compare the mean post-operative hospital stay between early (within 8 weeks) and delayed (after 8 weeks) ileostomy closure following bowel surgery. Sixty eligible patients will be randomized equally into two groups. The findings will help determine the optimal timing of ileostomy reversal and may improve patient outcomes while reducing healthcare utilization.
Read the detailed description
Temporary ileostomy is frequently performed after bowel surgery as a protective measure for intestinal anastomosis or as part of emergency surgical management. Although ileostomy closure is considered a routine procedure, the ideal timing of closure remains uncertain. Early closure has the potential to improve patient quality of life, reduce stoma-related complications, and shorten the overall treatment course. Conversely, delayed closure may provide additional time for recovery and anastomotic healing but may increase the duration of stoma-related morbidity and healthcare resource utilization.
This prospective, randomized controlled trial will be conducted in the Department of General Surgery, Lady Reading Hospital-Medical Teaching Institution, Peshawar, Pakistan. A total of 60 adult patients (18-65 years) with temporary ileostomy following bowel surgery who meet the eligibility criteria will be enrolled using consecutive sampling and randomized in a 1:1 ratio into two study groups using block randomization.
Participants in the intervention group will undergo early ileostomy closure within 8 weeks of ileostomy creation, while participants in the comparator group will undergo delayed ileostomy closure after 8 weeks. The primary outcome will be post-operative hospital stay, measured as the number of days from ileostomy closure surgery until hospital discharge.
Baseline demographic and clinical characteristics, including age, sex, body mass index, smoking status, hypertension, diabetes mellitus, residence, financial background, and post-operative complications, will be recorded. Data will be analyzed using IBM SPSS version 25. Continuous variables will be analyzed using the independent-samples t-test or Mann-Whitney U test according to data distribution, with statistical significance set at p < 0.05.
The study has received ethical approval from the Institutional Review Board of Lady Reading Hospital-Medical Teaching Institution, Peshawar (IRB Reference No. 85/LRH/MTI, dated 06 February 2025). The results are expected to provide evidence regarding the optimal timing of temporary ileostomy closure in terms of reducing post-operative hospital stay and improving clinical outcomes.
- Conditions
- Colorectal Diseases, Intestinal Diseases, Ileostomy
- Being tested
- Early Ileostomy Closure, Delayed Ileostomy Closure
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Ileostomy ClosureProcedure or surgery
Surgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation.
Delayed Ileostomy ClosureProcedure or surgery
Surgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation.
| Study group | Role | What they receive |
|---|---|---|
| Early Ileostomy Closure | Experimental | Participants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery. Receives: Procedure: Early Ileostomy Closure |
| Delayed Ileostomy Closure | Active comparator | Participants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery. Receives: Procedure: Delayed Ileostomy Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hospital stay
Post-operative hospital stay will be measured as the number of days from ileostomy closure surgery until discharge from the hospital. The mean duration will be compared between patients undergoing early (≤8 weeks) and delayed (>8 weeks) ileostomy closure.
Measured: From the date of ileostomy closure until hospital discharge (up to 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start2 Jan 2026
- Primary completion5 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DiseasesStudies 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 will be randomly assigned in a 1:1 ratio to one of two parallel groups. Group A will undergo early ileostomy closure (within 8 weeks of ileostomy creation), while Group B will undergo delayed ileostomy closure (after 8 weeks). Participants will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Waseem Ullah
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Waseem Ullah, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754227
- Sponsor's protocol ID
- LRH-85-2025-ILEO
- Other IDs
- IRB Ref. No. 85/LRH/MTI (06-Fe
- Acronym
- EDIC
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data underlying the published results will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Post-Operative Hospital Stay in Early and Delayed Ileostomy Closure Following Bowel Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07754227
- Acronym / sponsor ID
- EDIC / LRH-85-2025-ILEO
- Conditions
- Colorectal Diseases, Intestinal Diseases, Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dr. Waseem UllahOther government
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 10 Aug 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.
Temporary ileostomy is commonly created following bowel surgery to protect distal anastomoses and reduce the consequences of anastomotic leakage. However, the optimal timing for ileostomy closure remains controversial. Early closure may improve quality of life and reduce stoma-related complications, whereas delayed closure may allow better recovery but prolong stoma-related morbidity and hospital care. This randomized controlled trial aims to compare the mean post-operative hospital stay between early (within 8 weeks) and delayed (after 8 weeks) ileostomy closure following bowel surgery. Sixty eligible patients will be randomized equally into two groups. The findings will help determine the optimal timing of ileostomy reversal and may improve patient outcomes while reducing healthcare utilization.
Detailed description
Temporary ileostomy is frequently performed after bowel surgery as a protective measure for intestinal anastomosis or as part of emergency surgical management. Although ileostomy closure is considered a routine procedure, the ideal timing of closure remains uncertain. Early closure has the potential to improve patient quality of life, reduce stoma-related complications, and shorten the overall treatment course. Conversely, delayed closure may provide additional time for recovery and anastomotic healing but may increase the duration of stoma-related morbidity and healthcare resource utilization.
This prospective, randomized controlled trial will be conducted in the Department of General Surgery, Lady Reading Hospital-Medical Teaching Institution, Peshawar, Pakistan. A total of 60 adult patients (18-65 years) with temporary ileostomy following bowel surgery who meet the eligibility criteria will be enrolled using consecutive sampling and randomized in a 1:1 ratio into two study groups using block randomization.
Participants in the intervention group will undergo early ileostomy closure within 8 weeks of ileostomy creation, while participants in the comparator group will undergo delayed ileostomy closure after 8 weeks. The primary outcome will be post-operative hospital stay, measured as the number of days from ileostomy closure surgery until hospital discharge.
Baseline demographic and clinical characteristics, including age, sex, body mass index, smoking status, hypertension, diabetes mellitus, residence, financial background, and post-operative complications, will be recorded. Data will be analyzed using IBM SPSS version 25. Continuous variables will be analyzed using the independent-samples t-test or Mann-Whitney U test according to data distribution, with statistical significance set at p < 0.05.
The study has received ethical approval from the Institutional Review Board of Lady Reading Hospital-Medical Teaching Institution, Peshawar (IRB Reference No. 85/LRH/MTI, dated 06 February 2025). The results are expected to provide evidence regarding the optimal timing of temporary ileostomy closure in terms of reducing post-operative hospital stay and improving clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. Group A will undergo early ileostomy closure (within 8 weeks of ileostomy creation), while Group B will undergo delayed ileostomy closure (after 8 weeks). Participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Early Ileostomy Closure | Experimental | Procedure: Early Ileostomy ClosureParticipants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery. |
| Delayed Ileostomy Closure | Active comparator | Procedure: Delayed Ileostomy ClosureParticipants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years.
- Male or female participants.
- Patients with a temporary ileostomy following bowel surgery.
- Patients scheduled for elective ileostomy closure.
- Participants willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Abdominal wall dehiscence.
- Tubercular perforation.
- Peritoneal contamination.
- Patients medically unfit for surgery.
- Refusal to provide informed consent.
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 |
|---|---|---|
| Early Ileostomy ClosureSurgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation. | Procedure or surgery | Early Ileostomy Closure |
| Delayed Ileostomy ClosureSurgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation. | Procedure or surgery | Delayed Ileostomy Closure |
Primary outcome
Post-operative hospital stay
Time frame: From the date of ileostomy closure until hospital discharge (up to 30 days).
Post-operative hospital stay will be measured as the number of days from ileostomy closure surgery until discharge from the hospital. The mean duration will be compared between patients undergoing early (≤8 weeks) and delayed (>8 weeks) ileostomy closure.
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 26 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data underlying the published results will be available upon reasonable request.
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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 Early Ileostomy Closure and Delayed Ileostomy Closure in people with Colorectal Diseases and Intestinal Diseases, run by Dr. Waseem Ullah 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 5 inclusion and 5 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 26 Aug 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?
Post-operative hospital stay (time frame: From the date of ileostomy closure until hospital discharge (up to 30 days).). 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 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.