An interventional study of Early Ileostomy Closure and Delayed Ileostomy Closure in Colorectal Diseases, Intestinal Diseases and Ileostomy, sponsored by Dr. Waseem Ullah. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Dr. Waseem Ullah · Not applicable, Interventional, and Treatment
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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.
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.
260 studies on the registry are indexed under Intestinal Diseases; 53 are open to participants now.
This study's enrollment of 64 is close to the median of 67 across 180 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Dr. Waseem Ullah is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery.
Procedure: Early Ileostomy Closure
Participants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery.
Procedure: Delayed Ileostomy Closure
Surgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation.
Surgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation.
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.
Time frame: From the date of ileostomy closure until hospital discharge (up to 30 days).
Plan to share: No — De-identified individual participant data underlying the published results will be available upon reasonable request.
No publications or documents are linked to this record.
Ran from Jan 2026 to primary completion in Jul 2026, 6 months.
Of 55 non-industry interventional studies with no phase under Intestinal Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 64 studies reached it within 21 months; a quarter within 12 and three quarters within 56.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Dr. Waseem Ullah