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 2026-08-26.
Sponsored by Dr. Waseem Ullah · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria
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.
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