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Completed

NCT Number: NCT07754227

Early Versus 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Reading Hospital

Peshawar, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Abdominal wall dehiscence. Tubercular perforation. Peritoneal contamination. Patients medically unfit for surgery. Refusal to provide informed consent.

Treatment and study plan

Early Ileostomy Closure

Procedure

Surgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation.

Delayed Ileostomy Closure

Procedure

Surgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dr. Waseem Ullah

Other Gov

Registry information

Official study title

Comparison of Mean Post-Operative Hospital Stay in Early and Delayed Ileostomy Closure Following Bowel Surgery: A Randomized Controlled Trial

Acronym: EDIC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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