Early Versus Delayed Ileostomy Closure Following Bowel Surgery: A Randomized Controlled Trial

NCT07754227 | Completed DMC

• 2 other identifiers: LRH-85-2025-ILEOIRB Ref. No. 85/LRH/MTI (06-Fe
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Diseases; Intestinal Diseases; Ileostomy

Outcome Measures

Primary Outcomes (1)

• 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.

  From the date of ileostomy closure until hospital discharge (up to 30 days).

Study Arms (2)

Early Ileostomy Closure

EXPERIMENTAL

Participants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery.

Procedure: Early Ileostomy Closure

Delayed Ileostomy Closure

ACTIVE COMPARATOR

Participants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery.

Procedure: Delayed Ileostomy Closure

Interventions

Early Ileostomy Closure PROCEDURE

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

Early Ileostomy Closure

Delayed Ileostomy Closure PROCEDURE

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

Delayed Ileostomy Closure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Waseem Ullah: lead

Study Sites (1)

Lady Reading Hospital

Peshawar, 25000, Pakistan

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label surgical trial. Neither participants nor treating surgeons can be blinded because the timing of ileostomy closure is evident. Outcome assessment is based on objective hospital records.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: January 2, 2026
• Primary Completion: July 5, 2026
• Study Completion: July 8, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)