Early vs Standard Ileostomy Reversal

Early Ileostomy Reversal at Two Months Versus Three Months: A Randomized Controlled Trial

This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Ileostomy
• Intervention / Treatment: Procedure: Ileostomy reversal

Detailed Description

This open-label randomized controlled trial was conducted at Gulab Devi Teaching Hospital, Lahore, Pakistan, between August 2025 and January 2026 to compare early versus standard timing of ileostomy reversal. Patients aged 14 to 55 years with a protective loop ileostomy following colorectal surgery and radiologically confirmed anastomotic healing were enrolled. Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at approximately 8 weeks (early group) or 12 weeks (standard group).

The primary outcome was the rate of postoperative complications occurring during the index hospital admission following ileostomy reversal. Secondary outcomes included length of hospital stay, time to first oral intake, time to return to normal activities, patient-reported comfort using a visual analogue scale, and 30-day readmission rates.

All procedures were performed using a standardized surgical technique by experienced surgeons within the same unit. Statistical analysis was performed using appropriate tests for continuous and categorical variables, with a significance threshold of p<0.05.

The study aimed to evaluate whether earlier ileostomy reversal is safe and associated with improved recovery outcomes in a resource-limited tertiary care setting.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Gulab Devi Teaching Hospital, Lahore, Pakistan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

- Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing

Exclusion Criteria:

• Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Reversal; Ileostomy reversal performed at approximately 8 weeks	Procedure: Ileostomy reversal; Surgical closure of loop ileostomy
Active Comparator: Standard Reversal; Ileostomy reversal performed at approximately 12 weeks	Procedure: Ileostomy reversal; Surgical closure of loop ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative complication rate	From enrollment to end of study at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	From enrollment to the end of study at 6 months
Time to oral intake	From enrollment to the discharge of patient which was upto 2 weeks
Return to normal activities	From enrollment to end of study at 6 months
Patient comfort score	From enrollment to the discharge of patient which was upto 2 weeks

Collaborators and Investigators

• Sponsor: Gulab Devi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal surgery; Postoperative complications; Ileostomy reversal; Loop ileostomy; Early stoma closure; Stoma closure timing; Anastomotic healing
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: GDTH-IR-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No