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Completed

NCT Number: NCT07601594

Early vs Standard Ileostomy Reversal

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.

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Key information

Conditions

Ileostomy Colorectal Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

14 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Teaching Hospital, Lahore, Pakistan

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia

Treatment and study plan

Ileostomy reversal

Procedure

Surgical closure of loop ileostomy

Primary outcomes

  1. Postoperative complication rate

    Time frame: From enrollment to end of study at 6 months

Secondary outcomes

  1. Length of hospital stay

    Time frame: From enrollment to the end of study at 6 months

  2. Time to oral intake

    Time frame: From enrollment to the discharge of patient which was upto 2 weeks

  3. Return to normal activities

    Time frame: From enrollment to end of study at 6 months

  4. Patient comfort score

    Time frame: From enrollment to the discharge of patient which was upto 2 weeks

Sponsors and collaborators

Lead sponsor

Gulab Devi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 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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