Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Reversal | Experimental | Ileostomy reversal performed at approximately 8 weeks |
|
| Standard Reversal | Active Comparator | Ileostomy reversal performed at approximately 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileostomy reversal | Procedure | Surgical closure of loop ileostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complication rate | From enrollment to end of study at 6 months |
| Measure | Description | 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 | |
Not provided
Inclusion criteria
- Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulab Devi Teaching Hospital, Lahore, Pakistan | Lahore | Punjab Province | 54000 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at 8 weeks (early group) or 12 weeks (standard group), with outcomes compared between the two parallel groups.
Not provided
Not provided
Not provided
Not provided
| 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 |