Colorectal Surgery, Ileostomy
Conditions
Keywords
Ileostomy reversal, Loop ileostomy, Early stoma closure, Colorectal surgery, Stoma closure timing, Anastomotic healing, Postoperative complications
Brief summary
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.
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.
Interventions
PROCEDUREIleostomy reversal
Surgical closure of loop ileostomy
Sponsors
Gulab Devi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
\- Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing
Exclusion criteria
* Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complication rate | From enrollment to end of study at 6 months |
Secondary
| 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 |
Countries
Pakistan
Outcome results
None listed