NCT07601594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 5, 2026

Last Update Submit

May 15, 2026

Conditions

IleostomyColorectal Surgery

Keywords

Ileostomy reversalLoop ileostomyEarly stoma closureColorectal surgeryStoma closure timingAnastomotic healingPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication rate

    From enrollment to end of study at 6 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Early Reversal

EXPERIMENTAL

Ileostomy reversal performed at approximately 8 weeks

Procedure: Ileostomy reversal

Standard Reversal

ACTIVE COMPARATOR

Ileostomy reversal performed at approximately 12 weeks

Procedure: Ileostomy reversal

Interventions

Ileostomy reversalPROCEDURE

Surgical closure of loop ileostomy

Early ReversalStandard Reversal

Eligibility Criteria

Age14 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi Teaching Hospital, Lahore, Pakistan

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 22, 2026

Study Start

August 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

PA(1)