NCT07730333

Brief Summary

The purpose of of this study is to compare the frequency of anastomotic leakage in early versus delayed oral feeding following feeding after illeostomy reversal so early oral feeding can be encouraged.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

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

March 30, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 21, 2026

Last Update Submit

July 24, 2026

Conditions

Malignancies Multiple

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leakage 7 days after surgery

    Within 14 days post operatively

Study Arms (2)

Group 1: Early oral feeding

EXPERIMENTAL

Patients receive oral liquids within or solid food within 24 hours after stoma reversal reversal surgery

Behavioral: Early oral feeding protocol

Group 2 : Delayed oral feeding

ACTIVE COMPARATOR

Patients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively

Behavioral: Delayed oral feeding protocol

Interventions

Early oral feeding protocolBEHAVIORAL

Patients receive oral liquids within or solid food within 24 hours after stoma reversal surgery

Group 1: Early oral feeding
Delayed oral feeding protocolBEHAVIORAL

Patients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively

Group 2 : Delayed oral feeding

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective ileostomy reversal surgery
  • age between 18 and 70 years
  • patient provided informed consent

You may not qualify if:

  • patients with active active peritonitis
  • Advanced malignancy
  • Patients requiring extensive bowel resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allied hospital Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate residen

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 28, 2026

Study Start

March 30, 2026

Primary Completion

July 20, 2026

Study Completion

July 20, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly to protect patient confidentiality only aggregated study findings and statistical results will be made available through publication

Locations

PA(1)