Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

Phase 4

• Conditions: Onset of Perineal Wound Infection
• Interventions: Other: enteral feeding

• Registration Number: NCT05297916
• Lead Sponsor: Tanta University

Brief Summary

to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula

Detailed Description

congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection.

Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence.

Patients and methods:

A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.

Study Timeline

• Study Start: 2022-02-02
• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-08-02
• Study Completion: 2022-10-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

• All female infants with congenital rectoperineal fistula

Exclusion Criteria

• patients with major anomalies, patients who have staged repair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early enteral feeding	enteral feeding	early enteral feeding
delayed enteral feeding	enteral feeding	delayed enteral feeding

Primary Outcome Measures

Name	Time	Method
perineal wound infection	WITHIN TWO WEEKS POST OPERATIVE	the occurrence of wound infection after ASARP

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Egypt