Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

Overview

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

Full Title of Study: “Early Versus Delayed Postoperative Enteral Feeding to Reduce the Incidence of Perineal Wound Infection Following Anterior Sagittal Anorectoplasty of Congenital Recto-vestibular Fistula”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Single (Participant)
• Study Primary Completion Date: August 2, 2022

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.

Interventions

• Other: enteral feeding
  • to intake oral feeding or delay it

Arms, Groups and Cohorts

• Active Comparator: delayed enteral feeding
  • delayed enteral feeding
• Active Comparator: early enteral feeding
  • early enteral feeding

Clinical Trial Outcome Measures

Primary Measures

• perineal wound infection
  • Time Frame: WITHIN TWO WEEKS POST OPERATIVE
  • the occurrence of wound infection after ASARP

Participating in This Clinical Trial

Inclusion Criteria

• All female infants with congenital rectoperineal fistula Exclusion Criteria:

• patients with major anomalies, patients who have staged repair

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Tanta University
• Provider of Information About this Clinical Study
  • Principal Investigator: Mohammad Gharieb Mohammad Khirallah, assistant professor of pediatric surgery – Tanta University