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Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

T

Tanta University

Status and phase

Unknown
Phase 4

Conditions

Onset of Perineal Wound Infection

Treatments

Other: enteral feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT05297916
35054/11/21

Details and patient eligibility

About

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

Full 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.

Enrollment

55 estimated patients

Sex

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All female infants with congenital rectoperineal fistula

Exclusion criteria

  • patients with major anomalies, patients who have staged repair

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

delayed enteral feeding
Active Comparator group
Description:
delayed enteral feeding
Treatment:
Other: enteral feeding
early enteral feeding
Active Comparator group
Description:
early enteral feeding
Treatment:
Other: enteral feeding

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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