Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

NCT ID: NCT05297916

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2022-10-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Onset of Perineal Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

delayed enteral feeding ingroup 1 early enteral feeding in group 2
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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delayed enteral feeding

delayed enteral feeding

Group Type ACTIVE_COMPARATOR

enteral feeding

Intervention Type OTHER

to intake oral feeding or delay it

early enteral feeding

early enteral feeding

Group Type ACTIVE_COMPARATOR

enteral feeding

Intervention Type OTHER

to intake oral feeding or delay it

Interventions

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enteral feeding

to intake oral feeding or delay it

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All female infants with congenital rectoperineal fistula

Exclusion Criteria

* patients with major anomalies, patients who have staged repair
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Gharieb Mohammad Khirallah

assistant professor of pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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35054/11/21

Identifier Type: -

Identifier Source: org_study_id

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