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Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

Primary Purpose

Onset of Perineal Wound Infection

Status

Enrolling by invitation

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

enteral feeding

About this trial

This is an interventional prevention trial for Onset of Perineal Wound Infection focused on measuring recto-vestibular fistula,, early enteral feeding, peripheral parenteral nutrition, perineal wound infection

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

Sites / Locations

Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

delayed enteral feeding

early enteral feeding

Arm Description

delayed enteral feeding

early enteral feeding

Outcomes

Primary Outcome Measures

perineal wound infection

the occurrence of wound infection after ASARP

Secondary Outcome Measures

Full Information

NCT ID

NCT05297916

First Posted

March 17, 2022

Last Updated

March 17, 2022

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05297916

Brief Title

Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

Official Title

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

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

August 2, 2022 (Anticipated)

Study Completion Date

October 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onset of Perineal Wound Infection

Keywords

recto-vestibular fistula,, early enteral feeding, peripheral parenteral nutrition, perineal wound infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

delayed enteral feeding ingroup 1 early enteral feeding in group 2

Masking

Participant

Allocation

Randomized

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

delayed enteral feeding

Arm Type

Active Comparator

Arm Description

delayed enteral feeding

Arm Title

early enteral feeding

Arm Type

Active Comparator

Arm Description

early enteral feeding

Intervention Type

Other

Intervention Name(s)

enteral feeding

Intervention Description

to intake oral feeding or delay it

Primary Outcome Measure Information:

Title

perineal wound infection

Description

the occurrence of wound infection after ASARP

Time Frame

WITHIN TWO WEEKS POST OPERATIVE

10. Eligibility

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All female infants with congenital rectoperineal fistula Exclusion Criteria: patients with major anomalies, patients who have staged repair

Facility Information:

Facility Name

Tanta University Hospitals

City

Tanta

ZIP/Postal Code

31111

Country

Egypt

12. IPD Sharing Statement

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Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy

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