NCT05297916

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 17, 2022

Last Update Submit

March 17, 2022

Conditions

Onset of Perineal Wound Infection

Keywords

recto-vestibular fistula,early enteral feedingperipheral parenteral nutritionperineal wound infection

Outcome Measures

Primary Outcomes (1)

  • perineal wound infection

    the occurrence of wound infection after ASARP

    WITHIN TWO WEEKS POST OPERATIVE

Study Arms (2)

delayed enteral feeding

ACTIVE COMPARATOR

delayed enteral feeding

Other: enteral feeding

early enteral feeding

ACTIVE COMPARATOR

early enteral feeding

Other: enteral feeding

Interventions

enteral feedingOTHER

to intake oral feeding or delay it

delayed enteral feedingearly enteral feeding

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All female infants with congenital rectoperineal fistula

You may not qualify if:

  • patients with major anomalies, patients who have staged repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, 31111, Egypt

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: delayed enteral feeding ingroup 1 early enteral feeding in group 2
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of pediatric surgery

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

February 2, 2022

Primary Completion

August 2, 2022

Study Completion

October 2, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

EG(1)