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A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children

NCT03920306 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-01

No results posted yet for this study

Summary

Gastrostomy tube placement is a common surgery, and involves placing a tube from the child's skin to the inside of their stomach, allowing an alternative route for nutrition and medication to patients who cannot tolerate oral intake. A common complication of gastrostomy tubes is the development of a persistent connection between the stomach and skin after their removal. This is called a gastrocutaneous fistula (GCF). Non-surgical options have shown some success in eliminating the need for surgery to close these fistulae. Their true efficacy is unknown however; this study evaluates a non-surgical intervention bundle in the prevention and treatment of GCFs.

Conditions

  • Gastrocutaneous Fistula
  • Gastrostomy Complications

Interventions

DRUG

oral anti-acid treatment

This study investigates a bundle of three commonly used treatments

Sponsors & Collaborators

  • Montreal Children's Hospital of the MUHC

    collaborator OTHER

  • St. Justine's Hospital

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920306 on ClinicalTrials.gov