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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03920306

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

Brief 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.

  • Condition or Disease:Gastrocutaneous Fistula
  • Intervention/Treatment: Drug: oral anti-acid treatment
  • Phase: Phase 4
Detailed Description

Purpose:To compare the efficacy of a non-surgical intervention bundle for the prevention and treatment of persistent gastrocutaneous fistulae. Hypothesis: The investigators hypothesize that the bundled delivery of 3 non-surgical interventions will reduce the development of GCFs and subsequently the need for surgical closure as compared to an established historical control group. Justification: Persistent gastrocutaneous fistulae are common complications after gastrostomy tube removal (33%), with the current gold-standard treatment being operative intervention; exposing the child to the risks of anesthesia and surgery. Several non-surgical treatments exist, and have shown promise in small retrospective studies, however their true efficacy is yet to be elucidated through a prospective trial. Non-surgical treatment options include the use of proton-pump inhibitors, topical fibrin glue, silver nitrate application, and collagen plugging. As standard of care, patients may receive one, none or a combination of these non-surgical treatments based on clinician decision. Objectives: The objective of this study is to prospectively evaluate the efficacy of a bundled delivery of non-surgical adjuncts immediately after gastrostomy tube removal and compare outcomes to the historical rate of GCF development. Research Design: This study is a prospective observational "pre-post" study, which will compare our intervention arm (non-surgical intervention bundle) with a recently established historical control group (completed systematic review of all reported cases). Baseline data will be entered at the time of enrollment. Assessment of our primary outcome (rate of GCF one month after treatment) and secondary outcomes (including an estimate of treatment cost, complications, treatment satisfaction, and need for further interventions) will be made at standard 2 and 4 week follow-up visits. Statistical Analysis: Standardized quantitative hypothesis testing will be performed for the primary outcome with the aid of a local biostatistician. Power analysis has been established based on a 50% reduction in GCF development, with a sample size of 100 subjects. Secondary outcomes will be tabulated and subjected to quantitative or qualitative assessment as appropriate.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Single prospective arm; historical control
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: October 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Intervention
Drug administration for the experimental arm includes: AgNO3 applied to the fistula tract. A topical adhesive of either 2-Octylcyanoacrylate glue (Dermabond), or Fibrin glue, or Histoacryl glue (Tissue Seal), will be applied over the fistula's aperture. Oral anti-reflux therapy of either Pantoprazole 20-40mg PO OD, or Ranitidine 5-10mg/kg/day PO divided twice daily or 150mg PO BID, for either 4 weeks or until gastrocutaneous fistula tract closure, whichever comes first.
Drug: oral anti-acid treatment
This study investigates a bundle of three commonly used treatments
Outcome Measures
  • Primary Outcome Measures: 1. Gastrocutaneous Fistula (GCF) [ Time Frame: 1 month ]
    Rate of gastrocutaneous fistula persistence based on clinical assessment
  • Other Outcome Measures: 1. Caregiver satisfaction Survey [ Time Frame: 1 month ]
    A 9 question Likert-style (Strongly disagree- Strongly agree) questionnaire evaluating caregiver perceptions of the study
Eligibility Criteria
  • Ages Eligible for Study: up to 18 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Eligible for gastrostomy tube removal

Exclusion Criteria:

- Recurrent gastrocutaneous fistula

- Non-consenting

- Unable to comply with follow up assessments

- Known allergic reaction to study products

Contacts and Locations
Contacts

Contact: Robert Baird, MDCM 6048752667 robert.baird@cw.bc.ca

Contact: Christine Adamson 604-875-7720 cadamson@cw.bc.ca

Locations

Canada, British Columbia
BC Children's Hospital
Vancouver

Sponsors and Collaborators

University of British Columbia

Montreal Children's Hospital of the MUHC

St. Justine's Hospital

Dalhousie University

University of Saskatchewan

More Information