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

Gastrostomy Complications Clinical Trial

— GCF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920306
• Other study ID #: H17-02821
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2022
• Source: University of British Columbia
• Contact: Robert Baird, MDCM
• Phone: 6048752667
• Email: robert.baird[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Gastric Fistula
• Gastrocutaneous Fistula
• Gastrostomy Complications

Intervention

Drug:
• oral anti-acid treatment
This study investigates a bundle of three commonly used treatments

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Montreal Children's Hospital of the MUHC, St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

St-Louis E, Safa N, Guadagno E, Baird R. Gastrocutaneous fistulae in children - A systematic review and meta-analysis of epidemiology and treatment options. J Pediatr Surg. 2018 May;53(5):946-958. doi: 10.1016/j.jpedsurg.2018.02.022. Epub 2018 Feb 8. Revi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver satisfaction Survey	A 9 question Likert-style (Strongly disagree- Strongly agree) questionnaire evaluating caregiver perceptions of the study	1 month
Primary	Gastrocutaneous Fistula (GCF)	Rate of gastrocutaneous fistula persistence based on clinical assessment	1 month