A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children (GCF)
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|ClinicalTrials.gov Identifier: NCT03920306|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastrocutaneous Fistula||Drug: oral anti-acid treatment||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single prospective arm; historical control|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
Drug administration for the experimental arm includes:
Drug: oral anti-acid treatment
This study investigates a bundle of three commonly used treatments
- Gastrocutaneous Fistula (GCF) [ Time Frame: 1 month ]Rate of gastrocutaneous fistula persistence based on clinical assessment
- Caregiver satisfaction Survey [ Time Frame: 1 month ]A 9 question Likert-style (Strongly disagree- Strongly agree) questionnaire evaluating caregiver perceptions of the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920306
|Contact: Robert Baird, MDCMfirstname.lastname@example.org|
|Contact: Christine Adamsonemail@example.com|
|Canada, British Columbia|
|BC Children's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6H3V4|
|Contact: Robert Baird, MDCM 6048752667 firstname.lastname@example.org|