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A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae Closure in Children
Amanda Phares1, Christine Adamson1, Sherif Emil2
1Department of Pediatric General and Thoracic Surgery, BC Children's Hospital, Canada.
Insights
A bundled treatment for pediatric gastrocutaneous fistulae (GCF) did not improve closure rates. Topical silver nitrate application caused discomfort without significant benefit, and this practice should be avoided.
Area of Science:
- Pediatric surgery
- Gastroenterology
- Medical device management
Background:
- Gastrocutaneous fistulae (GCF) occur in about one-third of children after gastrostomy tube removal.
- Previous non-surgical treatments for GCF have shown limited efficacy in small, uncontrolled studies.
Purpose of the Study:
- To evaluate the efficacy and tolerability of a standardized, bundled non-surgical therapy regimen for promoting GCF closure after gastrostomy removal.
- To assess factors predicting GCF closure and patient discomfort associated with the treatment.
Main Methods:
- A prospective, multi-center, pragmatic trial involving 97 children.
- Patients received topical silver nitrate (AgNO3) and a bioadhesive, plus a short-term proton-pump inhibitor.
- Primary outcome was GCF persistence at 4 weeks; discomfort was assessed.
Main Results:
- The GCF closure rate at 4 weeks was 47.4%.
- No significant differences in closure rates were observed based on gender, age, tube type, or gastrostomy duration.
- 33% of patients reported discomfort with topical AgNO3 application.
Conclusions:
- A bundled non-operative treatment approach did not significantly improve GCF closure rates in children.
- Topical AgNO3 application caused discomfort without appreciable benefit and should be discouraged.
Purpose:
Gastrocutaneous fistulae (GCF) persist after gastrostomy removal in one third of children. Several non-surgical treatment options have been described, including the use of proton-pump inhibitors, topical fibrin glue, silver nitrate application, and collagen plugging, albeit in underpowered and uncontrolled studies. We evaluated the efficacy and tolerability of a standardized, "bundled" regimen of non-surgical therapies given immediately after gastrostomy tube removal to promote closure.
Methods:
In this prospective, multi-center, pragmatic trial, enrolled patients received one or two treatments with the following: topical application of AgNO3 and a bioadhesive to the fistula tract as well as a short-term proton-pump inhibitor. The primary outcome was GCF persistence at 4 weeks after treatment. Factors that predicted closure were evaluated and discomfort was assessed throughout the study protocol.
Results:
Enrollment was completed across three sites over 6 years (n = 97). Mean age at enrollment was 58 months; mean duration with the gastrostomy was 45 months (range 57 days- 12.7 years). The GCF closure rate at 2 and 4 weeks was 36.1 % and 47.4 % respectively. No differences in closure rates were noted in gender, age, tube type or duration of gastrostomy. Of 85 patients, 33 % experienced discomfort with the application of AgNO3.
Conclusion:
A bundled treatment approach of non-operative adjuncts did not improve the closure rate of gastrocutaneous fistulae in children which remains significant. Given the incidence of discomfort associated with topical AgNO3 application without appreciable benefit, this practice should be discouraged.
Level Of Evidence:
Level II Prospective non-randomized trial.
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