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

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.