Abstract
BackgroundThe management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required.Methods/DesignThe study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period.DiscussionTo our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas.Trial registrationNCT01828892. Registration date: April 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0966-9) contains supplementary material, which is available to authorized users.
Highlights
The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort
To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas
An enterocutaneous fistula (ECF) still remains as one of the most complex and challenging complications encountered in surgical practice [1]
Summary
The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. Conservative treatment can result in spontaneous fistula closure, with rates varying from 15 % to 71 % [4] Use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. As a noninvasive option, it could avoid the risk of developing further dehiscence compared to surgical operations. Commercial fibrin sealants are usually made from porcine/bovine blood products, whereas autologous adhesives have potential advantages, such as a low risk of infection transmission [11] and provision of a matrix for tissue regeneration [12] Both are used in clinical practice, but they have not yet been compared to fistula sealing
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