Abstract
Background
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. 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/Design
The 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.
Discussion
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.
Trial registration
NCT01828892. Registration date: April 2013.
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Details
1 Medical School of Nanjing University, Department of Surgery, Jinling Hospital, Nanjing, China (GRID:grid.41156.37) (ISNI:000000012314964X)
2 The 1st Affiliated Hospital of Gannan Medical College, Department of General Surgery, Ganzhou, China (GRID:grid.41156.37)
3 The Affiliated Hospital of Neimenggu Medical University, Department of General Surgery, Huhehaote, China (GRID:grid.41156.37)
4 Chinese Medical University Aviation Hospital, Department of General Surgery, Beijing, China (GRID:grid.41156.37)
5 The 309th Hospital of The Chinese People’s Liberation Army, Department of General Surgery, Beijing, China (GRID:grid.413150.2) (ISNI:0000000403690780)
6 The Second Hospital of Jilin University, Department of Surgery, Changchun, China (GRID:grid.452829.0)
7 Affiliated Hospital of Medical College Qingdao University, Department of General Surgery, Qingdao, China (GRID:grid.412521.1)
8 Henan Province People’s Hospital, Department of General Surgery, Zhengzhou, China (GRID:grid.414011.1)
9 Xuzhou Central Hospital, Department of Gastrointestinal Surgery, Xuzhou, China (GRID:grid.452207.6) (ISNI:0000000417580558)
10 VA Medical Center, Department of Surgery, Providence, USA (GRID:grid.413904.b) (ISNI:0000000404204094)