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A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs (Glue-sealing)
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.
Details
| Lead sponsor | Jinling Hospital, China |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 30 |
| Start date | 2012-05 |
| Completion | 2014-12 |
Conditions
- Low-output External Gastrointestinal Fistula
Interventions
- Endoscopy exploration and glue application
- Anti-Bacterial Agents
- Nutrition support
- PRFG preparation
Primary outcomes
- Clinical outcome — 14 days
Closure time (defined as the interval between the day of enrollment and day of fistula closure), Closure rate up to 14 days, Closure rate up to 180 days, Fistula recurrence rate
Countries
China