Status:
UNKNOWN
Glue Application in the Treatment of Low-Output Fistulas
Lead Sponsor:
Jinling Hospital, China
Conditions:
Low-output External Gastrointestinal Fistula
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical ...
Detailed Description
* This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients. * Subjects are randomized to one of 3 groups: * Group 1: Autologous PRFG-treatment ...
Eligibility Criteria
Inclusion
- Patients with a single tubular ECF
- Low output volume (\<200 ml/24h)
- Tract length \>2cm
- Tract diameter \< 1cm
Exclusion
- Cancer-infiltrated fistula
- Abscess
- Foreign bodies
- Distal bowel obstruction
- Inflammatory Bowel Disease
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01828892
Start Date
March 1 2014
End Date
December 1 2017
Last Update
June 10 2015
Active Locations (1)
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1
Jinling Hospital
Nanjing, Jiangsu, China, 210002