Anal Fistula Repair With Platelet-rich Plasma
Phase 4
Withdrawn
- Conditions
- Rectal Fistula
- Interventions
- Biological: PRP
- Registration Number
- NCT02678936
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate.
The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- complicated anal fistula with patient fit for surgical treatment
- minimum 6 weeks after
- written informed consent
Exclusion Criteria
- age <18
- pregnancy
- drug abuse, drug substitution program
- homeless (follow-up difficult)
- restricted in legal capacity
- simple fistulas requiring fistulotomy
- complicated fistulas requiring an anus praeter naturalis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRP PRP The operation will be performed with application of platelet rich plasma
- Primary Outcome Measures
Name Time Method Healing rate 2 Years
- Secondary Outcome Measures
Name Time Method Influence of risk factor smoking on healing rate 2 years Influence of sex on healing rate 2 years Influence of risk factor high BMI on healing rate 2 years Influence of risk factor chronic renal failure on healing rate 2 years
Trial Locations
- Locations (1)
University Hospital of Basel
🇨ðŸ‡Basel, Switzerland