Rectal Fistula
Conditions
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.
Interventions
BIOLOGICALPRP
Application of platelet-rich plasma during surgery
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing rate | 2 Years |
Secondary
| Measure | Time frame |
|---|---|
| Influence of risk factor smoking 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 |
| Influence of sex on healing rate | 2 years |
Countries
Switzerland
Outcome results
None listed