Rectal Fistula Clinical Trial
Official title:
Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
Rationale:
Closure of the internal opening is the most accepted standard procedure in the treatment of
peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one
out of the three patients mucosal flap repair fails. Possible causal factors are incomplete
clearance of pus and debris, incomplete closure of the internal opening, inappropriate host
response in patients with risk factors like smoking or diabetes. Platelet derived growth
factors may facilitate closure of the internal opening, especially in patients with impaired
wound healing.
Objective:
The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal
advancement flap to achieve a better closure rate of complex peri-anal fistula's.
Study design:
Randomized, multicenter trial.
Study population:
Patients with complex cryptoglandular peri-anal fistula's.
Intervention:
Injection of PRP in the curretted fistula track under the mucosal flap.
Main study parameters/endpoints:
- Recurrence rate
- Post-operative pain
- Continence
- Quality of life.
Nature and extent of the burden and risks associated with participation, group relatedness:
Because autologous blood is used, no extra risk are expected.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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