Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Fistula
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 120
- Locations
- 6
- Primary Endpoint
- Recurrence of fistulas
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Complex peri-anal fistula.
- •Able to understand informed consent.
Exclusion Criteria
- •Pregnancy
- •Local malignancy
- •Crohn's disease or Ulcerative colitis
- •Traumatic or iatrogenic lesion
- •Thrombocytopenia
- •Splenomegaly
- •Bleeding disorders
- •Hematologic malignancies
Outcomes
Primary Outcomes
Recurrence of fistulas
Time Frame: Assessed up to 104 weeks after operation
The surgeon or docter in the outpatient clinic will decide if there is a recurrent fistula or not. In case of doubt a MRI will be made.
Secondary Outcomes
- Pain(Assessed at 104 weeks after operation)
- Quality of Life(Assessed at 16 weeks after operation)
- Incontinence(Assessed at 104 weeks after operation)
- Quality of life(Assessed at 104 weeks after operation)