Rectal Fistula
Conditions
Keywords
Rectal Fistula, Peri-anal Fistula, Platelet-Rich Plasma, Mucosa advancement flap
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.
Interventions
PROCEDUREMucosa advancement flap
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
The PRP will be injected into the fistula, after the mucosa advancement flap was created. For the PRP we will need to take 55 millilitres of blood of the patient. This blood will be centrifuged into PRP.
Sponsors
Biomet Nederland BV
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of fistulas | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain | Assessed at 2 weeks after operation | Measured using the Visual Analogue Scale (VAS-score) |
| Quality of Life | Assessed at 2 weeks after operation | Measured using the SF-36v2 questionnaire |
| Incontinence | Assessed at 2 weeks after operation | Measured using the Vaizey score |
| Quality of life | Assessed at 4 weeks after operation | Measured using the SF-36v2 questionnaire |
Countries
Netherlands
Contacts
Primary ContactKevin W.A. Göttgens, MD
Outcome results
None listed