Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?

Study Overview
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Brief Summary
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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.

Official Title
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Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.

Conditions
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Rectal Fistula

Intervention / Treatment
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* Procedure: Mucosa advancement flap
* Other: Platelet rich plasma (PRP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mucosa advancement flap<br> | Procedure: Mucosa advancement flap<br>* Mucosa advancement flap will be performed at the starting point of the fistula in the rectum<br>|
| Experimental: Mucosa advancement flap + PRP<br>Platelet rich plasma added to the mucosa advancement flap | Procedure: Mucosa advancement flap<br>* Mucosa advancement flap will be performed at the starting point of the fistula in the rectum<br>Other: Platelet rich plasma (PRP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of fistulas | 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. | Assessed up to 104 weeks after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 2 weeks after operation | 
| Quality of Life | Measured using the SF-36v2 questionnaire | Assessed at 2 weeks after operation | 
| Incontinence | Measured using the Vaizey score | Assessed at 2 weeks after operation | 
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 4 weeks after operation | 
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 16 weeks after operation | 
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 24 weeks after operation | 
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 52 weeks after operation | 
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 104 weeks after operation | 
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 4 weeks after operation | 
| Quality of Life | Measured using the SF-36v2 questionnaire | Assessed at 16 weeks after operation | 
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 24 weeks after operation | 
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 52 weeks after operation | 
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 104 weeks after operation | 
| Incontinence | Measured using the Vaizey score | Assesed at 4 weeks after operation | 
| Incontinence | Measured using the Vaizey score | Assessed at 16 weeks after operation | 
| Incontinence | Measured using the Vaizey score | Assessed at 52 weeks after operation | 
| Incontinence | Measured using the Vaizey score | Assessed at 24 weeks after operation | 
| Incontinence | Measured using the Vaizey score | Assessed at 104 weeks after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Fistula, Peri-anal Fistula, Platelet-Rich Plasma, Mucosa advancement flap