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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Atrium Medisch Centrum
Heerlen, Limburg, Netherlands
RECRUITINGUniversity Hospital Maastricht
Maastricht, Limburg, Netherlands
RECRUITINGLaurentius ziekenhuis
Roermond, Limburg, Netherlands
RECRUITINGAmphia ziekenhuis
Breda, North Brabant, Netherlands
WITHDRAWNCatharina ziekenhuis
Eindhoven, North Brabant, Netherlands
NOT_YET_RECRUITINGRefaja Ziekenhuis
Stadskanaal, Provincie Groningen, Netherlands
NOT_YET_RECRUITINGRecurrence 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.
Time frame: Assessed up to 104 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Time frame: Assessed at 2 weeks after operation
Quality of Life
Measured using the SF-36v2 questionnaire
Time frame: Assessed at 2 weeks after operation
Incontinence
Measured using the Vaizey score
Time frame: Assessed at 2 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Time frame: Assessed at 4 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Time frame: Assessed at 16 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Time frame: Assessed at 24 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Time frame: Assessed at 52 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Time frame: Assessed at 104 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Time frame: Assessed at 4 weeks after operation
Quality of Life
Measured using the SF-36v2 questionnaire
Time frame: Assessed at 16 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Time frame: Assessed at 24 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Time frame: Assessed at 52 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Time frame: Assessed at 104 weeks after operation
Incontinence
Measured using the Vaizey score
Time frame: Assesed at 4 weeks after operation
Incontinence
Measured using the Vaizey score
Time frame: Assessed at 16 weeks after operation
Incontinence
Measured using the Vaizey score
Time frame: Assessed at 52 weeks after operation
Incontinence
Measured using the Vaizey score
Time frame: Assessed at 24 weeks after operation
Incontinence
Measured using the Vaizey score
Time frame: Assessed at 104 weeks after operation
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