Is the use of bloodplatelets effective in the treatment of difficult fistulas related to the anal sfincter?

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 tree 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:

Randomised, multicenter trial.



Study population:

Patients with complex cryptoglandular peri-anal fistula’s.



Intervention:

Injection of PRP in the curreted 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.

The use of platelets in addition to mucosa advancement flap in the treatment of complex peri-anal fistula will reduce the recurrence rate of these fistulas.

2, 4, 16, 24, 52 and 104 weeks.

This study consists of two arms. One arm will be treated conventionally with a mucosa advancement flap, with a seton procedure in advance.

The other arm will be treated with a mucosa advancement flap after a seton procedure and additionally PRP wil be added to this group of patients. For the PRP we will need to take 55 millilitres of blood of the patient. This blood will be centrifuged into PRP. This PRP will be injected into the fistula, then the mucosa advancement flap will be created.