NCT01615302

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Fistula

Interventions

Type	Name	Description
PROCEDURE	Mucosa advancement flap	Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
OTHER	Platelet rich plasma (PRP)	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-04-01
• Completion: 2016-04-01
• First posted: 2012-06-08
• Last updated: 2012-08-22

Locations

6 sites across 1 country: Netherlands