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

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Rectal Fistula

Treatments: Procedure: Mucosa advancement flap; Other: Platelet rich plasma (PRP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01615302

METC 10-1-082

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Mucosa advancement flap

Active Comparator group

Treatment:

Procedure: Mucosa advancement flap

Mucosa advancement flap + PRP

Experimental group

Description:

Platelet rich plasma added to the mucosa advancement flap

Treatment:

Procedure: Mucosa advancement flap

Other: Platelet rich plasma (PRP)