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

Not Applicable

• Conditions: Rectal Fistula
• Interventions: Procedure: Mucosa advancement flap; Other: Platelet rich plasma (PRP)

• Registration Number: NCT01615302
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22
• Primary Completion: 2014-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucosa advancement flap	Mucosa advancement flap	-
Mucosa advancement flap + PRP	Mucosa advancement flap	Platelet rich plasma added to the mucosa advancement flap
Mucosa advancement flap + PRP	Platelet rich plasma (PRP)	Platelet rich plasma added to the mucosa advancement flap

Primary Outcome Measures

Name	Time	Method
Recurrence of fistulas	Assessed up to 104 weeks after operation	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.

Secondary Outcome Measures

Name	Time	Method
Pain	Assessed at 104 weeks after operation	Measured using the Visual Analogue Scale (VAS-score)
Quality of Life	Assessed at 16 weeks after operation	Measured using the SF-36v2 questionnaire
Incontinence	Assessed at 104 weeks after operation	Measured using the Vaizey score
Quality of life	Assessed at 104 weeks after operation	Measured using the SF-36v2 questionnaire

Trial Locations

Locations (6)

Amphia ziekenhuis; 🇳🇱 Breda, Noord Brabant, Netherlands

Refaja Ziekenhuis; 🇳🇱 Stadskanaal, Groningen, Netherlands

Atrium Medisch Centrum; 🇳🇱 Heerlen, Limburg, Netherlands

Laurentius ziekenhuis; 🇳🇱 Roermond, Limburg, Netherlands

Catharina ziekenhuis; 🇳🇱 Eindhoven, Noord Brabant, Netherlands

University Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands