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

Rectal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01615302
• Other study ID #: METC 10-1-082
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2012
• Last updated: August 21, 2012
• Start date: March 2012
• Est. completion date: April 2016

Study information

• Verified date: August 2012
• Source: Maastricht University Medical Center
• Contact: Kevin W.A. Göttgens, MD
• Phone: +31433876543
• Email: kevin.gottgens[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Rectal Fistula

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amphia ziekenhuis	Breda	Noord Brabant
Netherlands	Catharina ziekenhuis	Eindhoven	Noord Brabant
Netherlands	Atrium Medisch Centrum	Heerlen	Limburg
Netherlands	University Hospital Maastricht	Maastricht	Limburg
Netherlands	Laurentius ziekenhuis	Roermond	Limburg
Netherlands	Refaja Ziekenhuis	Stadskanaal	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Biomet Nederland BV

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van der Hagen SJ, Baeten CG, Soeters PB, van Gemert WG. Autologous platelet-derived growth factors (platelet-rich plasma) as an adjunct to mucosal advancement flap in high cryptoglandular perianal fistulae: a pilot study. Colorectal Dis. 2011 Feb;13(2):215-8. doi: 10.1111/j.1463-1318.2009.01991.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence 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.	Assessed up to 104 weeks after operation	No
Secondary	Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 2 weeks after operation	No
Secondary	Quality of Life	Measured using the SF-36v2 questionnaire	Assessed at 2 weeks after operation	No
Secondary	Incontinence	Measured using the Vaizey score	Assessed at 2 weeks after operation	No
Secondary	Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 4 weeks after operation	No
Secondary	Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 16 weeks after operation	No
Secondary	Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 24 weeks after operation	No
Secondary	Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 52 weeks after operation	No
Secondary	Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 104 weeks after operation	No
Secondary	Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 4 weeks after operation	No
Secondary	Quality of Life	Measured using the SF-36v2 questionnaire	Assessed at 16 weeks after operation	No
Secondary	Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 24 weeks after operation	No
Secondary	Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 52 weeks after operation	No
Secondary	Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 104 weeks after operation	No
Secondary	Incontinence	Measured using the Vaizey score	Assesed at 4 weeks after operation	No
Secondary	Incontinence	Measured using the Vaizey score	Assessed at 16 weeks after operation	No
Secondary	Incontinence	Measured using the Vaizey score	Assessed at 52 weeks after operation	No
Secondary	Incontinence	Measured using the Vaizey score	Assessed at 24 weeks after operation	No
Secondary	Incontinence	Measured using the Vaizey score	Assessed at 104 weeks after operation	No