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.

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Fistula
• Intervention / Treatment: Procedure: Mucosa advancement flap; Other: Platelet rich plasma (PRP)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin W.A. Göttgens, MD; Phone Number: +31433876543; Email: kevin.gottgens@mumc.nl

Study Locations

• Netherlands
  • Groningen
    • Stadskanaal, Groningen, Netherlands, 9501 HE
      • Not yet recruiting
      • Refaja ziekenhuis
      • Contact: Stephan J. van der Hagen, MD, PhD; Phone Number: +31599654654; Email: sjvanderhagen@refaja.nl
      • Principal Investigator: Stephan J. van der Hagen, MD, PhD
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Recruiting
      • Atrium medisch centrum
      • Contact: Wim G. v. Gemert, MD, PhD; Phone Number: +31455766666; Email: wgt01@atriummc.nl
      • Principal Investigator: Wim G. van Gemert, MD, PhD
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • University Hospital Maastricht
      • Contact: Kevin W.A. Göttgens, MD; Phone Number: +31433876543; Email: kevin.gottgens@mumc.nl
      • Sub-Investigator: Stephanie O. Breukink, MD, PhD
      • Principal Investigator: Kevin W.A. Göttgens, MD
    • Roermond, Limburg, Netherlands, 6043 CV
      • Recruiting
      • Laurentius Ziekenhuis
      • Contact: Jeroen Heemskerk, MD, PhD; Phone Number: +31475382222; Email: j.heemskerk@lzr.nl
      • Principal Investigator: Jeroen Heemskerk, MD, PhD
  • Noord Brabant
    • Breda, Noord Brabant, Netherlands, 4819 EV
      • Withdrawn
      • Amphia Ziekenhuis
    • Eindhoven, Noord Brabant, Netherlands, 5623 EJ
      • Not yet recruiting
      • Catharina Ziekenhuis
      • Contact: J.P. de Zoete, MD, PhD; Phone Number: +31402399111; Email: jean-paul.d.zoete@cze.nl
      • Principal Investigator: J.P. de Zoete, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mucosa advancement flap	Procedure: Mucosa advancement flap; Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
Experimental: Mucosa advancement flap + PRP; Platelet rich plasma added to the mucosa advancement flap	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 2 weeks after operation
Quality of Life	Measured using the SF-36v2 questionnaire	Assessed at 2 weeks after operation
Incontinence	Measured using the Vaizey score	Assessed at 2 weeks after operation
Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 4 weeks after operation
Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 16 weeks after operation
Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 24 weeks after operation
Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 52 weeks after operation
Pain	Measured using the Visual Analogue Scale (VAS-score)	Assessed at 104 weeks after operation
Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 4 weeks after operation
Quality of Life	Measured using the SF-36v2 questionnaire	Assessed at 16 weeks after operation
Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 24 weeks after operation
Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 52 weeks after operation
Quality of life	Measured using the SF-36v2 questionnaire	Assessed at 104 weeks after operation
Incontinence	Measured using the Vaizey score	Assesed at 4 weeks after operation
Incontinence	Measured using the Vaizey score	Assessed at 16 weeks after operation
Incontinence	Measured using the Vaizey score	Assessed at 52 weeks after operation
Incontinence	Measured using the Vaizey score	Assessed at 24 weeks after operation
Incontinence	Measured using the Vaizey score	Assessed at 104 weeks after operation

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Biomet Nederland BV
• Investigators: Principal Investigator: Stephanie O. Breukink, MD, PhD, Maastricht University Medical Center; Study Director: Cor G.M.I. Baeten, MD, PhD, Prof., Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.
• Gottgens KW, Vening W, van der Hagen SJ, van Gemert WG, Smeets RR, Stassen LP, Baeten CG, Breukink SO. Long-term results of mucosal advancement flap combined with platelet-rich plasma for high cryptoglandular perianal fistulas. Dis Colon Rectum. 2014 Feb;57(2):223-7. doi: 10.1097/DCR.0000000000000023.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Platelet-Rich Plasma; Rectal Fistula; Peri-anal Fistula; Mucosa advancement flap
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: METC 10-1-082