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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Maastricht University Medical Center
Sponsor:
Collaborator:
Biomet Nederland BV
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01615302
First received: May 30, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Rectal Fistula
Procedure: Mucosa advancement flap
Other: Platelet rich plasma (PRP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Recurrence of fistulas [ Time Frame: Assessed up to 104 weeks after operation ] [ Designated as safety issue: No ]

    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:
  • Pain [ Time Frame: Assessed at 2 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Visual Analogue Scale (VAS-score)

  • Quality of Life [ Time Frame: Assessed at 2 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the SF-36v2 questionnaire

  • Incontinence [ Time Frame: Assessed at 2 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Vaizey score

  • Pain [ Time Frame: Assessed at 4 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Visual Analogue Scale (VAS-score)

  • Pain [ Time Frame: Assessed at 16 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Visual Analogue Scale (VAS-score)

  • Pain [ Time Frame: Assessed at 24 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Visual Analogue Scale (VAS-score)

  • Pain [ Time Frame: Assessed at 52 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Visual Analogue Scale (VAS-score)

  • Pain [ Time Frame: Assessed at 104 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Visual Analogue Scale (VAS-score)

  • Quality of life [ Time Frame: Assessed at 4 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the SF-36v2 questionnaire

  • Quality of Life [ Time Frame: Assessed at 16 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the SF-36v2 questionnaire

  • Quality of life [ Time Frame: Assessed at 24 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the SF-36v2 questionnaire

  • Quality of life [ Time Frame: Assessed at 52 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the SF-36v2 questionnaire

  • Quality of life [ Time Frame: Assessed at 104 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the SF-36v2 questionnaire

  • Incontinence [ Time Frame: Assesed at 4 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Vaizey score

  • Incontinence [ Time Frame: Assessed at 16 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Vaizey score

  • Incontinence [ Time Frame: Assessed at 52 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Vaizey score

  • Incontinence [ Time Frame: Assessed at 24 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Vaizey score

  • Incontinence [ Time Frame: Assessed at 104 weeks after operation ] [ Designated as safety issue: No ]
    Measured using the Vaizey score


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615302

Contacts
Contact: Kevin W.A. Göttgens, MD +31433876543 kevin.gottgens@mumc.nl

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01615302     History of Changes
Other Study ID Numbers: METC 10-1-082
Study First Received: May 30, 2012
Last Updated: August 21, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Rectal Fistula
Peri-anal Fistula
Platelet-Rich Plasma
Mucosa advancement flap

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 31, 2014