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

Primary Purpose

Rectal Fistula

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mucosa advancement flap
Platelet rich plasma (PRP)
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Fistula focused on measuring Rectal Fistula, Peri-anal Fistula, Platelet-Rich Plasma, Mucosa advancement flap

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Refaja Ziekenhuis
  • Atrium Medisch CentrumRecruiting
  • University Hospital MaastrichtRecruiting
  • Laurentius ziekenhuisRecruiting
  • Amphia ziekenhuis
  • Catharina ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mucosa advancement flap

Mucosa advancement flap + PRP

Arm Description

Platelet rich plasma added to the mucosa advancement flap

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain
Measured using the Visual Analogue Scale (VAS-score)
Quality of Life
Measured using the SF-36v2 questionnaire
Incontinence
Measured using the Vaizey score
Pain
Measured using the Visual Analogue Scale (VAS-score)
Pain
Measured using the Visual Analogue Scale (VAS-score)
Pain
Measured using the Visual Analogue Scale (VAS-score)
Pain
Measured using the Visual Analogue Scale (VAS-score)
Pain
Measured using the Visual Analogue Scale (VAS-score)
Quality of life
Measured using the SF-36v2 questionnaire
Quality of Life
Measured using the SF-36v2 questionnaire
Quality of life
Measured using the SF-36v2 questionnaire
Quality of life
Measured using the SF-36v2 questionnaire
Quality of life
Measured using the SF-36v2 questionnaire
Incontinence
Measured using the Vaizey score
Incontinence
Measured using the Vaizey score
Incontinence
Measured using the Vaizey score
Incontinence
Measured using the Vaizey score
Incontinence
Measured using the Vaizey score

Full Information

First Posted
May 30, 2012
Last Updated
August 21, 2012
Sponsor
Maastricht University Medical Center
Collaborators
Biomet Nederland BV
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1. Study Identification

Unique Protocol Identification Number
NCT01615302
Brief Title
Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?
Official Title
Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Biomet Nederland BV

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Fistula
Keywords
Rectal Fistula, Peri-anal Fistula, Platelet-Rich Plasma, Mucosa advancement flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mucosa advancement flap
Arm Type
Active Comparator
Arm Title
Mucosa advancement flap + PRP
Arm Type
Experimental
Arm Description
Platelet rich plasma added to the mucosa advancement flap
Intervention Type
Procedure
Intervention Name(s)
Mucosa advancement flap
Intervention Description
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
Intervention Type
Other
Intervention Name(s)
Platelet rich plasma (PRP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of fistulas
Description
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.
Time Frame
Assessed up to 104 weeks after operation
Secondary Outcome Measure Information:
Title
Pain
Description
Measured using the Visual Analogue Scale (VAS-score)
Time Frame
Assessed at 2 weeks after operation
Title
Quality of Life
Description
Measured using the SF-36v2 questionnaire
Time Frame
Assessed at 2 weeks after operation
Title
Incontinence
Description
Measured using the Vaizey score
Time Frame
Assessed at 2 weeks after operation
Title
Pain
Description
Measured using the Visual Analogue Scale (VAS-score)
Time Frame
Assessed at 4 weeks after operation
Title
Pain
Description
Measured using the Visual Analogue Scale (VAS-score)
Time Frame
Assessed at 16 weeks after operation
Title
Pain
Description
Measured using the Visual Analogue Scale (VAS-score)
Time Frame
Assessed at 24 weeks after operation
Title
Pain
Description
Measured using the Visual Analogue Scale (VAS-score)
Time Frame
Assessed at 52 weeks after operation
Title
Pain
Description
Measured using the Visual Analogue Scale (VAS-score)
Time Frame
Assessed at 104 weeks after operation
Title
Quality of life
Description
Measured using the SF-36v2 questionnaire
Time Frame
Assessed at 4 weeks after operation
Title
Quality of Life
Description
Measured using the SF-36v2 questionnaire
Time Frame
Assessed at 16 weeks after operation
Title
Quality of life
Description
Measured using the SF-36v2 questionnaire
Time Frame
Assessed at 24 weeks after operation
Title
Quality of life
Description
Measured using the SF-36v2 questionnaire
Time Frame
Assessed at 52 weeks after operation
Title
Quality of life
Description
Measured using the SF-36v2 questionnaire
Time Frame
Assessed at 104 weeks after operation
Title
Incontinence
Description
Measured using the Vaizey score
Time Frame
Assesed at 4 weeks after operation
Title
Incontinence
Description
Measured using the Vaizey score
Time Frame
Assessed at 16 weeks after operation
Title
Incontinence
Description
Measured using the Vaizey score
Time Frame
Assessed at 52 weeks after operation
Title
Incontinence
Description
Measured using the Vaizey score
Time Frame
Assessed at 24 weeks after operation
Title
Incontinence
Description
Measured using the Vaizey score
Time Frame
Assessed at 104 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin W.A. Göttgens, MD
Phone
+31433876543
Email
kevin.gottgens@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie O. Breukink, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cor G.M.I. Baeten, MD, PhD, Prof.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Refaja Ziekenhuis
City
Stadskanaal
State/Province
Groningen
ZIP/Postal Code
9501 HE
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan J. van der Hagen, MD, PhD
Phone
+31599654654
Email
sjvanderhagen@refaja.nl
First Name & Middle Initial & Last Name & Degree
Stephan J. van der Hagen, MD, PhD
Facility Name
Atrium Medisch Centrum
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim G. v. Gemert, MD, PhD
Phone
+31455766666
Email
wgt01@atriummc.nl
First Name & Middle Initial & Last Name & Degree
Wim G. van Gemert, MD, PhD
Facility Name
University Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin W.A. Göttgens, MD
Phone
+31433876543
Email
kevin.gottgens@mumc.nl
First Name & Middle Initial & Last Name & Degree
Stephanie O. Breukink, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kevin W.A. Göttgens, MD
Facility Name
Laurentius ziekenhuis
City
Roermond
State/Province
Limburg
ZIP/Postal Code
6043 CV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Heemskerk, MD, PhD
Phone
+31475382222
Email
j.heemskerk@lzr.nl
First Name & Middle Initial & Last Name & Degree
Jeroen Heemskerk, MD, PhD
Facility Name
Amphia ziekenhuis
City
Breda
State/Province
Noord Brabant
ZIP/Postal Code
4819 EV
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Catharina ziekenhuis
City
Eindhoven
State/Province
Noord Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.P. de Zoete, MD, PhD
Phone
+31402399111
Email
jean-paul.d.zoete@cze.nl
First Name & Middle Initial & Last Name & Degree
J.P. de Zoete, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19575739
Citation
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.
Results Reference
background
PubMed Identifier
24401885
Citation
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.
Results Reference
derived

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

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