Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?
NCT ID: NCT01615302
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2012-03-31
2016-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mucosa advancement flap
Mucosa advancement flap
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
Mucosa advancement flap + PRP
Platelet rich plasma added to the mucosa advancement flap
Mucosa advancement flap
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
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.
Interventions
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Mucosa advancement flap
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
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 Criteria
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Inclusion Criteria
* Able to understand informed consent.
Exclusion Criteria
* Local malignancy
* Crohn's disease or Ulcerative colitis
* Traumatic or iatrogenic lesion
* Thrombocytopenia
* Splenomegaly
* Bleeding disorders
* Hematologic malignancies
18 Years
80 Years
ALL
No
Sponsors
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Biomet Nederland BV
INDUSTRY
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Stephanie O. Breukink, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Cor G.M.I. Baeten, MD, PhD, Prof.
Role: STUDY_DIRECTOR
Maastricht University Medical Center
Locations
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Atrium Medisch Centrum
Heerlen, Limburg, Netherlands
University Hospital Maastricht
Maastricht, Limburg, Netherlands
Laurentius ziekenhuis
Roermond, Limburg, Netherlands
Amphia ziekenhuis
Breda, North Brabant, Netherlands
Catharina ziekenhuis
Eindhoven, North Brabant, Netherlands
Refaja Ziekenhuis
Stadskanaal, Provincie Groningen, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Wim G. v. Gemert, MD, PhD
Role: primary
Kevin W.A. Göttgens, MD
Role: primary
Jeroen Heemskerk, MD, PhD
Role: primary
J.P. de Zoete, MD, PhD
Role: primary
Stephan J. van der Hagen, MD, PhD
Role: primary
References
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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.
Other Identifiers
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METC 10-1-082
Identifier Type: -
Identifier Source: org_study_id