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.
1 other identifier
interventional
120
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedAugust 22, 2012
August 1, 2012
2.1 years
May 30, 2012
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Pain
Assessed at 2 weeks after operation
Quality of Life
Assessed at 2 weeks after operation
Incontinence
Assessed at 2 weeks after operation
Pain
Assessed at 4 weeks after operation
Pain
Assessed at 16 weeks after operation
- +13 more secondary outcomes
Study Arms (2)
Mucosa advancement flap
ACTIVE COMPARATORMucosa advancement flap + PRP
EXPERIMENTALPlatelet rich plasma added to the mucosa advancement flap
Interventions
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
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
You may qualify if:
- Complex peri-anal fistula.
- Able to understand informed consent.
You may not qualify if:
- Pregnancy
- Local malignancy
- Crohn's disease or Ulcerative colitis
- Traumatic or iatrogenic lesion
- Thrombocytopenia
- Splenomegaly
- Bleeding disorders
- Hematologic malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Biomet Nederland BVcollaborator
Study Sites (6)
Atrium Medisch Centrum
Heerlen, Limburg, 6419 PC, Netherlands
University Hospital Maastricht
Maastricht, Limburg, 6229 HX, Netherlands
Laurentius ziekenhuis
Roermond, Limburg, 6043 CV, Netherlands
Amphia ziekenhuis
Breda, North Brabant, 4819 EV, Netherlands
Catharina ziekenhuis
Eindhoven, North Brabant, 5623 EJ, Netherlands
Refaja Ziekenhuis
Stadskanaal, Provincie Groningen, 9501 HE, Netherlands
Related Publications (2)
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.
PMID: 19575739BACKGROUNDGottgens 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.
PMID: 24401885DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 8, 2012
Study Start
March 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2016
Last Updated
August 22, 2012
Record last verified: 2012-08