Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?
This study is currently recruiting participants.
Verified August 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
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
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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
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:
| 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 May 16, 2013