Rectal FistulaNCT01615302
Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?
A study testing Mucosa advancement flap and Platelet rich plasma (PRP) in people with Rectal Fistula, run by Maastricht University Medical Center at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Fistula
- What is being tested?
- Mucosa advancement flap and Platelet rich plasma (PRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesNetherlands
- Study dates
- Mar 2012to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complex peri-anal fistula.
- Able to understand informed consent.
Who cannot join
- Pregnancy
- Local malignancy
- Crohn's disease or Ulcerative colitis
- Traumatic or iatrogenic lesion
- Thrombocytopenia
- Splenomegaly
- Bleeding disorders
- Hematologic malignancies
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 5 recruiting
- Withdrawn
Amphia ziekenhuis
Breda, North Brabant, 4819 EV
- Not yet recruiting
Catharina ziekenhuis
Eindhoven, North Brabant, 5623 EJ
J.P. de Zoete, MD, PhD, +31402399111, jean-paul.d.zoete@cze.nl
J.P. de Zoete, MD, PhD
- Recruiting
Atrium Medisch Centrum
Heerlen, Limburg, 6419 PC
Wim G. v. Gemert, MD, PhD, +31455766666, wgt01@atriummc.nl
Wim G. van Gemert, MD, PhD
- Recruiting
University Hospital Maastricht
Maastricht, Limburg, 6229 HX
Kevin W.A. Göttgens, MD, +31433876543, kevin.gottgens@mumc.nl
Stephanie O. Breukink, MD, PhD
- Recruiting
Laurentius ziekenhuis
Roermond, Limburg, 6043 CV
Jeroen Heemskerk, MD, PhD, +31475382222, j.heemskerk@lzr.nl
Jeroen Heemskerk, MD, PhD
- Not yet recruiting
Refaja Ziekenhuis
Stadskanaal, Provincie Groningen, 9501 HE
Stephan J. van der Hagen, MD, PhD, +31599654654, sjvanderhagen@refaja.nl
Stephan J. van der Hagen, MD, PhD
About this study
Official title: Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
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.
Read more
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.
- Conditions
- Rectal Fistula
- Being tested
- Mucosa advancement flap, Platelet rich plasma (PRP)
- Keywords
- Rectal Fistula, Peri-anal Fistula, Platelet-Rich Plasma, Mucosa advancement flap
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosa advancement flapProcedure or surgery
Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
Platelet rich plasma (PRP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Mucosa advancement flap | Active comparator | Not described Receives: Procedure: Mucosa advancement flap |
| Mucosa advancement flap + PRP | Experimental | Platelet rich plasma added to the mucosa advancement flap Receives: Procedure: Mucosa advancement flap; Other: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed up to 104 weeks after operation
Secondary outcomes (18)
Pain
Measured using the Visual Analogue Scale (VAS-score)
Measured: Assessed at 2 weeks after operation
Quality of Life
Measured using the SF-36v2 questionnaire
Measured: Assessed at 2 weeks after operation
Incontinence
Measured using the Vaizey score
Measured: Assessed at 2 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Measured: Assessed at 4 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Measured: Assessed at 16 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Measured: Assessed at 24 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Measured: Assessed at 52 weeks after operation
Pain
Measured using the Visual Analogue Scale (VAS-score)
Measured: Assessed at 104 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Measured: Assessed at 4 weeks after operation
Quality of Life
Measured using the SF-36v2 questionnaire
Measured: Assessed at 16 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Measured: Assessed at 24 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Measured: Assessed at 52 weeks after operation
Quality of life
Measured using the SF-36v2 questionnaire
Measured: Assessed at 104 weeks after operation
Incontinence
Measured using the Vaizey score
Measured: Assesed at 4 weeks after operation
Incontinence
Measured using the Vaizey score
Measured: Assessed at 16 weeks after operation
Incontinence
Measured using the Vaizey score
Measured: Assessed at 52 weeks after operation
Incontinence
Measured using the Vaizey score
Measured: Assessed at 24 weeks after operation
Incontinence
Measured using the Vaizey score
Measured: Assessed at 104 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal FistulaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biomet Nederland BV
- Responsible party
- Sponsor
- Investigators
- Stephanie O. Breukink, MD, PhD, Principal investigator, Maastricht University Medical CenterCor G.M.I. Baeten, MD, PhD, Prof., Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615302
- Sponsor's protocol ID
- METC 10-1-082
- Status last verified
- Aug 2012
- First submitted
- 30 May 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19575739Gottgens 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.
PubMed 24401885
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
- ClinicalTrials.gov ID
- NCT01615302
- Acronym / sponsor ID
- METC 10-1-082
- Conditions
- Rectal Fistula
- Keywords
- Rectal Fistula, Peri-anal Fistula, Platelet-Rich Plasma, Mucosa advancement flap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Biomet Nederland BV
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucosa advancement flap | Active comparator | Procedure: Mucosa advancement flap |
| Mucosa advancement flap + PRP | Experimental | Procedure: Mucosa advancement flap, Other: Platelet rich plasma (PRP)Platelet rich plasma added to the mucosa advancement flap |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complex peri-anal fistula.
- Able to understand informed consent.
Key exclusion criteria (8 listed)
- Pregnancy
- Local malignancy
- Crohn's disease or Ulcerative colitis
- Traumatic or iatrogenic lesion
- Thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucosa advancement flapMucosa advancement flap will be performed at the starting point of the fistula in the rectum | Procedure or surgery | Mucosa advancement flap, Mucosa advancement flap + PRP |
| 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. | Other | Mucosa advancement flap + PRP |
Primary outcome
Recurrence of fistulas
Time frame: Assessed up to 104 weeks after operation
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.
18 secondary outcomes
Pain
Time frame: Assessed at 2 weeks after operation
Quality of Life
Time frame: Assessed at 2 weeks after operation
Incontinence
Time frame: Assessed at 2 weeks after operation
Pain
Time frame: Assessed at 4 weeks after operation
Pain
Time frame: Assessed at 16 weeks after operation
Pain
Time frame: Assessed at 24 weeks after operation
Pain
Time frame: Assessed at 52 weeks after operation
Pain
Time frame: Assessed at 104 weeks after operation
Quality of life
Time frame: Assessed at 4 weeks after operation
Quality of Life
Time frame: Assessed at 16 weeks after operation
Quality of life
Time frame: Assessed at 24 weeks after operation
Quality of life
Time frame: Assessed at 52 weeks after operation
Quality of life
Time frame: Assessed at 104 weeks after operation
Incontinence
Time frame: Assesed at 4 weeks after operation
Incontinence
Time frame: Assessed at 16 weeks after operation
Incontinence
Time frame: Assessed at 52 weeks after operation
Incontinence
Time frame: Assessed at 24 weeks after operation
Incontinence
Time frame: Assessed at 104 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- Background: PubMed 19575739van 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.
- Derived from this study: PubMed 24401885Gottgens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie O. Breukink, MD, PhD principal investigator
Maastricht University Medical Center
Cor G.M.I. Baeten, MD, PhD, Prof. study director
Maastricht University Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucosa advancement flap and Platelet rich plasma (PRP) in people with Rectal Fistula, run by Maastricht University Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin W.A. Göttgens, MD (+31433876543, kevin.gottgens@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of fistulas (time frame: Assessed up to 104 weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615302, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.