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| Name | Class |
|---|---|
| Biomet Nederland BV | INDUSTRY |
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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:
Nature and extent of the burden and risks associated with participation, group relatedness:
Because autologous blood is used, no extra risk are expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucosa advancement flap | Active Comparator |
| |
| Mucosa advancement flap + PRP | Experimental | Platelet rich plasma added to the mucosa advancement flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucosa advancement flap | Procedure | Mucosa advancement flap will be performed at the starting point of the fistula in the rectum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 2 weeks after operation |
| Quality of Life | Measured using the SF-36v2 questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin W.A. Göttgens, MD | Contact | +31433876543 | kevin.gottgens@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie O. Breukink, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Cor G.M.I. Baeten, MD, PhD, Prof. | Maastricht University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Medisch Centrum | Recruiting | Heerlen | Limburg | 6419 PC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19575739 | Background | 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. | |
| 24401885 | Derived |
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| 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. |
|
| Assessed at 2 weeks after operation |
| Incontinence | Measured using the Vaizey score | Assessed at 2 weeks after operation |
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 4 weeks after operation |
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 16 weeks after operation |
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 24 weeks after operation |
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 52 weeks after operation |
| Pain | Measured using the Visual Analogue Scale (VAS-score) | Assessed at 104 weeks after operation |
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 4 weeks after operation |
| Quality of Life | Measured using the SF-36v2 questionnaire | Assessed at 16 weeks after operation |
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 24 weeks after operation |
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 52 weeks after operation |
| Quality of life | Measured using the SF-36v2 questionnaire | Assessed at 104 weeks after operation |
| Incontinence | Measured using the Vaizey score | Assesed at 4 weeks after operation |
| Incontinence | Measured using the Vaizey score | Assessed at 16 weeks after operation |
| Incontinence | Measured using the Vaizey score | Assessed at 52 weeks after operation |
| Incontinence | Measured using the Vaizey score | Assessed at 24 weeks after operation |
| Incontinence | Measured using the Vaizey score | Assessed at 104 weeks after operation |
| University Hospital Maastricht | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
|
| Laurentius ziekenhuis | Recruiting | Roermond | Limburg | 6043 CV | Netherlands |
|
| Amphia ziekenhuis | Withdrawn | Breda | North Brabant | 4819 EV | Netherlands |
| Catharina ziekenhuis | Not yet recruiting | Eindhoven | North Brabant | 5623 EJ | Netherlands |
|
| Refaja Ziekenhuis | Not yet recruiting | Stadskanaal | Provincie Groningen | 9501 HE | Netherlands |
|
| 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. |
| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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