|- candidate number||9267|
|- NTR Number||NTR2830|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mrt-2011|
|- Secondary IDs||10-1-082 MEC MUMC|
|- Public Title||Is the use of bloodplatelets effective in the treatment of difficult fistulas related to the anal sfincter?|
|- Scientific Title||Use of platelet rich plasma as an adjunct in the treatment of high peri-anal fistulas.|
|- hypothesis||The use of platelets in addition to mucosa advancement flap in the treatment of complex peri-anal fistula will reduce the recurrence rate of these fistulas.|
|- Healt Condition(s) or Problem(s) studied||Perianal fistula, Platelet rich plasma|
|- Inclusion criteria||1. Age 18-80 years;|
2. Able to understand informed consent;
3. Complex peri-anal fistula.
|- Exclusion criteria||1. Pregnancy;|
2. Local malignancy;
3. Crohn's disease/ulcerative colitis;
4. A traumatic or iatrogenic lesion;
7. Bleeding disorders;
8. Hematologic malignancies.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-apr-2013|
|- Target number of participants||120|
|- Interventions||This study consists of two arms. One arm will be treated conventionally with a mucosa advancement flap, with a seton procedure in advance. |
The other arm will be treated with a mucosa advancement flap after a seton procedure and additionally PRP wil be added to this group of patients. For the PRP we will need to take 55 millilitres of blood of the patient. This blood will be centrifuged into PRP. This PRP will be injected into the fistula, then the mucosa advancement flap will be created.
|- Primary outcome||Recurrent 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.|
|- Secondary outcome||1. Visual analogue scale (VAS-score);|
2. Quality of life (SF-36 questionnare);
3. Incontinence (Vaizey score).
|- Timepoints||2, 4, 16, 24, 52 and 104 weeks.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| W. Vening|
|- CONTACT for SCIENTIFIC QUERIES|| W. Vening|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Biomet Nederland, Dordrecht|
|- Publications||van der Hagen SJ, baten CG, Soters PB, van Gemert WG. Autologous platelelet derived grow factors(platelet rich plasma) as an adjunct to mucosal advancement flap in high cryptoglandular peri-anal fistulae: a pilot study. Colorectal Dis. 2009 Jul 3.|
|- 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 tree 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.
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.
Randomised, multicenter trial.
Patients with complex cryptoglandular peri-anal fistula’s.
Injection of PRP in the curreted 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.
|- Main changes (audit trail)|
|- RECORD||24-mrt-2011 - 8-apr-2011|