No registrations found.
ID
Source
Health condition
platelet rich plasma, peri-anal fistulas
trombocytenrijk plasma, peri-anale fistels
Sponsors and support
adress: P.Debyelaan 25 6229 HX Maastricht
phonenumber: 043-387 65 43
adress: Toermalijnring 600
3316 LC Dordrecht
The Netherlands
phone number: +31622981737
Intervention
Outcome measures
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).
Background 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.
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:
Randomised, multicenter trial.
Study population:
Patients with complex cryptoglandular peri-anal fistula’s.
Intervention:
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.
Study objective
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.
Study design
2, 4, 16, 24, 52 and 104 weeks.
Intervention
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.
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;
5. Trombocytopenia;
6. Splenomegaly;
7. Bleeding disorders;
8. Hematologic malignancies.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2301 |
| NTR-old | NTR2830 |
| Other | MEC MUMC : 10-1-082 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |