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 high peri-anal fistula*s.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoint primary: recurrence rate
Secondary outcome
Main study parameters/endpoints secundary: post-operative pain, continence,
quality of life.
Background summary
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 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 high
peri-anal fistula*s. Study design: randomised, multicenter trial. Study
population: patients with high cryptoglandular peri-anal fistula*s.
Intervention: injection of PRP at 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
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 high
peri-anal fistula*s.
Study design
Study design: randomised, multicenter trial.
Intervention
Intervention: injection of PRP at the curreted fistula track under the mucosal
flap.
Study burden and risks
The possible complications associated to treatment are complications which can
be epxected by a vena punction like pain, deep venous trmobosis and scar
formation. Until now no complications are described for the use of PRP.
p. Debyelaan 25
6202 AZ Maastricht 6229 HX
NL
p. Debyelaan 25
6202 AZ Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
no bias to sex, age 16-80 years, able to understand informed consent, high peri-anal fistula
Exclusion criteria
-inability to fullfill follow-up criteria
-pregnant
-local malignancy
-Crohn*s disease/Ulcerative colitis
-patients with a traumatic/iatrogenic lesion
-Trombocytopenia
- Splenomegaly
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 |
|---|---|
| ClinicalTrials.gov | NCT01615302 |
| CCMO | NL33967.068.10 |