Clinical trial NCT01615302: Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?
Official title: Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Fistula
Keywords: Rectal Fistula
Peri-anal Fistula
Platelet-Rich Plasma
Mucosa advancement flap
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Biomet Nederland BV
First posted: 2012-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* Complex peri-anal fistula.
* Able to understand informed consent.

Exclusion Criteria:

* Pregnancy
* Local malignancy
* Crohn's disease or Ulcerative colitis
* Traumatic or iatrogenic lesion
* Thrombocytopenia
* Splenomegaly
* Bleeding disorders
* Hematologic malignancies

Primary outcomes:
measure: Recurrence of fistulas
timeFrame: Assessed up to 104 weeks after operation
Secondary outcomes:
measure: Pain
timeFrame: Assessed at 2 weeks after operation
measure: Quality of Life
timeFrame: Assessed at 2 weeks after operation
measure: Incontinence
timeFrame: Assessed at 2 weeks after operation
measure: Pain
timeFrame: Assessed at 4 weeks after operation
measure: Pain
timeFrame: Assessed at 16 weeks after operation
measure: Pain
timeFrame: Assessed at 24 weeks after operation
measure: Pain
timeFrame: Assessed at 52 weeks after operation
measure: Pain
timeFrame: Assessed at 104 weeks after operation
measure: Quality of life
timeFrame: Assessed at 4 weeks after operation
measure: Quality of Life
timeFrame: Assessed at 16 weeks after operation
measure: Quality of life
timeFrame: Assessed at 24 weeks after operation
measure: Quality of life
timeFrame: Assessed at 52 weeks after operation
measure: Quality of life
timeFrame: Assessed at 104 weeks after operation
measure: Incontinence
timeFrame: Assesed at 4 weeks after operation
measure: Incontinence
timeFrame: Assessed at 16 weeks after operation
measure: Incontinence
timeFrame: Assessed at 52 weeks after operation
measure: Incontinence
timeFrame: Assessed at 24 weeks after operation
measure: Incontinence
timeFrame: Assessed at 104 weeks after operation
Other outcomes:
Locations:
city: Stadskanaal
country: Netherlands
facility: Refaja Ziekenhuis
state: Groningen
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
state: Limburg
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
state: Limburg
city: Roermond
country: Netherlands
facility: Laurentius ziekenhuis
state: Limburg
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
state: Noord Brabant
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
state: Noord Brabant
Study officials:
affiliation: Maastricht University Medical Center
name: Stephanie O. Breukink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Cor G.M.I. Baeten, MD, PhD, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.