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Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?

NCT01615302 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-08-22

No results posted yet for this study

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.

Conditions

  • Rectal Fistula

Interventions

PROCEDURE

Mucosa advancement flap

Mucosa advancement flap will be performed at the starting point of the fistula in the rectum

OTHER

Platelet rich plasma (PRP)

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.

Sponsors & Collaborators

  • Biomet Nederland BV

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Stephanie O. Breukink, MD, PhD · Maastricht University Medical Center

  • Cor G.M.I. Baeten, MD, PhD, Prof. · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-04-30
Completion
2016-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615302 on ClinicalTrials.gov