Anal Fistula Repair With Platelet-rich Plasma

Overview

Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate. The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.

Full Title of Study: “Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2015

Interventions

  • Biological: PRP
    • Application of platelet-rich plasma during surgery

Arms, Groups and Cohorts

  • Experimental: PRP
    • The operation will be performed with application of platelet rich plasma
  • No Intervention: non-PRP
    • The operation will be performed without addition of platelet-rich plasma

Clinical Trial Outcome Measures

Primary Measures

  • Healing rate
    • Time Frame: 2 Years

Secondary Measures

  • Influence of risk factor smoking on healing rate
    • Time Frame: 2 years
  • Influence of risk factor high BMI on healing rate
    • Time Frame: 2 years
  • Influence of risk factor chronic renal failure on healing rate
    • Time Frame: 2 years
  • Influence of sex on healing rate
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • complicated anal fistula with patient fit for surgical treatment – minimum 6 weeks after – written informed consent Exclusion Criteria:

  • age <18 – pregnancy – drug abuse, drug substitution program – homeless (follow-up difficult) – restricted in legal capacity – simple fistulas requiring fistulotomy – complicated fistulas requiring an anus praeter naturalis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andreas Lorenz, MD, Principal Investigator, University Hospital, Basel, Switzerland

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