Anal Fistula Repair With Platelet-rich Plasma (Aurora)

February 5, 2016 updated by: University Hospital, Basel, Switzerland

Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4051
        • University Hospital of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP
The operation will be performed with application of platelet rich plasma
Biological: PRP
Application of platelet-rich plasma during surgery
No Intervention: non-PRP
The operation will be performed without addition of platelet-rich plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing rate
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Andreas Lorenz, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AURORA (Other Identifier: Mayo Clinic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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