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Anal Fistula Repair With Platelet-rich Plasma (Aurora)

Primary Purpose

Rectal Fistula

Status
Withdrawn
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
PRP
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Fistula

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRP

non-PRP

Arm Description

The operation will be performed with application of platelet rich plasma

The operation will be performed without addition of platelet-rich plasma

Outcomes

Primary Outcome Measures

Healing rate

Secondary Outcome Measures

Influence of risk factor smoking on healing rate
Influence of risk factor high BMI on healing rate
Influence of risk factor chronic renal failure on healing rate
Influence of sex on healing rate

Full Information

First Posted
December 19, 2014
Last Updated
February 5, 2016
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02678936
Brief Title
Anal Fistula Repair With Platelet-rich Plasma
Acronym
Aurora
Official Title
Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP
Arm Type
Experimental
Arm Description
The operation will be performed with application of platelet rich plasma
Arm Title
non-PRP
Arm Type
No Intervention
Arm Description
The operation will be performed without addition of platelet-rich plasma
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
Application of platelet-rich plasma during surgery
Primary Outcome Measure Information:
Title
Healing rate
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Influence of risk factor smoking on healing rate
Time Frame
2 years
Title
Influence of risk factor high BMI on healing rate
Time Frame
2 years
Title
Influence of risk factor chronic renal failure on healing rate
Time Frame
2 years
Title
Influence of sex on healing rate
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Lorenz, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Basel
City
Basel
ZIP/Postal Code
4051
Country
Switzerland

12. IPD Sharing Statement

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Anal Fistula Repair With Platelet-rich Plasma

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