Anal Fistula Repair With Platelet-rich Plasma (Aurora)

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University Hospital Basel

Status and phase

Withdrawn
Phase 4

Conditions

Rectal Fistula

Treatments

Biological: PRP

Study type

Interventional

Funder types

Other

Identifiers

NCT02678936
Aurora

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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