Anal Fistula Repair With Platelet-rich Plasma (Aurora)

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Status and phase: Withdrawn; Phase 4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)

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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