Anal Fistula Repair With Platelet-rich Plasma

University Hospital, Basel, Switzerland

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Rectal Fistula

Interventions

PRPBIOLOGICAL

Application of platelet-rich plasma during surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Healing rate

Time frame: 2 Years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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