Anal Fistula Repair With Platelet-rich Plasma

NCT ID: NCT02678936

Last Updated: 2016-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP

The operation will be performed with application of platelet rich plasma

Group Type EXPERIMENTAL

PRP

Intervention Type BIOLOGICAL

Application of platelet-rich plasma during surgery

non-PRP

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRP

Application of platelet-rich plasma during surgery

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Lorenz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital of Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Aurora

Identifier Type: -

Identifier Source: org_study_id

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