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A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

NCT ID: NCT00545441

Last Updated: 2014-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.

Detailed Description

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Conditions

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Anal Fistula

Keywords

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Anal fistula fistula in ano anorectal 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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1

Surgisis® AFP

Group Type EXPERIMENTAL

Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

Intervention Type DEVICE

Surgical placement of the Surgisis AFP is performed under general anesthesia.

2

Flap

Group Type ACTIVE_COMPARATOR

Flap

Intervention Type DEVICE

Advancement flap surgery is performed; no anal fistula plug is placed

Interventions

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Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

Surgical placement of the Surgisis AFP is performed under general anesthesia.

Intervention Type DEVICE

Flap

Advancement flap surgery is performed; no anal fistula plug is placed

Intervention Type DEVICE

Other Intervention Names

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Surgisis Biodesign

Eligibility Criteria

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Inclusion Criteria

* Over eighteen years old
* Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
* Pre-placement of seton required for at least 6 weeks prior to surgical treatment
* Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer

Exclusion Criteria

* Recurrent fistula tracts
* J-pouch fistulas
* Superficial fistulas
* Fistulas with active abscess, infection, or acute inflammation
* History of Chron's Disease
* History of Ulcerative Colitis
* History of HIV or other immune system disease
* History of collagen disease
* History of radiation to the anorectal region
* Allergies to pig tissue or pig products
* Religious or cultural objection to the use of pig tissue
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Biotech Incorporated

INDUSTRY

Sponsor Role collaborator

Cook Ireland, Ltd.

INDUSTRY

Sponsor Role collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thilo Schwandner, MD

Role: PRINCIPAL_INVESTIGATOR

Justus-Liebig-Universitat Giessen

Locations

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Justus-Liebig-Universitat Giessen

Giessen, Giessen, Germany

Site Status

Krankenhaus Waldfriede

Berlin, , Germany

Site Status

End-und Dickdarmzentrum Hannover

Hanover, , Germany

Site Status

Enddarmzentrum Mannheim

Mannheim, , Germany

Site Status

Caritas-Krankenhaus St. Joseph

Regensburg, , Germany

Site Status

St. Joseph Hospital

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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07-006

Identifier Type: -

Identifier Source: org_study_id