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

This study is currently recruiting participants.

Verified by Cook, April 2009

First Received: October 16, 2007 Last Updated: April 10, 2009 History of Changes

Sponsors and Collaborators:	Cook Cook Medical Incorporated Cook Biotech Incorporated Cook Ireland, Ltd.
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00545441

Purpose

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.

Condition	Intervention
Anal Fistula	Device: Surgisis Biodesign Anal Fistula Plug (Surgisis AFP) Device: Flap

MedlinePlus related topics: Fistulas

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

Further study details as provided by Cook:

Primary Outcome Measures:

Healing [ Time Frame: One Year ]

Secondary Outcome Measures:

Quality of Life, Continence, Complications [ Time Frame: One Year ]

Estimated Enrollment:	106
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AFP	Device: Surgisis Biodesign Anal Fistula Plug (Surgisis AFP) Surgical placement of the Surgisis AFP is performed under general anesthesia.
2: Active Comparator Flap	Device: Flap Advancement flap surgery is performed; no anal fistula plug is placed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545441

Contacts

Contact: Jason P. Hodde, MS

765-497-3355

hodde@cookbiotech.com

Locations

Germany
Enddarmzentrum Mannheim	Recruiting
Mannheim, Germany
Contact: Prof. Dr. med. Alexander Herold +49621/123475-10
Caritas-Krankenhaus St. Joseph	Recruiting
Regensburg, Germany
Contact: Dr. Alois Fuerst +49941/7823310
St. Joseph Hospital	Recruiting
Wiesbaden, Germany
Contact: Dr. Ulrike Soetje +49611/1771376
Krankenhaus Waldfriede	Recruiting
Berlin, Germany
Contact: Dr. Roland Scherer +4930/81810151
Justus-Liebig-Universitat Giessen	Recruiting
Giessen, Germany, 35385
Contact: Thilo Schwandner, MD +49-641-994-4200 t.schwandner@web.de

Sponsors and Collaborators

Cook

Cook Medical Incorporated

Cook Biotech Incorporated

Cook Ireland, Ltd.

Investigators

Principal Investigator:

Thilo Schwandner, MD

Justus-Liebig-Universitat Giessen

More Information

No publications provided

Responsible Party:	Cook Biotech Incorporated ( Jason Hodde, Clinical Affairs Manager )
Study ID Numbers:	07-006
Study First Received:	October 16, 2007
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00545441 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cook:

Anal fistula
fistula in ano
anorectal fistula

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Rectal Fistula
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Fistula

Anesthetics
Intestinal Diseases
Rectal Diseases
Fistula

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Rectal Fistula
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Fistula

Digestive System Fistula
Intestinal Diseases
Rectal Diseases
Fistula

ClinicalTrials.gov processed this record on May 06, 2009