Fistula Plug Study

This study is currently recruiting participants.

Verified April 2012 by Central Finland Hospital District

Sponsor:

Information provided by (Responsible Party):

Central Finland Hospital District

ClinicalTrials.gov Identifier:

NCT01584752

First received: April 24, 2012

Last updated: NA

Last verified: April 2012

History: No changes posted

Purpose

This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsfincteric fistulas. Follow-up time is six months

Condition	Intervention
Anal Fistula Fecal Incontinence Surgery	Procedure: Gore-BioA fistula plug

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsfincteric Perianal Fistulas

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Fistulas

U.S. FDA Resources

Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:

Healing of the fistula [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms of fecal incontinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2011
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Fistula patients	Procedure: Gore-BioA fistula plug Gore-BioA fistula plug for high transsfincteric fistula

Detailed Description:

Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsfincteric perianal fistula. Patients with Crohns disease, immunosupressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Inhabitants of Finland

Criteria

Inclusion Criteria:

Age 18-70 years, male or femal
High cryptoglandular perianal fistula
Written approval for the study
Sufficient co-operation for the study
Localization of the fistula by ultrasound or MRI

Exclusion Criteria:

Crohns disease
Immunosuppressive treatment
Anovaginal fistula
Radiation therapy 6 months before study
Chemotherapy 6 months before study
Low- or interssfincteric fistula

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584752

Contacts

Contact: Matti V Kairaluoma, Ph.D

+358142693133

matti.kairaluoma@ksshp.fi

Locations

Finland
Helsinki University Hospital	Recruiting
Helsinki, Finland
Central Hospital	Recruiting
Joensuu, Finland
Central Hospital	Recruiting
Jyväskylä, Finland
Central Hospital	Recruiting
Lahti, Finland
Oulu University Hospital	Recruiting
Oulu, Finland
Central Hospital	Recruiting
Seinäjoki, Finland
Turku University Hospital	Recruiting
Turku, Finland

Sponsors and Collaborators

Central Finland Hospital District

More Information

No publications provided

Responsible Party:	Central Finland Hospital District
ClinicalTrials.gov Identifier:	NCT01584752 History of Changes
Other Study ID Numbers:	KSSHP1U/2011
Study First Received:	April 24, 2012
Last Updated:	April 24, 2012
Health Authority:	Finland: National Advisory Board on Health Care Ethics

Additional relevant MeSH terms:

Fecal Incontinence
Fistula
Rectal Fistula
Rectal Diseases
Intestinal Diseases

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

ClinicalTrials.gov processed this record on May 23, 2013

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