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Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584752
First Posted: April 25, 2012
Last Update Posted: November 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Central Finland Hospital District
  Purpose
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months

Condition Intervention Phase
Anal Fistula Fecal Incontinence Surgery Procedure: Gore-BioA Fistula Plug Phase 3

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas

Resource links provided by NLM:


Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:
  • Healing of the fistula [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Symptoms of fecal incontinence [ Time Frame: 6 months ]

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
Gore-BioA Fistula Plug
Procedure: Gore-BioA Fistula Plug
Gore-BioA Fistula Plug

Detailed Description:
Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inhabitants of Finland
Criteria

Inclusion Criteria:

  • Age 18-70 years, male or female
  • 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 intersphincteric fistula
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584752


Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Central Hospital
Joensuu, Finland
Central Hospital
Jyväskylä, Finland
Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Central Hospital
Seinäjoki, Finland
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Central Finland Hospital District
Investigators
Study Director: Matti V Kairaluoma, ph.D Central Hospital, Jyväskylä, Finland
  More Information

Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT01584752     History of Changes
Other Study ID Numbers: KSSHP1U/2011
First Submitted: April 24, 2012
First Posted: April 25, 2012
Last Update Posted: November 24, 2014
Last Verified: April 2012

Additional relevant MeSH terms:
Fistula
Fecal Incontinence
Rectal Fistula
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Fistula
Digestive System Fistula