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Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

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ClinicalTrials.gov Identifier: NCT01584752
Recruitment Status : Terminated
First Posted : April 25, 2012
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Central Finland Hospital District

Brief Summary:
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 or disease Intervention/treatment
Anal Fistula Fecal Incontinence Surgery Procedure: 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.

Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
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
Study Start Date : November 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Group/Cohort Intervention/treatment
Fistula patients
Gore-BioA Fistula Plug
Procedure: Gore-BioA Fistula Plug
Gore-BioA Fistula Plug



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

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


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

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

Responsible Party: Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT01584752     History of Changes
Other Study ID Numbers: KSSHP1U/2011
First Posted: April 25, 2012    Key Record Dates
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