A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas

Completed

Conditions: Anorectal Fistulas

Registration Number: NCT01624350

Lead Sponsor: Medtronic - MITG

Brief Summary: This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas.

The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 3 months, 6 months and 12 months post-surgery.

Detailed Description: The study will enroll 100 subjects at up to 10 centers throughout the European Union. The expected duration of the enrollment period is approximately 9 months. The duration of each subject's participation in the study will be approximately one year. However, at sites where the routine follow-up period is greater than one year, subjects may be followed for up to 36 months at their surgeon's discretion if they agree to it.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Male or female subjects age 18 or older
Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin

Key

Exclusion Criteria

History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis)
Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas
Indication of an actively infected fistula/abscess (acute sepsis)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fistula Healing in Patients at 6 Months Following Surgery	6 months	Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.

Secondary Outcome Measures

Name	Time	Method
Fistula Healing in Patients at 3 and 12 Months Following Surgery	3 months and 12 months	Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
Participant Response to Quality of Life EQ-5D Questionnaire	Baseline, and 3 months, 6 months and 12 months post op	Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Fecal Incontinence	3 months, 6 months and 12 months	Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.
Patient Satisfaction Between the First and Last Post-operative Visit	Between the first and last visits	Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.
Pain	Baseline, 1 month, 3 months, 6 months and 12 months	Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.

Trial Locations

Locations (10): Aarhus University Hospital
🇩🇰
Aarhus C, Denmark
Ninewells Hospital & Medical School
🇬🇧
Dundee, United Kingdom
AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia
🇮🇹
Pordenone, Italy
King's College Hospital
🇬🇧
London, United Kingdom
Aalborg Hospital
🇩🇰
Aalborg, Denmark
Whipps Cross University Hospital
🇬🇧
London, United Kingdom
Royal Victoria Infirmary
🇬🇧
New Castle, United Kingdom
Leicester General Hospital
🇬🇧
Leicester, United Kingdom
Casa di Cura PIO X
🇮🇹
Milan, Italy
University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata
🇮🇹
Rome, Italy