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

Study Overview
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Brief Summary
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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
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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.

Official Title
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MASERATI 100 - 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

Conditions
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Anorectal Fistulas

Intervention / Treatment
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* Device: Permacol collagen paste


Participation Criteria
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Eligibility Criteria
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Key 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Permacol collagen paste|Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula Healing in Patients at 3 and 12 Months Following Surgery | Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed. | 3 months and 12 months | 
| Participant Response to Quality of Life EQ-5D Questionnaire | 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. | Baseline, and 3 months, 6 months and 12 months post op | 
| Fecal Incontinence | 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. | 3 months, 6 months and 12 months | 
| Patient Satisfaction Between the First and Last Post-operative Visit | Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation. | Between the first and last visits | 
| Pain | Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain. | Baseline, 1 month, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorectal Fistulas