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.
Primary Outcome Measures:
Secondary Outcome Measures:
- Fistula Healing in Patients at 3 and 12 Months Following Surgery [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, and 3 months, 6 months and 12 months post op ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Between the first and last visits ] [ Designated as safety issue: No ]
Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.
- Pain [ Time Frame: Baseline, 1 month, 3 months, 6 months and 12 months ] [ Designated as safety issue: Yes ]
Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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.
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.