Anorectal Fistulas Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | June 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Key Inclusion Criteria: 1. Male or female subjects age 18 or older 2. Subjects diagnosed with a solitary tract anorectal fistula of cryptoglandular origin Key Exclusion Criteria: 1. History or suspicion of Inflammatory Bowel Disease (i.e.Crohn's Disease, Ulcerative Colitis) 2. Subjects with secondary tracts, horseshoe fistulas, ano/recto-vaginal fistulas, or rectourethral fistulas 3. Indication of an actively infected fistula/abscess (acute sepsis) |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aalborg Hospital | Aalborg | |
| Denmark | Aarhus University Hospital | Aarhus C | |
| Italy | Casa di Cura PIO X | Milan | |
| Italy | AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia | Pordenone | |
| Italy | University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata | Rome | |
| United Kingdom | Ninewells Hospital & Medical School | Dundee | |
| United Kingdom | Leicester General Hospital | Leicester | |
| United Kingdom | King's College Hospital | London | |
| United Kingdom | Whipps Cross University Hospital | London | |
| United Kingdom | Royal Victoria Infirmary | New Castle |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
Denmark, Italy, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | Yes |