Clinical trial NCT01624350: A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorectal Fistulas
Keywords: Anorectal Fistulas
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who meet the eligibility criteria that are planned to undergo surgical treatment for anorectal fistulas with Permacol™ Collagen Paste and agree to 12 months of follow-up.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fistula Healing in Patients at 6 Months Following Surgery
timeFrame: 6 months
Secondary outcomes:
measure: Fistula Healing in Patients at 3 and 12 Months Following Surgery
timeFrame: 3 months and 12 months
measure: Participant Response to Quality of Life EQ-5D Questionnaire
timeFrame: Baseline, and 3 months, 6 months and 12 months post op
measure: Fecal Incontinence
timeFrame: 3 months, 6 months and 12 months
measure: Patient Satisfaction Between the First and Last Post-operative Visit
timeFrame: Between the first and last visits
measure: Pain
timeFrame: Baseline, 1 month, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Milan
country: Italy
facility: Casa di Cura PIO X
city: Pordenone
country: Italy
facility: AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia
city: Rome
country: Italy
facility: University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: New Castle
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Whipps Cross University Hospital
name: Pasquale Giordano, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: