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NCT Number: NCT01624350

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

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Key information

Conditions

Anorectal Fistulas Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Permacol collagen paste

Device

Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.

Primary outcomes

  1. Fistula Healing in Patients at 6 Months Following Surgery

    Time frame: 6 months

    Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.

Secondary outcomes

  1. Fistula Healing in Patients at 3 and 12 Months Following Surgery

    Time frame: 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.

  2. Participant Response to Quality of Life EQ-5D Questionnaire

    Time frame: 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.

  3. Fecal Incontinence

    Time frame: 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.

  4. Patient Satisfaction Between the First and Last Post-operative Visit

    Time frame: Between the first and last visits

    Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.

  5. Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2012
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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