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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624350
First Posted: June 20, 2012
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
  Purpose

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.


Condition Intervention
Anorectal Fistulas Device: Permacol collagen paste

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 100
Study Start Date: September 2012
Study Completion Date: June 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624350


Locations
Denmark
Aalborg Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus C, Denmark
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, Italy
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, United Kingdom
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Pasquale Giordano, MD, FRCS Whipps Cross University Hospital
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01624350     History of Changes
Other Study ID Numbers: COVPERP0200
First Submitted: June 15, 2012
First Posted: June 20, 2012
Results First Submitted: July 21, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by Medtronic - MITG:
Anorectal Fistulas

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases