A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
|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.|
|ClinicalTrials.gov Identifier: NCT01624350|
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
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 or disease||Intervention/treatment|
|Anorectal Fistulas||Device: Permacol collagen paste|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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 Start Date :||September 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||June 2015|
- 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.
- 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.
- 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.
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
|Aarhus University Hospital|
|Aarhus C, Denmark|
|Casa di Cura PIO X|
|AO S.Maria degli Angeli, S.S.D. Degenze Brevi 1^ 2^ Chirurgia Ginecologia e Urologia|
|University of Rome Tor Vergata, Surgery-Policlinico Tor Vergata|
|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|
|Principal Investigator:||Pasquale Giordano, MD, FRCS||Whipps Cross University Hospital|