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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Participant Response to Quality of Life EQ-5D Questionnaire |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pasquale Giordano, MD, FRCS | Whipps Cross University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Permacol Collagen Paste |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 |
| 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 |
| 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 |
| 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 |
| Aarhus C |
| Denmark |
| 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 |
| 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 | Newcastle | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Permacol Collagen Paste |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early. | Posted | Number | percentage of participants | 6 months |
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| 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. | Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early. | Posted | Number | 95% Confidence Interval | percentage of patients | 3 months and 12 months |
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| 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. | Number analyzed include participants who completed questionnaire. | Posted | Number | participants | Baseline, and 3 months, 6 months and 12 months post op |
|
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| 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. | The CCF-FI score was calculated if a score was ticked for each of the five types of incontinence. If a patient had a type of incontinence with a missing score, then the CCF-FI score was not calculated. Change = Value and Month X - Value at Baseline. | Posted | Mean | Standard Deviation | units on a scale | 3 months, 6 months and 12 months |
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| 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. | Number of participants completed a satisfaction questionnaire at least twice. | Posted | Count of Participants | Participants | Between the first and last visits |
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| 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. | Participants include number of patients who completed questionnaire | Posted | Count of Participants | Participants | Baseline, 1 month, 3 months, 6 months and 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Permacol Collagen Paste | 6 | 100 | 29 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders |
| |||
| Anal Abscess | Infections and infestations |
| |||
| Complex regional pain syndrome | Nervous system disorders |
| |||
| Pregnancy | Pregnancy, puerperium and perinatal conditions |
| |||
| Procedural pain | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders |
| |||
| Ear Pain | Ear and labyrinth disorders |
| |||
| Anal Fissure | Gastrointestinal disorders |
| |||
| Anal Fistula | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Haemorrhoids | Gastrointestinal disorders |
| |||
| Proctalgia | Gastrointestinal disorders |
| |||
| Rectal Haemorrhage | Gastrointestinal disorders |
| |||
| Pain | General disorders |
| |||
| Anal abscess | Infections and infestations |
| |||
| Anal fistula infection | Infections and infestations |
| |||
| Infected fistula | Infections and infestations |
| |||
| Pilonidal cyst | Infections and infestations |
| |||
| pneumonia | Infections and infestations |
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| postoperative wound infection | Infections and infestations |
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| purulent discharge | Infections and infestations |
| |||
| facial bones fracture | Injury, poisoning and procedural complications |
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| procedural pain | Injury, poisoning and procedural complications |
| |||
| Seroma | Injury, poisoning and procedural complications |
| |||
| Complex regional pain syndrome | Nervous system disorders |
| |||
| pregnancy | Pregnancy, puerperium and perinatal conditions |
| |||
| breast mass | Reproductive system and breast disorders |
| |||
| Asthma | Respiratory, thoracic and mediastinal disorders |
| |||
| decubitus ulcer | Skin and subcutaneous tissue disorders |
| |||
| eczema | Skin and subcutaneous tissue disorders |
| |||
| hypertrophic scar | Skin and subcutaneous tissue disorders |
| |||
| haemorrhage | Vascular disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medtronic (Sponsor) | Medtronic | 508.452.4095 | michelle.v.disalvo@medtronic.com |
| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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