Anorectal Fistulas
Conditions
Keywords
Anorectal Fistulas
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.
Interventions
DEVICEPermacol collagen paste
Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.
Sponsors
Medtronic - MITG
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula Healing in Patients at 6 Months Following Surgery | 6 months | Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fistula Healing in Patients at 3 and 12 Months Following Surgery | 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 | 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 | 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 | Between the first and last visits | Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation. |
| Pain | 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. |
Countries
Denmark, Italy, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Permacol Collagen Paste | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Permacol Collagen Paste |
|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 13.68 |
| Gender Female | 30 Participants |
| Gender Male | 70 Participants |
| Region of Enrollment Denmark | 15 participants |
| Region of Enrollment Italy | 33 participants |
| Region of Enrollment United Kingdom | 52 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 100 |
| serious Total, serious adverse events | 6 / 100 |
Outcome results
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.
Time frame: 6 months
Population: Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Permacol Collagen Paste | Fistula Healing in Patients at 6 Months Following Surgery | Yes | 56.7 percentage of participants |
| Permacol Collagen Paste | Fistula Healing in Patients at 6 Months Following Surgery | No | 43.3 percentage of participants |
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.
Time frame: 3 months, 6 months and 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Permacol Collagen Paste | Fecal Incontinence | -1.0 units on a scale | Standard Deviation 3.75 |
| Permacol Collagen Paste - 12 Month Follow up | Fecal Incontinence | -1.1 units on a scale | Standard Deviation 3.58 |
| Permacol Collagen Paste - 6 Month Post-op | Fecal Incontinence | -0.9 units on a scale | Standard Deviation 3.75 |
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.
Time frame: 3 months and 12 months
Population: Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Permacol Collagen Paste | Fistula Healing in Patients at 3 and 12 Months Following Surgery | Yes | 53.2 percentage of patients |
| Permacol Collagen Paste | Fistula Healing in Patients at 3 and 12 Months Following Surgery | No | 46.8 percentage of patients |
| Permacol Collagen Paste - 12 Month Follow up | Fistula Healing in Patients at 3 and 12 Months Following Surgery | Yes | 53.5 percentage of patients |
| Permacol Collagen Paste - 12 Month Follow up | Fistula Healing in Patients at 3 and 12 Months Following Surgery | No | 46.5 percentage of patients |
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.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months
Population: Participants include number of patients who completed questionnaire
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Permacol Collagen Paste | Pain | Severe Pain (7-10) | 8 Participants |
| Permacol Collagen Paste | Pain | Mild Pain (1-3) | 44 Participants |
| Permacol Collagen Paste | Pain | No Pain (0) | 29 Participants |
| Permacol Collagen Paste | Pain | Moderate Pain (4-6) | 17 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Pain | No Pain (0) | 45 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Pain | Severe Pain (7-10) | 1 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Pain | Moderate Pain (4-6) | 11 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Pain | Mild Pain (1-3) | 41 Participants |
| Permacol Collagen Paste - 6 Month Post-op | Pain | Moderate Pain (4-6) | 7 Participants |
| Permacol Collagen Paste - 6 Month Post-op | Pain | No Pain (0) | 47 Participants |
| Permacol Collagen Paste - 6 Month Post-op | Pain | Mild Pain (1-3) | 33 Participants |
| Permacol Collagen Paste - 6 Month Post-op | Pain | Severe Pain (7-10) | 1 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | Severe Pain (7-10) | 2 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | Mild Pain (1-3) | 26 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | No Pain (0) | 47 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | Moderate Pain (4-6) | 4 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | Moderate Pain (4-6) | 5 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | Severe Pain (7-10) | 3 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | Mild Pain (1-3) | 13 Participants |
| Permacol Collagen Paste - 12 Month Post-op | Pain | No Pain (0) | 53 Participants |
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.
Time frame: Baseline, and 3 months, 6 months and 12 months post op
Population: Number analyzed include participants who completed questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have extreme pain or discomfort | 0 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems doing my usual activities | 72 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems in walking about | 0 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe pain or discomfort | 2 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am extremely anxious or depressed | 1 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate pain or discomfort | 13 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems doing my usual activities | 4 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems doing my usual activities | 8 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems doing my usual activities | 13 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems washing or dressing mysel | 1 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to walk about | 0 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am severely anxious or depressed | 1 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems washing or dressing myself | 7 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems in walking about | 10 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems washing or dressing myself | 87 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems in walking about | 74 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems washing or dressing myself | 1 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems in walking about | 13 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am moderately anxious or depressed | 8 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am slightly anxious or depressed | 24 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight pain or discomfort | 44 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to wash or dress myself | 1 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I have no pain or discomfort | 38 participants |
| Permacol Collagen Paste | Participant Response to Quality of Life EQ-5D Questionnaire | I am not anxious or depressed | 63 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am moderately anxious or depressed | 6 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems in walking about | 77 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems in walking about | 1 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to walk about | 0 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems washing or dressing myself | 0 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to wash or dress myself | 0 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems doing my usual activities | 69 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems doing my usual activities | 12 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems doing my usual activities | 1 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have no pain or discomfort | 46 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate pain or discomfort | 10 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have extreme pain or discomfort | 0 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am not anxious or depressed | 69 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am slightly anxious or depressed | 13 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems in walking about | 7 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems in walking about | 3 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems washing or dressing myself | 84 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems washing or dressing myself | 3 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems washing or dressing mysel | 1 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems doing my usual activities | 6 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight pain or discomfort | 31 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe pain or discomfort | 1 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am severely anxious or depressed | 0 participants |
| Permacol Collagen Paste - 12 Month Follow up | Participant Response to Quality of Life EQ-5D Questionnaire | I am extremely anxious or depressed | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am extremely anxious or depressed | 1 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems washing or dressing myself | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have extreme pain or discomfort | 1 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am moderately anxious or depressed | 2 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am severely anxious or depressed | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems washing or dressing mysel | 1 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe pain or discomfort | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems in walking about | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems in walking about | 2 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to wash or dress myself | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems in walking about | 76 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems doing my usual activities | 1 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems doing my usual activities | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no pain or discomfort | 52 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am slightly anxious or depressed | 9 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight pain or discomfort | 22 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems in walking about | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems doing my usual activities | 6 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am not anxious or depressed | 67 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate pain or discomfort | 4 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems washing or dressing myself | 78 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems doing my usual activities | 72 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems washing or dressing myself | 0 participants |
| Permacol Collagen Paste - 6 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to walk about | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems doing my usual activities | 63 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have extreme pain or discomfort | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am not anxious or depressed | 56 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems washing or dressing myself | 0 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am extremely anxious or depressed | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am slightly anxious or depressed | 13 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems washing or dressing mysel | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems in walking about | 0 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to walk about | 0 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am moderately anxious or depressed | 4 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems in walking about | 72 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no problems washing or dressing myself | 72 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems washing or dressing myself | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems in walking about | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems in walking about | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate problems doing my usual activities | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight problems doing my usual activities | 9 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am severely anxious or depressed | 0 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have no pain or discomfort | 49 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have slight pain or discomfort | 20 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe problems doing my usual activities | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have moderate pain or discomfort | 3 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I have severe pain or discomfort | 1 participants |
| Permacol Collagen Paste - 12 Month Post-op | Participant Response to Quality of Life EQ-5D Questionnaire | I am unable to wash or dress myself | 0 participants |
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.
Time frame: Between the first and last visits
Population: Number of participants completed a satisfaction questionnaire at least twice.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Permacol Collagen Paste | Patient Satisfaction Between the First and Last Post-operative Visit | Very Satisfied | 37 Participants |
| Permacol Collagen Paste | Patient Satisfaction Between the First and Last Post-operative Visit | Dissatisfied | 8 Participants |
| Permacol Collagen Paste | Patient Satisfaction Between the First and Last Post-operative Visit | Very Dissatisfied | 1 Participants |
| Permacol Collagen Paste | Patient Satisfaction Between the First and Last Post-operative Visit | Satisfied | 39 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Patient Satisfaction Between the First and Last Post-operative Visit | Dissatisfied | 18 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Patient Satisfaction Between the First and Last Post-operative Visit | Very Satisfied | 44 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Patient Satisfaction Between the First and Last Post-operative Visit | Satisfied | 18 Participants |
| Permacol Collagen Paste - 12 Month Follow up | Patient Satisfaction Between the First and Last Post-operative Visit | Very Dissatisfied | 5 Participants |