Trial Outcomes & Findings for A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas (NCT NCT01624350)
NCT ID: NCT01624350
Last Updated: 2016-11-30
Results Overview
Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
COMPLETED
100 participants
6 months
2016-11-30
Participant Flow
Participant milestones
| Measure |
Permacol Collagen Paste
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
Baseline characteristics by cohort
| Measure |
Permacol Collagen Paste
n=100 Participants
|
|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 13.68 • n=5 Participants
|
|
Gender
Female
|
30 Participants
n=5 Participants
|
|
Gender
Male
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.
Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
Outcome measures
| Measure |
Permacol Collagen Paste
n=97 Participants
|
Permacol Collagen Paste - 12 Month Follow up
|
Permacol Collagen Paste - 6 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
|---|---|---|---|---|---|
|
Fistula Healing in Patients at 6 Months Following Surgery
Yes
|
56.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Fistula Healing in Patients at 6 Months Following Surgery
No
|
43.3 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months and 12 monthsPopulation: Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.
Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.
Outcome measures
| Measure |
Permacol Collagen Paste
n=94 Participants
|
Permacol Collagen Paste - 12 Month Follow up
n=99 Participants
|
Permacol Collagen Paste - 6 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
|---|---|---|---|---|---|
|
Fistula Healing in Patients at 3 and 12 Months Following Surgery
Yes
|
53.2 percentage of patients
Interval 42.6 to 63.6
|
53.5 percentage of patients
Interval 43.2 to 63.6
|
—
|
—
|
—
|
|
Fistula Healing in Patients at 3 and 12 Months Following Surgery
No
|
46.8 percentage of patients
Interval 42.6 to 63.6
|
46.5 percentage of patients
Interval 43.2 to 63.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, and 3 months, 6 months and 12 months post opPopulation: Number analyzed include participants who completed 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.
Outcome measures
| Measure |
Permacol Collagen Paste
n=97 Participants
|
Permacol Collagen Paste - 12 Month Follow up
n=88 Participants
|
Permacol Collagen Paste - 6 Month Post-op
n=79 Participants
|
Permacol Collagen Paste - 12 Month Post-op
n=74 Participants
|
Permacol Collagen Paste - 12 Month Post-op
|
|---|---|---|---|---|---|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have no problems in walking about
|
74 participants
|
77 participants
|
76 participants
|
72 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have moderate problems in walking about
|
10 participants
|
3 participants
|
0 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have severe problems in walking about
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am unable to walk about
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have no problems washing or dressing myself
|
87 participants
|
84 participants
|
78 participants
|
72 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have slight problems washing or dressing myself
|
7 participants
|
3 participants
|
0 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have moderate problems washing or dressing mysel
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have severe problems washing or dressing myself
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am unable to wash or dress myself
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have slight problems doing my usual activities
|
13 participants
|
12 participants
|
6 participants
|
9 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have moderate problems doing my usual activities
|
8 participants
|
6 participants
|
0 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have no pain or discomfort
|
38 participants
|
46 participants
|
52 participants
|
49 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have slight pain or discomfort
|
44 participants
|
31 participants
|
22 participants
|
20 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have severe pain or discomfort
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have extreme pain or discomfort
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am not anxious or depressed
|
63 participants
|
69 participants
|
67 participants
|
56 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am severely anxious or depressed
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have slight problems in walking about
|
13 participants
|
7 participants
|
2 participants
|
0 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have no problems doing my usual activities
|
72 participants
|
69 participants
|
72 participants
|
63 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have severe problems doing my usual activities
|
4 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I have moderate pain or discomfort
|
13 participants
|
10 participants
|
4 participants
|
3 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am slightly anxious or depressed
|
24 participants
|
13 participants
|
9 participants
|
13 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am moderately anxious or depressed
|
8 participants
|
6 participants
|
2 participants
|
4 participants
|
—
|
|
Participant Response to Quality of Life EQ-5D Questionnaire
I am extremely anxious or depressed
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Permacol Collagen Paste
n=85 Participants
|
Permacol Collagen Paste - 12 Month Follow up
n=76 Participants
|
Permacol Collagen Paste - 6 Month Post-op
n=70 Participants
|
Permacol Collagen Paste - 12 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
|---|---|---|---|---|---|
|
Fecal Incontinence
|
-1.0 units on a scale
Standard Deviation 3.75
|
-1.1 units on a scale
Standard Deviation 3.58
|
-0.9 units on a scale
Standard Deviation 3.75
|
—
|
—
|
SECONDARY outcome
Timeframe: Between the first and last visitsPopulation: Number of participants completed a satisfaction questionnaire at least twice.
Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.
Outcome measures
| Measure |
Permacol Collagen Paste
n=85 Participants
|
Permacol Collagen Paste - 12 Month Follow up
n=85 Participants
|
Permacol Collagen Paste - 6 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
Permacol Collagen Paste - 12 Month Post-op
|
|---|---|---|---|---|---|
|
Patient Satisfaction Between the First and Last Post-operative Visit
Very Satisfied
|
37 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Patient Satisfaction Between the First and Last Post-operative Visit
Satisfied
|
39 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Patient Satisfaction Between the First and Last Post-operative Visit
Dissatisfied
|
8 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Patient Satisfaction Between the First and Last Post-operative Visit
Very Dissatisfied
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months and 12 monthsPopulation: Participants include number of patients who completed questionnaire
Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.
Outcome measures
| Measure |
Permacol Collagen Paste
n=98 Participants
|
Permacol Collagen Paste - 12 Month Follow up
n=98 Participants
|
Permacol Collagen Paste - 6 Month Post-op
n=88 Participants
|
Permacol Collagen Paste - 12 Month Post-op
n=79 Participants
|
Permacol Collagen Paste - 12 Month Post-op
n=74 Participants
|
|---|---|---|---|---|---|
|
Pain
Severe Pain (7-10)
|
8 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Pain
No Pain (0)
|
29 Participants
|
45 Participants
|
47 Participants
|
47 Participants
|
53 Participants
|
|
Pain
Mild Pain (1-3)
|
44 Participants
|
41 Participants
|
33 Participants
|
26 Participants
|
13 Participants
|
|
Pain
Moderate Pain (4-6)
|
17 Participants
|
11 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
Permacol Collagen Paste
Serious adverse events
| Measure |
Permacol Collagen Paste
n=100 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Anal fistula
|
1.0%
1/100 • Number of events 1
|
|
Infections and infestations
Anal Abscess
|
2.0%
2/100
|
|
Nervous system disorders
Complex regional pain syndrome
|
1.0%
1/100
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
1/100
|
Other adverse events
| Measure |
Permacol Collagen Paste
n=100 participants at risk
|
|---|---|
|
Cardiac disorders
Tachycardia
|
1.0%
1/100
|
|
Ear and labyrinth disorders
Ear Pain
|
1.0%
1/100
|
|
Gastrointestinal disorders
Anal Fissure
|
1.0%
1/100
|
|
Gastrointestinal disorders
Anal Fistula
|
2.0%
2/100
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/100
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/100
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
2/100
|
|
Gastrointestinal disorders
Proctalgia
|
6.0%
6/100
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.0%
1/100
|
|
General disorders
Pain
|
1.0%
1/100
|
|
Infections and infestations
Anal abscess
|
4.0%
4/100
|
|
Infections and infestations
Anal fistula infection
|
2.0%
2/100
|
|
Infections and infestations
Infected fistula
|
1.0%
1/100
|
|
Infections and infestations
Pilonidal cyst
|
1.0%
1/100
|
|
Infections and infestations
pneumonia
|
1.0%
1/100
|
|
Infections and infestations
postoperative wound infection
|
3.0%
3/100
|
|
Infections and infestations
purulent discharge
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
facial bones fracture
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
procedural pain
|
3.0%
3/100
|
|
Injury, poisoning and procedural complications
Seroma
|
2.0%
2/100
|
|
Nervous system disorders
Complex regional pain syndrome
|
1.0%
1/100
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
1.0%
1/100
|
|
Reproductive system and breast disorders
breast mass
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
decubitus ulcer
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
eczema
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
hypertrophic scar
|
1.0%
1/100
|
|
Vascular disorders
haemorrhage
|
1.0%
1/100
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place