Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care. The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter. Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy. The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site. Primary endpoint and secondary endpoints Primary endpoint: • LARS score, obtained from the LARS score questionnaire\* Secondary endpoints: * Number of subjects with Major LARS\* * FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\* * FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\* * EQ-5D-5L - utility score\* * EQ-5D-5L - VAS score (scale 0-10 cm)\* * Satisfaction with treatment (scale 0-10 cm)\* * Number of adverse events\* \*All endpoints are measured per subject at study completion
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
32
The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.
Coloplast A/S
Humlebæk, Denmark
LARS Score
Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.
Time frame: Total score measured per subject at study completion after 12 weeks
Number of Subjects With Major LARS
Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.
Time frame: 12 weeks
FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire
The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).
Time frame: 12 weeks
EQ-5D-5L - Utility Score
Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels: 1. no problem 2. slight problems 3. moderate problems 4. severe problems 5. unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1.
Time frame: 12 weeks
EQ-5D-5L - VAS Score
The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible.
Time frame: 12 weeks
Satisfaction With Treatment
Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction)" rated on a VAS scale from 0 to 10 cm.
Time frame: 12 weeks
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