Low Anterior Resection SyndromeNCT04586634
Randomized Clinical Trial on Transanal Irrigation
A study testing Peristeen cone catheter in people with Low Anterior Resection Syndrome, run by Coloplast A/S at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Peristeen cone catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jan 2020to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age and have full legal Capacity
- Have given written informed consent
- Be mental and physical capable to perform transanal irrigation with cone catheter
- Have a LARS score ≥ 30 after rectal resection
- Be treated according to individual treatment protocol for conservatory bowel management at participating site
- Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
- At least 3-months from last surgery in colorectum
- Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure
Who cannot join
- Active/recurrent colorectal cancer
- Leaking anastomosis
- Known anal or colorectal stenosis
- Within 4 weeks of endoscopic polypectomy
- Ischaemic colitis
- Acute inflammatory bowel disease
- Acute diverticulitis
- Current or planned pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection
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.
Read more
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
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Peristeen cone catheter
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristeen cone catheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Peristeen | Active comparator | Subjects to use newly developed Peristeen cone catherter device Receives: Device: Peristeen cone catheter |
| Standard of care | No intervention | subjects continue with their standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Total score measured per subject at study completion after 12 weeks
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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:
- no problem
- slight problems
- moderate problems
- severe problems
- 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start21 Jan 2020
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- Guillaume Meurette, MD, Principal investigator, CHU Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586634
- Sponsor's protocol ID
- CP327
- Status last verified
- May 2023
- First submitted
- 30 Sep 2020
- Last updated
- 22 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection
- ClinicalTrials.gov ID
- NCT04586634
- Acronym / sponsor ID
- CP327
- Conditions
- Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 22 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peristeen | Active comparator | Device: Peristeen cone catheterSubjects to use newly developed Peristeen cone catherter device |
| Standard of care | No intervention | –subjects continue with their standard of care treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age and have full legal Capacity
- Have given written informed consent
- Be mental and physical capable to perform transanal irrigation with cone catheter
- Have a LARS score ≥ 30 after rectal resection
- Be treated according to individual treatment protocol for conservatory bowel management at participating site
Key exclusion criteria (8 listed)
- Active/recurrent colorectal cancer
- Leaking anastomosis
- Known anal or colorectal stenosis
- Within 4 weeks of endoscopic polypectomy
- Ischaemic colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peristeen cone catheterThe 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. | Device | Peristeen |
Primary outcome
LARS Score
Time frame: Total score measured per subject at study completion after 12 weeks
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.
8 secondary outcomes
Number of Subjects With Major LARS
Time frame: 12 weeks
FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire
Time frame: 12 weeks
FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire
Time frame: 12 weeks
FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire
Time frame: 12 weeks
FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire
Time frame: 12 weeks
EQ-5D-5L - Utility Score
Time frame: 12 weeks
EQ-5D-5L - VAS Score
Time frame: 12 weeks
Satisfaction With Treatment
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Meurette, MD principal investigator
CHU Nantes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peristeen cone catheter in people with Low Anterior Resection Syndrome, run by Coloplast A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARS Score (time frame: Total score measured per subject at study completion after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.