Anterior Resection SyndromeLARRISNCT04246775
Low Anterior Resection Syndrome and Rectal Irrigation Study
A study testing Peristeen in people with Anterior Resection Syndrome, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Resection Syndrome
- What is being tested?
- Peristeen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity
- LARS score of >20 (defined LARS syndrome)
- patients > 18 years of age.
Who cannot join
- previous use of rectal irrigation
- patients who are unable to give informed consent
- patients who are not physically capable of performing the treatment in their home
Trial locations and contacts
1 site in 1 country.
About this study
Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function.
Read the detailed description
Aims: To assess if rectal irrigation improves patient symptoms and quality of life in patients with LARS and to see if the treatment is acceptable to patients.
Methods: This is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between Jan 2009 and Jan 2014. Those patients deemed to have LARS who consent to participation in the study will be offered rectal irrigation.
- Conditions
- Anterior Resection Syndrome
- Being tested
- Peristeen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeristeenDevice
rectal irrigation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Peristeen given Receives: Device: Peristeen |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF12
quality of life
Measured: pre intervention and 6 months post
Secondary outcomes (4)
EORTC
quality of life
Measured: pre intervention and 6 months post
Low anterior resection score
bowel function
Measured: pre intervention and 6 months post
St Marks Faecal incontinence score
bowel function
Measured: pre intervention and 6 months post
treatment acceptability questionnaire
Measured: post training for treatment and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study startApr 2015
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- South East Wales Trials Unit (SEWTU), Tenovus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246775
- Sponsor's protocol ID
- NIHR/UKCRN Portfolio ID: 18113
- Acronym
- LARRIS
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Anterior Resection Syndrome and Rectal Irrigation Study
- ClinicalTrials.gov ID
- NCT04246775
- Acronym / sponsor ID
- LARRIS / NIHR/UKCRN Portfolio ID: 18113
- Conditions
- Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- South East Wales Trials Unit (SEWTU), Tenovus
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function.
Detailed description
Aims: To assess if rectal irrigation improves patient symptoms and quality of life in patients with LARS and to see if the treatment is acceptable to patients.
Methods: This is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between Jan 2009 and Jan 2014. Those patients deemed to have LARS who consent to participation in the study will be offered rectal irrigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: PeristeenPeristeen given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity
- LARS score of >20 (defined LARS syndrome)
- patients > 18 years of age.
Key exclusion criteria (3 listed)
- previous use of rectal irrigation
- patients who are unable to give informed consent
- patients who are not physically capable of performing the treatment in their home
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 |
|---|---|---|
| Peristeenrectal irrigation | Device | Treatment |
Primary outcome
SF12
Time frame: pre intervention and 6 months post
quality of life
4 secondary outcomes
EORTC
Time frame: pre intervention and 6 months post
Low anterior resection score
Time frame: pre intervention and 6 months post
St Marks Faecal incontinence score
Time frame: pre intervention and 6 months post
treatment acceptability questionnaire
Time frame: post training for treatment and 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
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A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
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Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Anterior Resection Syndrome, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 3 inclusion and 3 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 29 Jan 2020. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SF12 (time frame: pre intervention and 6 months post). 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 29 Jan 2020.