Low Anterior Resection SyndromeHiLoV_TAINCT05245331
Transanal Irrigation for Low Anterior Resection Syndrome.
A study testing Peristeen® Transanal irrigation system with the conic catheter and Standard reusable enema in people with Low Anterior Resection Syndrome, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
Trial summary
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Peristeen® Transanal irrigation system with the conic catheter and Standard reusable enema
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 4 Aug 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.
- Major LARS (score 30-42).
- At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.
- Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2.
- Age≥ 18 years
Who cannot join
- Side to end mechanical anastomosis or J-pouch colorectal anastomosis
- Partial or total intersphincteric resection.
- Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.
- Persona history of other colorectal, proctologic or pelvis surgery or disease.
- Personal history of bariatric surgery.
- Functioning sacral neurostimulator carriers.
Show all 13Show fewer
- Previous use of transanal irrigation systems for LARS treatment
- Presence of an ostomy.
- Local or distant rectal cancer recurrence and/or any other active neoplastic disease.
- Altered cognitive status.
- Pregnancy and age < 18 years
- Any other diseases that may alter results of the study.
- Refusal to sign the informed consent.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Bellvitge University Hospital
Barcelona, Barcelona, 08907
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
Read the detailed description
Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Peristeen® Transanal irrigation system with the conic catheter, Standard reusable enema
- Keywords
- Rectal Cancer, LARS, Low Anterior Resection Syndrome, Transanal Irrigation
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristeen® Transanal irrigation system with the conic catheterDevice
The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference.
The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.
Standard reusable enemaDevice
The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference.
The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.
| Study group | Role | What they receive |
|---|---|---|
| High-volume TAI | Active comparator | This group will be instructed on High-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to Low-TAI treatment for 2 months. Receives: Device: Peristeen® Transanal irrigation system with the conic catheter; Device: Standard reusable enema |
| Low volume - TAI | Active comparator | This group will be instructed on Low-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to the Low-TAI treatment for 2 months. Receives: Device: Peristeen® Transanal irrigation system with the conic catheter; Device: Standard reusable enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS score
LARS score changes with treatments.
No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.
Measured: day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary outcomes (6)
Daily bowel movements number (total, day, and night)
Defecation habits change with treatments
Measured: recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)
Short Form 36 quality of live questionnaire (SF-36)
Quality of life changes with treatments.
Values between 0-100 (higher score means better outcome).
Measured: day 1st, 30th, 60th, 75th, 105th, and 135th.
Vaizey score
Fecal incontinence symptoms change with treatments.
Values between 0-24 (higher score means worse outcome).
Measured: day 1st, 30th, 60th, 75th, 105th, and 135th.
Satisfaction grade (VAS: 0-10).
Patients' satisfaction grade related with treatments
Measured: day 1st, 30th, 60th, 75th, 105th, and 135th.
Preferred treatments
What treatment is preferred by the patients after having tried both
Measured: day 135
Adverse effects related to both treatments.
Adverse effects and complication directly related with one of the two treatments.
Measured: day 1 to 135.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start4 Aug 2022
- Primary completion1 Nov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Española de Coloproctologia, Asociación Española de Cirugía
- Responsible party
- Principal investigator, Loris Trenti, Hospital Universitari de Bellvitge
- Investigators
- Loris Trenti, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245331
- Sponsor's protocol ID
- PR297/21
- Acronym
- HiLoV_TAI
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05245331
- Acronym / sponsor ID
- HiLoV_TAI / PR297/21
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Rectal Cancer, LARS, Low Anterior Resection Syndrome, Transanal Irrigation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Asociacion Española de Coloproctologia, Asociación Española de Cirugía
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Feb 2022 (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.
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
Detailed description
Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-volume TAI | Active comparator | Device: Peristeen® Transanal irrigation system with the conic catheter, Device: Standard reusable enemaThis group will be instructed on High-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to Low-TAI treatment for 2 months. |
| Low volume - TAI | Active comparator | Device: Peristeen® Transanal irrigation system with the conic catheter, Device: Standard reusable enemaThis group will be instructed on Low-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to the Low-TAI treatment for 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.
- Major LARS (score 30-42).
- At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.
- Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2.
Key exclusion criteria (13 listed)
- Side to end mechanical anastomosis or J-pouch colorectal anastomosis
- Partial or total intersphincteric resection.
- Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.
- Persona history of other colorectal, proctologic or pelvis surgery or disease.
- Personal history of bariatric surgery.
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® Transanal irrigation system with the conic catheterThe High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference. | Device | High-volume TAI, Low volume - TAI |
| Standard reusable enemaThe High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference. | Device | High-volume TAI, Low volume - TAI |
Primary outcome
LARS score
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.
6 secondary outcomes
Daily bowel movements number (total, day, and night)
Time frame: recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)
Short Form 36 quality of live questionnaire (SF-36)
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Vaizey score
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Satisfaction grade (VAS: 0-10).
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Preferred treatments
Time frame: day 135
Adverse effects related to both treatments.
Time frame: day 1 to 135.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- 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.
Loris Trenti, PhD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peristeen® Transanal irrigation system with the conic catheter and Standard reusable enema in people with Low Anterior Resection Syndrome, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
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: day 1st, 30th, 60th, 75th, 105th, and 135th.). 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 16 Sep 2025.