Low Anterior Resection Syndrome (LARS)EARLY-TAINCT07696689
Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery
A study testing Water-based transanal irrigation system in people with Low Anterior Resection Syndrome (LARS), run by Simona Ascanelli.
Trial summary
This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome (LARS)
- What is being tested?
- Water-based transanal irrigation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2029
- 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
- Adults aged ≥ 18 years
- Colorectal resection for rectal cancer with a protective ostomy
- Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure
- LARS score > 30 (major LARS)
- Not previously treated with TAI (except for enemas)
- Completion of training on TAI irrigation by trained medical/nursing staff
- Use of only the Peristeen® Plus device for TAI
- Written informed consent
Who cannot join
- Neurological diseases
- Psychiatric disorders
- Refusal to consent to follow-up
- Current or planned pregnancy
- Known allergy to latex
- Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Simona Ascanelli Ascanelli, MD, Department of Surgery contact
About this study
Official title: Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study
This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer.
The main question it aims to answer is:
Read more
"Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later.
The study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure.
Participants will:
- Undergo a preliminary visit to assess their eligibility to participate
- Undergo training to understand how to use the device correctly
- Perform regular TAI
- Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.
- Conditions
- Low Anterior Resection Syndrome (LARS)
- Being tested
- Water-based transanal irrigation system
- Keywords
- LARS, Trans-Anal Irrigation, Rectal Cancer, Low Anterior Resection Syndrome, Constipation, Bowel movements, Fecal incontinence, TAI, Peristeen Plus
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms, Constipation, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based transanal irrigation systemDevice
The procedure involves the introduction of water into the rectum and colon via the anus, which stimulates colonic reflex activity and acts as a mechanical bowel washout, thereby facilitating faecal evacuation. The device will deliver a controlled amount of warm water using a catheter - cone or balloon catheter - while sitting on the toilet. Once the desired amount of water has been introduced, the patient will expel the water and bowel contents. The procedure will take approximately 15-30 minutes, depending on the individual patient's response.
| Study group | Role | What they receive |
|---|---|---|
| Early TAI-treated group | Experimental | This arm will start trans-anal irrigation within 3 months after stoma closure Receives: Device: Water-based transanal irrigation system |
| Late TAI-treated group | Other | This arm will begin trans-anal irrigation between three and six months after stoma closure Receives: Device: Water-based transanal irrigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours.
The difference in the change from baseline (V0) in the number of bowel movements (i.e. defecations) in 24 hours at 3 months after stoma closure (V2) between the early TAI group and the late TAI-treated group.
Measured: From baseline to 3 months
Secondary outcomes (5)
Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up to 9 months).
The difference in the change from baseline (V0) in the number of bowel movements in 24 hours at 6 and 9 months (V3 and V4) after stoma closure between the early TAI group and the late TAI-treated group.
Measured: From baseline to 9 months
Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points).
The difference in the change from baseline (V0) in the Low Anterior Resection Syndrome (LARS) score (with a focus on the individual components of fecal urgency, incontinence, and incomplete evacuation) at various time points (V2, V3, V4) between the two groups (early TAI and late TAI-treated group). The LARS score ranges from 0 to 42 points. Patients are classified into one of three categories: no LARS (0-20 points), minor LARS (21-29 points) or major LARS (30-42 points).
Measured: From baseline to 9 months
Efficacy of early administration of TAI improving quality of life at all time points
Changes in quality of life (QoL) scores (across all domains of the Short Form-36 (SF-36) questionnaire) from baseline (V0) at all time points (V2, V3 and V4), and an evaluation of differences between the two groups. SF-36 scores for each domain range from 0 to 100, with higher scores indicating a more favourable health state.
Measured: From baseline to 9 months
Efficacy of early administration of TAI improving patient satisfaction at all time points
Change in patient satisfaction at all time points from baseline (V0) using a visual analogue scale (VAS), and evaluation of the differences between the two groups. The VAS consists of a 10 cm line with two endpoints representing 0 = completely unsatisfied and 10 = completely satisfied.
Measured: From baseline to 9 months
Evaluate how various factors, such as the timing of TAI initiation, type of anastomosis, prior neoadjuvant radio-chemotherapy, and other patient baseline characteristics, influence LARS symptoms
The variation in Low Anterior Resection Syndrome (LARS) scores in relation to factors such as the time at which TAI was initiated, the type of anastomosis, previous neoadjuvant radio-chemotherapy, and other baseline patient characteristics in the two groups was examined. The LARS score ranges from 0 to 42 points. Patients are classified into one of three categories: no LARS (0-20 points), minor LARS (21-29 points) or major LARS (30-42 points).
Measured: From baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (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 Syndrome (LARS)Studies 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
- Parallel groups
- Model description
- The study will compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours. The first regimen involves the initiation of TAI within three months from ostomy closure (early TAI group), while the second involves initiation of TAI between three and six months after ostomy closure (late TAI-treated group).
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simona Ascanelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simona Ascanelli, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696689
- Sponsor's protocol ID
- 703/2025/Sper/AOUFe
- Acronym
- EARLY-TAI
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study
- ClinicalTrials.gov ID
- NCT07696689
- Acronym / sponsor ID
- EARLY-TAI / 703/2025/Sper/AOUFe
- Conditions
- Low Anterior Resection Syndrome (LARS)
- Keywords
- LARS, Trans-Anal Irrigation, Rectal Cancer, Low Anterior Resection Syndrome, Constipation, Bowel movements, Fecal incontinence, TAI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Simona AscanelliUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 10 Jul 2026 (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.
This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer.
The main question it aims to answer is:
"Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later.
The study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure.
Participants will:
- Undergo a preliminary visit to assess their eligibility to participate
- Undergo training to understand how to use the device correctly
- Perform regular TAI
- Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours. The first regimen involves the initiation of TAI within three months from ostomy closure (early TAI group), while the second involves initiation of TAI between three and six months after ostomy closure (late TAI-treated group).
| Arm | Type | Receives |
|---|---|---|
| Early TAI-treated group | Experimental | Device: Water-based transanal irrigation systemThis arm will start trans-anal irrigation within 3 months after stoma closure |
| Late TAI-treated group | Other | Device: Water-based transanal irrigation systemThis arm will begin trans-anal irrigation between three and six months after stoma closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged ≥ 18 years
- Colorectal resection for rectal cancer with a protective ostomy
- Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure
- LARS score > 30 (major LARS)
- Not previously treated with TAI (except for enemas)
Key exclusion criteria (6 listed)
- Neurological diseases
- Psychiatric disorders
- Refusal to consent to follow-up
- Current or planned pregnancy
- Known allergy to latex
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 |
|---|---|---|
| Water-based transanal irrigation systemThe procedure involves the introduction of water into the rectum and colon via the anus, which stimulates colonic reflex activity and acts as a mechanical bowel washout, thereby facilitating faecal evacuation. The device will deliver a controlled amount of warm water using a catheter - cone or balloon catheter - while sitting on the toilet. Once the desired amount of water has been introduced, the patient will expel the water and bowel contents. The procedure will take approximately 15-30 minutes, depending on the individual patient's response. | Device | Early TAI-treated group, Late TAI-treated group |
Primary outcome
Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours.
Time frame: From baseline to 3 months
The difference in the change from baseline (V0) in the number of bowel movements (i.e. defecations) in 24 hours at 3 months after stoma closure (V2) between the early TAI group and the late TAI-treated group.
5 secondary outcomes
Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up to 9 months).
Time frame: From baseline to 9 months
Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points).
Time frame: From baseline to 9 months
Efficacy of early administration of TAI improving quality of life at all time points
Time frame: From baseline to 9 months
Efficacy of early administration of TAI improving patient satisfaction at all time points
Time frame: From baseline to 9 months
Evaluate how various factors, such as the timing of TAI initiation, type of anastomosis, prior neoadjuvant radio-chemotherapy, and other patient baseline characteristics, influence LARS symptoms
Time frame: From baseline to 9 months
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 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Low Anterior Resection Syndrome (LARS)
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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
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Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
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Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
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Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
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Recruiting
Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant
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.
Simona Ascanelli Ascanelli, MD, Department of Surgery contact
Questions about this trial
What is this clinical trial studying?
A study testing Water-based transanal irrigation system in people with Low Anterior Resection Syndrome (LARS), run by Simona Ascanelli.
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 6 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: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Simona Ascanelli Ascanelli, MD, Department of Surgery (+39 348 6909238, simona.ascanelli@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours. (time frame: From baseline to 3 months). 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 10 Jul 2026.