An interventional study of Water-based transanal irrigation system in Low Anterior Resection Syndrome (LARS), sponsored by Simona Ascanelli. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Simona Ascanelli · Not applicable, Interventional, and Treatment
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:
82 studies on the registry are indexed under Low Anterior Resection Syndrome; 38 are open to participants now.
This study's planned enrollment of 250 is above the median of 72 across 56 interventional studies indexed under Low Anterior Resection Syndrome.
Browse Low Anterior Resection Syndrome studies →This is the only study on the registry with Simona Ascanelli as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will start trans-anal irrigation within 3 months after stoma closure
Device: Water-based transanal irrigation system
This arm will begin trans-anal irrigation between three and six months after stoma closure
Device: Water-based transanal irrigation system
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.
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.
Time frame: From baseline to 3 months
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.
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).
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).
Time frame: 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.
Time frame: 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.
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
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).
Time frame: From baseline to 9 months
Safety and tolerability
Evaluation of the frequency and severity of adverse events (AEs), serious adverse events (SAEs), devicerelated adverse events (ADEs) and serious device-related adverse events (SADEs) in the two groups
Time frame: From baseline to 9 months
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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