Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery

ConditionLow Anterior Resection Syndrome (LARS)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSimona Ascanelli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Neurological diseases

Psychiatric disorders

Refusal to consent to follow-up

Current or planned pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

Water-based transanal irrigation system
Device
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.

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Early TAI-treated groupExperimental treatment 1 intervention

Group B: Late TAI-treated groupOther 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Simona Ascanelli

Lead sponsor

University Hospital of Ferrara

Sponsor institution

Source ClinicalTrials.gov

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