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

NCT07696689 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-07-10

No results posted yet for this study

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.

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.

Conditions

  • Low Anterior Resection Syndrome (LARS)

Interventions

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.

Sponsors & Collaborators

  • Simona Ascanelli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-12-31
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696689 on ClinicalTrials.gov