Clinical Trial

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

Study acronym: EARLY-TAI
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07696689
Lead Sponsor Simona Ascanelli
Conditions Low Anterior Resection Syndrome (LARS)
Enrollment 250 participants
Start Date 2026-09
Primary Completion 2028-12 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-10