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

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

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

Treatments tested in this trial

  • Water-based transanal irrigation system

Treatment groups

250 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Simona Ascanelli

Lead sponsor

University Hospital of Ferrara

Sponsor institution