NCT05245331

Transanal Irrigation for Low Anterior Resection Syndrome.

High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).

Detailed description

Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.

Conditions

• Low Anterior Resection Syndrome

Interventions

Type	Name	Description
DEVICE	Peristeen® Transanal irrigation system with the conic catheter	The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.
DEVICE	Standard reusable enema	The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.

Timeline

• Start date: 2022-08-04
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2022-02-17
• Last updated: 2025-09-16

Locations

2 sites across 1 country: Spain