Spots Global Cancer Trial Database for Transanal Irrigation for Low Anterior Resection Syndrome.

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Trial Identification

Brief Title: Transanal Irrigation for Low Anterior Resection Syndrome.

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

Study ID: NCT05245331

Conditions

Low Anterior Resection Syndrome

Interventions

Peristeen® Transanal irrigation system with the conic catheter

Standard reusable enema

Study Description

Brief 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.