Transanal Irrigation for Low Anterior Resection Syndrome. (HiLoV_TAI)

Catalan Institute of Health

Status: Active, not recruiting

Conditions: Low Anterior Resection Syndrome

Treatments: Device: Standard reusable enema; Device: Peristeen® Transanal irrigation system with the conic catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05245331

PR297/21

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.
• Major LARS (score 30-42).
• At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.
• Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2.
• Age≥ 18 years

Exclusion criteria

• Side to end mechanical anastomosis or J-pouch colorectal anastomosis
• Partial or total intersphincteric resection.
• Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.
• Persona history of other colorectal, proctologic or pelvis surgery or disease.
• Personal history of bariatric surgery.
• Functioning sacral neurostimulator carriers.
• Previous use of transanal irrigation systems for LARS treatment
• Presence of an ostomy.
• Local or distant rectal cancer recurrence and/or any other active neoplastic disease.
• Altered cognitive status.
• Pregnancy and age < 18 years
• Any other diseases that may alter results of the study.
• Refusal to sign the informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

High-volume TAI

Active Comparator group

Description:

This group will be instructed on High-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to Low-TAI treatment for 2 months.

Treatment:

Device: Peristeen® Transanal irrigation system with the conic catheter

Device: Standard reusable enema

Low volume - TAI

Active Comparator group

Description:

This group will be instructed on Low-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to the Low-TAI treatment for 2 months.

Treatment:

Device: Peristeen® Transanal irrigation system with the conic catheter

Device: Standard reusable enema