Transanal Irrigation for Low Anterior Resection Syndrome.

Not Applicable

Recruiting

• Conditions: Low Anterior Resection Syndrome
• Interventions: Device: Peristeen® Transanal irrigation system with the conic catheter; Device: Standard reusable enema

• Registration Number: NCT05245331
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-17
• Study Start: 2022-08-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-11-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-volume TAI	Peristeen® Transanal irrigation system with the conic catheter	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.
High-volume TAI	Standard reusable enema	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.
Low volume - TAI	Standard reusable enema	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.
Low volume - TAI	Peristeen® Transanal irrigation system with the conic catheter	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.

Primary Outcome Measures

Name	Time	Method
LARS score	day 1st, 30th, 60th, 75th, 105th, and 135th.	LARS score changes with treatments.; No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.

Secondary Outcome Measures

Name	Time	Method
Daily bowel movements number (total, day, and night)	recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)	Defecation habits change with treatments
Adverse effects related to both treatments.	day 1 to 135.	Adverse effects and complication directly related with one of the two treatments.
Vaizey score	day 1st, 30th, 60th, 75th, 105th, and 135th.	Fecal incontinence symptoms change with treatments.; Values between 0-24 (higher score means worse outcome).
Short Form 36 quality of live questionnaire (SF-36)	day 1st, 30th, 60th, 75th, 105th, and 135th.	Quality of life changes with treatments.; Values between 0-100 (higher score means better outcome).
Satisfaction grade (VAS: 0-10).	day 1st, 30th, 60th, 75th, 105th, and 135th.	Patients' satisfaction grade related with treatments
Preferred treatments	day 135	What treatment is preferred by the patients after having tried both

Trial Locations

Locations (2)

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Bellvitge University Hospital; 🇪🇸 Barcelona, Spain