Transanal Irrigation for Low Anterior Resection Syndrome. (HiLoV_TAI)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Device: Peristeen® Transanal irrigation system with the conic catheter; Device: Standard reusable enema

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loris Trenti, PhD; Phone Number: 8107 +34 932607500; Email: loris.trenti@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona, Spain, 08907
    • Recruiting
    • Bellvitge University Hospital
    • Contact: Loris Trenti, MD; Phone Number: 8107 +34 932607500; Email: loris.trenti@bellvitgehospital.cat
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Loris Trenti, PhD; Phone Number: 8107 +34932607500; Email: loris.trenti@bellvitgehospital.cat
      • Contact: Alba Aramburu; Phone Number: +34695733675; Email: aaramburum@bellvitgehospital.cat
      • Principal Investigator: Loris Trenti, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High-volume TAI; 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.	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.
Active Comparator: Low volume - TAI; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Asociacion Española de Coloproctologia; Asociación Española de Cirugía
• Investigators: Principal Investigator: Loris Trenti, PhD

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rectal Cancer; Low Anterior Resection Syndrome; LARS; Transanal Irrigation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Low Anterior Resection Syndrome
• Other Study ID Numbers: PR297/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No