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Transanal Irrigation for Low Anterior Resection Syndrome. (HiLoV_TAI)

Primary Purpose

Low Anterior Resection Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Peristeen® Transanal irrigation system with the conic catheter
Standard reusable enema
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Anterior Resection Syndrome focused on measuring Rectal Cancer, LARS, Low Anterior Resection Syndrome, Transanal Irrigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitari de BellvitgeRecruiting
  • Bellvitge University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High-volume TAI

Low volume - TAI

Arm 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.

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.

Outcomes

Primary Outcome Measures

LARS score
LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.

Secondary Outcome Measures

Daily bowel movements number (total, day, and night)
Defecation habits change with treatments
Short Form 36 quality of live questionnaire (SF-36)
Quality of life changes with treatments. Values between 0-100 (higher score means better outcome).
Vaizey score
Fecal incontinence symptoms change with treatments. Values between 0-24 (higher score means worse outcome).
Satisfaction grade (VAS: 0-10).
Patients' satisfaction grade related with treatments
Preferred treatments
What treatment is preferred by the patients after having tried both
Adverse effects related to both treatments.
Adverse effects and complication directly related with one of the two treatments.

Full Information

First Posted
January 7, 2022
Last Updated
October 3, 2023
Sponsor
Hospital Universitari de Bellvitge
Collaborators
Asociacion Española de Coloproctologia, Asociación Española de Cirugía
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1. Study Identification

Unique Protocol Identification Number
NCT05245331
Brief Title
Transanal Irrigation for Low Anterior Resection Syndrome.
Acronym
HiLoV_TAI
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
Asociacion Española de Coloproctologia, Asociación Española de Cirugía

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection Syndrome
Keywords
Rectal Cancer, LARS, Low Anterior Resection Syndrome, Transanal Irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-volume TAI
Arm Type
Active Comparator
Arm 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.
Arm Title
Low volume - TAI
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Peristeen® Transanal irrigation system with the conic catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard reusable enema
Intervention Description
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.
Primary Outcome Measure Information:
Title
LARS score
Description
LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.
Time Frame
day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary Outcome Measure Information:
Title
Daily bowel movements number (total, day, and night)
Description
Defecation habits change with treatments
Time Frame
recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)
Title
Short Form 36 quality of live questionnaire (SF-36)
Description
Quality of life changes with treatments. Values between 0-100 (higher score means better outcome).
Time Frame
day 1st, 30th, 60th, 75th, 105th, and 135th.
Title
Vaizey score
Description
Fecal incontinence symptoms change with treatments. Values between 0-24 (higher score means worse outcome).
Time Frame
day 1st, 30th, 60th, 75th, 105th, and 135th.
Title
Satisfaction grade (VAS: 0-10).
Description
Patients' satisfaction grade related with treatments
Time Frame
day 1st, 30th, 60th, 75th, 105th, and 135th.
Title
Preferred treatments
Description
What treatment is preferred by the patients after having tried both
Time Frame
day 135
Title
Adverse effects related to both treatments.
Description
Adverse effects and complication directly related with one of the two treatments.
Time Frame
day 1 to 135.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loris Trenti, PhD
Phone
+34 932607500
Ext
8107
Email
loris.trenti@bellvitgehospital.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loris Trenti, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loris Trenti, PhD
Phone
+34932607500
Ext
8107
Email
loris.trenti@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Alba Aramburu
Phone
+34695733675
Email
aaramburum@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Loris Trenti, PhD
Facility Name
Bellvitge University Hospital
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loris Trenti, MD
Phone
+34 932607500
Ext
8107
Email
loris.trenti@bellvitgehospital.cat

12. IPD Sharing Statement

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Transanal Irrigation for Low Anterior Resection Syndrome.

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