Transanal Irrigation for Low Anterior Resection Syndrome.

NCT05245331 | Active Not Recruiting

• 1 other identifier: PR297/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Low Anterior Resection Syndrome

Keywords

Rectal Cancer; LARS; Low Anterior Resection Syndrome; Transanal Irrigation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• Short Form 36 quality of live questionnaire (SF-36)

  day 1st, 30th, 60th, 75th, 105th, and 135th.

• Vaizey score

  day 1st, 30th, 60th, 75th, 105th, and 135th.

• Satisfaction grade (VAS: 0-10).

  day 1st, 30th, 60th, 75th, 105th, and 135th.

• Preferred treatments

  day 135

Study Arms (2)

High-volume TAI

ACTIVE COMPARATOR

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; Device: Standard reusable enema

Low volume - TAI

ACTIVE COMPARATOR

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; Device: Standard reusable enema

Interventions

Peristeen® Transanal irrigation system with the conic catheter DEVICE

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.

High-volume TAI; Low volume - TAI

Standard reusable enema DEVICE

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.

High-volume TAI; Low volume - TAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Asociacion Española de Coloproctologia: collaborator
• Asociación Española de Cirugía: collaborator

Study Sites (2)

Bellvitge University Hospital

Barcelona, Barcelona, 08907, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Loris Trenti, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 17, 2022
• Study Start: August 4, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)