Transanal Irrigation for Low Anterior Resection Syndrome.

Last updated: October 3, 2023
Sponsor: Hospital Universitari de Bellvitge
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard reusable enema

Peristeen® Transanal irrigation system with the conic catheter

Clinical Study ID

NCT05245331
PR297/21
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Personal history of LAR or ultra-LAR with total mesorectal excision (TME) andsphincter preservation with stapled or manual end to end anastomosis for primaryrectal 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

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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Standard reusable enema
Phase:
Study Start date:
August 04, 2022
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • Hospital Universitari de Bellvitge

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Bellvitge University Hospital

    Barcelona, 08907
    Spain

    Active - Recruiting

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