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NCT Number: NCT05245331

Transanal Irrigation for Low Anterior Resection Syndrome.

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bellvitge University Hospital, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. LARS score

    Time frame: 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 outcomes

  1. Daily bowel movements number (total, day, and night)

    Time frame: recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)

    Defecation habits change with treatments

  2. Short Form 36 quality of live questionnaire (SF-36)

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

    Quality of life changes with treatments.

    Values between 0-100 (higher score means better outcome).

  3. Vaizey score

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

    Fecal incontinence symptoms change with treatments.

    Values between 0-24 (higher score means worse outcome).

  4. Satisfaction grade (VAS: 0-10).

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

    Patients' satisfaction grade related with treatments

  5. Preferred treatments

    Time frame: day 135

    What treatment is preferred by the patients after having tried both

  6. Adverse effects related to both treatments.

    Time frame: day 1 to 135.

    Adverse effects and complication directly related with one of the two treatments.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Asociacion Española de Coloproctologia
  • Asociación Española de Cirugía

Registry information

Official study title

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

Acronym: HiLoV_TAI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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