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Clinical Trials in Spain / NCT05245331
Active, not recruiting Not applicable

Transanal Irrigation for Low Anterior Resection Syndrome.

NCT05245331 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari de Bellvitge
Phase
Not applicable
Started
2022-08-04
Last updated
2025-09-16

Condition(s) studied

Low Anterior Resection Syndrome

Investigational drug(s) / intervention(s)

Peristeen® Transanal irrigation system with the conic catheterStandard reusable enema

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.

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.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • LARS score — 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.

Trial sites (2)

FacilityCityRegionStatus
Bellvitge University Hospital Barcelona Barcelona
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05245331 on ClinicalTrials.gov ↗ ← All trials in Spain