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Can water irrigation ease Post-Cancer bowel troubles?

NCT ID NCT05245331

Symptom relief Sponsor: Hospital Universitari de Bellvitge Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two types of water enemas to help people with bowel leakage and urgency after rectal cancer surgery. Twenty participants will try both a high-volume system and a standard low-volume enema to see which works better. The goal is to improve quality of life and reduce bowel symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peristeen® Transanal irrigation system (high-volume) and standard 250ml water enema (low-volume)
What this could lead to
If it works, this could point toward a better way to manage bowel leakage and urgency after rectal cancer surgery.
What could go wrong
This is a very small early study with only 20 people. Results may not apply to everyone, and the benefit over standard care is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Low Anterior Resection Syndrome rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low anterior resection syndrome

Contacts and locations

Locations

  • Bellvitge University Hospital

    Barcelona, Barcelona, 08907, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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