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Enema program may ease bowel troubles after rectal cancer surgery

NCT ID NCT06424522

Symptom relief Sponsor: Ohio State University Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a bowel management program that includes a retrograde rectal enema (RRE) against standard medical care (fiber, loperamide, pelvic floor therapy) for people with low anterior resection syndrome (LARS) after rectal cancer surgery. Researchers will enroll 80 adults with moderate to severe LARS who haven't improved with standard treatment. The goal is to see if adding the enema program better controls symptoms like fecal urgency, incontinence, and constipation.

What this could mean

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

Active substance
retrograde rectal enema (RRE)
What this could lead to
If successful, this could offer a more effective way to manage bowel symptoms like urgency and incontinence after rectal cancer surgery.
What could go wrong
This is a small, early-stage trial with only 80 participants, so results may not apply to everyone. The enema procedure may be uncomfortable or not work for some patients.

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 80 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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: * Age ≥ 18 years old * Moderate to Severe LARS diagnosis * Patients with history of rectal cancer that was treated with proctectomy * Has undergone standard medical management without improvement of symptoms for 3-6 months Exclusion Criteria: * Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit * Patients with any chemo or radiation therapy in the last 6 months * Patients who currently have colorectal cancer * Patients with recurrent colorectal cancer * Patients who have undergone a colorectal surgical procedure within the last three months * Patients with progressive neurological disease * Patients with active or recurrent sacral infection * Patients \< 18 years old * Active sacral nerve simulator * Pregnant or planning to become pregnant during the treatment portion of the study * Altered mental status or mental disability that would alter ability to self-administer enema * Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)

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Conditions

The condition(s) this trial relates to.

Low Anterior Resection Syndrome rectal carcinoma rectal neoplasm

As listed by the trial registrant

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

Low anterior resection syndrome Rectal carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

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