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Could a simple nerve stimulator fix bowel leakage after rectal cancer surgery?

NCT ID NCT07632196

Symptom relief Sponsor: Althaia Xarxa Assistencial Universitària de Manresa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a small nerve stimulator placed on the skin near the ankle can help people who have bowel leakage after rectal cancer surgery. Half of the 84 participants will use the active device at home, while the other half will use a sham device. Researchers will check bowel control, quality of life, and sexual function at 1, 6, and 12 months after surgery.

What this could mean

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

Active substance
Beurer EM-49 digital neurostimulator (transcutaneous posterior tibial nerve stimulation)
What this could lead to
If it works, this could offer a non-drug, at-home way to reduce bowel leakage and improve quality of life after rectal cancer surgery.
What could go wrong
This is a small, early-stage trial with only 84 people. The treatment may not work better than a placebo, and results may not apply to everyone.

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 84 people

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

Started

Feb 2026

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: \- Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME). Exclusion Criteria: * Patients not operated or within active surveillance strategy programs (watch \& wait) * Patients with ostomy * Patients with contraindications to the use of the neurostimulator: * Pacemaker / Defibrillator / Other electronic devices * History of heart problems * Propensity to excessive bleeding (coagulopathies) * Damage to the nervous system (epilepsy) * Current pregnancy * Infections or skin lesions * Severe vascular disorders * Active neoplasms.

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Conditions

The condition(s) this trial relates to.

Ejaculatory Dysfunction Fecal Incontinence Low Anterior Resection Syndrome rectal cancer rectal neoplasm

As listed by the trial registrant

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

Disorder of ejaculation Fecal incontinence (FI) Low anterior resection syndrome (LARS) Quality of life (QOL) Rectal neoplasm malignant

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Althaia Xarxa Assistencial Universitària de Manresa

    RECRUITING

    Manresa, Barcelona, 08243, Spain

  • Xarxa Assistencial Universitària de Manresa, Althaia

    RECRUITING

    Manresa, Barcelona, 08243, Spain

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