Can a nerve pacemaker tame Post-Cancer bowel chaos?
NCT ID NCT07761884
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether implanting a sacral neuromodulation device soon after rectal cancer surgery can reduce severe bowel urgency and incontinence, known as low anterior resection syndrome (LARS). Half of the participants receive the device within 120 days of surgery, while the other half gets standard conservative care. The goal is to see if early nerve stimulation improves bowel control and daily life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sacral neuromodulation, a device that sends mild electrical pulses to the sacral nerves to help control bowel function
- What this could lead to
- If effective, early sacral neuromodulation could offer a new way to reduce severe bowel urgency and incontinence after rectal cancer surgery, improving quality of life.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The device requires surgery and carries risks like infection or lead migration, and not all patients may respond.
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
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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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 (18 years of age or older) who are capable of signing the appropriate informed consent form. * Patients who have undergone an anterior rectal resection for rectal cancer, with an anastomosis, whether or not they have received neoadjuvant therapy, and who have bowel function, either via a direct anastomosis or following reconstruction of a lateral ileostomy. * Patients who experience more than 6 episodes of urgency and/or incontinence in the following two weeks after the screening visit, as recorded in a daily bowel diary. * Patients with a LARS score \>21 points (major or minor LARS). * Patients who report at least one symptom and one consequence as defined by the international definition. Exclusion Criteria: * Metastatic disease at the time of surgery. * Need for adjuvant chemotherapy at the time of assessment. * Active chemotherapy. * Patients with an ileostomy. * Intellectual or language-related difficulty in answering the questionnaires. * Refusal to participate in the study or failure to commit to follow-up visits. * Patients with contraindications for sacral neuromodulation implantation (those with pacemakers, active infections, or allergies to prosthetic materials). * Patients with active inflammatory bowel disease at the time of surgery. * Patients who have undergone other intestinal resections in addition to rectal resection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Vall d'Hebron Barcelona Hospital Campus
Barcelona, Catalonia, 08035, Spain
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