Sacral neuromodulation: Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
Study summary
A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (\<120 days after discharge following intestinal bypass reconstruction) with sacral nerve root neuromodulation, compared with another group receiving personalized conservative treatment as performed in routine clinical practice.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
To evaluate bowel function in terms of at least a 50% improvement in episodes of urgency and/or incontinence due to LARS, as measured by a two-week bowel diary, following early NMS implantation compared with personalized conservative treatment. — 6 months
Trial sites (1)
Facility
City
Region
Status
Vall d'Hebron Barcelona Hospital Campus
Barcelona
Catalonia
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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.
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