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NCT07761884
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Conditions: Low Anterior Resection Syndrome (LARS)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Location: Vall d'Hebron Barcelona Hospital Campus Barcelona Catalonia
Summary
A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (\
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07761884). StuddyBuddy aggregates publicly available trial information.