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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07761884). StuddyBuddy aggregates publicly available trial information.