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.
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).
Metastatic disease at the time of surgery.
Need for adjuvant chemotherapy at the time of assessment.
Active chemotherapy.
Patients with an ileostomy.
Parallel
Sacral neuromodulation
DeviceSacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
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.
Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.
Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.
Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.
Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.
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