Spots Global Cancer Trial Database for Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome
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Trial Identification
Brief Title: Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome
Official Title: Prospective Randomized Cross-over Trial to Assess the Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome. SANLARS Trial (SAcral Neuromodulation for Low Anterior Resection Syndrome)
Study ID: NCT03598231
Interventions
Study Description
Brief Summary: Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo rectal resection mainly due to rectal cancer. It is characterized by fecal incontinence, fragmented defecation, constipation, defecatory urgency among others, which induce an impairment in quality of life. LARS treatment armamentarium is scarce and with no long-term relief, being a difficult challenge for surgeons. There is evidence showing that sacral neuromodulation (SNM) improves patients' symptoms and quality of life. However, no prospective randomized studies have supported this improvement. This is a prospective randomized cross-over study which evaluates the effectiveness of SNM in LARS, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Universitari Vall d'Hebrón Research Institute, Barcelona, , Spain
Contact Details
Name: Franco Marinello, MD, PhD
Affiliation: Hospital Universitari Vall d'Hebrón
Role: PRINCIPAL_INVESTIGATOR
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