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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
Vall d'Hebron Barcelona Hospital Campus
Barcelona, Catalonia, Spain
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.
Time frame: 6 months
Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.
Time frame: 6 months
Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.
Time frame: 6 months
Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.
Time frame: 6 months
Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.
Time frame: 6 months
Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the LARS score (Low Anterior Resection Syndrome Score), which divides patients in three groups: 0-20 No LARS; 21-29: Mild LARS; 30-42: Severe
Time frame: 6 months
Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the Vaizey score, which measures the presence and severity of incontinence assigning a score from 0 (meaning complete continence) to 24 (mean
Time frame: 5 years
Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: ad hoc scale. The minimum value for the scale is 0 (meaning the worst health the patient can imagine) and the maximum value is 100 (meaning t
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Time frame: 6 months
Analyze subjective clinical improvement as assessed by patients using PGI-I scale (Patient Global Impression of Improvement). It consists of the answer to a question choosing one of 7 options from "1=Much better" to "7=Much worst".
Time frame: 6 months
Examine changes in urinary and sexual function, analyzed by gender and specific scale. For male, the IIEF-5 (Índice Internacional De Función Erectil) will be used, which assesses erectile dysfunction from 5 (severe) to 25 (healthy). For female, The Rec
Time frame: 6 months