NCT07761884Not yet recruitingNot Applicable
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: a Randomized, Multicenter, Prospective, Open-label, Pragmatic Study.
Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country40 target enrollmentStarted: August 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sacral neuromodulation
Experimental
Intervention: Sacral neuromodulation (Device)
Personalized conservative treatment
No Intervention
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.(6 months)
- Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.(6 months)
- Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.(6 months)
- Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.(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(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(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(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".(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(6 months)
Investigators
Study Sites (1)
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