Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
NCT07761884 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-12
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.
Conditions
- Low Anterior Resection Syndrome (LARS)
Interventions
- DEVICE
-
Sacral neuromodulation
Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
Sponsors & Collaborators
-
Hospital Universitari Vall d'Hebron Research Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2029-08-31
- Completion
- 2030-02-28
Countries
- Spain
Study Locations
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