Colorectal Surgery
Conditions
Brief summary
The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior Tibial Nerve for the treatment of this syndrome. A multicentric, prospective, randomized study will be performed in patients affected with severe LARS symptoms. Patients will be randomized in two groups: 1. Control group- placebo 2. Treatment group: neuroestimulation of the posterior tibial nerve
Interventions
DEVICESham posterior tibial nerve stimulation
Sponsors
Instituto de Salud Carlos III
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 and under 75 years who have been undergone anterior resection of the rectum with sphincter preservation for rectal cancer * Patients with LARS score \> 29
Exclusion criteria
* Patient with intestinal inflammatory disease * Patients with known irritable colon disease * Pregnancy patients * Patients with others intestinal resection segments different from the rectum * Patients with metastatic disease * Patient with previous history of posterior tibial neurostimulation or sacral nerve stimulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tibial nerve stimulation efficacy measured by LARS score | 1 month |
Countries
Spain
Outcome results
None listed