Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)

Hospital Universitari Vall d'Hebron Research Institute2 sites in 1 country41 target enrollmentFebruary 1, 2016

ConditionsColorectal Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Colorectal Surgery
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Enrollment: 41
Locations: 2
Primary Endpoint: Tibial nerve stimulation efficacy measured by LARS score
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

Control group- placebo
Treatment group: neuroestimulation of the posterior tibial nerve

Registry

clinicaltrials.gov

Start Date

February 1, 2016

End Date

August 7, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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