Efficiency of Neurostimulation of Tibial Nerve in the Treatment of Low Anterior Resection Syndrome

November 27, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tibial nerve stimulation
Tibial nerve stimulation during 16 sessions
Device: Posterior tibial nerve stimulation
Sham Comparator: Sham comparator
Sham tibial nerve stimulation during 16 sessions
Device: Sham posterior tibial nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tibial nerve stimulation efficacy measured by LARS score
Time Frame: 1 month
1 month
Tibial nerve stimulation efficacy measured by LARS score
Time Frame: 3 months
3 months
Tibial nerve stimulation efficacy measured by LARS score
Time Frame: 6 months
6 months
Tibial nerve stimulation efficacy measured by LARS score
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

August 6, 2018

Study Completion (Actual)

August 7, 2019

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NETP-01-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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