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OpenTrials
Completed

NCT Number: NCT02517853

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

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

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Key information

Conditions

Colorectal Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior tibial nerve stimulation

Device

Sham posterior tibial nerve stimulation

Device

Primary outcomes

  1. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 1 month

  2. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 3 months

  3. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 6 months

  4. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 7, 2015
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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