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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517853
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : November 29, 2019
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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

Condition or disease Intervention/treatment Phase
Colorectal Surgery Device: Posterior tibial nerve stimulation Device: Sham posterior tibial nerve stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official 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)
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : August 7, 2019

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



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517853


Locations
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Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Instituto de Salud Carlos III

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02517853    
Other Study ID Numbers: NETP-01-2014
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019