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

Colorectal Surgery Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517853
• Other study ID #: NETP-01-2014
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: August 7, 2019

Study information

• Verified date: November 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 7, 2019
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Device:
• Posterior tibial nerve stimulation

• Sham posterior tibial nerve stimulation

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tibial nerve stimulation efficacy measured by LARS score		1 month
Primary	Tibial nerve stimulation efficacy measured by LARS score		3 months
Primary	Tibial nerve stimulation efficacy measured by LARS score		6 months
Primary	Tibial nerve stimulation efficacy measured by LARS score		12 months