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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2019-08-07

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tibial nerve stimulation

Tibial nerve stimulation during 16 sessions

Group Type EXPERIMENTAL

Posterior tibial nerve stimulation

Intervention Type DEVICE

Sham comparator

Sham tibial nerve stimulation during 16 sessions

Group Type SHAM_COMPARATOR

Sham posterior tibial nerve stimulation

Intervention Type DEVICE

Interventions

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Posterior tibial nerve stimulation

Intervention Type DEVICE

Sham posterior tibial nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No