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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Colorectal Surgery

Treatments: Device: Sham posterior tibial nerve stimulation; Device: Posterior tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02517853

NETP-01-2014

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Tibial nerve stimulation

Experimental group

Description:

Tibial nerve stimulation during 16 sessions

Treatment:

Device: Posterior tibial nerve stimulation

Sham comparator

Sham Comparator group

Description:

Sham tibial nerve stimulation during 16 sessions

Treatment:

Device: Sham posterior tibial nerve stimulation