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

Not Applicable

Completed

• Conditions: Colorectal Surgery
• Interventions: Device: Sham posterior tibial nerve stimulation; Device: Posterior tibial nerve stimulation

• Registration Number: NCT02517853
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-07
• Study Start: 2016-02-01
• Primary Completion: 2018-08-06
• Study Completion: 2019-08-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham comparator	Sham posterior tibial nerve stimulation	Sham tibial nerve stimulation during 16 sessions
Tibial nerve stimulation	Posterior tibial nerve stimulation	Tibial nerve stimulation during 16 sessions

Primary Outcome Measures

Name	Time	Method
Tibial nerve stimulation efficacy measured by LARS score	12 months

Trial Locations

Locations (2)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain