NCT02517853

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. 1.Control group- placebo
  2. 2.Treatment group: neuroestimulation of the posterior tibial nerve

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

2.5 years

First QC Date

July 28, 2015

Last Update Submit

November 27, 2019

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (4)

  • Tibial nerve stimulation efficacy measured by LARS score

    1 month

  • Tibial nerve stimulation efficacy measured by LARS score

    3 months

  • Tibial nerve stimulation efficacy measured by LARS score

    6 months

  • Tibial nerve stimulation efficacy measured by LARS score

    12 months

Study Arms (2)

Tibial nerve stimulation

EXPERIMENTAL

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

Interventions

Posterior tibial nerve stimulationDEVICE
Tibial nerve stimulation
Sham posterior tibial nerve stimulationDEVICE
Sham comparator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (3)

  • Marinello F, Planellas P, Fraccalvieri D, Ortega-Torrecilla N, Gil J, Kreisler E, Pellino G, Espin-Basany E. Exploratory Analysis of Urinary and Sexual Dysfunction in Patients With Low Anterior Resection Syndrome Undergoing Sacral Neuromodulation: Insights From the SANLARS Trial. Dis Colon Rectum. 2026 Feb 1;69(2):226-234. doi: 10.1097/DCR.0000000000004050. Epub 2025 Nov 18.

    PMID: 41538382DERIVED

  • Marinello F, Fraccalvieri D, Planellas P, Adell Trape M, Gil JM, Kreisler E, Pellino G, Espin-Basany E. Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: The SANLARS Randomized Clinical Trial. Dis Colon Rectum. 2024 Mar 1;67(3):435-447. doi: 10.1097/DCR.0000000000003143. Epub 2023 Dec 11.

    PMID: 38084933DERIVED

  • Marinello FG, Jimenez LM, Talavera E, Fraccalvieri D, Alberti P, Ostiz F, Frago R, Blanco A, Pellino G, Espin-Basany E. Percutaneous tibial nerve stimulation in patients with severe low anterior resection syndrome: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):380-387. doi: 10.1093/bjs/znaa171.

    PMID: 33793754DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 7, 2015

Study Start

February 1, 2016

Primary Completion

August 6, 2018

Study Completion

August 7, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations

ES(2)