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CompletedNCT02517853Updated Nov 29, 2019

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

An interventional study of Posterior tibial nerve stimulation and Sham posterior tibial nerve stimulation in Colorectal Surgery, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 2 sites in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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
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Conditions studied

  • Colorectal Surgery
03

In context

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 275 studies on the registry; 63 are open to participants now.

Browse Hospital Universitari Vall d'Hebron Research Institute studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Tibial nerve stimulation

    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

  • DevicePosterior tibial nerve stimulation
  • DeviceSham posterior tibial nerve stimulation
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What researchers measure

Primary outcomes

  1. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 1 month

  2. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 3 months

  3. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 6 months

  4. Tibial nerve stimulation efficacy measured by LARS score

    Time frame: 12 months

07

Study locations

2 sites
  • Hospital Universitari de Bellvitge
    L'Hospitalet de Llobregat, Barcelona 08907, Spain
  • Hospital Vall d'Hebron
    Barcelona, 08035, Spain
08

References and documents

Publications

  • 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. PubMed 41538382 ↗
  • 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. PubMed 38084933 ↗
  • 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. PubMed 33793754 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02517853
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Instituto de Salud Carlos III
Responsible party
Sponsor
First posted
Aug 7, 2015
Start date
Feb 1, 2016
Primary completion
Aug 6, 2018
Completion
Aug 7, 2019
Last update
Nov 29, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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