Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial nerve stimulation | Experimental | Tibial nerve stimulation during 16 sessions |
|
| Sham comparator | Sham Comparator | Sham tibial nerve stimulation during 16 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior tibial nerve stimulation | Device |
| ||
| Sham posterior tibial nerve stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Hospital Vall d'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41538382 | Derived | 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. | |
| 38084933 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| Barcelona |
| 08035 |
| Spain |
| Derived |
| 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. |
| 33793754 | Derived | 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. |