Colorectal SurgeryNCT02517853
Efficiency of Neurostimulation of Tibial Nerve in the Treatment of Low Anterior Resection Syndrome
A study testing Posterior tibial nerve stimulation in people with Colorectal Surgery, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Posterior tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2016to 7 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)
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:
- Control group- placebo
- Treatment group: neuroestimulation of the posterior tibial nerve
- Conditions
- Colorectal Surgery
- Being tested
- Posterior tibial nerve stimulation, Sham posterior tibial nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior tibial nerve stimulationDevice
Sham posterior tibial nerve stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Tibial nerve stimulation | Experimental | Tibial nerve stimulation during 16 sessions Receives: Device: Posterior tibial nerve stimulation |
| Sham comparator | Sham comparator | Sham tibial nerve stimulation during 16 sessions Receives: Device: Sham posterior tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial nerve stimulation efficacy measured by LARS score
Measured: 1 month
Tibial nerve stimulation efficacy measured by LARS score
Measured: 3 months
Tibial nerve stimulation efficacy measured by LARS score
Measured: 6 months
Tibial nerve stimulation efficacy measured by LARS score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start1 Feb 2016
- Primary completion6 Aug 2018
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517853
- Sponsor's protocol ID
- NETP-01-2014
- Status last verified
- Nov 2019
- First submitted
- 28 Jul 2015
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
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 41538382Marinello 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 38084933Marinello 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)
- ClinicalTrials.gov ID
- NCT02517853
- Acronym / sponsor ID
- NETP-01-2014
- Conditions
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Control group- placebo
- Treatment group: neuroestimulation of the posterior tibial nerve
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibial nerve stimulation | Experimental | Device: Posterior tibial nerve stimulationTibial nerve stimulation during 16 sessions |
| Sham comparator | Sham comparator | Device: Sham posterior tibial nerve stimulationSham tibial nerve stimulation during 16 sessions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior tibial nerve stimulation | Device | Tibial nerve stimulation |
| Sham posterior tibial nerve stimulation | Device | Sham comparator |
Primary outcome
Tibial nerve stimulation efficacy measured by LARS score
Time frame: 1 month
Tibial nerve stimulation efficacy measured by LARS score
Time frame: 3 months
Tibial nerve stimulation efficacy measured by LARS score
Time frame: 6 months
Tibial nerve stimulation efficacy measured by LARS score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Derived from this study: PubMed 41538382Marinello 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.
- Derived from this study: PubMed 38084933Marinello 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.
- Derived from this study: PubMed 33793754Marinello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior tibial nerve stimulation in people with Colorectal Surgery, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibial nerve stimulation efficacy measured by LARS score (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02517853, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.