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Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery

NCT02177084 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-06-27

No results posted yet for this study

Summary

The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).

The secondary aims are the evaluation of the following parameters:

* Effect of PTNS on manometric parameters
* Effect of PTNS on quality of life
* Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation
* Safety of PTNS

Conditions

Interventions

DEVICE

PTNS

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02177084 on ClinicalTrials.gov