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Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia

RecruitingNAAges 18 Years - anyAllAlthaia Xarxa Assistencial Universitària de Manre…
NCT07632196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rectal neoplasia is one of the most prevalent cancers in Spain, and the treatment of choice is total mesorectal excision (TME), as it has demonstrated significant oncological improvements. However, mesorectal excision is not without complications, and patients often experience altered bowel function in the form of low anterior resection syndrome (LARS), as well as erectile dysfunction. However, few studies evaluate faecal incontinence, as most focus on oncological outcomes. The aim of our study is to evaluate the efficacy and safety of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who underwent to rectal surgery for rectal neoplasia. It will be conducted a randomized clinical trial (1:1) with two arms: half of the patients will receive posterior tibial nerve stimulation, while the other half will undergo stimulation with s

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📋 Eligibility rules (as published)
Inclusion Criteria: \- Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME). Exclusion Criteria: * Patients not operated or within active surveillance strategy programs (watch \& wait) * Patients with ostomy * Patients with contraindications to the use of the neurostimulator: * Pacemaker / Defibrillator / Other electronic devices * History of heart problems * Propensity to excessive bleeding (coagulopathies) * Damage to the nervous system (epilepsy) * Current pregnancy * Infections or skin lesions * Severe vascular disorders * Active neoplasms.
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What it tests

  • Posterior tibial nerve stimulation intervention group
  • Control group
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Where

2 sites
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Spain
Xarxa Assistencial Universitària de Manresa, Althaia
Manresa, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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