Posterior tibial nerve stimulation to help bowel function after rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares active posterior tibial nerve stimulation with a sham-like, subtherapeutic stimulation in adults who have undergone rectal cancer surgery. Outcomes focus on fecal incontinence, bowel function, sexual function, and overall quality of life. Participants are assigned 1:1 to the active or control arm, and symptoms are measured using LARS and Wexner scores. The study aims to determine safety and potential benefit of neuromodulation after rectal neoplasm surgery. Eligible participants include adults who had high anterior resection, while certain medical conditions or devices exclude participation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Althaia Xarxa Assistencial Universitària de Manresa
  Manresa, Barcelona, Spain Recruiting
• Xarxa Assistencial Universitària de Manresa, Althaia
  Manresa, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Meritxell Font
• Email: meritxell.fontprat@gmail.com
• Phone: +34 676131774

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.