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

Официальное название

Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia

Обзор

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 subtherapeutic doses. Faecal incontinence will be assessed using the LARS and Wexner questionnaires, and quality of life and sexual function will be assessed using the Fecal Incontinence Quality of Life Scale (FIQLS) and the Colorectal Cancer Quality of Life Questionnaire (QLQ-CR38), at one month, six months and one year after surgery.

Вмешательства

• Устройство Posterior tibial nerve stimulation intervention group
  In the intervention group, Beurer EM-49 digital neurostimulator will be used, with CE marking, and a dose of 20 Hertz (Hz) - 200 microseconds (μs) will be applied. As the control group and the intervention group, the pelvic floor rehabilitator will program the neurostimulator for each case and then they will be trained on how to perform the neurostimulation. The first session will be carried out with the rehabilitator to learn how it works and resolve doubts about its use, and later the sessio
• Устройство Control group
  In the intervention group, Beurer EM-49 digital neurostimulator will be used, with CE marking; and a dose of 80 Hertz (Hz) - 150 microseconds (μs) will be applied. As the control group and the intervention group, the pelvic floor rehabilitator will program the neurostimulator for each case and then they will be trained on how to perform the neurostimulation. In order to apply the therapy, the patient must sit down for the placement of the electrodes. It will be performed on 2 feet at the same

Первичные конечные точки

• Faecal incontinence (FI) - LARS 1st month [Срок оценки: 1st month post-surgery]
• Faecal incontinence (FI) - LARS 6th month [Срок оценки: 6th month post-surgery]
• Faecal incontinence (FI) - LARS 12th month [Срок оценки: 12th month post-surgery]
• Feacal incontinence (FI) - Wexner 1st month [Срок оценки: 1st month post-surgery]
• Faecal incontinence (FI) - Wexner 6th month [Срок оценки: 6th month post-surgery]
• Faecal incontinece (FI) - Wexner 12th month [Срок оценки: 12th month post-surgery]

Вторичные конечные точки (10)

• Sexual impairment 1st month [Срок оценки: 1st month post-surgery]
• Sexual impairment - 6th month [Срок оценки: 6th month post-surgery]
• Sexual impairment - 12th month [Срок оценки: 12th month post-surgery]
• Quality of life (QoL) - FIQLS 1st month [Срок оценки: 1st month post-surgery]
• Quality of life (QoL) - FIQLS 6th month [Срок оценки: 6th month post-surgery]
• Quality of life (QoL) - FIQLS 12th month [Срок оценки: 12th month post-surgery]
• Quality of life (QoL) - QLQ-CR 38 1st month [Срок оценки: 1st month]
• Quality of life (QoL) - QLQ-CR38 6th month [Срок оценки: 6th month post-surgery]
• Quality of life (QoL) - QLQ-CR38 12th month [Срок оценки: 12th month post-surgery]
• Patient global impression of improvement (PGI-I) [Срок оценки: 1 year]

Критерии участия

Критерии включения

\- 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Althaia Xarxa Assistencial Universitària de Manresa — Manresa
• Xarxa Assistencial Universitària de Manresa, Althaia — Manresa

Идентификаторы

NCT: NCT07632196 · CEIm 25/080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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