Идёт набор NCT05368168

Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome

Без фазы С лечением Rectal Disorders Low Anterior Resection Syndrome Low Anterior Resection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Posterior tibial nerve stimulation (PTNS).
Кому может быть актуально: Состояния в реестре: Rectal Disorders, Low Anterior Resection Syndrome, Low Anterior Resection. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum, associated with neoadjuvant radiochemotherapy. Surgical resections with sphincter preservation are frequently (60% of cases) associated with problems related to intestinal and defecatory function, which together are called Anterior Resection Syndrome (ARS) with varying degrees of severity. Among the different treatments the investigators find posterior tibial nerve stimulation, a simple and non-invasive technique, which is currently used. The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome (LARS) and therefore on the quality of life of patients undergoing this type of intervention. Therefore, treatment with PNTS is currently established for the management of LARS symptoms. Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome, the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS. It is also an intervention with a low rate of side effects, the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment. The investigators´ hypothesis is: Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer.

Вмешательства

Устройство Posterior tibial nerve stimulation (PTNS)
Posterior tibial nerve neurostimulation in postoperative patients treated for rectal neoplasms for 6 weeks at a rate of 2 sessions per week (12 sessions). The sessions will be carried out by the nursing staff of the anorectal functional testing cabinet. The sessions will begin 3 weeks after hospital discharge for patients without lateral ileostomy and after ileostomy closure for patients with lateral ileostomy.

Первичные конечные точки

Efficacy of PTNS (Posterior Tibial Nerve Stimulation) treatment on the incidence and duration of RAS symptoms in patients undergoing anterior rectal resection with sphincter-sparing surgery. [Срок оценки: 12 months]
Impact of PTNS on the quality of life (EORTC-QLQ C30) [Срок оценки: 12 months]

Вторичные конечные точки (2)

LARS Scale [Срок оценки: 12 months]
Impact of PTNS on the quality of life (EORTC-QLQ C29) [Срок оценки: 12 months]

Критерии участия

Критерии включения

Patients undergoing elective surgery (scheduled, non-urgent) who underwent anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at the Hospital Álvaro Cunqueiro in Vigo after the start date of the study.
Anastomotic tightness (absence of dehiscence).
Patients older than 18 years old.
Acceptance to participate in the study.