Меню
Идёт набор NCT06082648

Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors

Без фазы С лечением Rectal Neoplasms

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: Transcranial magnetic stimulation, Sham Transcranial magnetic stimulationt.
Кому может быть актуально
Состояния в реестре: Rectal Neoplasms. Базовые параметры: 18 лет — 75 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors

Обзор

To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the "new" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.

Подробное описание

This study is a Single-center Phase II, Open, Three-Arm clinical trial. We prospectively enroll patients who undergo ISR for ultra-low rectal tumor in the department of General Surgery, Huashan Hospital, Fudan University. Patients with ileostomy closure are randomly divided into two groups (TMS group and false stimulation group), and healthy volunteers were recruited. The differences of task-state fMRI between healthy volunteers, and ISR patients (both preoperative and postoperative) are compared, combined with rectal function scores (Wexner score, LARS score) and quality of life scale (EORTC QLQ-C30, EORTC QLQ-CR38). Proctoanal manometry are used to find the precise location of the proctoanal motor function area in the cerebral cortex, and to evaluate the effect and value of TMS on postoperative anorectal motor function remodeling in patients with ISR.

Вмешательства

  • Устройство Transcranial magnetic stimulation
    The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla.Stimulation group: Intermittentpulse transcranial magnetic stimulation (iTBS) will be performed with : the cluster consists of 3 pulses, the intra-cluster frequency is 50Hz, the intercluster frequency is 5Hz, the interval is 8.2s for every stimulus. There
  • Устройство Sham Transcranial magnetic stimulationt
    The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla. Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation gr

Первичные конечные точки

  • The differences of cortical activated areas in task-state fMRI in ISR patients. [Срок оценки: pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.]
  • The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients. [Срок оценки: 12 month after ileostomy closure。]
  • Rectal function scores (Wexner score) [Срок оценки: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
  • Rectal function scores (LARS score) [Срок оценки: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
  • Quality of life Scale (EORTC QLQ-C30) [Срок оценки: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
  • Quality of life Scale (EORTC QLQ-CR38) [Срок оценки: pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.]
Вторичные конечные точки (1)
  • Proctoanal manometry [Срок оценки: pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.]

Критерии участия

Критерии включения

  • Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.
  • Patient who is willing to participate in the study, and voluntarily sign informed consent.

Критерии исключения

  • Anastomotic leakage or other serious complications occur after surgery.
  • Advanced tumor, tumor recurrence or metastasis.
  • Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.
  • Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.
  • Combined with organic brain disease and drug abuse history.
  • Combined with other mental diseases.
  • Pregnant or lactating women.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT06082648 · KY2023-087

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗