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Набор скоро начнётся NCT07696689

Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery

Без фазы С лечением Low Anterior Resection Syndrome (LARS)

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: Water-based transanal irrigation system.
Кому может быть актуально
Состояния в реестре: Low Anterior Resection Syndrome (LARS). 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study

Обзор

This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer. The main question it aims to answer is: "Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later. The study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure. Participants will: * Undergo a preliminary visit to assess their eligibility to participate * Undergo training to understand how to use the device correctly * Perform regular TAI * Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.

Вмешательства

  • Устройство Water-based transanal irrigation system
    The procedure involves the introduction of water into the rectum and colon via the anus, which stimulates colonic reflex activity and acts as a mechanical bowel washout, thereby facilitating faecal evacuation. The device will deliver a controlled amount of warm water using a catheter - cone or balloon catheter - while sitting on the toilet. Once the desired amount of water has been introduced, the patient will expel the water and bowel contents. The procedure will take approximately 15-30 minute

Первичные конечные точки

  • Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours. [Срок оценки: From baseline to 3 months]
Вторичные конечные точки (5)
  • Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up to 9 months). [Срок оценки: From baseline to 9 months]
  • Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points). [Срок оценки: From baseline to 9 months]
  • Efficacy of early administration of TAI improving quality of life at all time points [Срок оценки: From baseline to 9 months]
  • Efficacy of early administration of TAI improving patient satisfaction at all time points [Срок оценки: From baseline to 9 months]
  • Evaluate how various factors, such as the timing of TAI initiation, type of anastomosis, prior neoadjuvant radio-chemotherapy, and other patient baseline characteristics, influence LARS symptoms [Срок оценки: From baseline to 9 months]

Критерии участия

Критерии включения

  • Adults aged ≥ 18 years
  • Colorectal resection for rectal cancer with a protective ostomy
  • Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure
  • LARS score > 30 (major LARS)
  • Not previously treated with TAI (except for enemas)
  • Completion of training on TAI irrigation by trained medical/nursing staff
  • Use of only the Peristeen® Plus device for TAI
  • Written informed consent

Критерии исключения

  • Neurological diseases
  • Psychiatric disorders
  • Refusal to consent to follow-up
  • Current or planned pregnancy
  • Known allergy to latex
  • Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07696689 · 703/2025/Sper/AOUFe

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗