Colorectal Cancer Screnning Colonoscopy Under Hypnosis
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: Colonoscopy under hypnosis.
- Кому может быть актуально
- Состояния в реестре: Colorectal (Colon or Rectal) Cancer. Базовые параметры: 18 лет — 100 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
- Франция
- 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
Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
Обзор
Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated
Подробное описание
Colorectal cancer is the 3rd most common cancer. Colonoscopy, a screening examination, has led to an increase in patient survival. In more than 90% of cases, this examination is performed under general anesthesia (GA) because it is considered painful, even though several studies have shown its feasibility without GA with a good tolerance in 75% of cases. However, only 28% of patients accept the examination without GA because of great apprehension. GA entails an increased risk of complications but also additional costs. Thus, performing colonoscopies without GA would reduce risks and costs by 15 to 30%. In order to make the examination more acceptable and less anxiety-provoking, methods such as hypnosis have been tested with the result that pain and anxiety are reduced and the hemodynamic state of the patients is stabilized, thus reducing the examination time. To date, the majority of studies on hypnosis, of varying indications, are small, mono-centric and non-randomized.
The use of hypnosis for colorectal cancer screening colonoscopies would reduce patient anxiety, avoid complications related to GA and reduce the organizational constraints and costs related to GA.
Вмешательства
- Процедура Colonoscopy under hypnosis
The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
Первичные конечные точки
- Rate of complete colonoscopies [Срок оценки: The day of the colonoscopy, from the start to the end of the colonoscopy]
Вторичные конечные точки (8)
- Level of anxiety [Срок оценки: The day of the colonoscopy, before the exam]
- Level of pain [Срок оценки: During the consultation before the colonoscopy]
- Level of pain [Срок оценки: Up to 24 hours the day of colonoscopy]
- Duration of colonoscopy [Срок оценки: The day of colonoscopy from the start to the end of the exam]
- Rate of polyps resected [Срок оценки: The day of colonoscopy from the start to the end of the exam]
- Rate of complications [Срок оценки: To the day of the exam to 8 days after]
- Patient satisfaction [Срок оценки: Up to 24 hours the day of the colonoscopy]
- Medico economic criteria [Срок оценки: To the day of the exam to 3 months after]
Критерии участия
Критерии включения
- Patients 18 years of age or older
- Undergoing a screening colonoscopy (mass screening Fecal Immunochemical Test positive or as an individual (family history of colon cancer or adenoma, personal history of adenoma, cancer, chronic inflammatory bowel disease) or in the context of a transit disorder, hemorrhage or anemia
- Affiliated with a French social security system
- Having signed a written consent
Критерии исключения
- Patient requiring emergency colonoscopy
- History of colonic resection
- Carriers of behavioral disorders and/or psychiatric illness
- Limited cognitive abilities making it impossible to read or fill out a discrete choice questionnaire (language problems, comprehension problems)
- Contraindication to hypnosis, preventing quality interaction (comprehension and/or language problems, hearing impairment)
- Contraindication to general anesthesia
- Under a legal protection regime
- Pregnant or breastfeeding woman
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
- Диагностика
Центры проведения
Франция · 1 центр
- Chu Angers — Angers
Идентификаторы
NCT: NCT05051046 · DR200072