Video Tutorial and Oral Explanation Vs Oral Explanation Alone in Colonoscopy Preparation
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.
- Кому может быть актуально
- Состояния в реестре: Colonoscopy, Gastro-Intestinal Disorder. Базовые параметры: 18 лет — 80 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
Prospective Multicenter Randomized Trial Comparing Oral Explanation Alone and With Video Tutorial for Bowel Preparation Quality and Adenoma Detection
Обзор
Colonoscopy which is the standard examination for the exploration of the colon and rectum is performed very frequently. Colon preparation before the examination is an essential step and pescription of the colonic preparation is carried out by the gastroenterologist. However, despite a standardized explanation of the colon preparation, there is heterogeneity in understanding the colonic preparation, which in some cases compromises the quality of the colonoscopy examination. This clinical study aims to investigate whether an explanation of colonic preparation by tutorial films would increase the quality of colon preparation and would reach the recommendations of the Société française d'endoscopie digestive (SFED) in 2019.
Подробное описание
The quality of the colonic preparation is essential for the quality of the colonic examination: in one hand, a good preparation will allow the feasibility of the colonoscopy and will allow a complete examination. On the other hand, the presence of stercoral residues due to a bad colonic preparation reduces the sensitivity of the examination by hiding small lesions or with a very discreet relief. A poorer quality will also increase the length of the examination, which increase the risk of complications. However, in the literature, 20 to 30% of poor colonic preparation is found and 5% of colonoscopies are incomplete, including 42% due to poor preparation. The Pacôme survey, reveals that 6% of patients did not have prior consultation with the gastroenterologist. In addition, if 81% of patients were informed of the importance of the preparation, only 64% were aware of its practical modalities. Only 57% of patients were aware of the risks of inadequate preparation, despite the fact that doctors feel they have well informed their patients. It is also reported in "2 days of endoscopy 2008", that 8% of the information is given by someone other than the gastroenterologist himself. These data demonstrate that there is a heterogeneity in the explanatory content of the consultation prior to the colonoscopy examination. This can then explain the rate of poor quality colonic preparation and consequently the colonoscopy examination. The consultation must be a real therapeutic education and must be sufficiently informative to result in a colonic preparation of quality. We then hypothesize that an informative explanation in the form of a tutorial film would ensure homogeneous and standardized information between practitioners. In addition, the tutorial film will be available to be viewed at home several times by the patient, which may reduce the risk of misunderstanding.
Вмешательства
- Процедура Colonoscopy
The explanation of the colonic preparation will be done at home by film tutorial, before the colonic procedure or as usual, by the physician during a specific consultation before the colonic procedure but the quality of preparation will be evaluated by the boston score as usual.
Первичные конечные точки
- Assessment of the quality of the colonic preparation by the boston score for each groupe [Срок оценки: During the colonoscopy procedure]
Вторичные конечные точки (3)
- Detection rate of adenomas in each arm will be compared [Срок оценки: During the colonoscopy procedure]
- The rate of complete colonoscopy in each group [Срок оценки: During the colonoscopy procedure]
- Incidence of procedure- adverse events as assessed by complications reports [Срок оценки: From the colonoscopy procedure to one day after]
Критерии участия
Критерии включения
- Consecutive patients undergoing their first colonoscopy for gastrointestinal symptoms, family history of CRC or suspected CRC.
- Ability to use the internet and a link to a video.
- Life expectancy over three months.
- Patient ≥ 18 years old, requiring a colonoscopy procedure.
Критерии исключения
- Patient with any psychiatric or psychological disorder that does not allow them a properd understanding and follow-up of the study.
- Patient without internet access.
- Patient requiring a colonoscopy procedure in emergency
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 · 5 центров
- Saint Joseph Saint Luc Hospital, Lyon, RHONE-ALPES — Lyon
- Clinique De L'infirmerie Protestante 3 Chem. du Penthod 69300 Caluire-et-Cuire — Lyon
- Clinique du Val d'ouest 39 chemin de la Vernique 69130 Ecully — Lyon
- Clinique Médico-Chirurgicale Charcot 51 rue Commandant Charcot 69110 Sainte-Foy-lès-lyon — Lyon
- Les portes du sud 2 avenue du 11 novembre 1918 69200 Vénissieux — Lyon
Идентификаторы
NCT: NCT07355777 · PREPACO -TUTO