Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).

Официальное название

A Single-blind, Randomized Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).

Обзор

Low-residue diet (LRD) in patient improves the quality of the colon cleanliness and thus the adenoma detection rate (ADR). This is a key criterion in colonoscopy screening for colorectal cancer (CRC). The benefit of an LRD lasting more than 24 hours before colonoscopy has not been demonstrated compared to a 24-hour LRD. Few studies have evaluated the benefit of a prepackaged 24-hour LRD compared to simply receiving oral and written LRD instructions during a consultation. The aim of the study is to evaluate the usefulness of a prepackaged LRD (Colobox®) compared to simple LRD instructions on colon cleanliness (Boston score) in patients examined by endoscopy.

Вмешательства

• Процедура Colonoscopy
  Colonoscopy performed and Boston score evaluated
• Другое Questionnaires
  LRD satisfaction questionnaire LRD compliance questionnaire
• Другое Pre-colonoscopy diet according to the investigator's oral instructions
  24 hours before the colonoscopy, The patients follow a special diet, either by themselves according to the investigator's oral instructions
• Другое Pre-colonoscopy diet by following a special preparation, Colobox.
  24 hours before the colonoscopy, The patients follow a special diet, by following a special preparation, Colobox.

Первичные конечные точки

• Boston Score [Срок оценки: 1 day]

Критерии участия

Критерии включения

• Patient of one of the investigators for total colonoscopy (no prior colonic surgery);
• Patient aged 18 years or older;
• Patient classified as ASA 1, ASA 2, or ASA 3;
• Not participating in any other current clinical trial;
• Free, informed, and signed consent;
• Patient affiliated with or a beneficiary of a social security scheme, according to Article L.1124-1 of the French Public Health Code;

Критерии исключения

• Patient taking major psychotropic medications;
• Patient with uncontrolled diabetes;
• Patient with coagulation abnormalities preventing polypectomy: PT <50%, Platelets <50,000/mm³, current effective anticoagulation therapy (clopidogrel, prasugrel, or ticagrelor);
• Patient referred for removal of a known polyp;
• Chronic inflammatory bowel disease;
• Known colonic stenosis;
• Diverticulitis of less than 6 weeks duration;
• Pregnant, parturient, or breastfeeding woman;
• Patient deprived of liberty by administrative or judicial order, or under guardianship or limited legal protection;
• Patient unable to understand the objectives and constraints of the study.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Clinique Paris Bercy — Charenton-le-Pont

Идентификаторы

NCT: NCT07361575 · POG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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