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Идёт набор NCT06878378

Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

— Наблюдательное Colonoscopy Colonoscopy: Bowel 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: Investigation of Factors Influencing Bowel Preparation Quality.
Кому может быть актуально
Состояния в реестре: Colonoscopy, Colonoscopy: Bowel Preparation. 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
Китай
Следующий шаг
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Официальное название

Identification of Risk Factors for Inadequate Bowel Preparation Before Colonoscopy and Construction of a Predictive Model: a Nationwide Multicenter Prospective Study

Обзор

The primary objectives of this study are twofold: Firstly, to investigate the current status of bowel preparation protocols and their quality across hospitals at various levels in China, particularly following the release of the updated 2023 bowel preparation guidelines. This aims to standardize and optimize bowel preparation protocols nationwide. Secondly, to identify and analyze risk factors contributing to suboptimal bowel preparation quality in patients undergoing colonoscopy. The study will examine the correlation between these factors and bowel preparation scores, establish a risk prediction model for preparation failure, and provide a theoretical foundation for developing personalized bowel preparation regimens tailored to individual patient characteristics.

Подробное описание

The project is divided into three key phases:

1. Initiation Phase:

Develop a Bowel Preparation Assessment Questionnaire (BPAQ) to standardize data collection.

Establish collaborative centers (multicenter hospitals) nationwide for coordinated implementation. 2. Implementation Phase:

Conduct on-site audits to evaluate bowel preparation practices across participating centers.

Deliver protocol-specific training to healthcare providers, emphasizing compliance with the 2023 guidelines.

Systematically collect bowel preparation data, including patient demographics, protocol adherence metrics, and clinical outcomes. 3. Conclusion Phase:

Prioritize data quality assurance through dual-entry validation and logic checks to ensure authenticity, comprehensiveness, and objectivity.

Generate consolidated reports to identify systemic gaps and propose evidence-based optimization strategies.

Вмешательства

  • Другое Investigation of Factors Influencing Bowel Preparation Quality
    Observed parameters include BMI, history of abdominal surgery, history of diabetes, history of diarrhea and constipation, stool characteristics, and specific bowel preparation protocols.

Первичные конечные точки

  • adequate bowel preparation rate [Срок оценки: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy]
Вторичные конечные точки (1)
  • adenoma detection rate [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients aged >18 years, regardless of gender, scheduled for colonoscopy
  • Written informed consent has been obtained

Критерии исключения

  • History of acute myocardial infarction (within 6 months), severe cardiac/hepatic/renal insufficiency, or psychiatric disorders
  • Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders
  • Pregnancy or lactation;
  • History of inflammatory bowel disease or acute intestinal infection within the past 2 weeks;
  • History of colorectal cancer, familial adenomatous polyposis (FAP), or Peutz-Jeghers syndrome;
  • History of intestinal obstruction, perforation, stricture, or other conditions precluding completion of colonoscopy;
  • Non-compliance with bowel preparation protocols (e.g., ingestion of <80% of prescribed polyethylene glycol (PEG) electrolyte solution);
  • Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the study;
  • Prior enrollment in this study with a repeat colonoscopy appointment;
  • Current participation in other clinical trials or participation in any trial within the preceding 60 days;
  • Refusal to provide written informed consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT06878378 · CHEC2025-083

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗