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Идёт набор NCT07749989

A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset

— Наблюдательное Gastroesophageal Reflux Disease

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: Clinical Data Collection.
Кому может быть актуально
Состояния в реестре: Gastroesophageal Reflux Disease. Базовые параметры: 18 лет — 90 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

Establishing an Innovative Cohort of Chinese Patients With Gastroesophageal Reflux Disease Based on the Prospective Database of the National Clinical Research Center for Digestive Diseases: A Retrospective Study

Обзор

This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese patients with gastroesophageal reflux disease (GERD), as well as to evaluate post-treatment improvements in both GERD symptoms and psychological well-being. The study retrospectively enrolled approximately 5,000 patients with a confirmed diagnosis of GERD, with data derived from the prospective registry of the National Clinical Research Center for Digestive Diseases. Investigators systematically extracted data on baseline demographics, clinical presentations, objective diagnostic findings, preoperative psychological status, surgical complications, and longitudinal follow-up outcomes for all eligible patients. Ultimately, this study sought to provide high-quality, China-specific evidence to inform the precise phenotyping of GERD and to guide standardized, individualized clinical decision-making.

Вмешательства

  • Другое Clinical Data Collection
    Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.

Первичные конечные точки

  • Pre- and Post-Treatment Improvement in GERD-HRQL Scores [Срок оценки: From pre-treatment to up to 10 years post-treatment]
Вторичные конечные точки (12)
  • Pre- and Post-Treatment Improvement in GERD-Q Scores [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Pre- and Post-Treatment Improvement in GSAS Scores [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Pre- and Post-Treatment Improvement in GIQLI Scores [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Pre- and Post-Treatment Improvement in EHAS Scores [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Pre- and Post-Treatment Improvement in HADS Scores [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Esophagitis Severity [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Severity of Hiatal Hernia [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Presence of Barrett's Esophagus [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Acid Exposure Time (AET) [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Number of Reflux Episodes [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • DeMeester Score [Срок оценки: From pre-treatment to up to 10 years post-treatment]
  • Symptom Index (SI) [Срок оценки: From pre-treatment to up to 10 years post-treatment]

Критерии участия

Критерии включения

  • Aged between 18 and 90 years old.
  • Patients were required to present with at least one typical symptom of gastroesophageal reflux disease (GERD)-such as heartburn, regurgitation, or non-cardiac chest pain-and to have presented to Beijing Friendship Hospital for the evaluation and management of these symptoms.
  • Received treatment, including pharmacological therapy and anti-reflux surgery, at Beijing Friendship Hospital.
  • Voluntary signing of informed consent, agreeing to the use of clinical information for future research.

Критерии исключения

  • Female patients who were pregnant or lactating.
  • Patients with significantly incomplete or missing critical clinical data.
  • Patients with an equivocal or unconfirmed diagnosis of GERD.
  • Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
  • Refusal to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Friendship Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07749989 · 2026-P2-209-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗