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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Pre- and Post-Treatment Improvement in GERD-HRQL Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GERD Retrospective Cohort
A retrospective cohort of approximately 5,000 patients with a confirmed diagnosis of gastroesophageal reflux disease (GERD) treated at Beijing Friendship Hospital was established using data extracted from the prospective clinical registry of the National Clinical Research Center for Digestive Diseases.
干预措施: Clinical Data Collection (Other)
结局指标
主要结局
Pre- and Post-Treatment Improvement in GERD-HRQL Scores
时间窗: From pre-treatment to up to 10 years post-treatment
The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is utilized to assess patient outcomes as a quantitative variable. The scale comprises 11 items, each scored from 0 to 5, with higher scores indicating a better quality of life (QoL). Clinical success is defined as a \>50% reduction in the total symptom score.
次要结局
- Pre- and Post-Treatment Improvement in GERD-Q Scores(From pre-treatment to up to 10 years post-treatment)
- Pre- and Post-Treatment Improvement in GSAS Scores(From pre-treatment to up to 10 years post-treatment)
- Pre- and Post-Treatment Improvement in GIQLI Scores(From pre-treatment to up to 10 years post-treatment)
- Acid Exposure Time (AET)(From pre-treatment to up to 10 years post-treatment)
- Pre- and Post-Treatment Improvement in EHAS Scores(From pre-treatment to up to 10 years post-treatment)
- Pre- and Post-Treatment Improvement in HADS Scores(From pre-treatment to up to 10 years post-treatment)
- Esophagitis Severity(From pre-treatment to up to 10 years post-treatment)
- Severity of Hiatal Hernia(From pre-treatment to up to 10 years post-treatment)
- Presence of Barrett's Esophagus(From pre-treatment to up to 10 years post-treatment)
- Number of Reflux Episodes(From pre-treatment to up to 10 years post-treatment)
- DeMeester Score(From pre-treatment to up to 10 years post-treatment)
- Symptom Index (SI)(From pre-treatment to up to 10 years post-treatment)
- Symptom Reflux Index (SRI)(From pre-treatment to up to 10 years post-treatment)
- Esophagogastric Junction (EGJ) Expiratory Pressure(From pre-treatment to up to 10 years post-treatment)
- Integrated Relaxation Pressure (IRP)(From pre-treatment to up to 10 years post-treatment)
- Esophagogastric Junction (EGJ) Morphology(From pre-treatment to up to 10 years post-treatment)
- Distal Latency (DL)(From pre-treatment to up to 10 years post-treatment)
- Distal Contractile Integral (DCI)(From pre-treatment to up to 10 years post-treatment)
- Esophageal Motility Type(From pre-treatment to up to 10 years post-treatment)
- Hiatal Hernia Size(From pre-treatment to up to 10 years post-treatment)
- Helicobacter pylori Infection Status(From 30 days prior to surgery to 10 years post-surgery)
- Acid-Suppressive Medication Regimen(From enrollment to the end of treatment, assessed up to 12 weeks)
- Operation Time(At the time of surgery)
- Blood Loss(At the time of surgery)
- Abdominal Drainage Fluid Volume(From treatment to 30 days after surgery)
- Total Duration of Hospitalization(From treatment to 30 days after surgery)
- Incidence of Postoperative Complications(From treatment to 30 days after surgery)
研究者
JunZhang
Chief Surgeon
Beijing Friendship Hospital