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

NCT07749989 | Recruiting

• 1 other identifier: 2026-P2-209-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Disease; Retrospective Cohort; Surgical Treatment; Real-World Data; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Pre- and Post-Treatment Improvement in GERD-HRQL Scores

  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.

  From pre-treatment to up to 10 years post-treatment

Secondary Outcomes (27)

• 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

• 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

Study Arms (1)

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.

Other: Clinical Data Collection

Interventions

Clinical Data Collection OTHER

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

GERD Retrospective Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from the clinical registry of the National Clinical Research Center for Digestive Diseases at Beijing Friendship Hospital, Capital Medical University. This retrospective cohort study will enroll approximately 5,000 patients with a confirmed diagnosis of gastroesophageal reflux disease (GERD). During the study period, all eligible patients documented in the registry who meet the inclusion criteria will be consecutively enrolled. The source population comprises patients presenting to Beijing Friendship Hospital for the diagnosis and management of GERD. This registry encompasses comprehensive data on clinical symptoms, objective diagnostic findings, treatment details, and longitudinal follow-up outcomes for all enrolled individuals. As Beijing Friendship Hospital is a major tertiary referral center in China serving a broad geographical catchment area, the study cohort is anticipated to be highly representative of diverse patient demographics and clinical

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Zhi Zheng, Attending surgon

CONTACT

+86-13811132175; zhengzhi@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgeon

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)