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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Clinical Data Collection

    Other intervention

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

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: GERD Retrospective Cohort1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Pre- and Post-Treatment Improvement in GERD-Q Scores

The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) is utilized to evaluate GERD symptoms. The total score ranges from 0 to 18, with higher scores indicating greater symptom severity.

Time frame
From pre-treatment to up to 10 years post-treatment
2

Pre- and Post-Treatment Improvement in GSAS Scores

The GERD Symptom Assessment Scale (GSAS) is employed to evaluate GERD symptoms. The total score ranges from 0 to 45, with higher scores indicating greater symptom severity.

Time frame
From pre-treatment to up to 10 years post-treatment
3

Pre- and Post-Treatment Improvement in GIQLI Scores

The Gastrointestinal Quality of Life Index (GIQLI) is utilized to assess quality of life in patients with gastrointestinal diseases. It comprises five subscales with a total score ranging from 0 to 144. Higher scores indicate a better quality of life and superior therapeutic efficacy.

Time frame
From pre-treatment to up to 10 years post-treatment
4

Pre- and Post-Treatment Improvement in EHAS Scores

The Esophageal Hypervigilance and Anxiety Scale (EHAS) is utilized to assess esophageal-specific hypervigilance and anxiety. It comprises two subscales with a total score ranging from 0 to 56, with higher scores indicating more severe esophageal hypervigilance and anxiety.

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

Other outcomes

Sponsors and contacts

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