Gastroesophageal Reflux Disease in the Dutch Population

NCT05689918 | Unknown

• 1 other identifier: 2022-13720
• Study Type: observational
• Target: 4,719
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies. Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population. Study design: Cross-sectional population-based survey. Study population: Dutch citizens aged 18-75 years. Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey. Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (2)

• Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)

  The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.

  7 days

• Level of awareness of esophageal cancer risk factors and alarm symptoms

  The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age\>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree).

  Baseline

Secondary Outcomes (4)

• Number of individuals that sought help for GERD (general practitioner/referral)

  20 years

• Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)

  6 months

• Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)

  6 months

• Beliefs about esophageal cancer

  Baseline

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Dutch population registry, 'Basisregistratie Personen' (BRP).

You may qualify if:

• Age 18 - 75 years

You may not qualify if:

• Unable to provide informed consent for any reason;
• Unable to fill out the digital survey for any reason.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (1)

• Huibertse LJ, Sijben J, Peters Y, Siersema PD. Self-management and help-seeking behavior for gastroesophageal reflux symptoms: A population-based survey. World J Gastroenterol. 2026 Jan 14;32(2):112395. doi: 10.3748/wjg.v32.i2.112395.

  PMID: 41551831 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 19, 2023
• Study Start: December 7, 2022
• Primary Completion: March 7, 2023
• Study Completion: May 7, 2023
• Last Updated: January 19, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

NL (1)