NCT05689918: REFLUX

Gastroesophageal Reflux Disease in the Dutch Population

Status unknown Last updated 19 January 2023

What this trial tests

trial testing No intervention in Gastro Esophageal Reflux in 4,719 participants. Status unknown.

Timeline

7 December 2022

Primary endpoint
7 March 2023

7 May 2023

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	4,719
Start date	7 December 2022
Primary completion	7 March 2023
Estimated completion	7 May 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• No intervention

Conditions studied

• Gastro Esophageal Reflux — all drugs for Gastro Esophageal Reflux →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 75, any sex, with Gastro Esophageal Reflux. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oesophageal cancer awareness and anticipated time to help-seeking: results from a population-based survey.
   Sijben J, Huibertse LJ, Rainey L, Broeders MJM, et al · · 2024 · cited 4× · PMID 38555316 · DOI 10.1038/s41416-024-02663-1
2. Self-management and help-seeking behavior for gastroesophageal reflux symptoms: A population-based survey.
   Huibertse LJ, Sijben J, Peters Y, Siersema PD. · · 2026 · PMID 41551831 · DOI 10.3748/wjg.v32.i2.112395