Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia

Summary

Indigestion or dyspepsia is highly prevalent worldwide. Often these symptoms are of benign nature and subside without treatment, or with lifestyle interventions like dietary modifications. Too often, gastroscopy is performed because of dyspepsia. Although this is indicated when malignancy is suspected, in a substantial part of the cases the gastroscopy is not indicated and will not achieve clinically relevant results. It is suspected that gastroscopy is often used for reassurance of patients or as a 'last resort'.

Our hypothesis is that adequate education of patients can replace this need for invasive measures. The aim of this study was therefore to reduce the volume of gastroscopies for dyspepsia, by offering patients an e-learning containing educational material on dyspepsia.

During the trial, 119 dyspeptic patients, referred for gastroscopy by the GP, will randomly be divided into two groups: One group will receive the e-learning instead of gastroscopy (intervention), the other group will receive the gastroscopy (control).

After a twelve week follow-up, change in symptom severity, disease specific quality of life and fear of disease will be compared between the two groups.

Conditions

• Dyspepsia
• Indigestion

Interventions

DEVICE

e-learning

The e-learning for patients is a user friendly, audiovisual based, online-accessible program, designed especially for this study. The e-learning will contain information on dyspepsia and advice on lifestyle interventions

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• VieCuri Medical Centre

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Prof. Dr. Drenth, MD, PhD · Radboud University Medical Center

• Prof. Dr. Masclee, MD, PhD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-20

Primary Completion

2019-03-01

Completion

2019-03-01

Countries

• Netherlands

Study Locations