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NCT Number: NCT03205319

Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia

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.

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Key information

Conditions

Dyspepsia Indigestion Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Gelderse Vallei, Ede, Gelderland, Netherlands

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About this study

Rationale: Upper gastrointestinal (GI) symptoms, such as dyspepsia without alarm symptoms, are highly prevalent in the general population. Lifestyle modifications and medication can reduce symptoms in most patients. Guidelines state that oesophagogastroduodenoscopy (OGD) is only indicated in a selected high risk group. In spite of these guidelines, OGD referrals for dyspepsia without alarm symptoms are still substantial, subjecting patients to unnecessary risks and causing a burden on healthcare costs and endoscopic capacity. Therefore a strategy is needed to reduce the volume of OGDs in dyspepsia without alarm symptoms.

Objective: To evaluate the clinical use of a patient-centred, education based, clinical strategy to reduce the volume of endoscopies for dyspepsia in patients over 18 years of age without alarm symptoms, referred for OGD through open-access endoscopy compared to usual care.

Study design: A multicentre, randomised, controlled superiority trial, with two parallel arms and a primary endpoint of the percentage of patients receiving OGD. Intervention and usual care will be compared.

Study population: 119 Patients, aged 18 years or above, with upper GI symptoms without alarm symptoms, referred for open-access OGD.

Intervention: Patients will be offered e-learning instead of endoscopy. The e-learning will contain educational material and questionnaires. Questionnaire data will be extracted from the e-learning.

Main study endpoints: The main study endpoint is the difference in proportion of patients receiving OGD between both arms and Patient Reported Outcomes (PROMS), after a follow-up of 12 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Reported upper gastrointestinal symptoms in the past 6 months
  • Referred for OGD
  • Guidelines for referral not met
  • Signed informed consent

Exclusion criteria

Patients who fulfil the criteria for OGD according to the Dutch college of General Practitioners (NHG) guidelines and NICE guidelines on 'Upper gastrointestinal tract cancers'.

In addition, patients with:

  • A family history of gastric- or oesophageal cancer (at least one first or second grade family member with a malignancy at the age of 50 or younger)
  • Diseases or circumstances that will most likely impair understanding of the e-learning
  • Any argument provided by a patient's own GP stating the urge of OGD, notwithstanding the guidelines

Treatment and study plan

E-learning

Device

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

Primary outcomes

  1. The difference in proportion performed OGDs between groups

    Time frame: 12 weeks

    The difference between the two study arms in proportion of patients that have received OGD, measured 12 weeks after the initial visit to the endoscopy clinic, out of the total number of patients referred for open-access endoscopy

Secondary outcomes

  1. The influence of the intervention on health-related anxiety

    Time frame: 12 weeks

    The difference between the change scores of the two study arms concerning health-related anxiety, measured by the total score on the validated Short Health Anxiety Inventory

  2. The influence of the intervention on severity of upper GI symptoms

    Time frame: 12 weeks

    The difference between the change scores of the two study arms concerning severity of upper GI symptoms, measured by the mean on the subscale scores of the validated PAGI-SYM questionnaire

  3. The influence of the intervention on dyspepsia-related quality of life

    Time frame: 12 weeks

    The difference between the change scores of the two study arms concerning dyspepsia-related quality of life, measured by the sum of the subscale scores of the validated Nepean Dyspepsia Index

  4. The ability of the e-learning to improve knowledge

    Time frame: 15 minutes

    Using a knowledge test integrated in the e-learning and administered before and after the e-learning, the difference in correctly answered questions will be measured

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Maastricht University Medical Center
  • VieCuri Medical Centre
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

To Scope or Not to Scope: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia; a Randomised Controlled Trial

Acronym: TRIODe

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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