To Scope or Not to Scope: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia; a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 7
- 主要终点
- The difference in proportion performed OGDs between groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Masking will be impossible in this study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reported upper gastrointestinal symptoms in the past 6 months
- •Referred for OGD
- •Guidelines for referral not met
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
Intervention arm / e-learning
Patients will receive e-learning instead of upper GI endoscopy.
干预措施: e-learning (Device)
Control arm / upper GI endoscopy
Patients will receive the upper GI endoscopy, i.e. standard of care
结局指标
主要结局
The difference in proportion performed OGDs between groups
时间窗: 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
次要结局
- The influence of the intervention on health-related anxiety(12 weeks)
- The influence of the intervention on severity of upper GI symptoms(12 weeks)
- The influence of the intervention on dyspepsia-related quality of life(12 weeks)
- The ability of the e-learning to improve knowledge(15 minutes)