RELIEF-pathway in Patients With Upper Abdominal Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRadboud University Medical Center

About this trial

Upper abdominal pain (UAP) is a common symptom and frequently the reason to visit the hospital. The prevalence of epigastric pain in the Dutch population is estimated to be as high as 37%. Moreover, Dutch hospitals yearly record \>100.000 diagnoses related to UAP. In most patients, UAP can be attributed to symptomatic (functional) dyspepsia (FD), Irritable Bowel Syndrome (IBS) or uncomplicated gallstone disease (cholecystolithiasis), with a prevalence in the general population of 20-30%, 20%, and 6-9%, respectively. However, these conditions may have overlapping symptom patterns and generally affect similar populations. which contributes to ineffective (diagnostic) interventions. Patients are generally not aware of the similarity of symptoms and the poor outcome of some treatments.

Education positively influences patients' self-management and health judgment. In a recent open-label, multicentre trial the effectiveness of web-based patients' education is applied to reduce overuse of upper gastrointestinal endoscopies in patients with dyspepsia. This study illustrated that an web-based education tool safely reduced 40% in upper gastrointestinal endoscopies. Lifestyle interventions (such as change of diet and/or physical activity) are widely incorporated in treatment programs for cardio-vascular diseases including diabetes mellitus and obesity. An web-based education tool on upper abdominal pain and other complaints combined with a lifestyle interventions for patients may be an effective treatment option for this large group of patients.

This study investigates the potential of an individualized web-based education tool as intervention for patients with functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis with the possibility to visit the Prevention and Lifestyle clinic (RELIEF pathway). The RELIEF pathway aims to reduce unnecessary health care utilization and, secondly, to maintain and improve quality of life by educating patients on lifestyle improvement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients between 18 and 70 years old.

First referral due to upper abdominal pain (UAP) and symptoms due to Functional dyspepsia (ICPC code 87.02), Irritable Bowel syndrome (ICPC 93.0) or uncomplicated symptomatic cholecystolithiasis (ICPC 98.03).

Proficient in reading and understanding of the Dutch language.

Referred to the outpatient clinic of gastroenterology or surgery.

Disqualifiers

If the following alarm symptoms are reported in the referral letter by the GP: weight loss, persistent vomiting, dysphagia, jaundice, hematemesis, melena, haematochezia, or anaemia.

Any other direct or indirect signs of cancer or upper GI tract bleeding.

Patients with a first or second-degree relative with a history of upper GI tract malignant neoplasm.

Patients with a history of complicated cholecystolithiasis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RELIEF-pathway

    Other intervention

    The personalized web-based education tool contains information on: * Information of cause and symptoms of functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis; * Symptom checker based on the ROME III and ROME IV criteria; * Red flags symptoms defined as direct or indirect signs of upper GI hemorrhage. * Lifestyle adjustments to improve abdominal symptoms and quality of life. * Information on effect of upper gastrointestinal endoscopy, colonoscopy and laparoscopic cholecystectomy. After the web-based education tool is completed we will offer an additional visit at the Prevention and Lifestyle clinic, this is optional and not obligatory.

Treatment groups

471 Participants
are divided into 2 treatment groups
Group A: RELIEF pathwayExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary endpoint

Healthcare-utilization regarding to upper abdominal pain: * Number of outpatient clinics regarding to UAP * Number of diagnostics (Upper GI endoscopies, colonoscopies). * Number of treatments (laparoscopic cholecystectomy). * Number of ER visits. Medical records will be evaluated on above mentioned points.

Time frame
6 months

Secondary outcomes

1

Patient-reported outcomes

Assessed by the following questionnaires: * ROME III criteria for biliary colic (ROMEIII) * ROME IV criteria for FGID (ROMEIV)) * Hospital anxiety and depression scale (HADS questionnaire) * Symptom severity (PAGI-SYM questionnaire). * Short-Form Health and Labour Questionnaire (SF-HLQ questionnaire).

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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