RELIEF-pathway in Patients With Upper Abdominal Pain

Objective: The main goal is to evaluate the effect of the RELIEF pathway versus usual care on health care utilization in terms of hospital visits and number of interventions.

Study design: A multicenter randomized controlled open-label superiority trial, with two parallel arms, usual care (control arm) versus the RELIEF pathway (intervention arm). Patients will randomly be assigned (1:1) to usual care or the RELIEF pathway with use of stratification for disease severity, age and sex.

Study population: All patients between 18 and 70 years old, with a first referral by their general practitioner (GP) to the Department of Surgery or Gastroenterology with functional dyspepsia (ICPC D87.02), irritable bowel syndrome (ICPC D93) or uncomplicated symptomatic cholecystolithiasis (ICPC D98.03). Patients are not eligible for inclusion if they and/or GP report alarm symptoms, which may be direct or indirect signs of cancer or upper GI tract bleeding: weight loss, persistent vomiting, dysphagia, jaundice, hematemesis, melena, haematochezia, or anaemia. Patients with a first or second-degree relative with a history of upper GI tract malignant neoplasm, patients with a history of complicated cholecystolithiasis (acute cholecystitis, choledocholithiasis, biliary pancreatitis and cholangitis) or a history of or current malignancy (except SCC or BCC of the skin).

Intervention:

Patients in the intervention group (RELIEF-pathway) will receive access to the web-based education tool before visit of the outpatient clinic of Surgery or Gastroenterology.

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.

The investigators aim that the patient will complete the web-based education tool before visiting the outpatient clinic of Surgery and Gastroenterology. The web-based education tool is available during 12 months after randomization.

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.

Control: Patients assigned to the control group will receive the usual care given at participating centers. During the first visit at the surgery or gastroenterology outpatient clinic subjects are seen by a random medical specialist, who will assess history, examine the patient, and review investigations.Diagnostic and treatment decisions will be based on the physician's preference and experience and on the patients' preferred choice of treatment.

Inclusion criteria

• 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.
• Providing informed consent.

Exclusion criteria

• Unexplained weight loss
• Persistent vomiting
• Gastrointestinal bleeding
• Any other direct or indirect signs of cancer or upper GI tract bleeding
• Anemia
• Jaundice
• Pregnancy
• An expected life span of less than 12 months
• Known liver diseases
• A history of complicated cholecystolithiasis
• A history of inflammatory bowel disease
• A history of malignancy, except squamous cell carcinoma (SCC)/basal cell -carcinoma (BCC)
• First or second degree relative with history of upper GI malignancy