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RELIEF-pathway in Patients With Upper Abdominal Pain (RELIEF)

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ClinicalTrials.gov Identifier: NCT06002516
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abdominal Pain Gallstone; Colic Dyspepsia Irritable Bowel Syndrome Health Care Utilization Patient Reported Outcomes Upper Abdominal Pain Decision Aid Other: RELIEF-pathway Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The RELIEF-pathway in Patients With Upper Abdominal Pain; an Open-label Multicenter Randomized Controlled Trial
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : May 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: RELIEF pathway
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.
 Other: RELIEF-pathway

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.
No Intervention: Usual care
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.


Outcome Measures
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Primary Outcome Measures :
  1. Primary endpoint [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures :
  1. Patient-reported outcomes [ Time Frame: 12 months ]

    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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
  • A history of or current malignancy (except SCC or BCC of the skin).
  • Pregnancy;
  • Expected short life span of less than 12 months.
  • Known cirrhosis of the liver
  • Current schizophrenia, memory deficiency, or any other disorder that predispose them to unreliable questionnaire responses;
  • Mentally incompetent;
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002516


Contacts
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Contact: Daan Comes, MD 024 361 3808 ext +31 daan.comes@radboudumc.nl
Contact: Philip de Reuver, MD PhD 024 361 3808 ext +31 philip.dereuver@radboudumc.nl

Sponsors and Collaborators
Radboud University Medical Center
Investigators
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Principal Investigator: Cornelis van Laarhoven, MD PhD Radboud University Medical Center
More Information
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Publications:

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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT06002516    
Other Study ID Numbers: 2021-12618
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
Abdominal pain
Health care utilization
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Gallstones
Dyspepsia
Abdominal Pain
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Signs and Symptoms, Digestive
Pain
Neurologic Manifestations
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical