xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002516</url>
    </required_header>
    <id_info>
      <org_study_id>2021-12618</org_study_id>
      <nct_id>NCT06002516</nct_id>
    </id_info>
    <brief_title>RELIEF-pathway in Patients With Upper Abdominal Pain</brief_title>
    <acronym>RELIEF</acronym>
    <official_title>The RELIEF-pathway in Patients With Upper Abdominal Pain; an Open-label Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Radboud University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Radboud University Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Upper abdominal pain (UAP) is a common symptom and frequently the reason to visit the&#xD;
        hospital. The prevalence of epigastric pain in the Dutch population is estimated to be as&#xD;
        high as 37%. Moreover, Dutch hospitals yearly record &gt;100.000 diagnoses related to UAP. In&#xD;
        most patients, UAP can be attributed to symptomatic (functional) dyspepsia (FD), Irritable&#xD;
        Bowel Syndrome (IBS) or uncomplicated gallstone disease (cholecystolithiasis), with a&#xD;
        prevalence in the general population of 20-30%, 20%, and 6-9%, respectively. However, these&#xD;
        conditions may have overlapping symptom patterns and generally affect similar populations.&#xD;
        which contributes to ineffective (diagnostic) interventions. Patients are generally not aware&#xD;
        of the similarity of symptoms and the poor outcome of some treatments.&#xD;
  &#xD;
        Education positively influences patients' self-management and health judgment. In a recent&#xD;
        open-label, multicentre trial the effectiveness of web-based patients' education is applied&#xD;
        to reduce overuse of upper gastrointestinal endoscopies in patients with dyspepsia. This&#xD;
        study illustrated that an web-based education tool safely reduced 40% in upper&#xD;
        gastrointestinal endoscopies. Lifestyle interventions (such as change of diet and/or physical&#xD;
        activity) are widely incorporated in treatment programs for cardio-vascular diseases&#xD;
        including diabetes mellitus and obesity. An web-based education tool on upper abdominal pain&#xD;
        and other complaints combined with a lifestyle interventions for patients may be an effective&#xD;
        treatment option for this large group of patients.&#xD;
  &#xD;
        This study investigates the potential of an individualized web-based education tool as&#xD;
        intervention for patients with functional dyspepsia, irritable bowel syndrome and&#xD;
        uncomplicated symptomatic cholecystolithiasis with the possibility to visit the Prevention&#xD;
        and Lifestyle clinic (RELIEF pathway). The RELIEF pathway aims to reduce unnecessary health&#xD;
        care utilization and, secondly, to maintain and improve quality of life by educating patients&#xD;
        on lifestyle improvement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: The main goal is to evaluate the effect of the RELIEF pathway versus usual care on&#xD;
        health care utilization in terms of hospital visits and number of interventions.&#xD;
  &#xD;
        Study design: A multicenter randomized controlled open-label superiority trial, with two&#xD;
        parallel arms, usual care (control arm) versus the RELIEF pathway (intervention arm).&#xD;
        Patients will randomly be assigned (1:1) to usual care or the RELIEF pathway with use of&#xD;
        stratification for disease severity, age and sex.&#xD;
  &#xD;
        Study population: All patients between 18 and 70 years old, with a first referral by their&#xD;
        general practitioner (GP) to the Department of Surgery or Gastroenterology with functional&#xD;
        dyspepsia (ICPC D87.02), irritable bowel syndrome (ICPC D93) or uncomplicated symptomatic&#xD;
        cholecystolithiasis (ICPC D98.03). Patients are not eligible for inclusion if they and/or GP&#xD;
        report alarm symptoms, which may be direct or indirect signs of cancer or upper GI tract&#xD;
        bleeding: weight loss, persistent vomiting, dysphagia, jaundice, hematemesis, melena,&#xD;
        haematochezia, or anaemia. Patients with a first or second-degree relative with a history of&#xD;
        upper GI tract malignant neoplasm, patients with a history of complicated cholecystolithiasis&#xD;
        (acute cholecystitis, choledocholithiasis, biliary pancreatitis and cholangitis) or a history&#xD;
        of or current malignancy (except SCC or BCC of the skin).&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        Patients in the intervention group (RELIEF-pathway) will receive access to the web-based&#xD;
        education tool before visit of the outpatient clinic of Surgery or Gastroenterology.&#xD;
  &#xD;
        The personalized web-based education tool contains information on:&#xD;
  &#xD;
          -  Information of cause and symptoms of functional dyspepsia, irritable bowel syndrome and&#xD;
             uncomplicated symptomatic cholecystolithiasis;&#xD;
  &#xD;
          -  Symptom checker based on the ROME III and ROME IV criteria;&#xD;
  &#xD;
          -  Red flags symptoms defined as direct or indirect signs of upper GI hemorrhage.&#xD;
  &#xD;
          -  Lifestyle adjustments to improve abdominal symptoms and quality of life.&#xD;
  &#xD;
          -  Information on effect of upper gastrointestinal endoscopy, colonoscopy and laparoscopic&#xD;
             cholecystectomy.&#xD;
  &#xD;
        The investigators aim that the patient will complete the web-based education tool before&#xD;
        visiting the outpatient clinic of Surgery and Gastroenterology. The web-based education tool&#xD;
        is available during 12 months after randomization.&#xD;
  &#xD;
        After the web-based education tool is completed we will offer an additional visit at the&#xD;
        Prevention and Lifestyle clinic, this is optional and not obligatory.&#xD;
  &#xD;
        Control: Patients assigned to the control group will receive the usual care given at&#xD;
        participating centers. During the first visit at the surgery or gastroenterology outpatient&#xD;
        clinic subjects are seen by a random medical specialist, who will assess history, examine the&#xD;
        patient, and review investigations.Diagnostic and treatment decisions will be based on the&#xD;
        physician's preference and experience and on the patients' preferred choice of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 1, 2024</start_date>
    <completion_date type="Anticipated">May 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary endpoint</measure>
      <time_frame>6 months</time_frame>
      <description>Healthcare-utilization regarding to upper abdominal pain:&#xD;
  Number of outpatient clinics regarding to UAP&#xD;
  Number of diagnostics (Upper GI endoscopies, colonoscopies).&#xD;
  Number of treatments (laparoscopic cholecystectomy).&#xD;
  Number of ER visits.&#xD;
  Medical records will be evaluated on above mentioned points.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient-reported outcomes</measure>
      <time_frame>12 months</time_frame>
      <description>Assessed by the following questionnaires:&#xD;
  ROME III criteria for biliary colic (ROMEIII)&#xD;
  ROME IV criteria for FGID (ROMEIV))&#xD;
  Hospital anxiety and depression scale (HADS questionnaire)&#xD;
  Symptom severity (PAGI-SYM questionnaire).&#xD;
  Short-Form Health and Labour Questionnaire (SF-HLQ questionnaire).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">471</enrollment>
    <condition>Abdominal Pain</condition>
    <condition>Gallstone; Colic</condition>
    <condition>Dyspepsia</condition>
    <condition>Irritable Bowel Syndrome</condition>
    <condition>Health Care Utilization</condition>
    <condition>Patient Reported Outcomes</condition>
    <condition>Upper Abdominal Pain</condition>
    <condition>Decision Aid</condition>
    <arm_group>
      <arm_group_label>RELIEF pathway</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>RELIEF-pathway</intervention_name>
      <description>The personalized web-based education tool contains information on:&#xD;
  Information of cause and symptoms of functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis;&#xD;
  Symptom checker based on the ROME III and ROME IV criteria;&#xD;
  Red flags symptoms defined as direct or indirect signs of upper GI hemorrhage.&#xD;
  Lifestyle adjustments to improve abdominal symptoms and quality of life.&#xD;
  Information on effect of upper gastrointestinal endoscopy, colonoscopy and laparoscopic cholecystectomy.&#xD;
  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.</description>
      <arm_group_label>RELIEF pathway</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between 18 and 70 years old.&#xD;
  &#xD;
            -  First referral due to upper abdominal pain (UAP) and symptoms due to Functional&#xD;
               dyspepsia (ICPC code 87.02), Irritable Bowel syndrome (ICPC 93.0) or uncomplicated&#xD;
               symptomatic cholecystolithiasis (ICPC 98.03).&#xD;
  &#xD;
            -  Proficient in reading and understanding of the Dutch language.&#xD;
  &#xD;
            -  Referred to the outpatient clinic of gastroenterology or surgery.&#xD;
  &#xD;
            -  Providing informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  If the following alarm symptoms are reported in the referral letter by the GP: weight&#xD;
               loss, persistent vomiting, dysphagia, jaundice, hematemesis, melena, haematochezia, or&#xD;
               anaemia.&#xD;
  &#xD;
            -  Any other direct or indirect signs of cancer or upper GI tract bleeding.&#xD;
  &#xD;
            -  Patients with a first or second-degree relative with a history of upper GI tract&#xD;
               malignant neoplasm.&#xD;
  &#xD;
            -  Patients with a history of complicated cholecystolithiasis.&#xD;
  &#xD;
            -  A history of or current malignancy (except SCC or BCC of the skin).&#xD;
  &#xD;
            -  Pregnancy;&#xD;
  &#xD;
            -  Expected short life span of less than 12 months.&#xD;
  &#xD;
            -  Known cirrhosis of the liver&#xD;
  &#xD;
            -  Current schizophrenia, memory deficiency, or any other disorder that predispose them&#xD;
               to unreliable questionnaire responses;&#xD;
  &#xD;
            -  Mentally incompetent;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cornelis van Laarhoven, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radboud University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daan Comes, MD</last_name>
      <phone>024 361 3808</phone>
      <phone_ext>+31</phone_ext>
      <email>daan.comes@radboudumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Philip de Reuver, MD PhD</last_name>
      <phone>024 361 3808</phone>
      <phone_ext>+31</phone_ext>
      <email>philip.dereuver@radboudumc.nl</email>
    </overall_contact_backup>
    <reference>
      <citation>de Jong JJ, Lantinga MA, Tan ACITL, Aquarius M, Scheffer RCH, Uil JJ, de Reuver PR, Keszthelyi D, Westert GP, Masclee AAM, Drenth JPH. Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract Endoscopy: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jun 1;181(6):825-833. doi: 10.1001/jamainternmed.2021.1408.</citation>
      <PMID>33900373</PMID>
    </reference>
    <reference>
      <citation>van Dijk AH, Wennmacker SZ, de Reuver PR, Latenstein CSS, Buyne O, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Hof KI', Janssen J, Nieuwenhuijs VB, Schaap HM, Steenvoorde P, Stockmann HBAC, Boerma D, Westert GP, Drenth JPH, Dijkgraaf MGW, Boermeester MA, van Laarhoven CJHM. Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial. Lancet. 2019 Jun 8;393(10188):2322-2330. doi: 10.1016/S0140-6736(19)30941-9. Epub 2019 Apr 27. Erratum In: Lancet. 2019 May 11;393(10184):1936.</citation>
      <PMID>31036336</PMID>
    </reference>
    <reference>
      <citation>Kok L, Elias SG, Witteman BJ, Goedhard JG, Romberg-Camps MJ, Muris JW, Moons KG, de Wit NJ. Application of the Rome III criteria is not likely to reduce the number of unnecessary referrals for colonoscopy in primary care. Eur J Gastroenterol Hepatol. 2013 May;25(5):568-74. doi: 10.1097/MEG.0b013e32835d4ddd.</citation>
      <PMID>23325277</PMID>
    </reference>
    <reference>
      <citation>Latenstein CSS, Hannink G, van der Bilt JDW, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Nieuwenhuijs VB, Schreinemakers JMJ, Wiering B, Boermeester MA, Drenth JPH, van Laarhoven CJHM, Dijkgraaf MGW, de Reuver PR; SECURE trial collaborators. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021 Oct 1;156(10):e213706. doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.</citation>
      <PMID>34379080</PMID>
    </reference>
    <reference>
      <citation>de Jong JJ, Latenstein CSS, Boerma D, Hazebroek EJ, Hirsch D, Heikens JT, Konsten J, Polat F, Lantinga MA, van Laarhoven CJHM, Drenth JPH, de Reuver PR. Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial). Ann Surg. 2022 Jun 1;275(6):e766-e772. doi: 10.1097/SLA.0000000000004453. Epub 2020 Sep 1.</citation>
      <PMID>32889877</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Abdominal pain</keyword>
    <keyword>Health care utilization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Irritable Bowel Syndrome</mesh_term>
      <mesh_term>Gallstones</mesh_term>
      <mesh_term>Dyspepsia</mesh_term>
      <mesh_term>Abdominal Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002516
  org study id: 2021-12618
  nct id: NCT06002516
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary endpoint
  time frame: 6 months
  description: 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.
  measure: Patient-reported outcomes
  time frame: 12 months
  description: 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).
  arm group label: RELIEF pathway
  arm group type: Experimental
  description: 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.
  arm group label: Usual care
  arm group type: No Intervention
  description: 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.
  intervention type: Other
  intervention name: RELIEF-pathway
  description: 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.
  arm group label: RELIEF pathway
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Cornelis van Laarhoven, MD PhD
  role: Principal Investigator
  affiliation: Radboud University Medical Center
  last name: Daan Comes, MD
  phone: 024 361 3808
  phone ext: +31
  email: daan.comes@radboudumc.nl
  last name: Philip de Reuver, MD PhD
  phone: 024 361 3808
  phone ext: +31
  email: philip.dereuver@radboudumc.nl
  citation: de Jong JJ, Lantinga MA, Tan ACITL, Aquarius M, Scheffer RCH, Uil JJ, de Reuver PR, Keszthelyi D, Westert GP, Masclee AAM, Drenth JPH. Web-Based Educational Intervention for Patients With Uninvestigated Dyspepsia Referred for Upper Gastrointestinal Tract Endoscopy: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jun 1;181(6):825-833. doi: 10.1001/jamainternmed.2021.1408.
  PMID: 33900373
  citation: van Dijk AH, Wennmacker SZ, de Reuver PR, Latenstein CSS, Buyne O, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Hof KI', Janssen J, Nieuwenhuijs VB, Schaap HM, Steenvoorde P, Stockmann HBAC, Boerma D, Westert GP, Drenth JPH, Dijkgraaf MGW, Boermeester MA, van Laarhoven CJHM. Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial. Lancet. 2019 Jun 8;393(10188):2322-2330. doi: 10.1016/S0140-6736(19)30941-9. Epub 2019 Apr 27. Erratum In: Lancet. 2019 May 11;393(10184):1936.
  PMID: 31036336
  citation: Kok L, Elias SG, Witteman BJ, Goedhard JG, Romberg-Camps MJ, Muris JW, Moons KG, de Wit NJ. Application of the Rome III criteria is not likely to reduce the number of unnecessary referrals for colonoscopy in primary care. Eur J Gastroenterol Hepatol. 2013 May;25(5):568-74. doi: 10.1097/MEG.0b013e32835d4ddd.
  PMID: 23325277
  citation: Latenstein CSS, Hannink G, van der Bilt JDW, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Nieuwenhuijs VB, Schreinemakers JMJ, Wiering B, Boermeester MA, Drenth JPH, van Laarhoven CJHM, Dijkgraaf MGW, de Reuver PR; SECURE trial collaborators. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021 Oct 1;156(10):e213706. doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.
  PMID: 34379080
  citation: de Jong JJ, Latenstein CSS, Boerma D, Hazebroek EJ, Hirsch D, Heikens JT, Konsten J, Polat F, Lantinga MA, van Laarhoven CJHM, Drenth JPH, de Reuver PR. Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial). Ann Surg. 2022 Jun 1;275(6):e766-e772. doi: 10.1097/SLA.0000000000004453. Epub 2020 Sep 1.
  PMID: 32889877
  responsible party type: Sponsor
  mesh term: Irritable Bowel Syndrome
  mesh term: Gallstones
  mesh term: Dyspepsia
  mesh term: Abdominal Pain