[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516284":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":38,"collaborators":18,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":67,"overallStatus":70,"whyStopped":18,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":18},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RELIEF pathway","EXPERIMENTAL","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.",[13],"Other: RELIEF-pathway",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","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.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"RELIEF-pathway","The personalized web-based education tool contains information on:\n\n* Information of cause and symptoms of functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis;\n* Symptom checker based on the ROME III and ROME IV criteria;\n* Red flags symptoms defined as direct or indirect signs of upper GI hemorrhage.\n* Lifestyle adjustments to improve abdominal symptoms and quality of life.\n* Information on effect of upper gastrointestinal endoscopy, colonoscopy and laparoscopic cholecystectomy.\n\nAfter 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.",[9],[25],{"name":26,"affiliation":5,"role":27},"Cornelis van Laarhoven, MD PhD","PRINCIPAL_INVESTIGATOR",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Daan Comes, MD","CONTACT","024 361 3808","+31","daan.comes@radboudumc.nl",{"name":36,"role":31,"phone":32,"phoneExt":33,"email":37},"Philip de Reuver, MD PhD","philip.dereuver@radboudumc.nl",{"type":39,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100516284","relief-pathway-in-patients-with-upper-abdominal-pain-100516284",false,"NCT06002516","RELIEF-pathway in Patients With Upper Abdominal Pain","The RELIEF-pathway in Patients With Upper Abdominal Pain; an Open-label Multicenter Randomized Controlled Trial","RELIEF","Inclusion Criteria:\n\n* Patients between 18 and 70 years old.\n* 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).\n* Proficient in reading and understanding of the Dutch language.\n* Referred to the outpatient clinic of gastroenterology or surgery.\n* Providing informed consent.\n\nExclusion Criteria:\n\n* 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.\n* Any other direct or indirect signs of cancer or upper GI tract bleeding.\n* Patients with a first or second-degree relative with a history of upper GI tract malignant neoplasm.\n* Patients with a history of complicated cholecystolithiasis.\n* A history of or current malignancy (except SCC or BCC of the skin).\n* Pregnancy;\n* Expected short life span of less than 12 months.\n* Known cirrhosis of the liver\n* Current schizophrenia, memory deficiency, or any other disorder that predispose them to unreliable questionnaire responses;\n* Mentally incompetent;","ALL","18 Years","70 Years",{"count":52,"type":53},471,"ESTIMATED","INTERVENTIONAL",[56],"NA","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.\n\nEducation 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\u002For 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.\n\nThis 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.",[59,60,61,62,63,64,65,66],"Abdominal Pain","Gallstone; Colic","Dyspepsia","Irritable Bowel Syndrome","Health Care Utilization","Patient Reported Outcomes","Upper Abdominal Pain","Decision Aid",[68,69],"Abdominal pain","Health care utilization","NOT_YET_RECRUITING","2023-08-15",{"date":73,"type":74},"2023-08-21","ACTUAL",{"date":76,"type":53},"2024-05-01",{"date":78,"type":53},"2027-05-01",{"name":5,"class":6}]