An interventional study of RELIEF-pathway in Abdominal Pain, Gallstone; Colic and Dyspepsia, sponsored by Radboud University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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:
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.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's planned enrollment of 471 is above the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Primary endpoint
The primary outcome is the proportion of patients who will undergo diagnostic or treatment intervention within 12 months.
Time frame: 12 months
Time to diagnosis
time to diagnosis in days minimum value: 3 days, maxium value: 365 days, higher scores mean worse outcome.
Time frame: 12 months
outpatient clinic- or emergency room visits
outpatient clinic- or emergency room visits in numbers minimum value: 0 maximum value: 50 higher scores mean worse outcome
Time frame: 12 months
Pain severity
measured with Izbicky pain izbicky pain score: 0-100 scale, minimum: 0, maximum: 100, higher scores means worse outcome
Time frame: 12 months
Imaging use
Numbers of Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) Minimum: 0, maximum: 50, higher numbers means worse outcome
Time frame: 12 months
Morbidity and complications
will be specified by type of morbidity and complication minimum: 0 maximum: 100 Higher scores mean worse outcome
Time frame: 12 months
Patient-reported outcomes
Questionnaire: PAGI-SYM Patient Assessment of Upper Gastrointestinal Symptom Severity Index Heartburn / Regurgitation (7 items)Nausea / Vomiting (3 items)Postprandial Fullness / Early Satiety (4 items)Bloating (2 items)Upper Abdominal Pain (2 items)Lower Abdominal Pain (2 items). Patients rank their symptoms based on a 2-week recall period. Each symptom is rated on a 6-point scale:0 = None / Absent1 = Mild2 = Moderate3 = Severe4 = Very Severe5 = Extremely Severe A higher score indicates more severe symptoms and a greater physical burden. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Time frame: 12 months
Pain severity
VAS (visual analogue score): 0-10, minimum: 0, maximum: 10, higher scores means worse outcome
Time frame: 12 months
Patient-reported outcomes
Questionnaire: SHAI The Short Health Anxiety Inventory (SHAI) is an 18-item self-report questionnaire used to measure the severity of health anxiety and hypochondriasis. Total scores range from 0 to 54. Higher numerical scores reflect greater levels of preoccupation with health, bodily vigilance, and distress regarding potential illness.
Time frame: 12 months
Patient-reported outcomes
Questionnaire: SDM-Q-9 9-item Shared Decision Making Questionnaire. A 9-item self-report tool used to measure a patient's perception of shared decision-making during a medical consultation. Each item is rated on a 6-point scale from 0 ("completely disagree") to 5 ("completely agree"). 0 to 100 scale (higher scores mean greater perceived involvement (= better outcome)).
Time frame: 12 Months
Patient-reported outcome measurements
The iMTA Medical Consumption Questionnaire (iMCQ) scoring works by multiplying the self-reported frequency of each health care service use by its corresponding standard unit cost price. Higher score means worse outcome.
Time frame: 12 months
Plan to share: Undecided
Ran from Nov 2024 to primary completion in Apr 2026, 17 months.
Of 85 non-industry interventional studies with no phase under Abdominal Pain, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's 17 months is close to that.
Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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