Abdominal PainRELIEFNCT06002516
RELIEF-pathway in Patients With Upper Abdominal Pain
A study testing RELIEF-pathway in people with Abdominal Pain and Gallstone; Colic, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Pain, Gallstone; Colic, Dyspepsia
- What is being tested?
- RELIEF-pathway
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2024to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unexplained weight loss
- Persistent vomiting
- Gastrointestinal bleeding
- Any other direct or indirect signs of cancer or upper GI tract bleeding
- Anemia
- Jaundice
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
About this study
Official title: The RELIEF-trial for Patients With Upper Abdominal Pain: Study Protocol for a Randomized Controlled Trial to Investigate the Effectiveness of a Web-based Self-management Tool Compared With Usual Care for Reduction of Healthcare Utilization and Improvement of Patient-reported Outcomes
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.
Read the 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.
- Conditions
- Abdominal Pain, Gallstone; Colic, Dyspepsia, Irritable Bowel Syndrome, Health Care Utilization, Patient Reported Outcomes
- Being tested
- RELIEF-pathway
- Keywords
- Abdominal pain, Health care utilization
- Medical subject headings
- Abdominal Pain, Gallstones, Colic, Dyspepsia, Irritable Bowel Syndrome, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELIEF-pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RELIEF-pathway |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
The primary outcome is the proportion of patients who will undergo diagnostic or treatment intervention within 12 months.
Measured: 12 months
Secondary outcomes (10)
Time to diagnosis
time to diagnosis in days
minimum value: 3 days, maxium value: 365 days, higher scores mean worse outcome.
Measured: 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
Measured: 12 months
Pain severity
measured with Izbicky pain
izbicky pain score: 0-100 scale, minimum: 0, maximum: 100, higher scores means worse outcome
Measured: 12 months
Imaging use
Numbers of Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)
Minimum: 0, maximum: 50, higher numbers means worse outcome
Measured: 12 months
Morbidity and complications
will be specified by type of morbidity and complication
minimum: 0 maximum: 100 Higher scores mean worse outcome
Measured: 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.
Measured: 12 months
Pain severity
VAS (visual analogue score): 0-10, minimum: 0, maximum: 10, higher scores means worse outcome
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 471 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cornelis van Laarhoven, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002516
- Sponsor's protocol ID
- 2021-12618
- Acronym
- RELIEF
- Status last verified
- Jul 2026
- First submitted
- 7 Aug 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33900373van 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.
PubMed 31036336Kok 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.
PubMed 23325277Latenstein 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.
PubMed 34379080de 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.
PubMed 32889877
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELIEF-trial for Patients With Upper Abdominal Pain: Study Protocol for a Randomized Controlled Trial to Investigate the Effectiveness of a Web-based Self-management Tool Compared With Usual Care for Reduction of Healthcare Utilization and Improvement of Patient-reported Outcomes
- ClinicalTrials.gov ID
- NCT06002516
- Acronym / sponsor ID
- RELIEF / 2021-12618
- Conditions
- Abdominal Pain, Gallstone; Colic, Dyspepsia, Irritable Bowel Syndrome, Health Care Utilization, Patient Reported Outcomes
- Keywords
- Abdominal pain, Health care utilization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 471 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RELIEF pathway | Experimental | Other: RELIEF-pathwayPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Unexplained weight loss
- Persistent vomiting
- Gastrointestinal bleeding
- Any other direct or indirect signs of cancer or upper GI tract bleeding
- Anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELIEF-pathwayThe 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. | Other | RELIEF pathway |
Primary outcome
Primary endpoint
Time frame: 12 months
The primary outcome is the proportion of patients who will undergo diagnostic or treatment intervention within 12 months.
10 secondary outcomes
Time to diagnosis
Time frame: 12 months
outpatient clinic- or emergency room visits
Time frame: 12 months
Pain severity
Time frame: 12 months
Imaging use
Time frame: 12 months
Morbidity and complications
Time frame: 12 months
Patient-reported outcomes
Time frame: 12 months
Pain severity
Time frame: 12 months
Patient-reported outcomes
Time frame: 12 months
Patient-reported outcomes
Time frame: 12 Months
Patient-reported outcome measurements
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 33900373de 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.
- Background: PubMed 31036336van 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.
- Background: PubMed 23325277Kok 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.
- Background: PubMed 34379080Latenstein 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.
- Background: PubMed 32889877de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelis van Laarhoven, MD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELIEF-pathway in people with Abdominal Pain and Gallstone; Colic, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002516, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.