Irritable Bowel Syndrome Clinical Trial
— RELIEFOfficial title:
The RELIEF-pathway in Patients With Upper Abdominal Pain; an Open-label Multicenter Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 471 |
Est. completion date | May 1, 2027 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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; |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Radboud University Medical Center |
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary endpoint | 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. |
6 months | |
Secondary | Patient-reported outcomes | 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). |
12 months |
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