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Gallstone; Colic clinical trials

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NCT ID: NCT06405906 Recruiting - Dietary Habits Clinical Trials

A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

RADIGAL
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in patients undergoing cholecystectomy for gallstone disease. The main question it aims to answer is: • Is balanced WHO diet as good as low-fat diet in terms of patient reported outcomes when gallstone disease is managed non-operatively (RADIGAL-1) or cholecystectomy is performed (RADIGAL-2)? A validated QoL questionnaire (Gastrointestinal Quality of Life Index - GIQLI) will be administered both at baseline and during follow-up. Analysis of covariance with ordinary least squares estimation will be applied to estimate between-group differences in GIQLI scores at 3 months (primary endpoint). Patient adherence and the disease-related symptoms occurrence or hospitalizations will also be appraised (secondary endpoint). Participants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing cholecystectomy for gallstones (RADIGAL-2) will: - be randomly assigned to recommending either a fat-free or a balanced WHO diet . - be contacted via phone call to complete the GIQLI questionnaire and document overall adherence to the diets and secondary outcome events. This trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.

NCT ID: NCT06002516 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome

RELIEF-pathway in Patients With Upper Abdominal Pain

RELIEF
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04661319 Not yet recruiting - Gallstone; Colic Clinical Trials

Impact of Video Editing Training for Novice Trainees in Laparoscopic Cholecystectomy

Start date: January 2, 2021
Phase: N/A
Study type: Interventional

Surgical practice training often suffers from poor educational efficiency due to the technical difficulties of the cases, the lack of resources and the cases in the operating room. The video editing training method is not included in the standard surgical training, but it has the advantage of reducing trial and error and errors during surgery, simplifying training time, and cost-effective. Investigators analyzed whether the video editing teaching method has effective value for trainees compared to the traditional teaching method. The primary purpose of the study is the trainee's learning achievement in terms of surgical skills. Learning achievement is measured as the difference in pre- and post-educational test scores (The Global Operative Assessment of Laparoscopic Skills (GOALS)) to compare the difference in achievement. The secondary objective of the study was to evaluate the satisfaction with the video editing method as an educational method by conducting a questionnaire survey to all the trainees participating in the study. In addition, the degree of postoperative pain, postoperative hospitalization period, postoperative readmission and the need for additional procedures were compared and analyzed.