Rationale Diet for Gallstone Disease (RADIGAL Trial): A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(RADIGAL1):
- •18 years old or older
- •presenting with biliary colic in the ED or outpatient clinic, with the surgical team deciding to proceed with non-operative treatment (Group 1)
- •presenting with acute calculous cholecystitis in the ED, with the surgical team deciding to proceed with non-operative management (Group 2)
排除标准
- •(RADIGAL1):
- •history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome
- •inability to provide informed consent
- •unwillingness to adhere to the recommended diet
- •food allergies or intolerances that would prevent following the diet
- •dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet
- •gallstone related cholangitis without biliary colic or cholecystitis
- •complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
- •Inclusion Criteria (RADIGAL2):
- •18 years old or older
- •undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to a history of biliary colic (Group 1)
- •undergoing uncomplicated cholecystectomy (open or laparoscopic without bile duct exploration) due to acute cholecystitis (Group 2)
- •Exclusion Criteria (RADIGAL2):
- •history of gastrointestinal disease which might affect diet, e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome
- •inability to provide informed consent
- •unwillingness to adhere to the recommended diet
- •food allergies or intolerances that would prevent following the diet - dietary habits (e.g., vegetarians, vegans) that preclude adherence to the recommended diet
- •gallstone related cholangitis without biliary colic or cholecystitis
- •complications from acute pancreatitis, such as pseudocysts, walled off necrosis, among others
- •choledocholithiasis
- •complicated cholecystectomy
- •patients undergoing subtotal cholecystectomy
- •whether primary operation differs from cholecystectomy (e.g., colectomy)
- •patients having treated with percutaneous cholecystostomy
结局指标
主要结局
Change in health-related quality of life as measured by the GIQLI score (RADIGAL1/2)
时间窗: Baseline, 3-month follow-up
The GIQLI questionnaire contains 36 questions on gastrointestinal symptoms (19 items), physical status (7 items), emotional status (5 items), and social function status (5 items). Patient responses are recorded as 'all the time, most of the time, some of the time, a little of the time, or never'. The most favorable option is scored as 4 points, whereas the least favorable option receives 0 points.
次要结局
- Unplanned Emergency Department (ED) visit or hospital admission (RADIGAL1/2)(Baseline, 3-month follow-up)
- Symptom Recurrence (RADIGAL1/2)(Baseline, 3-month follow-up)
- Unplanned or elective cholecystectomy (RADIGAL1)(Baseline, 3-month follow-up)
- Reason for discontinuing diet (RADIGAL1/2)(Baseline, 3-month follow-up)
- Food categories chosen when not following diet (RADIGAL1/2)(Baseline, 3-month follow-up)
- Patient adherence to the suggested diet (RADIGAL1/2)(Baseline, 3-month follow-up)
- Time of Diet Discontinuation (weeks or months) (RADIGAL1/2)(Baseline, 3-month follow-up)
研究者
Konstantinos Lasithiotakis
Assistant Professor of Surgery
University Hospital of Crete