Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Incidence of gallstones formation after bariatric surgery
研究概览
简要总结
Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. Many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in them. According to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.
详细描述
Study format: Prospective, randomized, blinded study. 266 candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40-50 and aged 18-65 will be studied.
The patients will be randomly divided into two groups (according to the last digit of the identity card number):
- Treatment group will receive preventive therapy with Ursodiol 600 mg per day as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.
- Placebo group will receive placebo as of day 10 after the surgery (at the first routine visit after the surgery) and for six months or until the formation of gallstones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for sleeve gastrectomy or gastric bypass surgery due to morbid obesity with BMI range of 40 to
- •Aged 18 to
- •No presence of gallstones.
- •Patients who have signed the consent form.
排除标准
- •Pregnant women,
- •Age over 65,
- •Sensitive to Ursodiol,
- •Gallstones,
- •Biliary tract pathologies,
- •Gallbladder wall thickening,
- •Patients after cholecystectomy,
- •Patients participating in another clinical trial.
研究组 & 干预措施
URSODIOL - URSODEOXYCHOLIC ACID
300 mg twice a day
干预措施: URSODIOL (Drug)
placebo
placebo twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of gallstones formation after bariatric surgery
时间窗: six month
- Six months after the surgery the subjects will be invited to re-evaluation of the presence of gallstones using: 1. Clinical interview: Did he experience epigastric pain? Was he hospitalized with diagnosis of biliary colic or cholecystitis? 2. US of the upper abdomen to assess the presence of gallstones, gallbladder wall thickening or other disorder. 3. Blood tests for liver functions and lipids profile
次要结局
未报告次要终点
研究者
Nasser Sakran
MD
HaEmek Medical Center, Israel