Comparison of Laparoscopic Ultrasound to Transabdominal Ultrasound for the Detection of Gallbladder Pathology in the Bariatric Surgical Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.
研究概览
简要总结
The objective of this study is to prospectively compare laparoscopic ultrasound to transabdominal ultrasound for the detection of gallbladder pathology in obese patients presenting for laparoscopic gastric bypass. We hypothesize that laparoscopic ultrasound will be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly obese patients.
详细描述
Asymptomatic cholelithiasis is a prevalent condition in obese patients presenting for bariatric surgery. Transabdominal ultrasound (TAU) remains the gold standard for detection of cholelithiasis. The sensitivity and specificity of transabdominal ultrasound for cholelithiasis reported in literature is between 88-97% and 97-99%, respectively. The ability to detect cholelithiasis with TAU in the obese population may be inhibited due to the presence of increased subcutaneous and visceral fat. Laparoscopic ultrasound (LU) has the potential to overcome these technical challenges. In an era of minimally invasive bariatric surgery, it has been suggested that routine preoperative ultrasound TAU be performed for the detection of cholelithiasis since intraoperative palpation is not feasible. We hypothesize that laparoscopic ultrasound will be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly obese patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass
排除标准
- •Prior history of gallbladder surgery
结局指标
主要结局
Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.
时间窗: transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively
Number of patients with cholelithiasis.
Polyps on Transabdominal and Laparoscopic Ultrasound
时间窗: 6 years
Number of patients with polyps.
次要结局
- Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.(transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively)
研究者
Kara Kallies
Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI)
Gundersen Lutheran Medical Foundation
