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临床试验/NCT00971750
NCT00971750已完成不适用

Comparison of Laparoscopic Ultrasound to Transabdominal Ultrasound for the Detection of Gallbladder Pathology in the Bariatric Surgical Population.

Gundersen Lutheran Medical Foundation1 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2003年10月最近更新:
适应症

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

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

发起方
Gundersen Lutheran Medical Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kara Kallies

Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI)

Gundersen Lutheran Medical Foundation

研究点 (1)

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