Comparison of Laparoscopic Ultrasound to Transabdominal Ultrasound for the Detection of Gallbladder Pathology in the Bariatric Surgical Population.
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
Lead sponsor: Gundersen Lutheran Medical Foundation
Collaborator: Gundersen Lutheran Health System
|Source||Gundersen Lutheran Medical Foundation|
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.
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.
|Start Date||October 2003|
|Completion Date||October 2011|
|Primary Completion Date||October 2010|
Sampling method: Non-Probability Sample
Inclusion Criteria: - Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass Exclusion Criteria: - Prior history of gallbladder surgery
- Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass
- Prior history of gallbladder surgery
Minimum age: 18 Years
Maximum age: N/A
Healthy volunteers: No
Responsible party type: Principal Investigator
Investigator affiliation: Gundersen Lutheran Medical Foundation
Investigator full name: Kara Kallies
Investigator title: Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI)
|Has Expanded Access||No|
Arm group label: Ultrasound Study Group
Description: Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
|Study Design Info||
Observational model: Case-Only
Time perspective: Prospective