Clinical Trials Directory

Trials / Completed

CompletedNCT00971750

Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

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

Status
Completed
Phase
Study type
Observational
Enrollment
253 (actual)
Sponsor
Gundersen Lutheran Medical Foundation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2003-10-01
Primary completion
2010-10-01
Completion
2011-10-01
First posted
2009-09-04
Last updated
2012-07-11
Results posted
2012-07-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00971750. Inclusion in this directory is not an endorsement.