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Clinical Trials/NCT00971750
NCT00971750
Completed
Not Applicable

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

Gundersen Lutheran Medical Foundation1 site in 1 country253 target enrollmentOctober 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholelithiasis
Sponsor
Gundersen Lutheran Medical Foundation
Enrollment
253
Locations
1
Primary Endpoint
Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
October 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Gundersen Lutheran Medical Foundation
Responsible Party
Principal Investigator
Principal Investigator

Kara Kallies

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

Gundersen Lutheran Medical Foundation

Eligibility Criteria

Inclusion Criteria

  • Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass

Exclusion Criteria

  • Prior history of gallbladder surgery

Outcomes

Primary Outcomes

Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.

Time Frame: 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

Time Frame: 6 years

Number of patients with polyps.

Secondary Outcomes

  • 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)

Study Sites (1)

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