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

Sponsors

Lead sponsor: Gundersen Lutheran Medical Foundation

Collaborator: Gundersen Lutheran Health System

Source Gundersen Lutheran Medical Foundation
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.

Overall Status Completed
Start Date October 2003
Completion Date October 2011
Primary Completion Date October 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively
Polyps on Transabdominal and Laparoscopic Ultrasound 6 years
Secondary Outcome
Measure Time Frame
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
Enrollment 253
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Prior history of gallbladder surgery

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Shanu N Kothari, MD Principal Investigator Gundersen Lutheran Health System
Location
facility Gundersen Lutheran Health System
Location Countries

United States

Verification Date

June 2012

Responsible Party

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)

Keywords
Has Expanded Access No
Condition Browse
Arm Group

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

Source: ClinicalTrials.gov