Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

Completed

• Conditions: Cholelithiasis; Ultrasonography; Laparoscopic Gastric Bypass

• Registration Number: NCT00971750
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2010-10
• Study Completion: 2011-10
• Results First Submitted: 2012-03-23
• Results First Submitted QC: 2012-05-29
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Results First Posted: 2012-07-02
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

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

Exclusion Criteria

• Prior history of gallbladder surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.	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	6 years	Number of patients with polyps.

Secondary Outcome Measures

Name	Time	Method
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	Mean CBD diameter.

Trial Locations

Locations (1)

Gundersen Lutheran Health System; 🇺🇸 La Crosse, Wisconsin, United States