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NCT00971750 Clinical Trial

Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

Ultrasonography Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00971750
Other study ID # 2-03-08-009
Secondary ID
Status Completed
Phase N/A
First received September 3, 2009
Last updated June 29, 2012
Start date October 2003
Est. completion date October 2011

Study information
Verified date June 2012
Source Gundersen Lutheran Medical Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 253
Est. completion date October 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Prior history of gallbladder surgery

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Gundersen Lutheran Health System La Crosse Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Gundersen Lutheran Medical Foundation Gundersen Lutheran Health System

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cronan JJ. US diagnosis of choledocholithiasis: a reappraisal. Radiology. 1986 Oct;161(1):133-4. — View Citation

Einstein DM, Lapin SA, Ralls PW, Halls JM. The insensitivity of sonography in the detection of choledocholithiasis. AJR Am J Roentgenol. 1984 Apr;142(4):725-8. — View Citation

Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81. — View Citation

Yang HL, Li ZZ, Sun YG. Reliability of ultrasonography in diagnosis of biliary lithiasis. Chin Med J (Engl). 1990 Aug;103(8):638-41. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. Number of patients with cholelithiasis. transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively No
Primary Polyps on Transabdominal and Laparoscopic Ultrasound Number of patients with polyps. 6 years No
Secondary Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. Mean CBD diameter. transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively No
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