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Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

This study has been completed.
Sponsor:
Collaborator:
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT00971750
First received: September 3, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Cholelithiasis
Ultrasonography
Laparoscopic Gastric Bypass

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Laparoscopic Ultrasound to Transabdominal Ultrasound for the Detection of Gallbladder Pathology in the Bariatric Surgical Population.

Resource links provided by NLM:

MedlinePlus related topics: Gallstones Obesity
U.S. FDA Resources

Further study details as provided by Gundersen Lutheran Medical Foundation:

Primary Outcome Measures:
  • Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. [ Time Frame: transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively ] [ Designated as safety issue: No ]
    Number of patients with cholelithiasis.

  • Polyps on Transabdominal and Laparoscopic Ultrasound [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Number of patients with polyps.


Secondary Outcome Measures:
  • Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. [ Time Frame: transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively ] [ Designated as safety issue: No ]
    Mean CBD diameter.


Enrollment: 253
Study Start Date: October 2003
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ultrasound Study Group
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior history of gallbladder surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971750

Locations
United States, Wisconsin
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Gundersen Lutheran Health System
Investigators
Principal Investigator: Shanu N Kothari, MD Gundersen Lutheran Health System
  More Information

Publications:

Responsible Party: Kara Kallies, Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI), Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT00971750     History of Changes
Other Study ID Numbers: 2-03-08-009
Study First Received: September 3, 2009
Results First Received: March 23, 2012
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gundersen Lutheran Medical Foundation:
ultrasonography
gallbladder
cholelithiasis
laparoscopic
 gastric bypass
obesity
bariatric surgery

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
 Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013