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OpenTrials
Completed

NCT Number: NCT00971750

Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Body Weight Digestive System Diseases Laparoscopic Gastric Bypass Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Ultrasonography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior history of gallbladder surgery

Treatment and study plan

Primary outcomes

  1. 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.

  2. Polyps on Transabdominal and Laparoscopic Ultrasound

    Time frame: 6 years

    Number of patients with polyps.

Secondary outcomes

  1. 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

    Mean CBD diameter.

Sponsors and collaborators

Lead sponsor

Gundersen Lutheran Medical Foundation

Other

Collaborators

  • Gundersen Lutheran Health System

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2010
Study completion
2011
First posted
Sep 4, 2009
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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