Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholelithiasis, Ultrasonography, Laparoscopic Gastric Bypass

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass Exclusion Criteria: Prior history of gallbladder surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound Study Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Polyps on Transabdominal and Laparoscopic Ultrasound | Number of patients with polyps. | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, gallbladder, cholelithiasis, laparoscopic, gastric bypass, obesity, bariatric surgery