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| Name | Class |
|---|---|
| Gundersen Lutheran Health System | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution.
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| Name | Affiliation | Role |
|---|---|---|
| Shanu N Kothari, MD | Gundersen Lutheran Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gundersen Lutheran Health System | La Crosse | Wisconsin | 54601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2122943 | Background | Yang HL, Li ZZ, Sun YG. Reliability of ultrasonography in diagnosis of biliary lithiasis. Chin Med J (Engl). 1990 Aug;103(8):638-41. | |
| 3532178 | Background | Cronan JJ. US diagnosis of choledocholithiasis: a reappraisal. Radiology. 1986 Oct;161(1):133-4. doi: 10.1148/radiology.161.1.3532178. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | Number of patients with cholelithiasis. | Posted | Number | participants | transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shanu Kothari | Gundersen Lutheran Health System | 608-775-2331 | snkothar@gundluth.org |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| 7979854 | Background | 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. |
| 6608231 | Background | 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. doi: 10.2214/ajr.142.4.725. |
| 23571143 | Derived | Kothari SN, Obinwanne KM, Baker MT, Mathiason MA, Kallies KJ. A prospective, blinded comparison of laparoscopic ultrasound with transabdominal ultrasound for the detection of gallbladder pathology in morbidly obese patients. J Am Coll Surg. 2013 Jun;216(6):1057-62. doi: 10.1016/j.jamcollsurg.2013.02.009. Epub 2013 Apr 6. |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | Mean CBD diameter. | Posted | Mean | Standard Deviation | millimeters | transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively |
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| Primary | Polyps on Transabdominal and Laparoscopic Ultrasound | Number of patients with polyps. | Posted | Number | participants | 6 years |
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| 0 |
| 253 |
| 0 |
| 253 |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |