Cholelithiasis, Laparoscopic Gastric Bypass, Ultrasonography
Conditions
Keywords
ultrasonography, gallbladder, cholelithiasis, laparoscopic, gastric bypass, obesity, bariatric surgery
Brief 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.
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.
Interventions
None listed
Sponsors
Gundersen Lutheran Health System
Gundersen Lutheran Medical Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass
Exclusion criteria
* Prior history of gallbladder surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively | Number of patients with cholelithiasis. |
| Polyps on Transabdominal and Laparoscopic Ultrasound | 6 years | Number of patients with polyps. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively | Mean CBD diameter. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 253 |
| Total | 253 |
Baseline characteristics
| Characteristic | Ultrasound Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 251 Participants |
| Age Continuous | 43.5 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 253 participants |
| Sex: Female, Male Female | 192 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 253 |
| serious Total, serious adverse events | 0 / 253 |
Outcome results
Primary
Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.
Number of patients with cholelithiasis.
Time frame: transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transabdominal Ultrasound | Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | 61 participants |
| Laparoscopic Ultrasound | Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | 60 participants |
p-value: 0.763Chi-squared
Primary
Polyps on Transabdominal and Laparoscopic Ultrasound
Number of patients with polyps.
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transabdominal Ultrasound | Polyps on Transabdominal and Laparoscopic Ultrasound | 6 participants |
| Laparoscopic Ultrasound | Polyps on Transabdominal and Laparoscopic Ultrasound | 41 participants |
p-value: <0.001Chi-squared
Secondary
Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.
Mean CBD diameter.
Time frame: transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transabdominal Ultrasound | Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | 4.0 millimeters | Standard Deviation 1.28 |
| Laparoscopic Ultrasound | Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. | 3.7 millimeters | Standard Deviation 1.37 |