N/A
N=253
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
Cholelithiasis · Ultrasonography · Laparoscopic Gastric Bypass
Bottom Line
View on ClinicalTrials.gov: NCT00971750 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. — 61; 60 participants — p=0.763
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gundersen Lutheran Medical Foundation
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound. |
61; 60 | 0.763 |
| PRIMARY Polyps on Transabdominal and Laparoscopic Ultrasound |
6; 41 | <0.001 sig |
| SECONDARY Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound. |
4.0; 3.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass
Exclusion Criteria
- Prior history of gallbladder surgery
Data sourced from ClinicalTrials.gov (NCT00971750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.