|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gundersen Lutheran Medical Foundation |
|---|---|
| Collaborator: |
Gundersen Lutheran Health System |
| Information provided by: | Gundersen Lutheran Medical Foundation |
| ClinicalTrials.gov Identifier: | NCT00971750 |
Purpose
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.
| Condition |
|---|
|
Cholelithiasis Ultrasonography Laparoscopic Gastric Bypass |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Comparison of Laparoscopic Ultrasound to Transabdominal Ultrasound for the Detection of Gallbladder Pathology in the Bariatric Surgical Population. |
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| Gundersen Lutheran Health System | |
| La Crosse, Wisconsin, United States, 54601 | |
| Principal Investigator: | Shanu N Kothari, MD | Gundersen Lutheran Health System |
More Information
| Responsible Party: | Gundersen Lutheran Health System ( Shanu N. Kothari, MD ) |
| Study ID Numbers: | 2-03-08-009 |
| Study First Received: | September 3, 2009 |
| Last Updated: | September 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00971750 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
ultrasonography gallbladder cholelithiasis laparoscopic |
gastric bypass obesity bariatric surgery |
|
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases |
Cholelithiasis Gallstones Biliary Tract Diseases Calculi |