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Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

This study has been completed.
Sponsor:
Collaborator:
Gundersen Lutheran Health System
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier:
NCT00971750
First received: September 3, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
Results First Received: March 23, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Cholelithiasis
Ultrasonography
Laparoscopic Gastric Bypass

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Ultrasound Study Group  
STARTED     253  
COMPLETED     253  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    Ultrasound Study Group  
Number of Participants  
[units: participants]
 		  253  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     251  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  43.5  ± 9.2  
Gender  
[units: participants]
 		 
Female     192  
Male     61  
Region of Enrollment  
[units: participants]
 		 
United States     253  



  Outcome Measures
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1.  Primary:   Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.   [ Time Frame: transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively ]
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2.  Primary:   Polyps on Transabdominal and Laparoscopic Ultrasound   [ Time Frame: 6 years ]
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3.  Secondary:   Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.   [ Time Frame: transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively ]
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Measure Type Secondary
Measure Title Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.
Measure Description Mean CBD diameter.
Time Frame transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Transabdominal Ultrasound 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.
Laparoscopic Ultrasound Laparoscopic ultrasound is performed intraoperatively during gastric bypass

Measured Values
    Transabdominal Ultrasound     Laparoscopic Ultrasound  
Number of Participants Analyzed  
[units: participants]
 		  253     253  
Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.  
[units: millimeters]
Mean ± Standard Deviation 		  4.0  ± 1.28     3.7  ± 1.37  

No statistical analysis provided for Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Shanu Kothari
Organization: Gundersen Lutheran Health System
phone: 608-775-2331
e-mail: snkothar@gundluth.org


Publications:


Responsible Party: Kara Kallies, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT00971750     History of Changes
Other Study ID Numbers: 2-03-08-009
Study First Received: September 3, 2009
Results First Received: March 23, 2012
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board