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Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00247377
First received: October 31, 2005
Last updated: May 11, 2010
Last verified: May 2010
History of Changes
Results First Received: January 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Morbid Obesity
Interventions: Procedure: Gastric bypass surgery
Procedure: Lap-Band

  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
recruitment between 2002 and 2007 in our bariatric surgery clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded because they did not want to undergo the randomized assignment or inability to obtain insurance coverage for the operation

Reporting Groups
  Description
Laparoscopic Gastric Bypass Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND) Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass

Participant Flow:   Overall Study
    Laparoscopic Gastric Bypass     Laparoscopic Adjustable Gastric Banding (LAP-BAND)  
STARTED     111     86  
COMPLETED     111     86  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Laparoscopic Gastric Bypass Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND) Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Total Total of all reporting groups

Baseline Measures
    Laparoscopic Gastric Bypass     Laparoscopic Adjustable Gastric Banding (LAP-BAND)     Total  
Number of Participants  
[units: participants]
 		  111     86     197  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     111     86     197  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  41.4  ± 11.0     45.8  ± 9.8     43.6  ± 10.4  
Gender  
[units: participants]
 		     
Female     86     65     151  
Male     25     21     46  
Region of Enrollment  
[units: participants]
 		     
United States     111     86     197  



  Outcome Measures
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1.  Primary:   Excess Weight Loss From Pre-operation to 5 Years Post-operation   [ Time Frame: Baseline to 5 years ]
  Show Outcome Measure 1

2.  Secondary:   Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Cost of Procedure to the Medical Facility on Date of Procedure   [ Time Frame: date of surgery ]
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4.  Secondary:   Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
  Show Outcome Measure 4

5.  Secondary:   Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
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6.  Secondary:   Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
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7.  Secondary:   Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
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8.  Secondary:   Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Measure Description change in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning
Time Frame Baseline to 12 months  
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.
No text entered.

Reporting Groups
  Description
Laparoscopic Gastric Bypass Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND) Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass

Measured Values
    Laparoscopic Gastric Bypass     Laparoscopic Adjustable Gastric Banding (LAP-BAND)  
Number of Participants Analyzed  
[units: participants]
 		  111     86  
Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation  
[units: units on a scale]
Mean ± Standard Deviation 		  92.8  ± 12     81.3  ± 31.3  

No statistical analysis provided for Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation



9.  Secondary:   Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
  Show Outcome Measure 9

10.  Secondary:   Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation   [ Time Frame: Baseline to 12 months ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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: Ninh Nguyen
Organization: UCI
phone: 714-456-8598
e-mail: ninhn@uci.edu


Publications of Results:


Responsible Party: Ninh T. Nguyen, MD, Chief, Division of Gastrointestinal Surgery University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00247377     History of Changes
Other Study ID Numbers: HS-2002-2394
Study First Received: October 31, 2005
Results First Received: January 19, 2010
Last Updated: May 11, 2010
Health Authority: United States: Institutional Review Board