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

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ClinicalTrials.gov Identifier: NCT00247377
Recruitment Status : Completed
First Posted : November 1, 2005
Results First Posted : April 6, 2010
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Morbid Obesity
Interventions Procedure: Gastric bypass surgery
Procedure: Lap-Band
Enrollment 197
Recruitment Details recruitment between 2002 and 2007 in our bariatric surgery clinic
Pre-assignment Details Patients were excluded because they did not want to undergo the randomized assignment or inability to obtain insurance coverage for the operation
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description Laparoscopic Gastric Bypass instead of LAP-Band Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Period Title: Overall Study
Started 111 86
Completed 111 86
Not Completed 0 0
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND) Total
Hide Arm/Group Description Laparoscopic Gastric Bypass instead of LAP-Band Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass Total of all reporting groups
Overall Number of Baseline Participants 111 86 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 86 participants 197 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
111
 100.0%
86
 100.0%
197
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 86 participants 197 participants
41.4  (11.0) 45.8  (9.8) 43.6  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 86 participants 197 participants
Female
86
  77.5%
65
  75.6%
151
  76.6%
Male
25
  22.5%
21
  24.4%
46
  23.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 86 participants 197 participants
111 86 197
1.Primary Outcome
Title Excess Weight Loss From Pre-operation to 5 Years Post-operation
Hide Description weight loss as measured by change in percent of excess body weight
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Availability of subjects and protocol design
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: percent change
68.4  (19.5) 45.4  (27.6)
2.Secondary Outcome
Title Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response where 0 is non-functioning and 100 is fully functioning
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
86.8  (14.2) 93.1  (8.8)
3.Secondary Outcome
Title Cost of Procedure to the Medical Facility on Date of Procedure
Hide Description operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery.
Time Frame date of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: dollars per patient
12310  (3099) 10767  (1631)
4.Secondary Outcome
Title Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
88.2  (12.5) 100.0  (0)
5.Secondary Outcome
Title Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.1  (28.8) 84.5  (24.5)
6.Secondary Outcome
Title Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.7  (18.1) 85.3  (12.7)
7.Secondary Outcome
Title Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale.
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.2  (22.4) 71.3  (14.3)
8.Secondary Outcome
Title Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
92.8  (12) 81.3  (31.3)
9.Secondary Outcome
Title Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.5  (47.6) 100  (0)
10.Secondary Outcome
Title Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation
Hide Description change in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description:
Laparoscopic Gastric Bypass instead of LAP-Band
Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.6  (14.1) 86  (14.3)
Time Frame 2002-2007
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Hide Arm/Group Description Laparoscopic Gastric Bypass instead of LAP-Band Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
All-Cause Mortality
Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/111 (32.43%)      12/86 (13.95%)    
Gastrointestinal disorders     
gastrointestinal hemorrhage   2/111 (1.80%)  2 0/86 (0.00%)  2
gastrointestinal obstruction   4/111 (3.60%)  5 1/86 (1.16%)  5
abdominal pain requiring laparoscopy   2/111 (1.80%)  2 0/86 (0.00%)  2
bowel obstruction   1/111 (0.90%)  1 0/86 (0.00%)  1
General disorders     
anastomotic stricture   17/111 (15.32%)  17 0/86 (0.00%)  17
failure of weight loss requiring revision of anastomosis   0/111 (0.00%)  2 2/86 (2.33%)  2
Injury, poisoning and procedural complications     
internal herniation   1/111 (0.90%)  1 0/86 (0.00%)  1
internal hernia   2/111 (1.80%)  2 0/86 (0.00%)  2
ventral hernia   3/111 (2.70%)  3 0/86 (0.00%)  3
death related to alcohol   1/111 (0.90%)  1 0/86 (0.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
marginal ulcer   2/111 (1.80%)  2 0/86 (0.00%)  2
Nervous system disorders     
peripheral neuropathy   1/111 (0.90%)  1 0/86 (0.00%)  1
Renal and urinary disorders     
renal insufficiency   0/111 (0.00%)  1 1/86 (1.16%)  1
Surgical and medical procedures     
anastomotic leak   0/111 (0.00%)  0 0/86 (0.00%)  0
port revision   0/111 (0.00%)  3 3/86 (3.49%)  3
band erosion/slippage erosion   0/111 (0.00%)  5 5/86 (5.81%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Laparoscopic Gastric Bypass Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/111 (28.83%)      4/86 (4.65%)    
Gastrointestinal disorders     
Prolonged Diarrhea   1/111 (0.90%)  1 0/86 (0.00%)  1
Ileus   1/111 (0.90%)  1 0/86 (0.00%)  1
Gastrointestinal Hemorrhage   1/111 (0.90%)  1 0/86 (0.00%)  1
Gastrointestinal Bleeding   2/111 (1.80%)  2 0/86 (0.00%)  2
Infections and infestations     
Wound infection   7/111 (6.31%)  7 0/86 (0.00%)  7
Clostridium difficile infection   1/111 (0.90%)  2 1/86 (1.16%)  2
Metabolism and nutrition disorders     
Dehydration require readmission   4/111 (3.60%)  5 1/86 (1.16%)  5
Severe iron deficiency requiring iron infusion   3/111 (2.70%)  3 0/86 (0.00%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Marginal ulcer   9/111 (8.11%)  9 0/86 (0.00%)  9
Renal and urinary disorders     
Urinary tract infection   2/111 (1.80%)  3 1/86 (1.16%)  3
Respiratory, thoracic and mediastinal disorders     
Clinically significant atelectasis   0/111 (0.00%)  1 1/86 (1.16%)  1
Social circumstances     
Alcohol Abuse   1/111 (0.90%)  1 0/86 (0.00%)  1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ninh Nguyen
Organization: UCI
Phone: 714-456-8598
EMail: ninhn@uci.edu
Layout table for additonal information
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
First Submitted: October 31, 2005
First Posted: November 1, 2005
Results First Submitted: January 19, 2010
Results First Posted: April 6, 2010
Last Update Posted: May 18, 2010