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

This study has been completed.

Study NCT00247377 Information provided by University of California, Irvine

First Received on October 31, 2005. Last Updated on May 11, 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

Hide Participant Flow

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

Hide Baseline Characteristics

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

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

Show All Outcome Measures

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 ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

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

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

Nguyen NT, Slone JA, Nguyen XM, Hartman JS, Hoyt DB. A Prospective Randomized Trial of Laparoscopic Gastric Bypass Versus Laparoscopic Adjustable Gastric Banding for the Treatment of Morbid Obesity: Outcomes, Quality of Life, and Costs. Ann Surg. 2009 Aug 27; [Epub ahead of print]

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