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

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00247377
• Collaborator: (none)
• Enrollment: 197
• Location: 1
• Arms: 2
• Duration (Months): 86
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as "morbid obesity", is defined as being 100 pounds in excess of ideal body weight. Nonsurgical treatments for morbid obesity include exercise, dietary restriction, behavior modification, and pharmacological intervention. However, it is estimated that most patients undergoing nonsurgical treatments for weight reduction will regain their weight within 2 to 4 years after treatment. According to the NIH consensus conference in 1991, surgery remains the only effective sustained weight loss treatment for morbid obesity. The Roux-en-Y gastric bypass (GBP) is currently considered the gold standard bariatric surgical operation. Mean weight loss following GBP is approximately 65% of the excess body weight during the first 12 to 18 months postoperatively. Long-term weight loss is in the range of 55-70% of excess body weight loss.

Recently, the laparoscopic approach to GBP was reported. Wittgrove and colleagues reported their results of 75 patients who underwent laparoscopic GBP and demonstrated significant short-term advantages with comparable weight loss and reversal of comorbidities compared to the open approach. However, GBP might it be done laparoscopic or open approach can potentially be associated with significant morbidity and mortality such as anastomotic leak, pulmonary embolism, bowel obstruction, and postoperative stricture.

The FDA recently approved the laparoscopic adjustable banding system (LAP-BAND) for use in the United States in June 2001. The LAP-BAND system is a device designed to induce weight loss in severely obese patients. It is surgically placed around the proximal stomach to create a small proximal stomach pouch and restricted opening, or stoma, through which passage of food will be slowed. An inflatable portion along the inner aspect of the band is connected to an access port, placed intramuscularly. This enabled stoma adjustments to be made without the need for further surgery. The advantages of the LAP-BAND system included no cutting or opening of the stomach wall, ability to adjust the stoma and a technically easier operation to perform than laparoscopic GBP. We wanted to evaluate if the LAP-BAND procedure is as effective as the laparoscopic GBP procedure for treatment of morbid obesity.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Gastric bypass surgery; Procedure: Lap-Band	N/A

Detailed Description

RATIONALE:

1. Morbid obesity and its health consequences is increasing in the United States

2. Roux-en-Y GBP is an effective treatment for morbid obesity but can be associated with substantial morbidities

3. LAP-BAND system can be an effective treatment for morbidly obese patients with potentially reduced morbidity compared to laparoscopic GBP

HYPOTHESIS:

1. LAP-BAND can be performed safely and are associated with reduced postoperative pain, decrease in morbidity, decrease ICU and hospital stay, reduced costs, comparable improvement in quality-of-life, and acceptable long-term weight loss compared with laparoscopic GBP

2. LAP-BAND is associated with a decrease in fluid requirement in the perioperative period, improved postoperative pulmonary function, and lower intraabdominal pressure compared to laparoscopic GBP

3. LAP-BAND does not alter esophageal motility and is effective in improvement of gastroesophageal reflux disease (GERD) symptoms.

OBJECTIVES AND SPECIFIC AIMS:

1. To determine the short-term outcome, quality-of-life, costs, and long-term weight loss after laparoscopic GBP compared with LAP-BAND.

2. To compare physiologic changes such as perioperative fluid requirement, postoperative pulmonary function, and intraabdominal pressure after laparoscopic GBP and LAP-BAND.

3. To evaluate the effect of LAP-BAND on esophageal motility and its effectiveness in controlling gastroesophageal reflux symptoms (GERD) for morbidly obese patients with GERD.

Please note: All physician, hospital, laboratory costs, the barium study tests, and the performance of the operation will be billed to the subject or their insurer as customary since these procedures are standard of care regardless of participation in the study. The research procedures such as the pulmonary function tests, intra-abdominal pressure, body fat composition tests, resting energy expenditure, exercise testing, strength testing, nutritional assessments, and esophageal function tests are considered research-related and will be paid for by the investigator.

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial of Laparoscopic Gastric Bypass vs Laparoscopic Adjustable Gastric Banding (LAP-BAND) for Treatment of Morbid Obesity
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic Gastric Bypass Subject undergoes Laparoscopic Gastric Bypass	Procedure: Gastric bypass surgery; in order to meet health requirements for patient, gastric bypass surgery was undergone; Other Names: gastric bypass bypass surgery weight loss surgery
Active Comparator: LAP-BAND Subject undergoes LAP-BAND procedure	Procedure: Lap-Band; in order to meet health requirements for patient, gastric band surgery was undergone; Other Names: weight loss surgery band

Outcome Measures

Primary Outcome Measures

1. Excess Weight Loss From Pre-operation to 5 Years Post-operation [Baseline to 5 years]

   weight loss as measured by change in percent of excess body weight

Secondary Outcome Measures

1. Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   change in quality of life survey response where 0 is non-functioning and 100 is fully functioning

2. Cost of Procedure to the Medical Facility on Date of Procedure [date of surgery]

   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.

3. Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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

4. Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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

5. Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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

6. Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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.

7. Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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

8. Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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

9. Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation [Baseline to 12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Eligibility:

Inclusion Criteria:

1. Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities

2. Good health status with acceptable operative risk (good cardiopulmonary function)

3. Willingness to follow protocol requirements: Signing informed consent, follow-up, and completing protocol diagnostic tests

Exclusion Criteria:

1. Prior upper abdominal surgery except cholecystectomy

2. Large abdominal ventral hernia

3. Patients with hiatal hernia

4. Inadequate prior medical management

5. Lack of patient's motivation and contribution to long-term success

6. Unacceptable operative risk

7. Minors and pregnant women are excluded as these patients do not qualify for the bariatric procedures. Minors are not psychologically fit to undergo such surgery and pregnant women are excluded because of safety for the fetus.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy of California, Irvine, Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: Ninh T Nguyen, MD, University of California, Irvine Medical Center, Orange, CA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• PubMed Abstract

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00247377
• Other Study ID Numbers: HS-2002-2394
• First Posted: Nov 1, 2005
• Last Update Posted: May 18, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Morbid Obesity; Laparoscopic Gastric Bypass; Laparoscopic Gastric Banding
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

Participant Flow

Recruitment Details	recruitment between 2002 and 2007 in our bariatric surgery clinic
Pre-assignment Detail	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)
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

Baseline Characteristics

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)	Total
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 Participants	111	86	197
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	111 100%	86 100%	197 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.4 (11.0)	45.8 (9.8)	43.6 (10.4)
Sex: Female, Male (Count of Participants)
Female	86 77.5%	65 75.6%	151 76.6%
Male	25 22.5%	21 24.4%	46 23.4%
Region of Enrollment (participants) [Number]
United States	111 100%	86 100%	197 100%

Outcome Measures

1. Secondary Outcome

Title	Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
Description	change in quality of life survey response where 0 is non-functioning and 100 is fully functioning
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [units on a scale]	86.8 (14.2)	93.1 (8.8)

2. Primary Outcome

Title	Excess Weight Loss From Pre-operation to 5 Years Post-operation
Description	weight loss as measured by change in percent of excess body weight
Time Frame	Baseline to 5 years

Outcome Measure Data

Analysis Population Description

Availability of subjects and protocol design

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [percent change]	68.4 (19.5)	45.4 (27.6)

3. Secondary Outcome

Title	Cost of Procedure to the Medical Facility on Date of Procedure
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laparoscopic Gastric Bypass	Laparoscopic Adjustable Gastric Banding (LAP-BAND)
Arm/Group Description	Laparoscopic Gastric Bypass instead of LAP-Band	Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
Measure Participants	111	86
Mean (Standard Deviation) [units on a scale]	83.6 (14.1)	86 (14.3)

Adverse Events

Time Frame	2002-2007
Arm/Group Title	Laparoscopic Gastric Bypass		Laparoscopic Adjustable Gastric Banding (LAP-BAND)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Laparoscopic Gastric Bypass		Laparoscopic Adjustable Gastric Banding (LAP-BAND)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/111 (32.4%)		12/86 (14%)
Gastrointestinal disorders
gastrointestinal hemorrhage	2/111 (1.8%)	2	0/86 (0%)	2
gastrointestinal obstruction	4/111 (3.6%)	5	1/86 (1.2%)	5
abdominal pain requiring laparoscopy	2/111 (1.8%)	2	0/86 (0%)	2
bowel obstruction	1/111 (0.9%)	1	0/86 (0%)	1
General disorders
anastomotic stricture	17/111 (15.3%)	17	0/86 (0%)	17
failure of weight loss requiring revision of anastomosis	0/111 (0%)	2	2/86 (2.3%)	2
Injury, poisoning and procedural complications
internal herniation	1/111 (0.9%)	1	0/86 (0%)	1
internal hernia	2/111 (1.8%)	2	0/86 (0%)	2
ventral hernia	3/111 (2.7%)	3	0/86 (0%)	3
death related to alcohol	1/111 (0.9%)	1	0/86 (0%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
marginal ulcer	2/111 (1.8%)	2	0/86 (0%)	2
Nervous system disorders
peripheral neuropathy	1/111 (0.9%)	1	0/86 (0%)	1
Renal and urinary disorders
renal insufficiency	0/111 (0%)	1	1/86 (1.2%)	1
Surgical and medical procedures
anastomotic leak	0/111 (0%)	0	0/86 (0%)	0
port revision	0/111 (0%)	3	3/86 (3.5%)	3
band erosion/slippage erosion	0/111 (0%)	5	5/86 (5.8%)	5
Other (Not Including Serious) Adverse Events
	Laparoscopic Gastric Bypass		Laparoscopic Adjustable Gastric Banding (LAP-BAND)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/111 (28.8%)		4/86 (4.7%)
Gastrointestinal disorders
Prolonged Diarrhea	1/111 (0.9%)	1	0/86 (0%)	1
Ileus	1/111 (0.9%)	1	0/86 (0%)	1
Gastrointestinal Hemorrhage	1/111 (0.9%)	1	0/86 (0%)	1
Gastrointestinal Bleeding	2/111 (1.8%)	2	0/86 (0%)	2
Infections and infestations
Wound infection	7/111 (6.3%)	7	0/86 (0%)	7
Clostridium difficile infection	1/111 (0.9%)	2	1/86 (1.2%)	2
Metabolism and nutrition disorders
Dehydration require readmission	4/111 (3.6%)	5	1/86 (1.2%)	5
Severe iron deficiency requiring iron infusion	3/111 (2.7%)	3	0/86 (0%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal ulcer	9/111 (8.1%)	9	0/86 (0%)	9
Renal and urinary disorders
Urinary tract infection	2/111 (1.8%)	3	1/86 (1.2%)	3
Respiratory, thoracic and mediastinal disorders
Clinically significant atelectasis	0/111 (0%)	1	1/86 (1.2%)	1
Social circumstances
Alcohol Abuse	1/111 (0.9%)	1	0/86 (0%)	1

Limitations/Caveats

[Not Specified]

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.