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

NCT00247377 | Completed Results

• 1 other identifier: HS-2002-2394
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Morbid Obesity; Laparoscopic Gastric Bypass; Laparoscopic Gastric Banding

Outcome Measures

Primary Outcomes (1)

• Excess Weight Loss From Pre-operation to 5 Years Post-operation

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

  Baseline to 5 years

Secondary Outcomes (9)

• Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation

  Baseline to 12 months

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

  date of surgery

• Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation

  Baseline to 12 months

• Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation

  Baseline to 12 months

• Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation

  Baseline to 12 months

Study Arms (2)

Laparoscopic Gastric Bypass

ACTIVE COMPARATOR

Subject undergoes Laparoscopic Gastric Bypass

Procedure: Gastric bypass surgery

LAP-BAND

ACTIVE COMPARATOR

Subject undergoes LAP-BAND procedure

Procedure: Lap-Band

Interventions

Gastric bypass surgery PROCEDURE

in order to meet health requirements for patient, gastric bypass surgery was undergone

Also known as: gastric bypass, bypass surgery, weight loss surgery

Laparoscopic Gastric Bypass

Lap-Band PROCEDURE

in order to meet health requirements for patient, gastric band surgery was undergone

Also known as: weight loss surgery, band

LAP-BAND

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities
• Good health status with acceptable operative risk (good cardiopulmonary function)
• Willingness to follow protocol requirements: Signing informed consent, follow-up, and completing protocol diagnostic tests

You may not qualify if:

• Prior upper abdominal surgery except cholecystectomy
• Large abdominal ventral hernia
• Patients with hiatal hernia
• Inadequate prior medical management
• Lack of patient's motivation and contribution to long-term success
• Unacceptable operative risk
• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Univeristy of California, Irvine, Medical Center

Orange, California, 92868, United States

Location

Related Publications (1)

• 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 Oct;250(4):631-41. doi: 10.1097/SLA.0b013e3181b92480.

  PMID: 19730234 RESULT

Related Links

• PubMed Abstract

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass; Coronary Artery Bypass; Bariatric Surgery; Chromosome Banding

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Cytogenetic Analysis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Staining and Labeling; Histocytological Preparation Techniques; Histological Techniques; Investigative Techniques; Genetic Techniques

Results Point of Contact

• Title: Ninh Nguyen
• Organization: UCI

ninhn@uci.edu

714-456-8598

Study Officials

• Ninh T Nguyen, MD

  University of California, Irvine Medical Center, Orange, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor, Department of Surgery

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 1, 2005
• Study Start: October 1, 2002
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 24, 2023
• Results First Posted: April 6, 2010

Record last verified: 2023-03

Locations

US (1)