NCT01703546

Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

Detailed description

Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
PROCEDURE	LAGB & LGCP	All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band \& Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-10-10
• Last updated: 2016-01-14

Locations

2 sites across 1 country: United States