Prospective, multicenter, 3-year trial of laparoscopic adjustable gastric banding with the MIDBAND™.

BACKGROUND

Although laparoscopic adjustable gastric banding (LAGB) is a popular metabolic/bariatric procedure, few prospective studies have assessed its outcomes. This study aimed to prospectively assess LAGB safety and effectiveness outcomes using the MIDBAND™ (MID, Dardilly, France).

METHODS

Between May 2005 and September 2006, 262 morbidly obese patients underwent primary gastric banding with pars flaccida technique in 13 French medical centers. Excess weight loss and change in body mass index (BMI, kilogram per square meter), percentage of patients with comorbidities, and obesity-related complications were recorded. Patients were followed at 6-month intervals for 3 years. A multivariable individual growth model was used to analyze weight change over time and determine potential predictors of weight loss.

RESULTS

The majority of patients were female (n = 233, 89%), with mean age of 36.4 ± 9.7 years. At 3 years, LAGB with MIDBAND resulted in significant decrease in mean BMI from 41.8 ± 4.2 to 30.7 ± 5.8 (p < 0.0001). Median excess weight loss and excess BMI loss were 61% and 68%, respectively. The prevalence of obesity-related comorbidities had significantly decreased from 71% to 15% (p < 0.0001). Complications were observed in 26 patients (10%); device-related complications occurred in 20 patients (8.2%), requiring band removal in 8 (3.3%), and port revision in 8 (3.3%). Individual growth analysis identified significant predictors of weight loss including the number of follow-up visits.

CONCLUSION

Prospective outcomes demonstrate the safety and efficacy of gastric banding over time using the MIDBAND. Individual growth modeling demonstrated that postoperative weight loss is strongly related to the frequency and consistency of follow-up visits.