G Lopez-Nava1, I Bautista-Castaño2, A Jimenez-Baños2, J P Fernandez-Corbelle2. 1. Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, C/Oña n° 10, 28050, Madrid, Spain. gontrandlopeznava@gmail.com. 2. Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, C/Oña n° 10, 28050, Madrid, Spain.
Abstract
BACKGROUND: Many obese patients fail conventional medical management and decline bariatric surgery. Less invasive weight loss options such as intragastric balloons may provide an opportunity to reach this large number of untreated patients. The aim of this study was to investigate the safety and effectiveness of the Dual Intragastric Balloon (DIGB) in the treatment of obese patients, as well as the impact of degree of obesity, age, and gender. METHODS: The study was conducted at the Bariatric Endoscopy Unit of the Madrid Sanchinarro University Hospital. Sixty patients (11 men, 49 women) underwent endoscopic placement of a DIGB filled with a total of 900 cc of saline (450 cc in each balloon) for at least 6 months, along with regular counseling from a multidisciplinary team. Study outcomes included: change in body weight (TBWL), % of loss of initial body weight (%TBWL), % of excess body weight loss (%EWL), and adverse events. RESULTS: Initial BMI 38.8 kg/m(2) decreased 6.1 units, with mean TBWL, %TBWL, and %EWL of 16.6 kg, 15.4 %, and 47.1 %, respectively. We found no difference in %TBWL between grade of obesity, age or sex, but morbidly obese patients demonstrated greater TBWL, and women and less obese subjects obtained higher %EWL. The DIGB was generally well tolerated, with one early removal for patient intolerance, one early deflation without migration, and one gastric perforation. Fourteen patients had small, clinically insignificant ulcers or erosions noted at the time of removal. CONCLUSIONS: The present study shows that the DIGB was easy to use, resulted in significant weight loss, safe, and well tolerated.
BACKGROUND: Many obesepatients fail conventional medical management and decline bariatric surgery. Less invasive weight loss options such as intragastric balloons may provide an opportunity to reach this large number of untreated patients. The aim of this study was to investigate the safety and effectiveness of the Dual Intragastric Balloon (DIGB) in the treatment of obesepatients, as well as the impact of degree of obesity, age, and gender. METHODS: The study was conducted at the Bariatric Endoscopy Unit of the Madrid Sanchinarro University Hospital. Sixty patients (11 men, 49 women) underwent endoscopic placement of a DIGB filled with a total of 900 cc of saline (450 cc in each balloon) for at least 6 months, along with regular counseling from a multidisciplinary team. Study outcomes included: change in body weight (TBWL), % of loss of initial body weight (%TBWL), % of excess body weight loss (%EWL), and adverse events. RESULTS: Initial BMI 38.8 kg/m(2) decreased 6.1 units, with mean TBWL, %TBWL, and %EWL of 16.6 kg, 15.4 %, and 47.1 %, respectively. We found no difference in %TBWL between grade of obesity, age or sex, but morbidly obesepatients demonstrated greater TBWL, and women and less obese subjects obtained higher %EWL. The DIGB was generally well tolerated, with one early removal for patient intolerance, one early deflation without migration, and one gastric perforation. Fourteen patients had small, clinically insignificant ulcers or erosions noted at the time of removal. CONCLUSIONS: The present study shows that the DIGB was easy to use, resulted in significant weight loss, safe, and well tolerated.
Authors: Evzen Machytka; Pavel Klvana; Asher Kornbluth; Steven Peikin; Lisbeth E M Mathus-Vliegen; Christopher Gostout; Gontrand Lopez-Nava; Scott Shikora; Jeffrey Brooks Journal: Obes Surg Date: 2011-10 Impact factor: 4.129