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/m2 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.
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Ethical Approval
All procedures were conducted in accordance with good clinical practice and within the guidelines of the Declaration of Helsinki for studies using human subjects. The study was registered with the institutional review board of the Sanchinarro University Hospital of Madrid. Written informed consent was obtained from all patients. Data were collected prospectively for analysis.
Conflict of Interest
The study was fully funded by ReShape Medical. All the authors declare that they have no conflict of interest.
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Lopez-Nava, G., Bautista-Castaño, I., Jimenez-Baños, A. et al. Dual Intragastric Balloon: Single Ambulatory Center Spanish Experience with 60 Patients in Endoscopic Weight Loss Management. OBES SURG 25, 2263–2267 (2015). https://doi.org/10.1007/s11695-015-1715-6
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DOI: https://doi.org/10.1007/s11695-015-1715-6