ABSTRACT
This article was originally published electronically on the publisher's internet portal on May 5, 2020 without open access.
ABSTRACT
An author name was incorrectly indicated in the Conflict of Interest Statement.
ABSTRACT
PURPOSE: The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population. MATERIALS AND METHODS: Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. RESULTS: Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically). CONCLUSION: The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.
Subject(s)
Gastric Balloon , Obesity, Morbid , Adult , Body Mass Index , Humans , Middle Aged , Obesity, Morbid/surgery , Treatment Outcome , Weight LossABSTRACT
BACKGROUND: We have an 11-year experience with Silastic ring vertical gastroplasy (SRVG) by laparotomy (1991-1994), followed by SRVG by mini-laparotomy (1995-2002), giving a total of 1,286 patients up to May 31, 2002. Searching for optimal results, we have utilized a new device; the Silastic ring has been replaced by the Proring-Band. METHODS: 174 mini-laparotomy SRVGs (mini-SRVG) were carried out with the Proring-Band from July 16, 2001 to May 31, 2002. RESULTS: The ring is more flexible, slightly elastic and white-colored. At the operation, handling, fixing to the stomach and extraction were easier. No immediate postoperative complications or overall morbidities were related to the new band. No side-effect has been noted. CONCLUSIONS: The Proring-Band appeared simpler in its use, during preparatory extra-body handling, placement and fixation. Considering its flexibility, its flat part and its smooth edges, the Proring-Band appears to present less risk of dysphagia, rupture and migration. This situation will be evaluated in a comparative blind study with a follow-up of more than 2 years. The Proring-Band ring is manufactured, sterilized and marketed by a pharmaceutical company. The use of this ring, provided as a medical device designed for restrictive surgery, assures to the surgeon a reproducibility of the material and of the sterilization conditions.
