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1.
Surg Obes Relat Dis ; 14(6): 748-750, 2018 06.
Article in English | MEDLINE | ID: mdl-29567060

ABSTRACT

BACKGROUND: We present our experience with same-day discharge (without an overnight stay) after laparoscopic sleeve gastrectomy (SG) in 821 consecutive patients from 2011 to 2015. This is the largest series published to date of patients undergoing ambulatory surgery for such a procedure. OBJECTIVES: To review our outcomes from ambulatory SG over 52 months to determine if SG can be safely performed in the ambulatory setting. SETTING: Ambulatory surgery center. METHODS: Retrospective review of all consecutive patients undergoing ambulatory SG from January 2011 to April 2015. All patients were discharged home the same day after surgery without an overnight stay at the hospital. Incidence of complications and admission to the hospital after discharge was reviewed up to 30 days from surgery. RESULTS: From January 2011 to April 2015, 821 consecutive patients underwent SG. Nineteen 30-day complications occurred in the series, 17 of them requiring admission to the hospital. Of the 19 cases, gastric leaks accounted for 7, intr-aabdominal abscess for 4, and dehydration/nausea/vomiting for 4; 4 were due to other causes. Complication and readmission rates at 30 days were 2.3% and 2.1%, respectively. Follow-up at 30 days was 98.4%. CONCLUSION: With stringent patient selection and utilization of enhanced recovery pathways, our study indicates that SG may be suitable for the outpatient setting. Experience and comfort with bariatric surgery is essential on the part of the operating surgeon to ensure good outcomes. Our low overall readmission and complication rate portends to the feasibility of laparoscopic SG as a safe outpatient procedure.


Subject(s)
Ambulatory Surgical Procedures/statistics & numerical data , Bariatric Surgery/statistics & numerical data , Gastrectomy/statistics & numerical data , Laparoscopy/statistics & numerical data , Adolescent , Adult , Aged , Ambulatory Surgical Procedures/adverse effects , Ambulatory Surgical Procedures/methods , Bariatric Surgery/adverse effects , Bariatric Surgery/methods , Feasibility Studies , Gastrectomy/adverse effects , Gastrectomy/methods , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Middle Aged , Obesity, Morbid/surgery , Patient Safety , Patient Selection , Postoperative Complications/etiology , Retrospective Studies , Treatment Outcome , Young Adult
2.
Clin Gastroenterol Hepatol ; 16(7): 1073-1080.e1, 2018 07.
Article in English | MEDLINE | ID: mdl-29425781

ABSTRACT

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.


Subject(s)
Bariatrics/adverse effects , Bariatrics/methods , Gastric Balloon/adverse effects , Obesity/therapy , Weight Loss , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Treatment Outcome , Young Adult
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