A Prospective Multicenter Standard of Care Study of Outpatient Laparoscopic Sleeve Gastrectomy.

A global shift is occurring as hospital procedures move to ambulatory surgical settings. Surgeons have performed outpatient sleeve gastrectomy (SG) in bariatric surgery since 2010. However, prospective trials are needed to ensure its safety before widespread adoption. PURPOSE: The study aimed to present a comprehensive report on the prospective data collection of 30-day outcomes of outpatient primary laparoscopic SG (LSG). This trial seeks to assess whether outpatient LSG is non-inferior to hospital-based surgery in selected patients who meet the outpatient surgery criteria set by the American Society for Metabolic and Bariatric Surgery. MATERIALS AND METHODS: This study is funded by the Society of American Gastrointestinal and Endoscopic Surgeons and has been approved by the Advarra Institutional Review Board (Pro00055990). Cognizant of the necessity for a prospective approach, data collection commenced after patients underwent primary LSG procedures, spanning from August 2021 to September 2022, at six medical centers across the USA. Data centralization was facilitated through ArborMetrix. Each center has its own enhanced recovery protocols, and no attempt was made to standardize the protocols. RESULTS: The analysis included 365 patients with a mean preoperative BMI of 43.7 ± 5.7 kg/m2. Rates for 30-day complications, reoperations, readmissions, emergency department visits, and urgent care visits were low: 1.6%, .5%, .2%, .2%, and 0%, respectively. Two patients (0.5%) experienced grade IIIb complications. There were no mortalities or leaks reported. CONCLUSION: The prospective cohort study suggests that same-day discharge following LSG seems safe in highly selected patients at experienced US centers.

LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study.

OBJECTIVE: The goal of this study was to examine the safety and effectiveness of the LAP-BAND System for patients with 30-39.9 BMI and associated comorbidities. DESIGN AND METHODS: In this prospective, multicenter, interventional cohort study, subjects with a BMI between 30 and 39.9 who had failed prior weight loss attempts were recruited from 7 surgical centers. The primary effectiveness endpoint required that >40% of subjects achieve ≥30% excess weight loss (EWL) at 1 year. Secondary endpoints included assessment of comorbidities and quality-of-life. RESULTS: Of 149 subjects, 90.6% were female, with mean BMI of 35.3 kg/m2 . At 1 year, 84.6% of subjects achieved ≥30% EWL (P < 0.0001), with 65.0% mean EWL; 66.4% of subjects were no longer obese (BMI < 30). Baseline comorbidities improved at 1 year for 64.4% with dyslipidemia, 59.6% with hypertension, and 85.7% with diabetes. Quality-of-life (IWQOL-Lite) also improved (P < 0.0001). The Year 1 results were maintained or improved at 2 years. Regression analysis indicates that each additional 10% weight loss at Year 2 was associated with an increase in IWQOL-Lite by 7.1 points and a decrease in triglycerides by 13.7 mg/dL, fasting glucose by 3.5 mg/dL, and systolic blood pressure by 3.3 mmHg. Most adverse events were mild to moderate and resolved without sequelae within 1 month. Five subjects (3.4%) had explantations. CONCLUSION: LAGB is safe and effective for people with 30-39.9 BMI, with weight loss and comorbidity improvement through at least 2 years.

Hyperbaric side effects in a traumatic brain injury randomized clinical trial.

OBJECTIVE: To catalog the side effects of 2.4 atmospheres absolute (atm abs) hyperbaric oxygen (HBO2) vs. sham on post-concussion symptoms in military service members with combat-related, mild traumatic brain injury (TBI). METHODS: Fifty subjects diagnosed with TBI were randomized to either a sham (1.3 atm abs breathing air) or treatment (2.4 atm abs breathing 100% oxygen) hyperbaric profile. Forty-eight subjects completed 30 exposures. Medical events during hyperbaric exposures were separately annotated by medical staff and chamber operators. After the blind was broken, events were segregated into the exposure groups. RESULTS: These side effects were observed as rate (sham/treatment): ear block (ear barotrauma) 5.51% (1.09%/5.91%), sinus squeeze 0.14% (0.0%/0.27%), and confinement anxiety 0.27% (0.27%/0.27%). Other conditions that occurred included: headache 0.61% (0.68%/0.54%); nausea 0.2% (0.14%/0.27%); numbness 0.07% (0%/0.13%); heartburn 0.07% (0.14%/0%); musculoskeletal chest pain 0.07% (0%/0.13%); latex allergy 0.07% (0.14%/0%); and hypertension 0.07% (0.14%/0%). CONCLUSION: This study demonstrated no major adverse events, such as pulmonary barotraumas, pulmonary edema or seizure. Given the infrequent, mild side effect profile, the authors feel the study demonstrated that hyperbaric oxygen therapy (HBO2T) was safe at a relatively high treatment pressure in TBI subjects, and these data can be used to evaluate the risk/ benefit calculation when deciding to utilize HBO2T for treatment of various diseases in the TBI population.

Neurological altitude decompression sickness among U-2 pilots: 2002-2009.

INTRODUCTION: Compared to the previous 47 yr, U-2 pilots reported an increased number of altitude decompression sickness (DCS) incidents with central nervous system (CNS) manifestations during 2002-2009. Due to increasing incident severity during military operations, the U.S. Air Force initiated an investigation to prevent future mishaps. METHODS: We retrospectively examined all neurological DCS cases observed among U-2 pilots during 2002-2009. Urgency to prevent further pilot losses limited this study to using existing, often incomplete data sources. RESULTS: During 2002-2009, 16 confirmed incidents of CNS DCS occurred with 13 pilots, plus 4 possible incidents with 4 pilots. Significantly, 12 of 16 confirmed incidents occurred at 1 operating location, including 4 of 5 life-threatening cases. This series of cases were of a type and severity rarely found in flight operations and correlated temporally with increased sortie frequency/duration associated with combat operations. Multiple investigations confirmed no defects in aircraft, support equipment, or oxygen supplies. Nor were significant trends observed with age, habitus, environmental exposure, medication use, or cardiac defects. In 11 cases, symptom recognition occurred well after the 4-h point where clinical experience indicated risk should stabilize. Symptoms also recurred days later and responded to repeat hyperbaric oxygen therapy in three of four cases. Finally, neuropsychiatric symptoms persisted in six pilots for years and may represent permanent injury. CONCLUSIONS: An increase in U-2 CNS DCS cases probably resulted from more cockpit activity combined with longer, more frequent high-altitude exposures. Adjustments in preoxygenation, cabin altitude, exercise at altitude, and frequency of flights may reduce incidence.

Laparoscopic adjustable gastric banding in an ambulatory surgery center.

BACKGROUND: In the management of morbid obesity by laparoscopic adjustable gastric banding (LAGB), careful patient preparation and attentive follow-up have been shown to produce the best long-term results. METHODS: Between November 2002 and August 2007, prospective data were collected on 2,411 consecutive patients, 84% of whom underwent LAGB at our freestanding outpatient surgery center, staffed by our dedicated multidisciplinary bariatric team. Outcomes reported include changes in mean body mass index (BMI), percentage excess body weight loss (%EBWL), and incidence of complications at 1 year, as well as the slippage rate up to 3 years. RESULTS: A total of 2,003 (83%) female and 409 (17%) male patients with a mean age of 44.1 years (range 15-76 yrs) and a BMI (mean +/- SD) of 45.7 +/- 7.9 kg/m2 (range 29.1-83.1 kg/m2) underwent LAGB. In 2,027 patients (84%), LAGB was performed as an outpatient procedure, with 1 (0.04%), conversion from a laparoscopic to an open procedure. The majority of operations were completed in less than 1 hour, using the pars flaccida technique. One-year weight loss data were available in 1,144 patients (47%). BMI decreased to 36.9 +/- 7.4 kg/m2 (-8.8). Mean %EBWL at 1 year (+/- 60 days) was 41.0% +/- 18.1% (range 0.7%-113.9%). Complications occurred in 241 of 2,411 (10%) patients. There was 1 death (0.04%). Cumulative slippage at 1, 2, and 3 years, respectively, was 0.4%, 2.4%, and 10%. There were 56 (2.3%) port-related problems, and 13 band explantations (0.54%). CONCLUSIONS: With extensive staff experience and patient preparation, LAGB can be performed safely as an outpatient procedure for select patients. Close follow-up is crucial in order to optimize LAGB outcomes for the long term.

Outpatient laparoscopic adjustable gastric banding in super-obese patients.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a safe and effective treatment for morbid obesity that is well suited to outpatient surgery. Super-obese patients (BMI > or = 50) are often viewed as higher risk patients, with their surgical procedures limited to hospital operating-rooms. We report our experience performing LAGB for super-obese patients in a freestanding ambulatory surgery center and describe the program elements that make this feasible and safe. METHODS: Database records containing 1,780 consecutive patients from program inception (November 2002 to November 2006) were searched for patients with a BMI >49.9 undergoing an outpatient LAGB and reviewed to identify complications. RESULTS: 320 super-obese patients underwent an outpatient LAGB. Mean preoperative weight was 155.2 kg (range 112.3-220.5 kg), and mean BMI was 55.4 kg/m2 (range 50.0-71.1 kg/m2). 53 patients (16.6%) had BMI >60. There were no deaths, significant cardiopulmonary complications, significant intraoperative bleeding, conversion to open laparotomy, or hospital admissions. 3 patients (0.1%) developed gastric edema causing transient obstruction, and 1 developed a delayed colon perforation from electrocautery incurred during adhesiolysis. No complication arose or was more difficult to manage as a result of the procedure being done on an outpatient basis. CONCLUSIONS: Outpatient LAGB can be safely performed in super-obese patients with a complication rate similar to lower BMI patients. Patient selection and preoperative preparation are essential to achieve excellent outcomes. The decision to offer an outpatient LAGB should rest on the overall physiological condition rather than BMI or weight alone.

Medical waiver experience at U.S. Air Force Special Operations Command, 1992-2003.

INTRODUCTION: Strict physical standards are applied to military applicants and service members, but these standards can be waived on a case-by-case basis when a member is felt to be capable of continued service in spite of their infirmity. Knowledge of the waiver experience at the unit or major command (MAJCOM) level could yield important operational risk management insight. The present study examined the waiver experience at Air Force Special Operations Command (AFSOC) from 1992 through 2003. METHODS: A dataset reflecting the accumulated waiver experience at AFSOC from 1992 to 2003 was reviewed. Diagnostic groups and occupations were tallied, and waiver rates determined for each. RESULTS: There were 1042 individuals considered for waivers of 1270 medical conditions. Combat controllers made up the largest occupational group, and were statistically more likely to seek waiver consideration than would be expected in the general AFSOC population. The five most commonly encountered diagnostic groups were: otorhinolaryngologic, 26.9%; musculoskeletal, 17.6%; ophthalmologic, 10.9%; cardiovascular, 7.2%; and gastrointestinal, 7.9%. Waivers were granted to 83.9% of the group. Pilots and navigators were more likely to receive a waiver, and aerial gunners were less likely to receive a waiver. DISCUSSION: The five most commonly encountered diagnostic groups accounted for 69% of waiver requests, and the overall waiver rate of 83.9% exceeded that reported in other studies. This MAJCOM-specific data could serve as a valuable resource for comparison to waiver data obtained from other MAJCOMs, and could aid in the development of targeted operational risk management activities.

Laparoscopic choledochoduodenostomy: review of a 4-year experience with an uncommon problem.

A laparoscopic choledochoduodenostomy (LCDD) may be performed when the common bile duct (CBD) is obstructed by primary or secondary stones or strictures. A biliary bypass procedure has two goals in view. The short-term goal is complete removal of stones and bypass of obstruction and stricture to restore biliary drainage. The long-term goal is preventing a recurrence of the problem. There is debate over the superiority of any one procedure to achieve both goals. Therefore, it may help the practicing clinician to be aware of the success (or failure), on a case-by-case basis, of these procedures. This awareness may help in the choice of technique. To date, since 1991, we have performed 16 LCDDs; however, in this report, we describe our results with LCDD over the last 4 years to emphasize the usefulness of this procedure. We find that it is a safe and effective procedure for treating patients with benign bile duct obstruction, even for those whose condition may be described as complicated or difficult. Evidence is slowly accumulating that LCDD is also successful in promoting long-term biliary drainage. We reviewed our LCDDs done over the past 4 years, documenting our preoperative, intraoperative, and postoperative experience. A successful LCDD was performed on all six patients. None of the patients had postoperative leaks. There was only one death, which was due to the patient's comorbidities and not the procedure itself. The hepatobiliary enzyme levels returned to normal in all of the surviving patients. The average postoperative length of stay was 6 days. With proper selection and adequate laparoscopic experience, LCDD can be performed in a safe and effective way.