Thirty day outcomes for laparoscopic versus robotic sleeve gastrectomy: Does the stapler matter?

BACKGROUND: Sleeve gastrectomy (SG) remains a safe and effective treatment for severe obesity. The number of robotic SG (RSG) has steadily increased from 2015 to 2021. Prior studies have shown higher rates of some adverse outcomes with RSG but have not accounted for staplers used. OBJECTIVE: The aim of this study is to compare outcomes for RSG compared to laparoscopic sleeve gastrectomy (LSG), accounting for stapler type used. SETTING: National hospital derived administrative data. METHODS: The PINC AI Healthcare Database was used for the current study. Analyzed cohort included elective LSG or RSG performed between January 1, 2019, and December 31, 2021. Patient, hospital, billing, provider, insurance, and operative data were captured. Bleeding, leak, and other outcomes were identified by ICD-10-CM diagnosis codes. Propensity score matching (PSM) compared outcomes between RSG with SureForm stapler vs. LSG with powered stapler. RESULTS: 56,013 LSG and 13,832 RSG were analyzed. RSG increased from 15 % in 2019 to 25 % in 2021 with an absolute 27 â€‹% increase in robotic stapler utilization for RSG. PSM analysis compared, 5434 RSG with SureForm Stapler vs. 5434 LSG with powered staplers showed equivalent complication rates, shorter LOS, but longer operative time with RSG. CONCLUSIONS: When stapler type used is accounted for, patient outcomes following RSG and LSG are equivalent.

New-Onset Type 2 Diabetes after Bariatric Surgery: A Matched Cohort Study.

INTRODUCTION: The objective of this study is to determine the difference in rates of new-onset type 2 diabetes (T2D) for individuals who have had metabolic and bariatric surgery (MBS) and similar individuals who did not have MBS, and to determine whether differences in new-onset T2D differ depending on whether the individual had prediabetes at baseline. METHODS: This study used data from a large United States employer-based retrospective claims database from 2016 to 2021 (analysis completed in 2023). Individuals who did and did not have MBS were matched 1:1 on index year, sex, age, health plan type, region, body mass index, baseline healthcare costs, other obesity-related comorbidities, prediabetes diagnosis, and inpatient admissions in the year before the index date. New-onset T2D was examined at 1 (18,752 matches) and 3 (5,416 matches) years after the index date and stratified by baseline prediabetes. RESULTS: Among the full cohort of individuals with and without prediabetes at baseline, 0.1% and 2.7% of individuals who had did and did not have MBS developed T2D within 1 year after the index date, respectively (difference=2.6, 95% CI 2.4-2.8), and 0.3% and 8.4% of individuals who did and did not have MBS developed T2D within 3 years after the index date, respectively (difference=8.1, 95% CI 7.3-8.8). The difference in new-onset T2D was greatest among individuals with prediabetes at baseline. CONCLUSIONS: This study demonstrated patients with obesity and without T2D who undergo MBS are significantly less likely to develop new-onset T2D compared to matched non-MBS patients.

Antihypertensive Medication Use Trajectories After Bariatric Surgery: A Matched Cohort Study.

BACKGROUND: Metabolic and bariatric surgery (MBS) is the most effective and durable treatment for obesity. We aimed to compare the trajectories of antihypertensive medication (AHM) use among obese individuals treated and not treated with MBS. METHODS: Adults with a body mass index of ≥35 kg/m2 were identified in the Merative Database (US employer-based claims database). Individuals treated with versus without MBS were matched 1:1 using baseline demographic and clinical characteristics as well as AHM utilization. Monthly AHM use was examined in the 3 years after the index date using generalized estimating equations. Subanalyses investigated rates of AHM discontinuation, AHM initiation, and apparent treatment-resistant hypertension. RESULTS: The primary cohort included 43 206 adults who underwent MBS matched with 43 206 who did not. Compared with no MBS, those treated with MBS had sustained, markedly lower rates of AHM use (31% versus 15% at 12 months; 32% versus 17% at 36 months). Among patients on AHM at baseline, 42% of patients treated with MBS versus 7% treated medically discontinued AHM use (P<0.01). The risk of apparent treatment-resistant hypertension was 3.41× higher (95% CI, 2.91-4.01; P<0.01) 2 years after the index date in patients who did not undergo MBS. Among those without hypertension treated with MBS versus no MBS, 7% versus 21% required AHM at 2 years. CONCLUSIONS: MBS is associated with lower rates of AHM use, higher rates of AHM discontinuation, and lower rates of AHM initiation among patients not taking AHM. These findings suggest that MBS is both an effective treatment and a preventative measure for hypertension.

Out-of-Pocket Costs among Commercially Insured Individuals with type 2 Diabetes and Obesity: Comparison between Ozempic and Sleeve Gastrectomy.

OBJECTIVE: Determine out-of-pocket (OOP) costs two years after sleeve gastrectomy (SG) or initiating Ozempic for patients with type 2 diabetes (T2D) and obesity. SUMMARY BACKGROUND DATA: Individuals with obesity and T2D have a variety of treatment options. Risks and benefits of these treatment options are becoming more well documented; however, the real-world patient costs of these options are not known. METHODS: Adults with body mass index (BMI) 35 kg/m2 or higher, and T2D who had an SG or used Ozempic were identified in the employer-based retrospective claims database Merative™ (previously Truven IBM Marketscan) from 2017 to 2021. SG cohort was defined as having a SG (without filling a prescription for Ozempic) and Ozempic cohort was defined as continuously filling a prescription for Ozempic for at least 2 years (and not having any bariatric surgery). Individuals in each cohort were 1:1 propensity matched on demographics, obesity-related comorbidities, and baseline OOP costs. in the year before treatment. OOP costs were compared in the two years after treatment using paired t-tests. RESULTS: 302 SG were matched to 302 Ozempic patients (mean age 50, mean baseline BMI 40, 41% male). OOP healthcare costs were similar for the SG ($2,267) and Ozempic ($2,131) cohorts 1-year after index date (difference=$136, P=0.19). OOP healthcare costs were significantly lower in the SG cohort ($1,155 vs. $2,084, P<0.01) 2-years after index date. CONCLUSIONS: Within 2 years of starting treatment, OOP healthcare costs were significantly lower among individuals who had a SG versus those treated with Ozempic.

Equity in bariatric surgery use: a cohort study.

BACKGROUND: Metabolic and bariatric surgery (MBS) is the most effective and durable treatment for obesity; however, access to MBS is not equitable. OBJECTIVE: To determine the rate of MBS among eligible adults with obesity by demographics, health characteristics, and geography to better define populations that would benefit from resources to reduce barriers to access for this treatment. SETTING: Adults with obesity were identified in the US employer-based retrospective claims database (Merative™). METHODS: Rates of MBS were examined across demographics (age, sex, region, year, health plan type) health characteristics (obesity-related comorbidities, healthcare costs, inpatient admissions), and by state. Given differences in coverage requirements, rates are examined for 2 populations: Class 2 (BMI 35-39.9 kg/m2) and Class 3 (BMI 40+ kg/m2) obesity. RESULTS: Of the 777,565 eligible adults, 49,371 (6.4%) had MBS; 3.2% of those with Class 2 and 8.3% of those with Class 3 obesity had MBS. MBS rates varied substantially by demographic and health characteristics, ranging from 1% to 14%, and from 2% to 41% among those with Class 2 and Class 3 obesity, respectively. Geographically, rates ranged from 0% (Hawaii) to 7.4% (New Mexico) for those with Class 2 Obesity and from 4.2% (Hawaii) to 15.3% (Mississippi) among those with Class 3 Obesity. CONCLUSIONS: Use of MBS among eligible adults with obesity varies substantially across characteristics, indicating inequity in access to this treatment. To ensure greater access to the most effective treatment for obesity, policies should be implemented to reduce or eliminate barriers to care.

Observational cohort investigating health outcomes and healthcare costs after metabolic and bariatric surgery: a study protocol.

INTRODUCTION: As the rate of obesity increases, so does the incidence of obesity-related comorbidities. Metabolic and bariatric surgery (MBS) is the most effective treatment for obesity, yet this treatment is severely underused. MBS can improve, resolve, and prevent the development of obesity-related comorbidities; this improvement in health also results in lower healthcare costs. The studies that have examined these outcomes are often limited by small sample sizes, reliance on outdated data, inconsistent definitions of outcomes, and the use of simulated data. Using recent real-world data, we will identify characteristics of individuals who qualify for MBS but have not had MBS and address the gaps in knowledge around the impact of MBS on health outcomes and healthcare costs. METHODS AND ANALYSIS: Using a large US employer-based retrospective claims database (Merative), we will identify all obese adults (21+) who have had a primary MBS from 2016 to 2021 and compare their characteristics and outcomes with obese adults who did not have an MBS from 2016 to 2021. Baseline demographics, health outcomes, and costs will be examined in the year before the index date, remission and new-onset comorbidities, and healthcare costs will be examined at 1 and 3 years after the index date. ETHICS AND DISSEMINATION: As this was an observational study of deidentified patients in the Merative database, Institutional Review Board approval and consent were exempt (in accordance with the Health Insurance Portability and Accountability Act Privacy Rule). An IRB exemption was approved by the wcg IRB (#13931684). Knowledge dissemination will include presenting results at national and international conferences, sharing findings with specialty societies, and publishing results in peer-reviewed journals. All data management and analytic code will be made available publicly to enable others to leverage our methods to verify and extend our findings.

A retrospective study of laparoscopic, robotic-assisted, and open emergent/urgent cholecystectomy based on the PINC AI Healthcare Database 2017-2020.

BACKGROUND: Robotic-assisted cholecystectomy (RAC) is becoming increasingly common, but the outcomes of emergent/urgent robotic-assisted cholecystectomies compared to emergent laparoscopic (LC) and open cholecystectomies (OC) remain understudied. METHODS: The PINC AI Healthcare Database was queried to identify adults who underwent emergent or urgent (Em-Ur) cholecystectomy between January 1, 2017, and December 31, 2020. Immediate postoperative and 30-day outcomes were identified including intraoperative complications, transfusion, conversion, postoperative complication, and hospital length of stay. Propensity score matching was done to compare outcomes between Em-Ur robotic-assisted, laparoscopic, and open cholecystectomies Subgroup analyses were performed comparing RAC done with and without fluorescent imaging as well as comparing RAC and LC performed for patients with class 3 obesity (BMI ≥ 40 kg/m2). RESULTS: RAC Em-Ur cholecystectomies are being performed with increasing frequency and is the most utilized modality for patients with class 3 obesity. There was no difference in intraoperative complications (0.3%), bile duct injury (0.2%), or postoperative outcomes between RAC and LC. LC had significantly shorter operating room times (96 min (75,128)) compared to RAC (120 min (90,150)). There was a significant lower rate of conversion to open in RAC (1.9%) relative to LC (3.2%) in both the overall population and the class 3 obesity sub-analysis (RAC-2.6% vs. LC-4.4%). There was no difference in outcomes in robotic-assisted cholecystectomies done with and without fluorescent imaging. CONCLUSIONS: A comparison of propensity score-matched cohorts of emergent/urgent robotic-assisted and laparoscopic cholecystectomy indicates that robotic-assisted cholecystectomy is a safe alternative to laparoscopic cholecystectomy, and that both have superior outcomes to open cholecystectomies.

Outliers in nutrient intake data for U.S. adults: national health and nutrition examination survey 2017-2018.

Objectives: An important step in preparing data for statistical analysis is outlier detection and removal, yet no gold standard exists in current literature. The objective of this study is to identify the ideal decision test using the National Health and Nutrition Examination Survey (NHANES) 2017-2018 dietary data. Methods: We conducted a secondary analysis of NHANES 24-h dietary recalls, considering the survey's multi-stage cluster design. Six outlier detection and removal strategies were assessed by evaluating the decision tests' impact on the Pearson's correlation coefficient among macronutrients. Furthermore, we assessed changes in the effect size estimates based on pre-defined sample sizes. The data were collected as part of the 2017-2018 24-h dietary recall among adult participants (N=4,893). Results: Effect estimate changes for macronutrients varied from 6.5 % for protein to 39.3 % for alcohol across all decision tests. The largest proportion of outliers removed was 4.0 % in the large sample size, for the decision test, >2 standard deviations from the mean. The smallest sample size, particularly for alcohol analysis, was most affected by the six decision tests when compared to no decision test. Conclusions: This study, the first to use 2017-2018 NHANES dietary data for outlier evaluation, emphasizes the importance of selecting an appropriate decision test considering factors such as statistical power, sample size, normality assumptions, the proportion of data removed, effect estimate changes, and the consistency of estimates across sample sizes. We recommend the use of non-parametric tests for non-normally distributed variables of interest.

Type 2 Diabetes Remission After Bariatric Surgery and Its Impact on Healthcare Costs.

PURPOSE: Bariatric surgery is the most effective and durable treatment of obesity and can put type 2 diabetes (T2D) into remission. We aimed to examine remission rates after bariatric surgery and the impacts of post-surgical healthcare costs. MATERIALS AND METHODS: Obese adults with T2D were identified in Merative™ (US employer-based retrospective claims database). Individuals who had bariatric surgery were matched 1:1 with those who did not with baseline demographic and health characteristics. Rates of remission and total healthcare costs were compared at 6-12 and 6-36 months after the index date. RESULTS: Remission rates varied substantially by baseline T2D complexity; differences in rates at 1 year ranged from 41% for those with high-complexity T2D to 66% for those with low- to mid-complexity T2D. At 3 years, those who had bariatric surgery had 56% higher remission rates than those who did not have bariatric surgery, with differences of 73%, 59%, and 35% for those with low-, mid-, and high-complexity T2D at baseline. Healthcare costs were $3401 and $20,378 lower among those who had bariatric surgery in the 6 to 12 months and 6 to 36 months after the index date, respectively, than their matched controls. The biggest cost differences were seen among those with high-complexity T2D; those who had bariatric surgery had $26,879 lower healthcare costs in the 6 to 36 months after the index date than those who did not. CONCLUSION: Individuals with T2D undergoing bariatric surgery have substantially higher rates of T2D remission and lower healthcare costs.

Utilizing Simulation to Evaluate Robotic Skill Acquisition and Learning Decay.

BACKGROUND: We aim to evaluate how new robotic skills are acquired and retained by having participants train and retest using exercises on the robotic platform. We hypothesized that participants with a 3-month break from the robotic platform will have less learning decay and increased retention compared with those with a 6-month break. METHODS: This was a prospective randomized trial in which participants voluntarily enrolled and completed an initial training phase to reach proficiency in 9 robot simulator exercises. They were then instructed to refrain from practicing until they retested either 3 or 6 months later. This study was completed at an academic medical center within the general surgery department. Participants were medical students, and junior-level residents with minimal experience in robotic surgery were enrolled. A total of 27 enrolled, and 13 participants completed the study due to attrition. RESULTS: Overall, intragroup analysis revealed that participants performed better in their retest phase compared with their initial training in terms of attempts to reach proficiency, time for completion, penalty score, and overall score. Specifically, during the first attempt in the retesting phase, the 3-month group did not deviate far from their final attempt in the training phase, whereas the 6-month group experienced significantly worse time to complete and overall score in interrupted suturing {[-4 (-18 to 20) seconds vs. 109 (55 to 118) seconds, P =0.02] [-1.3 (-8 to 1.9) vs. -18.9 (-19.5 to (-15.0)], P =0.04} and 3-arm relay {[3 (-4 to 23) seconds vs. 43 (30 to 50) seconds, P =0.02] [0.4 (-4.6 to 3.1) vs. -24.8 (-30.6 to (-20.3)], P =0.01] exercises. In addition, the 6-month group had a significant increase in penalty score in retesting compared with the 3-month group, which performed similarly to their training phase [3.3 (2.7 to 3.3) vs. 0 (-0.8 to 1.7), P =0.03]. CONCLUSIONS: This study identified statistically significant differences in learning decay, skills retention, and proficiency between 3-month and 6-month retesting intervals on a robotic simulation platform.

Methodology to standardize heterogeneous statistical data presentations for combining time-to-event oncologic outcomes.

Survival analysis following oncological treatments require specific analysis techniques to account for data considerations, such as failure to observe the time of event, patient withdrawal, loss to follow-up, and differential follow up. These techniques can include Kaplan-Meier and Cox proportional hazard analyses. However, studies do not always report overall survival (OS), disease-free survival (DFS), or cancer recurrence using hazard ratios, making the synthesis of such oncologic outcomes difficult. We propose a hierarchical utilization of methods to extract or estimate the hazard ratio to standardize time-to-event outcomes so that study inclusion into meta-analyses can be maximized. We also provide proof-of concept results from a statistical analysis that compares OS, DFS, and cancer recurrence for robotic surgery to open and non-robotic minimally invasive surgery. In our example, use of the proposed methodology would allow for the increase in data inclusion from 108 hazard ratios reported to 240 hazard ratios reported or estimated, resulting in an increase of 122%. While there are publications summarizing the motivation for these analyses, and comprehensive papers describing strategies to obtain estimates from published time-dependent analyses, we are not aware of a manuscript that describes a prospective framework for an analysis of this scale focusing on the inclusion of a maximum number of publications reporting on long-term oncologic outcomes incorporating various presentations of statistical data.

Incidence, associated risk factors, and impact of conversion to laparotomy in elective minimally invasive sigmoidectomy for diverticular disease.

BACKGROUND: Benefits of minimally invasive surgical approaches to diverticular disease are limited by conversion to open surgery. A comprehensive analysis that includes risk factors for conversion may improve patient outcomes. METHODS: The US Premier Healthcare Database was used to identify patients undergoing primary elective sigmoidectomy for diverticular disease between 2013 and September 2015. Propensity-score matching was used to compare conversion rates for laparoscopic and robotic-assisted sigmoidectomy. Patient, clinical, hospital, and surgeon characteristics associated with conversion were analyzed using multivariable logistic regression, providing odds ratios for comparative risks. Clinical and economic impacts were assessed comparing surgical outcomes in minimally invasive converted, completed, and open cases. RESULTS: The study population included 13,240 sigmoidectomy patients (8076 laparoscopic, 1301 robotic-assisted, 3863 open). Analysis of propensity-score-matched patients showed higher conversion rates in laparoscopic (13.6%) versus robotic-assisted (8.3%) surgeries (p < 0.001). Greater risk of conversion was associated with patients who were Black compared with Caucasian, were Medicaid-insured versus Commercially insured, had a Charlson Comorbidity Index ≥ 2 versus 0, were obese, had concomitant colon resection, had peritoneal abscess or fistula, or had lysis of adhesions. Significantly lower risk of conversion was associated with robotic-assisted sigmoidectomy (versus laparoscopic, OR 0.58), hand-assisted surgery, higher surgeon volume, and surgeons who were colorectal specialties. Converted cases had longer operating room time, length of stay, and more postoperative complications compared with minimally invasive completed and open cases. Readmission and blood transfusion rates were higher in converted compared with minimally invasive completed cases, and similar to open surgeries. Differences in inflation-adjusted total ($4971), direct ($2760), and overhead ($2212) costs were significantly higher for converted compared with minimally invasive completed cases. CONCLUSIONS: Conversion from minimally invasive to open sigmoidectomy for diverticular disease results in additional morbidity and healthcare costs. Consideration of modifiable risk factors for conversion may attenuate adverse associated outcomes.