A comprehensive analysis of health care Inequities in randomized clinical trials following bariatric surgeries.

BACKGROUND: Obesity is a global epidemic, leading to an increasing focus on interventions like bariatric surgeries. Despite this, there's a noticeable gap in understanding the demographic distribution of patients in clinical trials for bariatric surgery. METHODS: We conducted a comprehensive analysis of 117 registered randomized clinical trials related to bariatric surgery on ClinicalTrials.gov. We extracted demographic information, including age, sex, race, and ethnicity, and performed descriptive statistical analyses. RESULTS: The analysis covered 8,418 participants. The mean age was 43.8 years, with a substantial majority (93.8 â€‹%) falling within the 18-65 age group. Females comprised 74.9 â€‹% of participants, surpassing real-world estimates. Racially, 65.3 â€‹% of participants were White, while African Americans represented 18.5 â€‹%, Asians 1.2 â€‹%, Native Hawaiians 0.2 â€‹%, and American Indians 0.1 â€‹%, indicating an underrepresentation of diverse racial groups, notably lower compared to real-world demographic data. In terms of ethnicity, only 17.6 â€‹% were Hispanic. CONCLUSIONS: This study reveals significant demographic disparities in patients undergoing bariatric surgeries in clinical trials. This suggests a lack of generalizability, emphasizing the need for inclusive recruitment strategies to enhance health equity.

One Anastomosis Gastric Bypass as Revisional Surgery Following Sleeve Gastrectomy: A Systematic Review and Meta-Analysis.

BACKGROUND: Although sleeve gastrectomy (SG) is the most performed metabolic and bariatric surgery (MBS) worldwide, some patients require conversional procedures due to weight recurrence or late complications. Recently, one-anastomosis gastric bypass (OAGB) gained popularity as a viable option to address those problems. The aim of this meta-analysis is to assess the safety and efficacy of conversional OAGB after primary SG in the management of patients with obesity. METHODS: Cochrane, Embase, PubMed, Scopus, and Web of Science were searched for articles from their inception to February 2023 by two independent reviewers using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) system. The review was registered prospectively with PROSPERO (CRD42023403528). RESULTS: From 1,117 studies screened, twenty studies met the eligibility criteria, with a total of 1,057 patients with obesity undergoing conversional OAGB after primary SG. The mean age ranged from 28.2 to 49.5 years, and 744 patients (75.2%) were women. At one year after revisional OAGB, the pooled mean percent excess weight loss (%EWL) was 65.2% (95%CI: 56.9, 73.4, I2 = 97%). The pooled mean %EWL after conversional OAGB was 71.1% (95%CI: 62.2, 80.0, I2 = 90%) at two years and 71.6% (95%CI: 61.0, 82.2, I2 = 50%) at five years. Additionally, resolution rates of diabetes and hypertension were 65.4% (95%CI: 0.522, 0.785, I2 = 65%) and 58.9% (95%CI: 0.415, 0.762, I2 = 89%), respectively. CONCLUSIONS: Our meta-analysis demonstrated OAGB as an effective conversional procedure after primary SG in terms of weight loss and obesity-associated medical problems for selected patients. Despite the promising results, further randomized controlled studies with larger sample sizes and more extended follow-up periods are necessary to determine if the OAGB is the best conversional surgery after SG.

Third time's a charm: band to sleeve to bypass.

BACKGROUND: Adjustable gastric bands (AGB) are frequently converted to sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) due to weight recurrence or band complications. Such conversions carry a higher-risk than primary procedures. Some patients undergo two conversions-from AGB to SG, and subsequently from SG to RYGB. This presents a unique situation with limited literature on indications and complication rates associated with these double conversions. METHODS: We examined the 2020-2021 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Participant Use File to evaluate conversions from AGB to SG and then to RYGB. Patient and operative characteristics, along with outcomes, were evaluated. Descriptive statistics were applied. RESULTS: We identified 276 patients who underwent a conversion from AGB to SG and then to RYGB. The primary reason for the second conversion (SG to RYGB) was gastroesophageal reflux disease (GERD) at 55.1%, followed by inadequate weight loss or weight regain (IWL/WR) at 36.9%. The remaining reasons included dysphagia, nausea, vomiting, or others. Patients converted for IWL/WR demonstrated a higher baseline body mass index and prevalence of sleep apnea compared to other cohorts (both p < 0.001). Meanwhile, patients in the "other reasons" group had the highest rate of open surgical approaches (9.1%) and concurrent lysis of adhesions (p = 0.001 and p = 0.022), with correspondingly higher rates of anastomotic leak, reoperations, serious complications, and mortality. CONCLUSIONS: Patients undergoing double conversions (AGB to SG to RYGB) do so primarily for GERD or IWL/WR. Further research is required to better define the optimal primary operation for each patient, aiming to reduce the necessity for multiple conversions.

MBSAQIP database: are the data reliable?

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database collects data from all accredited centers in the US. A prior study showed data quality issues limiting use of up to 20% of the 2015 database. OBJECTIVES: To evaluate the completeness and data quality (internal validity, accuracy, and consistency) of the MBSAQIP database between 2015 and 2019. SETTING: United States. METHODS: All subsets of data from the MBSAQIP Participant User Data File (PUDF) were compiled into one main file. Completeness, internal validity, accuracy, and consistency were evaluated. Completeness was determined via missing values. Internal validity was assessed using the percentage of patients with a body mass index (BMI) < 30 kg/m2 who underwent primary bariatric surgery. Accuracy was evaluated using reported versus calculated BMI. Consistency was assessed using the percentage of patients with a gain of >5 or a loss of >20 units of BMI change in 30 days. Effects across years were assessed using a chi-squared test. RESULTS: Missing data for age, BMI, and ASA was consistently low (<2.5%) with no significant difference across years. Only .02% of patients who underwent a primary bariatric procedure had a reported BMI <30 kg/m2. The mean difference between reported versus calculated BMI was -.02 units. A maximum of .33% of patients gained >5 units of BMI, and a maximum of .85% of patients lost > 20 units of BMI in early follow-up. CONCLUSIONS: While the MBSAQIP is a database with acceptable data quality and minimal changes from 2015-2019, ongoing efforts are needed to improve data.

One Anastomosis Gastric Bypass Versus Single Anastomosis Duodenoileostomy with Sleeve: Comparative Analysis of 30-Day Outcomes Using the MBSAQIP.

INTRODUCTION/PURPOSE: One anastomosis gastric bypass (OAGB) and single anastomosis duodenoileostomy with sleeve (SADI-S) are two highly effective bariatric procedures that have been recently endorsed by the American Society of Metabolic and Bariatric Surgery (ASMBS). We compared the outcomes and safety profiles of SADI-S and OAGB using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. MATERIALS AND METHODS: Retrospective analysis on patients who underwent SADI-S or OAGB obtained from the MBSAQIP database 2020-2021. Patients who underwent concurrent procedures (besides EGD) or had missing data were removed. Variables included age, sex, body mass index, American Society of Anesthesiologists (ASA) class, and pertinent medical comorbidities. Data were analyzed for 30-day postoperative morbidity, mortality, reoperation, reintervention, and readmissions. p values were calculated using Student's t-test or Fisher analysis. RESULTS: A total of 694 and 1068 patients respectively underwent SADI-S or OAGB. Statistically significant comorbidities included age (42.2 ± 10.8 vs. 43.7 ± 12.2), BMI (50.6 ± 9.1 vs. 45.3 ± 7.1), ASA 2 (66 (9.5%) vs. 165 (15.4%)), ASA 4 [69 (9.9%) vs. 20 (1.9%)], and immunosuppressive therapy [24 (3.5%) vs. 17 (1.6%)]. Clavien-Dindo-based analysis highlighted that SADI-S had higher grade 2 (p = 0.005) and grade 4b (p = 0.001) complications. Patients who underwent SADI-S were twice as likely to be readmitted within 30 days (3.7% vs. 1.9%; p = 0.021). CONCLUSION: SADI-S had higher readmission rates and higher Clavien-Dindo grade 2 and 4b complications. To note, SADI-S patients had higher BMIs. Further studies are needed to determine the long-term complications and efficacy of both operations.