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.

The Trajectory of Revisional Bariatric Surgery: Open to Laparoscopic to Robotic.

Metabolic and bariatric surgery (MBS) is the most effective therapeutic intervention for patients with obesity, with sleeve gastrectomy (SG) being the most commonly performed primary MBS procedure. Long-term studies have demonstrated that 15-20% of patients require revisional bariatric surgery (RBS) due to weight-related issues or surgical complications. Despite the gold standard being laparoscopic revision, there are other available approaches such as open or robotic-assisted. An extensive literature review was performed for articles from their inception to February 2024. A descriptive review of MBS procedures (SG, Roux-en-Y gastric bypass (RYGB), single anastomosis duodeno-ileostomy (SADI) and biliopancreatic diversion-duodenal switch (BPD-DS)) was carried out to report and compare outcomes between primary and revisional bariatric surgery. A similar review was conducted to compare outcomes of revisional approaches (open, laparoscopic, robotic). RYGB remains the dominant RBS with a similar safety profile compared to revisional SADI and BPD-DS. In terms of the RBS surgical approach, all three options showed comparable short and long-term outcomes, with robotic RBS being associated with longer operative time and variable length of stay. Additional long-term studies are required to further validate our conclusions.

Clinical outcomes and safety of immune checkpoint inhibitors in patients with solid tumors and paraneoplastic syndromes.

BACKGROUND: Patients with paraneoplastic syndromes (PNS) are excluded from clinical trials involving immune checkpoint inhibitors (ICIs) due to safety concerns. Moreover, real-world data on efficacy and safety is scarce. METHODS: In this retrospective study, data were collected on patients with PNS and solid tumors receiving ICI between 2015 and 2022 at nine institutions. Patients were classified into: Cohort 1 (pre-existing PNS before ICI initiation), cohort 2 (PNS during ICI treatment), and cohort 3 (PNS after ICI discontinuation). Patients with metastatic non-small cell lung cancer (NSCLC) (mNSCLC) from cohort 1 were matched to patients who were PNS-free at each institution up to a 1:3 ratio for age, sex, type of ICI, use of concurrent chemotherapy, and number of lines of systemic therapy prior to ICI initiation. Kaplan-Meier method was used to assess overall survival (OS) and time-to-next treatment (TTNT). RESULTS: Among 109 patients with PNS treated with ICIs, median age at ICI initiation was 67 years (IQR: 58-74). The most represented cancer type was NSCLC (n=39, 36%). In cohort 1 (n=55), PNS exacerbations occurred in 16 (29%) patients with median time to exacerbation after ICI of 1.1 months (IQR: 0.7-3.3). Exacerbation or de novo PNS prompted temporary/permanent interruption of ICIs in 14 (13%) patients. For cohort 2 (n=16), median time between ICI initiation and de novo PNS was 1.2 months (IQR: 0.4-3.5). Treatment-related adverse events (trAEs) occurred in 43 (39%) patients. Grade ≥3 trAEs occurred in 18 (17%) patients. PNS-directed immunosuppressive therapy was required in 55 (50%) patients. We matched 18 patients with mNSCLC and PNS (cohort 1) to 40 without PNS, treated with ICIs. There was no significant difference in OS or TTNT between patients with mNSCLC with and without PNS, although a trend was seen towards worse outcomes in patients with PNS. TrAEs occurred in 6/18 (33%) and 14/40 (35%), respectively. Grade ≥3 trAEs occurred in 4 (22%) patients with PNS and 7 (18%) patients without PNS. CONCLUSIONS: Exacerbations of pre-existing PNS occurred in 29% of patients treated with ICIs and both exacerbations and de novo PNS occur early in the ICI course. TrAE from ICIs were similar between patients with and without PNS. Our data suggest that pre-existing PNS should not preclude consideration of ICI therapy although patients may not derive the same clinical benefit compared with patients without PNS.

The association between microvascular and macrovascular diseases and diabetes remission after bariatric surgery.

BACKGROUND: Type-2 diabetes mellitus (T2DM) results in detrimental vascular complications including both microvascular and macrovascular diseases. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective weight-loss therapies that enhance T2DM remission. However, limited data are present regarding the association between diabetes-associated diseases before RYGB and SG with T2DM remission. METHODS: This is a retrospective cohort study in patients with T2DM who underwent RYGB or SG. We collected data on preoperative microvascular (i.e., retinopathy, nephropathy, and neuropathy) and macrovascular (coronary artery disease, cerebrovascular accidents, and peripheral artery disease) diabetes-associated diseases. Our end points included assessment of association and cumulative effect of diabetes-associated diseases and disease remission. We also performed a multivariate logistic regression to evaluate the parameters associated with T2DM remission. RESULTS: A total of 536 patients (67% female, 94% White) were included in this study. Patients without diabetes-associated diseases had an OR of 2.72 (95% CI 1.92 to 3.88) to achieve T2DM remission compared to patients with diabetes-associated diseases (27.9% vs 59.4%; p < 0.001). Importantly, there was an additive effect of the number of diabetes-associated diseases on the T2DM remission (p < 0.001). We demonstrate a significant association between HbA1c (p < 0.001), number of diabetes medications (p < 0.001), T2DM duration (p < 0.001), surgery type (p = 0.009), and insulin use (p = 0.04) with T2DM remission. CONCLUSION: Patients with presurgical diabetes-associated diseases had a lower remission rate after RYGB and SG. Not only do these complications represent a more practical and consistent variable to predict T2DM remission, but also help planning a multidisciplinary management of patients with more severe T2DM.

Morgellons disease: a narrative review.

Morgellons disease is characterized by the persistent delusion of skin infestation, ultimately inflicting wounds and impairing quality of life. There is insufficient and conflicting research pertaining to this condition, imposing challenges on clinicians in understanding, diagnosing, and treating it. In this review, we summarize the available literature on Morgellons disease including its historical evolution, epidemiology, proposed pathophysiology, underlying structural and functional brain pathologies, typical and atypical clinical presentations, diagnosis, and treatment. A comprehensive review of the literature was conducted on PubMed, Embase, and Scopus using specified keywords. Selected articles were screened by two independent reviewers based on set inclusion and exclusion criteria. Conflicts were resolved by a third reviewer as needed. No limit to the date of selected articles was set due to the scarce literature available on the subject. Morgellons disease is an underdiagnosed entity, owing mostly to the lack of an established pathophysiology and treatment guidelines. While many authors classify it as a type of delusional infestation (DI), others correlate MD with an underlying spirochetal infection, namely Lyme disease. Neuroimaging studies have revealed abnormalities in the "fronto-striato-thalamo-parietal network", a finding common to patients with DI, in addition to alterations in structures related to the "Itch Processing Pathway". Patients tend to extract fibers from their skin lesions and place them in a match box hence the term "match box sign". The diagnosis is that of exclusion, requiring extensive work up to rule out secondary causes and differential diagnoses. Treatment is largely based on the use of antipsychotics, with or without cognitive behavioral therapy. Despite being a diagnosis of exclusion, clinicians must be aware of this entity and have a profound understanding of the pathogenesis underlying it. Upon clinical suspicion, secondary Morgellons should always be ruled out through a thorough history taking, physical examination, and laboratory exams. Despite the challenges brought by the heterogeneous presentation of the condition and the paucity of research revolving around it, the great impact that Morgellons disease has on patients' quality of life forms a pressing need for its adequate detection, diagnosis, and treatment.

Management of Malnutrition and Hepatic Impairment After Duodenal Switch.

BACKGROUND: Malnutrition and liver impairment after duodenal switch (DS) are possible and undesired complications, often conservatively treated. However, in specific cases, surgical revision may be necessary. This study aims to describe outcomes achieved by two bariatric surgery centers and address effectiveness and safety of revisional surgical procedures to resolve these complications. METHODS: A retrospective chart review was performed in two bariatric surgery centers from 2008 to 2022. Patients who required revisional surgery to treat malnutrition and/or liver impairment refractory to nutritional and total parenteral nutrition intervention (TPN) after duodenal switch were included. No comparisons were performed due to the descriptive nature of this study. RESULTS: Thirteen patients underwent revisional surgery, the mean age was 44.7, the 53.8% were females, and the mean preoperative BMI was 54.7 kg/m2; the mean time between DS and revisional procedure was 26.5 months, and 69.1% of patients were placed on TPN. One patient developed hepatic encephalopathy; one patient presented with ascites, pleural effusion, and renal insufficiency, undergoing reoperation after revisional procedure due to a perforated ileal loop. Mortality rate was 0%; all patients regained weight after the revisional procedure, and the mean total protein and albumin blood levels 12 months after surgery were 6.3 and 3.6 g/dl, respectively. CONCLUSIONS: While refractory malnutrition and/or liver failure are rare among patients post-DS, if underdiagnosed and untreated, this can lead to irreversible outcomes and death. All revisional procedures included in this study resulted in improvement of the nutritional status and reversal of liver impairment, with low complication rates.

Laparoscopic Median Arcuate Ligament Release: Surgical Technique and Clinical Outcomes.

BACKGROUND: Median arcuate ligament syndrome (MALS) is characterized by a constellation of symptoms related to the compression of the celiac artery trunk. Laparoscopic release of the ligament has demonstrated its effectiveness in alleviating these symptoms while showing lower postoperative complication rates, reduced hospital stays, and improved clinical outcomes. This study describes a single institution's experience with this procedure and reports on the preoperative assessment, surgical technique, and clinical outcomes of patients with MALS. METHODS: We performed a retrospective chart review of all patients who underwent a primary laparoscopic MAL release (MALR) at a single high-volume academic institution from June 2021 to July 2023. Patient demographics, preoperative assessment, postoperative complications, and resolution of preoperative symptoms data were collected. RESULTS: A total of 30 patients underwent laparoscopic MALR, with 76.7% being female and a mean age of 33.4±16.3 years. The most common presenting symptom was postprandial epigastric pain (100%), followed by abdominal pain and nausea (83.3%), among others. The preoperative evaluation for all patients included a duplex mesenteric doppler and CT angiogram during inspiration and expiration and 3D reconstruction. Successful laparoscopic decompression of the celiac artery was achieved in 96.6% of cases, with only one conversion to an open procedure. There was only one reported early (<30 d postoperatively) complication with no subsequent late complications or mortality. None of the patients required reintervention or reoperation. Only 1 patient required postoperative celiac plexus/splanchnic block injection to alleviate pain. CONCLUSIONS: MALS can be effectively and safely managed using a laparoscopic approach when performed by an experienced minimally invasive surgeon. Further studies with longer follow-ups are needed to confirm the long-term effectiveness of this technique.

Safety of EUS latex balloon use in patients with a latex allergy.

BACKGROUND AND AIMS: Balloons are used in EUS to improve visualization. However, data on the safety of latex balloons in patients with latex allergies are limited, and nonlatex alternatives can be costly. We investigated the safety of latex balloon use during EUS. METHODS: A retrospective review was conducted at a tertiary center between 2019 and 2022. Patients with reported latex allergies who underwent linear EUS were included. Baseline demographics, EUS characteristics, and adverse events were collected. The primary outcome was the rate of adverse events. RESULTS: Eighty-seven procedures were performed on 57 unique patients (mean age, 65.3 ± 14.5 years). Latex balloons were used in 59 procedures (67.8%), with only 8 procedures (13.6%) using prophylactic medications. No adverse events occurred during or after procedures, regardless of medication use or history of anaphylaxis. CONCLUSIONS: The use of EUS latex balloons in patients with a latex allergy was associated with no adverse events.

Comparative analysis of sleeve conversions of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program 2020 Database.

BACKGROUND: Although the sleeve gastrectomy (SG) is the dominant bariatric procedure, studies have shown conversion rates of up to 30%. These conversions are generally for weight regain (WR), insufficient weight loss (IWL) or gastroesophageal reflux disease (GERD). Before 2020, details on why conversions were being performed were not collected in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Participant Use Data File (PUF). Now, the indication for sleeve conversion is noted in the PUF, allowing identification and reporting sleeve conversion reasons. OBJECTIVE: We aimed to examine the reasons for SG conversions nationwide. SETTING: The 2020 MBSAQIP PUF. METHODS: The 2020 MBSAQIP PUF was examined to determine the reasons why SG were converted to other operations. The data field of "Revision/Conversion Final Indication" was used along with "Procedure type." Primary bariatric operations were excluded. Descriptive statistics were applied. Different reasons for conversion and operations were compared by preoperative characteristics and operative outcomes. RESULTS: There were 103,782 primary SG reported in the 2020 PUF. There were 7181 SG that were converted to other operations. The most common conversion (86.2%) was to Roux-en-Y gastric bypass (RYGB). The main reason for SG conversion was GERD at 48.4%, followed by WR/IWL (41.9%). Biliopancreatic diversion with duodenal switch and single-anastomosis duodenoileal bypass with sleeve patients differed significantly from RYGB patients in specific preoperative characteristics and operative outcomes. CONCLUSION: The most common procedure SG is converted to is the RYGB. GERD was the most common reason for SG conversion, followed by WR/IWL.

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.

Comparative multicenter analysis of sleeve gastrectomy, gastric bypass, and duodenal switch in patients with BMI ≥70kg/m2: a 2-year follow-up.

Patients undergoing metabolic and bariatric surgery (MBS) with body mass index (BMI) ≥ 70 kg/m2 are considered a high-risk group. There is limited literature to guide surgeons on the perioperative safety as well as the different procedural outcomes of MBS in this cohort. Our aim is to compare the safety profiles, early- and medium-term outcomes of sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and duodenal switch (DS) in patients with BMI ≥ 70 kg/m2. A total of 156 patients with BMI ≥ 70kg/m2 underwent MBS (SG = 40, RYGB = 40, and DS = 76). Mean baseline BMI was 75.5 kg/m2. Total weight loss (%TWL) at 24 months was highest in the DS group compared to RYGB (40.6% versus 33.8%, P value = .03) and SG (40.6% versus 28.5%, P value = .006). There was no significant difference in %TWL between RYGB and SG (33.8% versus 28.5%, P value = .20). The 30-day complication rates were similar [SG (7.5%), RYGB (10%), and DS (9.2%) (P value = 1.0)]. There was one reported leak (DS). The 30-day mortality was zero. MBS is safe and effective in patients with BMI ≥ 70 kg/m2. All procedures had comparable safety profiles and complication rates. While DS achieved the highest %TWL at 24 months, similar comorbidity resolution rates among the procedures attenuate its clinical significance.

Long-Term Outcomes of Bariatric Surgery in Patients on Chronic Anticoagulation.

BACKGROUND: Approximately 3% of patients undergoing metabolic and bariatric surgery (MBS) are receiving chronic anticoagulation therapy (CAT) prior to operation. The management of these patients is complex, as it involves balancing the potential risk of thrombosis against that of bleeding. Our primary objective is to assess the long-term bleeding risk in patients undergoing MBS. We also aim to observe the trends in anticoagulant dosing after MBS. METHODS: A single-center retrospective review of patients who underwent either primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) with preoperative CAT between 2008 and 2022 was performed. Data on baseline demographics, indication for anticoagulation, type of CAT, and dosing were collected. Events of bleeding and the CAT at event were subsequently evaluated. RESULTS: A total of 132 patients (82 RYGB and 50 SG) initially on CAT were identified, with atrial fibrillation being the most common indication. Incidence of long-term bleeding was significantly higher in the RYGB group (18.3%) compared to the SG group (4%) (p = 0.017) over a total of 5.2 ± 3.8 years. Bleeding marginal ulcer (MU) was the most common cause of bleeding in the RYGB group (13.4%). 84.2% of all bleeding events occurred in patients on chronic Warfarin therapy. CONCLUSION: Long-term CAT is associated with an increased risk of bleeding in RYGB patients, particularly MU bleeds. Patients on CAT seeking MBS should be counseled regarding this risk and potential implications. Direct-acting oral anticoagulants offer promise as an alternative to Warfarin in these patients; further research is necessary to better understand their safety.

Marginal Ulcer and Dumping Syndrome in Patients after Duodenal Switch: A Multi-Centered Study.

BACKGROUND: The current design of biliopancreatic diversion with duodenal switch (BPD/DS) and single anastomosis duodenal-ileal bypass with sleeve (SADI-S) emphasizes the importance of the pylorus' preservation to reduce the incidence of marginal ulcer (MU) and dumping. However, no institutional studies have yet reported data on their prevalence. We aimed to assess the incidence of MU and dumping after duodenal switch (DS) and identify the associative factors. METHODS: A multi-center review of patients who underwent BPD/DS or SADI-S between 2008 and 2022. Baseline demographics, symptoms, and management of both complications were collected. Fisher's exact test was used for categorical variables and the independent t-test for continuous variables. RESULTS: A total of 919 patients were included (74.6% female; age 42.5 years; BMI 54.6 kg/m2) with mean follow-up of 31.5 months. Eight patients (0.9%) developed MU and seven (0.8%) had dumping. Patients who developed MU were more likely to be using non-steroidal anti-inflammatory drugs (NSAID) (p = 0.006) and have a longer operation time (p = 0.047). Primary versus revisional surgery, and BDP/DS versus SADI-S were not associated with MU or dumping. CONCLUSIONS: The incidences of MU and dumping after DS were low. NSAID use and a longer operation time were associated with an increased risk of MU, whereas dumping was attributed to poor dietary habits.

Early Bowel Obstruction after Bariatric Surgery: An Analysis of the 2020-2021 MBSAQIP Database.

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program evaluates 30-day outcomes of bariatric cases performed in the United States. The Participant Use File in 2020 introduced bowel obstruction (BO). We compared the rates of BO, risk factors, and postoperative outcomes after laparoscopic Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and duodenal switch (DS). METHODS: Retrospective analysis of patients who underwent laparoscopic RYGB, SG, or DS obtained from the 2020-2021 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Patients who underwent either as a primary procedure with a body mass index >35 kg/m 2 were selected. Baseline characteristics, operative details, and postoperative complications were collected. The outcome of interest was BO occurring within 30 days. RESULTS: A total of 205,533 cases of which 148,944 were SG (72.4%), 54,606 were RYGB (26.5%), and 1983 were DS (1%). BO occurred in 0.74%, 0.4%, and 0.03% of patients who underwent an RYGB, DS, or SG, respectively. Patients with a BO in the RYGB group were more likely to be on immunosuppressive therapy (5.4% vs. 1.9%, P <0.001) with longer operative time (136.2 min±58.0 min vs. 117.4 min±53.6 min, P <0.001). SG patients with a BO were older (47.5±13.6 vs. 41.9±11.6, P =0.011) with longer operating times (98.6±63.8 vs. 68.9±33.4, P =0.002). Patients in the RYGB group with a BO had the highest rates of readmissions (71.9%) and reoperations (58.4%). CONCLUSIONS: Early bowel obstruction is rare after bariatric surgery. It is more common after RYGB and least common after SG. Readmission and reoperation rates were highest in patients with BO in the RYGB group.

Marginal Ulcers after Roux-en-Y Gastric Bypass: Etiology, Diagnosis, and Management.

Marginal ulcer (MU) is a potential complication following Roux-en-Y gastric bypass (RYGB), with a mean prevalence of 4.6%. Early identification and prompt intervention are crucial to mitigating further complications. The pathophysiology of MU is complex and involves multiple factors, including smoking, Helicobacter pylori infection, non-steroidal anti-inflammatory drug (NSAID) use, and larger pouch size. Patients with MU may experience acute or chronic abdominal pain. Rarely, they may present with a complication from the ulceration, such as bleeding, perforation, or strictures. Following diagnosis by endoscopy, management of MU typically involves modification of risk factors and medical therapy focused on proton pump inhibitors. In case of complicated ulcers, surgical intervention is often required for the repair of the perforation or resection of the stricture. For recurrent or recalcitrant ulcers, endoscopic coverage of the ulcer bed, resection of the anastomosis, and abdominal or thoracoscopic truncal vagotomy may be considered. This review aims at providing an overview of the etiology, diagnosis, and management of MU after RYGB.

Bariatric surgery outcomes in patients with bipolar or schizoaffective disorders.

BACKGROUND: Obesity is associated with many co-morbidities and can cause harm to physical and mental well-being. While much has been studied in the general population about the outcomes of bariatric surgery, its implications in patients with bipolar/schizoaffective disorder (BSD) are less well understood. OBJECTIVE: We aimed to describe outcomes of bariatric surgery in patients with BSD. SETTING: Referral center for bariatric surgery. METHODS: We conducted a retrospective chart review analysis of bariatric surgical procedures in patients with BSD between 2008 and 2021 at Mayo Clinic. Patients with BSD (cases) were matched via propensity score matching (1:2) with non-BSD controls based on surgical procedure, age, sex, body mass index, and type 2 diabetes. Hierarchical logistic regression model was performed using SAS software. RESULTS: We matched 71 patients with BSD with 142 controls in a 1:2 ratio. After adjusting for baseline preoperative weight, patients with BSD had a 3.4% greater total weight loss compared with controls over 24 months (P = .02 [95% CI, .65-6.08]). Remission in obesity-related diseases, such as diabetes, hypertension, dyslipidemia, and sleep apnea, was similar in both groups. Perioperative complication rates were similar other than deep venous thrombosis, which showed a higher rate in patients with BSD (P = .04). Patients with long-term BSD were at increased risk of alcohol use compared with controls. CONCLUSIONS: When compared with the general bariatric population, weight loss was similar to slightly improved, with a comparable risk and complication profile. Patients with BSD have increased alcohol use after bariatric surgery, highlighting the need for psychological care before and after surgery in this population.

Predictors of marginal ulcer after gastric bypass: a systematic review and meta-analysis.

INTRODUCTION: Marginal ulcer (MU) is a common complication following Roux-en-Y gastric bypass (RYGB) with an incidence rate of up to 25%. Several studies have evaluated different risk factors associated with MU with inconsistent findings. In this meta-analysis, we aimed to identify the predictors of MU after RYGB. METHODS: A comprehensive literature search of PubMed, Embase, and Web of Science databases was conducted through April 2022. All studies that used a multivariate model to assess risk factors for MU after RYGB were included. Pooled odds ratios (OR) with 95% confidence intervals (CI) for risk factors reported in ≥ 3 studies were obtained within a random-effects model. RESULTS: Fourteen studies with 344,829 patients who underwent RYGB were included. Eleven different risk factors were analyzed. Meta-analysis demonstrated that Helicobacter pylori (HP) infection (OR 4.97 [2.24-10.99]), smoking (OR 2.50 [1.76-3.54]), and diabetes mellitus (OR 1.80 [1.15-2.80]), were significant predictors of MU. Increased age, body mass index, female gender, obstructive sleep apnea, hypertension, and alcohol use were not predictors of MU. There was a trend of an increased risk of MU associated with nonsteroidal anti-inflammatory drugs (OR 2.43 [0.72-8.21]) and a lower risk of MU with proton pump inhibitors use (OR 0.44 [0.11-2.11]). CONCLUSIONS: Smoking cessation, optimizing glycemic control, and eradication of HP infection reduce the risk of MU following RYGB. Recognition of predictors of MU after RYGB will allow physicians to identify high-risk patients, improve surgical outcomes, and reduce the risk of MU.