Assessment of guidelines for bariatric and metabolic surgery: a systematic review and evaluation using appraisal of guidelines for research and evaluation II (AGREE II).

BACKGROUND: In recent years, multiple guidelines on bariatric and metabolic surgery were published, however, their quality remains unknown, leaving providers with uncertainty when using them to make perioperative decisions. This study aims to evaluate the quality of existing guidelines for perioperative bariatric surgery care. METHODS: A comprehensive search of MEDLINE and EMBASE were conducted from January 2010 to October 2022 for bariatric clinical practice guidelines. Guideline evaluation was carried out using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) framework. RESULTS: The initial search yielded 1483 citations, of which, 26 were included in final analysis. The overall median domain scores for guidelines were: (1) scope and purpose: 87.5% (IQR: 57-94%), (2) stakeholder involvement: 49% (IQR: 40-64%), (3) rigor of development: 42.5% (IQR: 22-68%), (4) clarity of presentation: 85% (IQR: 81-90%), (5) applicability: 6% (IQR: 3-16%), (6) editorial independence: 50% (IQR: 48-67%), (7) overall impressions: 48% (IQR: 33-67%). Only six guidelines achieved an overall score >70%. CONCLUSIONS: Bariatric surgery guidelines effectively outlined their aim and presented recommendations. However, many did not adequately seek patient input, state search criteria, use evidence rating tools, and consider resource implications. Future guidelines should reference the AGREE II framework in study design.

Fragility of statistically significant outcomes in randomized trials comparing bariatric surgeries.

BACKGROUND: Randomized controlled trials (RCTs) are regarded as high-level evidence, but the strength of their P values can be difficult to ascertain. The Fragility Index (FI) is a novel metric that evaluates the frailty of trial findings. It is defined as the minimum number of patients required to change from a non-event to event for the findings to lose statistical significance. This study aims to characterize the robustness of bariatric surgery RCTs by examining their FIs. METHODS: A search was conducted in MEDLINE, EMBASE, and CENTRAL from January 2000 to February 2022 for RCTs comparing two bariatric surgeries with statistically significant dichotomous outcomes. Bivariate correlation was conducted to identify associations between FI and trial characteristics. RESULTS: A total of 35 RCTs were included with a median sample size of 80 patients (Interquartile range [IQR] 58-109). The median FI was 2 (IQR 0-5), indicating that altering the status of two patients in one treatment arm would overturn the statistical significance of results. Subgroup analyses of RCTs evaluating diabetes-related outcomes produced a FI of 4 (IQR 2-6.5), while RCTs comparing Roux-en-Y gastric bypass and sleeve gastrectomy had an FI of 2 (IQR 0.5-5). Increasing FI was found to be correlated with decreasing P value, increasing sample size, increasing number of events, and increasing journal impact factor. CONCLUSION: Bariatric surgery RCTs are fragile, with only a few patients required to change from non-events to events to reverse the statistical significance of most trials. Future research should examine the use of FI in trial design.

Racial and ethnic differences in presentation severity and postoperative outcomes in vascular surgery.

BACKGROUND: We assessed the effect of race and ethnicity on presentation severity and postoperative outcomes in those with abdominal aortic aneurysms (AAAs), carotid artery stenosis (CAS), peripheral arterial disease (PAD), and type B aortic dissection (TBAD). METHODS: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception until December 2020. Two reviewers independently selected randomized controlled trials and observational studies reporting race and/or ethnicity and presentation severity and/or postoperative outcomes for adult patients who had undergone major vascular procedures. They independently extracted the study data and assessed the risk of bias using the Newcastle-Ottawa scale. The meta-analysis used random effects models to derive the odds ratios (ORs) and risk ratios (RRs) and their corresponding 95% confidence intervals (CIs). The primary outcome was presentation severity stratified by the proportion of patients with advanced disease, including ruptured vs nonruptured AAA, symptomatic vs asymptomatic CAS, chronic limb-threatening ischemia vs claudication, and complicated vs uncomplicated TBAD. The secondary outcomes included postoperative all-cause mortality and disease-specific outcomes. RESULTS: A total of 81 studies met the inclusion criteria. Black (OR, 4.18; 95% CI, 1.31-13.26), Hispanic (OR, 2.01; 95% CI, 1.85-2.19), and Indigenous (OR, 1.97; 95% CI, 1.39-2.80) patients were more likely to present with ruptured AAAs than were White patients. Black and Hispanic patients had had higher symptomatic CAS (Black: OR, 1.20; 95% CI, 1.04-1.38; Hispanic: OR, 1.32; 95% CI, 1.20-1.45) and chronic limb-threatening ischemia (Black: OR, 1.67; 95% CI, 1.14-2.43; Hispanic: OR, 1.73; 95% CI 1.13-2.65) presentation rates. No study had evaluated the effect of race or ethnicity on complicated TBAD. All-cause mortality was higher for Black (RR, 1.23; 95% CI, 1.01-1.51), Hispanic (RR, 1.90; 95% CI, 1.57-2.31), and Indigenous (RR, 1.24; 95% CI, 1.12-1.37) patients after AAA repair. Postoperatively, Black (RR, 1.54; 95% CI, 1.19-2.00) and Hispanic (RR, 1.54; 95% CI, 1.31-1.81) patients were associated with stroke/transient ischemic attack after carotid revascularization and lower extremity amputation (RR, 1.90; 95% CI, 1.76-2.06; and RR, 1.69; 95% CI, 1.48-1.94, respectively). CONCLUSIONS: Certain visible minorities were associated with higher morbidity and mortality across various vascular surgery presentations. Further research to understand the underpinnings is required.

Primary anastomosis with diverting loop ileostomy versus Hartmann's procedure for acute complicated diverticulitis: analysis of the National Inpatient Sample 2015-2019.

BACKGROUND: Up to 50% of patients with acute complicated diverticulitis require operative management on their index admission. There is ongoing debate as to whether primary anastomosis with diverting ileostomy versus a Hartmann's procedure is the optimal surgical approach for these patients. This study aims to compare postoperative complications in patients undergoing either Hartmann's procedure or primary anastomosis and diverting ileostomy for perforated diverticulitis using recent National Inpatient Sample data. METHODS: Patients who underwent either primary anastomosis with diverting ileostomy or Hartmann's procedure for acute complicated diverticulitis from the 2015 to 2019 NIS database sample were included. Primary outcomes were postoperative in-hospital mortality and morbidity. Secondary outcomes were postoperative cause-specific complications, total admission cost, and length of stay (LOS). Univariate and multivariate regression were utilized to compare the two operative approaches. RESULTS: Overall, 642 patients underwent primary anastomosis with diverting ileostomy and 4,482 patients underwent Hartmann's procedure. There was no difference in in-hospital mortality (OR 0.93, 95%CI 0.45-1.92, p = 0.84) or in-hospital morbidity (OR 1.10, 95%CI 0.90-1.35, p = 0.33). Adjusted analysis suggested shorter postoperative LOS for patients undergoing Hartmann's procedure (MD 0.79 days, 95%CI 0.15-1.43 days, p = 0.013) and decreased total admission cost (MD $4,893.99, 95%CI $1,425.04-$8,362.94, p = 0.006). CONCLUSIONS: The present study supports that primary anastomosis with diverting ileostomy is safe for properly selected patients presenting with complicated diverticulitis. Primary anastomosis with diverting ileostomy is associated with greater total hospitalization costs and LOS.

The short and long-term effects of open vs minimally invasive thymectomy in myasthenia gravis patients: a systematic review and meta-analysis.

OBJECTIVE: Thymectomy has been utilized as a treatment for Myasthenia Gravis (MG) for many decades, with both open and minimally invasive surgical (MIS) techniques currently used. Although MIS has shown improved short-term results, long-term effects remain uncertain. This systematic review and meta-analysis aim to compare the post-operative and long-term outcomes of MIS versus open thymectomy in MG patients. METHODS: MEDLINE, EMBASE and CENTRAL databases were searched from inception till January 2022 for keywords related to MG and open or MIS thymectomy. Primary outcome was complete stable remission (CSR), and secondary outcomes were clinical improvement, complications, length of stay, operation time, and blood loss. Grading of recommendations, assessment, development, and evaluation was used to assess the certainty of evidence. RESULTS: 26 studies with 3588 patients were included in the analysis. At 1, 3 and 5 years, there was no statistical difference noted in CSR between open versus MIS thymectomy. However, CSR was improved at 1 year for MIS thymectomy in non-thymomatous MG (P = 0.03). There was no significant difference in rates of partial clinical improvement between techniques at 1-year. Although analyses on length of hospital stay and blood loss showed improvement following MIS thymectomy, operative time was shorter for open thymectomy. CONCLUSION: This is the first systematic review and meta-analysis assessing long-term effects of MIS versus open thymectomy in MG patients. Given the lack of significant differences noted, either MIS or open thymectomy can be performed, based on surgeon preference. Further high-level, long-term research should be conducted to determine the benefit of each technique.

Fragility of statistically significant findings from randomized trials in comparing laparoscopic versus robotic abdominopelvic surgeries.

BACKGROUND: Utility of robotic over laparoscopic approach has been an area of debate across all surgical specialties over the past decade. The fragility index (FI) is a metric that evaluates the frailty of randomized controlled trials (RCTs) findings by altering the status of patients from an event to non-event until significance is lost. This study aims to evaluate the robustness of RCTs comparing laparoscopic and robotic abdominopelvic surgeries through the FI. METHODS: A search was conducted in MEDLINE and EMBASE for RCTs with dichotomous outcomes comparing laparoscopic and robot-assisted surgery in general surgery, gynecology, and urology. The FI and reverse fragility Index (RFI) metrics were used to assess the strength of findings reported by RCTs, and bivariate correlation was conducted to analyze relationships between FI and trial characteristics. RESULTS: A total of 21 RCTs were included, with a median sample size of 89 participants (Interquartile range [IQR] 62-126). The median FI was 2 (IQR 0-15) and median RFI 5.5 (IQR 4-8.5). The median FI was 3 (IQR 1-15) for general surgery (n = 7), 2 (0.5-3.5) for gynecology (n = 4), and 0 (IQR 0-8.5) for urology RCTs (n = 4). Correlation was found between increasing FI and decreasing p-value, but not sample size, number of outcome events, journal impact factor, loss to follow-up, or risk of bias. CONCLUSION: RCTs comparing laparoscopic and robotic abdominal surgery did not prove to be very robust. While possible advantages of robotic surgery may be emphasized, it remains novel and requires further concrete RCT data.

The fragility of significant results from randomized controlled trials in esophageal surgeries.

While randomized controlled trials (RCTs) are regarded as one of the highest forms of clinical research, the robustness of their P values can be difficult to ascertain. Defined as the minimum number of patients in a study arm that would need to be changed from a non-event to event for the findings to lose significance, the Fragility Index is a method for evaluating results from these trials. This study aims to calculate the Fragility Index for trials evaluating perioperative esophagectomy-related interventions to determine the strength of RCTs in this field. MEDLINE and EMBASE were searched for RCTs related to esophagectomy that reported a significant dichotomous outcome. Two reviewers independently screened articles and performed the data extractions with risk of bias assessment. The Fragility Index was calculated using a two-tailed Fisher's exact test. Bivariate correlation was conducted to evaluate associations between the Fragility Index and study characteristics. 41 RCTs were included, and the median sample size was 80 patients [Interquartile range (IQR) 60-161]. Of the included outcomes, 29 (71%) were primary, and 12 (29%) were secondary. The median Fragility Index was 1 (IQR 1-3), meaning that by changing one patient from a non-event to event, the results would become non-significant. Fragility Index was correlated with P value, number of events, and journal impact factor. The RCTs related to esophagectomy did not prove to be robust, as the significance of their results could be changed by altering the outcome status of a handful of patients in one study arm.

Role of Adjuvant Therapy in Esophageal Cancer Patients After Neoadjuvant Therapy and Esophagectomy: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of this study was to analyze esophageal cancer patients who previously underwent neoadjuvant therapy followed by a curative resection to determine whether additional adjuvant therapy is associated with improved survival outcomes. SUMMARY BACKGROUND DATA: Neoadjuvant therapy followed by surgery is the standard of care for locally advanced esophageal cancer, whereas adjuvant therapy is typically employed for patients with residual disease. However, the role of adjuvant therapy after a curative resection is still uncertain. METHODS: MEDLINE, EMBASE, and CENTRAL databases were searched for studies comparing patients with esophageal cancer who underwent neoadjuvant therapy and curative resection with and without adjuvant therapy. Primary outcome was overall survival (OS), and random effects meta-analysis was conducted where appropriate. Grading of recommendations, assessment, development, and evaluation was used to assess the certainty of evidence. RESULTS: Ten studies involving 6462 patients were included. When compared to patients who received neoadjuvant therapy and esophagectomy alone, adjuvant therapy groups experienced a significant decrease in mortality by 48% at 1 year (Risk Ratio (RR) 0.52, 95% confidence interval [CI] 0.41-0.65, P < 0.001, moderate certainty). This reduction in mortality was carried through to 5-year follow-up (RR 0.91, 95% CI 0.86-0.96, P < 0.001, moderate certainty). The difference between the adjuvant therapy and the control group was uncertain regarding the secondary outcomes. CONCLUSION: Adjuvant therapy after neoadjuvant treatment and esophagectomy with negative resection margins provide an improved OS at 1 and 5 years with moderate to high certainty of evidence, but the benefit for disease-free survival and locoregional/distal recurrence remain uncertain due to limited reporting of these outcomes.

A systematic review and meta-analysis of sex- and gender-based differences in presentation severity and outcomes in adults undergoing major vascular surgery.

BACKGROUND: Studies have investigated the effects of gender on vascular surgery care. However, to the best of our knowledge, no comprehensive synthesis of the literature has been performed on the presentation severity and postoperative outcomes for abdominal aortic aneurysms (AAAs), carotid artery stenosis (CAS), peripheral artery disease (PAD), and type B aortic dissection (TBAD). We conducted a systematic review and meta-analysis of the sex and gender differences in the presentation severity and outcomes for patients who had undergone major vascular surgery. METHODS: The MEDLINE, Embase, and Cochrane CENTRAL databases were searched from their inception to December 2020. All observational studies and randomized controlled trials that had evaluated the gender differences in presentation severity or outcomes for patients who had undergone open or endovascular AAA or TBAD repair, carotid endarterectomy or stenting, or lower extremity bypass or angioplasty were included. The presentation severity was defined as follows: AAA (symptomatic or ruptured vs asymptomatic), carotid artery disease (symptomatic vs asymptomatic), PAD (chronic limb-threatening ischemia [CLTI] vs claudication), and TBAD (complicated vs uncomplicated). The postoperative outcomes included long-term mortality, stroke, amputation, revascularization, and graft and/or stent thrombosis. A random effects model was used to derive the odds ratios (ORs), risk ratios (RRs), and 95% confidence intervals (CIs). RESULTS: A total of 236 studies met the inclusion criteria for our systematic review. Of the 236 studies, 86 (n = 2,099,534 patients), 62 (n = 2,300,888 patients), 28 (n = 2,394,143 patients), and 4 (n = 4525 patients) had evaluated the effects of gender on the outcomes for patients with AAA, CAS, PAD, and TBAD, respectively. The female patients were more likely to have presented with a ruptured AAA (OR, 1.18; 95% CI, 1.09-1.28) and CLTI (OR, 1.10; 95% CI, 1.02-1.19) than were the male patients. The all-cause mortality for those with an AAA (RR, 1.35; 95% CI, 1.20-1.52) and those with PAD (RR, 1.14; 95% CI, 1.05-1.23) was higher for the women. However, the female patients with CAS had had lower all-cause mortality (RR, 0.85; 95% CI, 0.76-0.94). No sex differences were found in the TBAD outcomes. CONCLUSIONS: We found that female patients who had undergone vascular surgery were associated with more severe disease at presentation, with a greater proportion of ruptured AAAs and CLTI. This potentially contributes to the higher mortality rates for female patients with AAAs and PAD compared with male patients. Future studies are needed to evaluate the reasons for these disparities, and greater efforts are required to support women in receiving more timely vascular surgical care.

The Effect of Chronic Kidney Disease or End-stage Kidney Disease on Perioperative Outcomes and Healthcare Utilization in Patients Undergoing Bariatric Surgery.

BACKGROUND: As chronic kidney disease (CKD) has a higher prevalence in patients with obesity, there is an increasing need to understand the safety of bariatric surgery for patients with advanced CKD. This study determined if short-term bariatric surgical outcomes and healthcare utilization differ in patients with advanced CKD. METHODS: A retrospective analysis of the Healthcare Cost and Utilization Project National Inpatient Sample (NIS) was performed. Patients with obesity who underwent bariatric surgery from 2015 to 2019 were included. Patients without CKD, with CKD, and end-stage kidney disease (ESKD) were compared for outcome differences. Univariate and multivariable regression was used to determine the association between perioperative outcomes to CKD status. RESULTS: The unadjusted analysis found significantly higher mortality and overall complication rate in CKD and ESKD patients, however, after adjustment for confounders, only the ICU admission rate remained significantly higher for patients CKD compared to non-CKD patients (odds ratio 4.21, 95% CI [3.29-5.39]). Length of stay was longer for patients with CKD (mean difference (MD) 0.14 days, 95% CI, [0.04, 0.23]) and patients with ESKD (MD 0.27 days, 95% CI, [0.10, 0.43]) compared to non-CKD patients. Patients with ESKD had higher admission costs compared to non-CKD patients (MD $1982.65). CONCLUSION: Patients with CKD and ESKD have increased healthcare utilization and higher rates of ICU admission after bariatric surgery compared to non-CKD patients. Otherwise, there is no significant difference in other post-operative complications and mortality. Bariatric surgery may therefore be safely offered to this patient population in hospitals with on-site ICU capacity.

The role of brachytherapy in treatment of stage I esophageal cancer: A systematic review.

PURPOSE: Despite advancements in the early detection of esophageal cancer, optimal radiotherapy methods for treatment of early disease have not yet been determined. Moreover, the benefit of intraluminal brachytherapy on local control or survival remains controversial. We performed a systematic review to establish the role of brachytherapy as boost therapy in stage I esophageal squamous cell carcinoma, and to evaluate associated survival outcomes. METHODS AND MATERIALS: A systematic search of three bibliographic databases from January 1950 to January 2019 was conducted. All studies investigating brachytherapy for curative intent were included and palliative treatment was excluded. Primary outcomes included overall survival and disease-free survival (DFS). Secondary outcomes included loco-regional control (LRC) and toxicity grades and/or complications. Two reviewers independently abstracted data and evaluated study quality using grading of recommendations assessment, development, and evaluation, pooled results were presented through risk ratios. RESULTS: A total of 12 retrospective studies met inclusion criteria. The overall quality of evidence yielded a Grade 1C rating (strong recommendation, low quality evidence). Of 525 included patients, 325 patients received both external beam radiation (EBRT), and brachytherapy, 132 underwent EBRT only, and 68 received brachytherapy with and/or without chemoradiation. For patient group treated with EBRT and brachytherapy, 5-year mortality, DFS and LRC were: 43% (27-59%), 63% (49-76%) and 72% (63-80%) respectively. Rates of complications reported included 82.1% Grade 1 esophagitis for a combined external beam radiation and brachytherapy cohort, 12.3% ulcerations, and 3.3% fistulae. CONCLUSIONS: Brachytherapy as a combined modality is encouraging, given its relative safety and effectiveness. Further prospective analysis using higher quality evidence is warranted to evaluate oncologic outcomes and survival advantage.

Iron supplementation following bariatric surgery: A systematic review of current strategies.

Iron deficiency (ID) and iron deficiency anemia (IDA) are common following bariatric surgery; however, there are limited standardized treatment recommendations for their management. The purpose of this study was to review the current strategies for iron supplementation following bariatric surgery and assess their relative efficacy in managing ID and IDA. MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched to January 2021. Primary outcomes of interest were prevention or improvement in ID or IDA with iron supplementation. Forty-nine studies with 12,880 patients were included. Most patients underwent Roux-en-Y gastric bypass (61.9%). Iron supplementation was most commonly administered orally for prevention of ID/IDA and was effective in 52% of studies. Both IV and oral iron were given for treatment of ID/IDA. Fifty percent (3/6) of the oral and 100% (3/3) of the IV supplementation strategies were effective at treating ID. Iron supplementation strategies employed following bariatric surgery are highly variable, and many do not provide sufficient iron to prevent the development of ID and IDA, potentially due to poor patient adherence. Further high-quality prospective trials, particularly comparing intravenous and oral iron, are warranted in order to determine the ideal dosage, route, and duration of iron supplementation.