PReoperative very low-Energy diets for obese PAtients undergoing non-bariatric surgery Randomized Evaluation (PREPARE): a protocol for a pilot randomized controlled trial.

BACKGROUND: Patients with obesity presenting in need of surgical intervention are at 2-to-sixfold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To mitigate some of these concerns, prescribed preoperative weight loss via very low-energy diets (VLEDs) has become a standard of care for patients with obesity undergoing bariatric surgery. While VLEDs have become standard prior to bariatric surgery, their application in other surgical settings remains limited. A large, definitive trial is required to resolve the uncertainty surrounding their use in these patients. Prior to a definitive trial to compare the efficacy of VLEDs in patients with obesity undergoing major non-bariatric surgery, we require a pilot trial. We argue a pilot trial will provide the following critical feasibility insights: (1) assessment of recruitment ability, (2) evaluation of adherence to VLED regimens, and (3) assessment of our ability follow patients completely. METHODS: The proposed trial will be a multi-center, surgeon, outcome assessor, and data-analyst blinded, parallel pilot randomized controlled trial (RCT). Patients older than 18 years of age with a body mass index (BMI) of greater than 30 kg/m2 undergoing major elective non-bariatric surgery will be eligible for inclusion. Consecutive patients will be allocated 1:1 according to a computer-generated randomization schedule. Randomization will be stratified by center and will employ randomly permutated blocks. All patients in the intervention group will receive standard patient counseling on weight loss and an active VLED protocol. The preoperative VLED protocol will utilize commercially available weight loss products for three weeks preoperatively. The primary outcomes (randomization percentage, recruitment rate, intervention adherence, follow-up completion, network development) will assess feasibility. Descriptive statistics will be used to characterize the study sample. DISCUSSION: The PREPARE pilot RCT will aim to provide feasibility and safety data that will allow for the successful completion of the definitive PREPARE trial that has the potential to provide practice changing data pertaining to the regular use of VLEDs as a means of pre-habilitation for patients with obesity undergoing major non-bariatric surgery. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov (reference #NCT05918471) on June 23, 2023.

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

PREscribing preoperative weight loss prior to major non-bariatric abdominal surgery for patients with Elevated weight: Patient and Provider Survey Protocols (PREPARE surveys).

BACKGROUND: Preoperative very low energy diet (VLED) interventions are used routinely in patients undergoing bariatric surgery, a surgical subspecialty that deals almost exclusively with patients with obesity. Yet, their use and study has been limited in non-bariatric abdominal surgery. To investigate the use of VLEDs in non-bariatric surgery, we plan on conducting a randomized controlled trial (RCT). Prior to proceeding, however, we have designed two surveys as important pre-emptive studies aimed at elucidating patient and provider perspectives regarding these interventions. METHODS: The patient survey is a cross-sectional, single-center survey aimed at assessing the safety, adherence, barriers to adherence, and willingness to participate in preoperative optimization protocols with VLEDs prior to undergoing elective non-bariatric intra-abdominal surgery (S1 File). The population of interest is all adult patients with obesity undergoing elective non-bariatric intra-abdominal surgery at St. Joseph's Healthcare Hamilton who were prescribed a course of preoperative VLED. The primary outcomes will be safety and adherence. The target sample size is 35 survey responses. The provider survey is a cross-sectional national survey of practicing surgeons in Canada who perform major non-bariatric abdominal surgery aimed assessing the willingness and ability to prescribe preoperative weight loss interventions amongst practicing Canadian surgeons who perform major non-bariatric abdominal surgery (S2 File). The population of interest is independent practicing surgeons in Canada who perform major non-bariatric abdominal surgery. The primary outcome will be willingness to prescribe preoperative VLED to patients with obesity undergoing major non-bariatric abdominal surgery for both benign and malignant indications. The target sample size is 61 survey responses. Descriptive statistics will be used to characterize the sample populations. To determine variables associated with primary outcomes in the surveys, regression analyses will be performed. DISCUSSION: These survey data will ultimately inform the design of an RCT evaluating the efficacy of preoperative VLEDs for patients with obesity undergoing major abdominal surgery.

Assessing the Modified Frailty Index and Post-Operative Outcomes in Adhesive Small Bowel Obstruction: A Retrospective Cohort Study.

INTRODUCTION: Studies identifying predictors of postoperative outcomes in adhesive small bowel obstruction are limited. This study investigates the efficacy of the modified frailty index (mFI)to predict postoperative morbidity and mortality among patients undergoing surgery for adhesive small bowel obstruction. METHODS: A multicentre retrospective cohort study including patients undergoing surgery for adhesive small bowel obstruction after failed trial of nonoperative management between January 2015 and December 2020 was performed. Impact of frailty status using the mFI, stratified as frail (≥0.27) and robust (<0.27), on postoperative morbidity, mortality, length of stay, and discharge destination was evaluated using multiple logistic regression. RESULTS: Ninety-two robust patients (mean age 62.4 y, 68% female) and 41 frail patients (mean age 81.7 y, 63% female) were included. On simple stratification, frail patients had significantly increased 30-d morbidity (overall morbidity 80% versus 49%) and need for higher level of care on discharge (41% versus 9%). However, on multiple regression, functional dependence but not the mFI, was independently associated with worse 30-d overall morbidity (odds ratio [OR] 3.97, confidence interval [CI] 1.29-12.19) and lower likelihood of returning to preoperative disposition (OR 0.21, CI 0.05-0.91). The delay in operation beyond 5 d was independently associated with worse 30-d outcomes including overall morbidity and mortality (OR 7.54, CI 2.13-26.73) and decreased return to preoperative disposition (OR 0.14, CI 0.04-0.56). CONCLUSIONS: The mFI, although promising, was not independently predictive of outcomes following surgery for adhesive small bowel obstruction. Further adequately powered studies are required.

Pilot and feasibility trials in surgery are incompletely reported according to the CONSORT checklist: a meta-research study.

OBJECTIVES: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness. SETTING: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021. RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported. CONCLUSION: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

Prucalopride and Bowel Function Post Gastrointestinal Surgery: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Prolonged postoperative ileus (PPOI) contributes to morbidity and prolonged hospitalization. Prucalopride, a selective 5-hydroxytryptamine receptor agonist, may enhance bowel motility. This review assesses whether the perioperative use of prucalopride compared to placebo is associated with accelerated return of bowel function post gastrointestinal (GI) surgery. METHODS: OVID, CENTRAL, and EMBASE were searched as of January 2024 to identify randomized controlled trials (RCTs) comparing prucalopride and placebo for prevention of PPOI in adult patients undergoing GI surgery. The primary outcomes were time to stool, time to flatus, and time to oral tolerance. The secondary outcomes were incidence of PPOI, length of stay (LOS), postoperative complications, adverse events, and overall costs. The Cochrane risk of bias tool for randomized trials and the Grading of Recommendations, Assessment, Development, and Evaluations framework were used. An inverse variance random effects model was used. RESULTS: From 174 citations, 3 RCTs with 139 patients in each treatment group were included. Patients underwent a variety of GI surgeries. Patients treated with prucalopride had a decreased time to stool (mean difference 36.82 hours, 95% CI 59.4 to 14.24 hours lower, I2 = 62%, low certainty evidence). Other outcomes were not statistically significantly different (very low certainty evidence). Postoperative complications and adverse events could not be meta-analyzed due to heterogeneity; yet individual studies suggested no significant differences (very low certainty evidence). DISCUSSION: Current RCT evidence suggests that prucalopride may enhance postoperative return of bowel function. Larger RCTs assessing patient important outcomes and associated costs are needed before routine use of this agent.

Financial toxicity among patients undergoing resectional surgery for inflammatory bowel disease in the United States.

AIM: Financial toxicity describes the financial burden and distress that patients experience due to medical treatment. Financial toxicity has yet to be characterized among patients with inflammatory bowel disease (IBD) undergoing surgical management of their disease. This study investigated the risk of financial toxicity associated with undergoing surgery for IBD. METHODS: This study used a retrospective analysis using the National Inpatient Sample from 2015 to 2019. Adult patients who underwent IBD-related surgery were identified using the International Classification of Diseases (10th Revision) diagnostic and procedure codes and stratified into privately insured and uninsured groups. The primary outcome was risk of financial toxicity, defined as hospital admission charges that constituted 40% or more of patient's post-subsistence income. Secondary outcomes included total hospital admission cost and predictors of financial toxicity. RESULTS: The analytical cohort consisted of 6412 privately insured and 3694 uninsured patients. Overall median hospital charges were $21 628 (interquartile range $14 758-$35 386). Risk of financial toxicity was 86.5% among uninsured patients and 0% among insured patients. Predictors of financial toxicity included emergency admission, being in the lowest residential income quartile and having ulcerative colitis (compared to Crohn's disease). Additional predictors were being of Black race or male sex. CONCLUSION: Financial toxicity is a serious consequence of IBD-related surgery among uninsured patients. Given the pervasive nature of this consequence, future steps to support uninsured patients receiving surgery, in particular emergency surgery, related to their IBD are needed to protect this group from financial risk.

Postoperative Gastrointestinal Dysfunction After Neuromuscular Blockade Reversal With Sugammadex Versus Cholinesterase Inhibitors in Patients Undergoing Gastrointestinal Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: Postoperative gastrointestinal dysfunction (POGD) commonly occurs following gastrointestinal (GI) surgery and is associated with specific anesthetic agents. Cholinesterase inhibitors employed for reversing neuromuscular blockade have been implicated in development of POGD. Sugammadex, a novel reversal agent, is linked with reduced POGD. However, there is a lack of comprehensive comparative review between these agents regarding their impact on POGD following GI surgery. This study aims to systematically review the effects of sugammadex on POGD compared to cholinesterase inhibitors following GI surgery. METHODS: MEDLINE, EMBASE, and CENTRAL were searched as of July 2022 to identify articles comparing sugammadex with cholinesterase inhibitors in patients undergoing gastrointestinal surgery, specifically in relation to POGD. Secondary endpoints included length of hospital stay, readmission rates, pulmonary complications, and postoperative morbidity. RESULTS: From 198 citations, 2 randomized controlled trials (RCTs) and 3 retrospective cohorts with 717 patients receiving sugammadex and 812 patients receiving cholinesterase inhibitors were included. Significantly lower rates of prolonged postoperative ileus (OR .44, 95% CI .25-.77, P < .05, I2 = 56%, low certainty evidence) was observed with sugammadex. No significant difference in any other outcome was observed. Narrative review of readmission data demonstrated no significant difference. CONCLUSION: The use of sugammadex following gastrointestinal surgery is associated with significantly lower rates of prolonged postoperative ileus compared to cholinesterase inhibitors. However, these do not translate into a significant reduction in length of stay, morbidity, or postoperative nausea and vomiting. Results are limited by the numer of studies included and missing data, more robust RCTs are needed before recommendations can be made.

Short-term postoperative outcomes for obese versus non-obese inflammatory bowel disease patients undergoing bowel resection: a propensity score matched analysis.

PURPOSE: Up to 40% of patients with inflammatory bowel disease (IBD) are obese. Obesity is a well-known risk factor for increased perioperative morbidity, but this risk has never been quantified in IBD patients undergoing abdominal surgery using the United States National Inpatient Sample (NIS) database. This study aims to compare postoperative morbidity between obese and non-obese patients undergoing bowel resection for IBD using recent NIS data. METHODS: Adult patients who underwent bowel resection for IBD from 2015 to 2019 were identified in the NIS using ICD-10-CM coding. Patients were stratified into obese (BMI > 30 kg/m2) and non-obese groups, then propensity score matched (PSM) for demographic, operative, and hospital characteristics. The primary outcome was postoperative in-hospital morbidity. Secondary outcomes included postoperative in-hospital mortality, system-specific postoperative complications, total admission healthcare costs, and length of stay (LOS). Univariable and multivariable regressions were utilized. RESULTS: Overall, 6601 non-obese patients and 671 obese patients were identified. The PSM cohort included 659 patients per group. Obese patients had significantly increased odds of experiencing postoperative in-hospital morbidity (aOR 1.50, 95% CI 1.10-2.03, p = 0.010) compared to non-obese patients. Specifically, obese patients experienced increased gastrointestinal complications (aOR 1.49, 95% CI 1.00-2.24, p = 0.050), and genitourinary complications (aOR 1.71, 95% CI 1.12-2.61, p = 0.013). There were no differences in total admission healthcare costs (MD - $2256.32, 95% CI - 19,144.54-14,631.9, p = 0.79) or LOS (MD 0.16 days, 95% CI - 0.93-1.27, p = 0.77). CONCLUSIONS: Obese IBD patients are at greater risk of postoperative in-hospital morbidity than non-obese IBD patients. This supports targeted preoperative weight loss protocols for IBD patients to optimize surgical outcomes.

Lymph Node Ratio as a Predictor of Survival for Colon Cancer: A Systematic Review and Meta-Analysis.

BACKGROUND: Lymph node ratio is the number of lymph nodes with evidence of metastases on pathological review compared to the total number of lymph nodes harvested during oncologic resection. Lymph node ratio is a proven predictor of long-term survival. These data have not been meta-analyzed to determine the prognosis associated with different lymph node ratio cut-offs in colon cancer. METHODS: Medline, Embase, and CENTRAL were systematically searched. Articles were included if they compared 5-year overall survival (OS) or disease-free survival (DFS) between different lymph node ratios for patients undergoing oncologic resection for stages I-III colon cancer. Pairwise meta-analyses using inverse variance random effects were performed. RESULTS: From 2587 citations, nine studies with 97,631 patients (female: 51.9%, median age: 61.65 years) were included. A lymph node ratio above .1 resulted in a 49% decrease in the odds of 5-year OS (2 studies; OR: 0.51, 95% CI: 0.49-.53, P < .00001). A lymph node ratio above .25 resulted in a 56% decrease in the odds of 5-year OS (3 studies; OR: 0.44, 95% CI: 0.43-.45, P < .00001). A lymph node ratio above .5 resulted in a 65% decrease in the odds of 5-year OS (3 studies; OR: 0.35, 95% CI: 0.33-.37, P < .00001). CONCLUSIONS: Lymph node ratios from .1 to .5 are effective predictors of 5-year OS for colon cancer. There appears to be an inverse dose-response relationship between lymph node ratio and 5-year OS. Further study is required to determine whether there is an optimal lymph node ratio cut-off for prognostication and whether it can inform which patients may benefit from more aggressive adjuvant therapy and follow-up protocols.

Fragility of Statistically Significant Outcomes in Colonic Diverticular Disease Randomized Trials: A Systematic Review.

BACKGROUND: The p value has been criticized as an oversimplified determination of whether a treatment effect exists. One alternative is the fragility index. It is a representation of the minimum number of nonevents that would need to be converted to events to increase the p value above 0.05. OBJECTIVE: To determine the fragility index of randomized controlled trials assessing the efficacy of interventions for patients with diverticular disease since 2010 to assess the robustness of current evidence. DESIGN: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to August 2022. SETTINGS: Articles were eligible for inclusion if they were randomized trials conducted between 2010 and 2022 with parallel, superiority designs evaluating interventions in patients with diverticular disease. Only randomized trials with dichotomous primary outcomes with an associated p value of <0.05 were considered for inclusion. PARTICIPANTS: Any surgical or medical intervention for patients with diverticular disease. MAIN OUTCOME MEASURES: The fragility index was determined by adding events and subtracting nonevents from the groups with the smaller number of events. Events were added until the p value exceeded 0.05. The smallest number of events required was considered the fragility index. RESULTS: After screening 1271 citations, 15 randomized trials met the inclusion criteria. Nine of the studies evaluated surgical interventions and 6 evaluated medical interventions. The mean number of patients randomly assigned and lost to follow-up per randomized controlled trial was 92 (SD 35.3) and 9 (SD 11.4), respectively. The median fragility index was 1 (range, 0-5). The fragility indices for the included studies did not correlate significantly with any study characteristics. LIMITATIONS: Small sample, heterogeneity, and lack of inclusion of studies with continuous outcomes. CONCLUSIONS: The randomized trials evaluating surgical and medical interventions for diverticular disease are not robust. Changing a single-outcome event in most studies was sufficient to make a statistically significant study finding not significant. See Video Abstract . FRAGILIDAD DE LOS RESULTADOS ESTADSTICAMENTE SIGNIFICATIVOS EN ENSAYOS ALEATORIOS DE ENFERMEDAD DIVERTICULAR DEL COLON UNA REVISIN SISTEMTICA: ANTECEDENTES:El valor p ha sido criticado por una determinación demasiado simplificada de si existe un efecto del tratamiento. Una alternativa es el Índice de Fragilidad. Es una representación del número mínimo de no eventos que deberían convertirse en eventos para aumentar el valor p por encima de 0,05.OBJETIVO:Determinar el IF de ensayos controlados aleatorios que evalúan la eficacia de las intervenciones para pacientes con enfermedad diverticular desde 2010 para evaluar la solidez de la evidencia actual.FUENTES DE DATOS:Se realizaron búsquedas en MEDLINE, Embase y CENTRAL desde el inicio hasta agosto de 2022.SELECCIÓN DE ESTUDIOS:Los artículos eran elegibles para su inclusión si eran ensayos aleatorizados realizados entre 2010 y 2022 con diseños paralelos de superioridad que evaluaran intervenciones en pacientes con enfermedad diverticular. Sólo se consideraron para su inclusión los ensayos aleatorizados con resultados primarios dicotómicos con un valor de p asociado menor que 0,05.INTERVENCIÓNES:Cualquier intervención quirúrgica o médica para pacientes con enfermedad diverticular.PRINCIPALES MEDIDAS DE VALORACIÓN:El índice de fragilidad se determinó sumando eventos y restando no eventos de los grupos con el menor número de eventos. Se agregaron eventos hasta que el valor p superó 0,05. El menor número de eventos requeridos se consideró índice de fragilidad.RESULTADOS:Después de examinar 1271 citas, 15 ensayos aleatorios cumplieron los criterios de inclusión. Nueve de los estudios evaluaron intervenciones quirúrgicas y seis evaluaron intervenciones médicas. El número medio de pacientes aleatorizados y perdidos durante el seguimiento por ECA fue 92 (DE 35,3) y 9 (DE 11,4), respectivamente. La mediana del índice de fragilidad fue 1 (rango: 0-5). Los índices de fragilidad de los estudios incluidos no se correlacionaron significativamente con ninguna característica del estudio.LIMITACIONES:Muestra pequeña, heterogeneidad y falta de inclusión de estudios con resultados continuos.CONCLUSIONES:Los ensayos aleatorios que evalúan las intervenciones quirúrgicas y médicas para la enfermedad diverticular no son sólidos. Cambiar un solo evento de resultado en la mayoría de los estudios fue suficiente para que un hallazgo estadísticamente significativo del estudio no fuera significativo. (Traducción- Dr. Ingrid Melo ).

The impact of operative approach for obese colorectal cancer patients: analysis of the National Inpatient Sample 2015-2019.

AIM: Obesity is a well-established risk factor for the development of colorectal cancer. As such, patients undergoing surgery for colorectal cancer have increasingly higher body mass indices (BMIs). The advances in minimally invasive surgical techniques in recent years have helped surgeons circumvent some of the challenges associated with operating in the setting of obesity. While previous studies suggest that laparoscopy improves outcomes compared with open surgery in obese patients, this has never been established at the population level. Therefore, we designed a retrospective database study using the National Inpatient Sample (NIS) with the aim of comparing laparoscopic with open approaches for obese patients undergoing surgery for colorectal cancer. METHOD: A retrospective analysis of the NIS from 2015 to 2019 was conducted including patients with a BMI of greater than 30 kg/m2 undergoing surgery for colorectal cancer. The primary outcomes were postoperative in-hospital morbidity and mortality. Secondary outcomes included postoperative system-specific complications, total admission healthcare cost and length of stay (LOS). Multivariable logistic and linear regressions were utilized to compare the two operative approaches. RESULTS: A total of 4742 patients underwent open surgery and 3231 underwent laparoscopic surgery. We observed a significant decrease in overall postoperative morbidity [17.5% vs. 31.4%, adjusted odds ratio (aOR) 0.56, 95% confidence interval (CI) 0.50-0.64; p < 0.001], gastrointestinal morbidity (8.1% vs. 14.5%, aOR 0.59, 95% CI 0.50-0.69; p < 0.001) and genitourinary morbidity (10.1% vs. 18.6%, aOR 0.61, 95% CI 0.52-0.70; p < 0.001) with the use of laparoscopy. Postoperative LOS was 1.7 days shorter (95% CI 1.5-2.0, p < 0.001) and cost of admission was decreased by $9106 (95% CI $4638-$13 573, p < 0.001) with laparoscopy. CONCLUSION: Laparoscopic surgery for obese patients with colorectal cancer is associated with significantly decreased postoperative morbidity and improved healthcare resource utilization compared with open surgery. Laparoscopic approaches should be relied upon whenever feasible for these patients.

A history of bariatric surgery before surgery for colorectal cancer may improve short-term postoperative outcomes: Analysis of the national inpatient sample 2015-2019.

BACKGROUND: Bariatric surgery is the most effective and sustainable form of weight loss. Bariatric surgery before elective operations for colorectal pathology may improve postoperative outcomes. To compare patients with and without prior bariatric surgery undergoing surgery for colorectal cancer in terms of postoperative morbidity and health care use. METHODS: Adult patients undergoing resection for colorectal cancer from 2015 to 2019 were identified from the National Inpatient Sample. Patients were stratified according to their history of bariatric surgery. Propensity score matching with 4:1 nearest-neighbor matching was performed according to demographic, operative, and hospital characteristics. The primary outcome was postoperative morbidity. Secondary outcomes included system-specific postoperative complications, postoperative mortality, postoperative length of stay, total admission health care cost, and post-discharge disposition. McNemar's test and Wilcoxon matched-pairs signed-rank test were performed. RESULTS: After propensity score matching, 1,197 patients without prior bariatric surgery and 376 patients with prior bariatric surgery were included. Patients with prior bariatric surgery had an absolute reduction of 6.5% in overall in-hospital postoperative morbidity (19.1% vs 25.6%, P < .0001), a $5,256 decrease in hospitalization cost ($70,344 vs $75,600, P = .034), and were more likely to be discharged home after their index operation (72.9% vs 63.9%, P < .0001). CONCLUSION: Bariatric surgery before surgery for colorectal cancer may be associated with decreased postoperative morbidity and health care use. Bariatric surgery and other forms of rapid and effective weight loss, such as very low-energy diets, should be evaluated further for the optimization of obese patients before nonbariatric abdominal surgery.

Financial toxicity risk among patients with gastric banding complications in the United States: analysis of the National Inpatient Sample.

BACKGROUND: Laparoscopic adjustable gastric banding (AGB) was historically among the most performed bariatric procedures but has fallen out of favor in recent years due to poor long-term weight loss and high revisional surgery rates. Significant financial hardship of medical care, known as "financial toxicity," can occur from experiencing unexpected complications of AGB. OBJECTIVE: To investigate the risk of financial toxicity among patients being admitted for AGB complications. SETTING: United States. METHODS: All uninsured and privately-insured patients who were admitted for AGB complications were identified from the National Inpatient Sample 2015-2019. Publicly available government data (U.S. Census Bureau, Bureau of Labor, The Centers for Medicare and Medicaid Services) were utilized to estimate patient income, food expenditures, and average maximum out-of-pocket expenditures. Financial toxicity was defined as total admission cost from AGB complications ≥40% of postsubsistence income. RESULTS: Among 28,005 patients, 66% patients had private insurance and 44% patients were uninsured. Median total admission cost was $12,443 (interquartile range $7959-$19,859) and $15,182 for those who received revisional bariatric surgery. Approximately 55% of the uninsured patients and 1% of insured patients were at risk of financial toxicity after admission for banding-related complications. Patients who had an emergency admission, revisional surgery, or postoperative intensive care unit admission were more likely to experience financial catastrophe following admission (P < .01). CONCLUSIONS: About 1 in 2 uninsured patients admitted for AGB-related complications were at risk of financial toxicity. In addition to surgical risks, providers should consider the potential financial consequences of AGB when counselling patients on their choice of surgery.

Very low energy diets prior to bariatric surgery may reduce postoperative morbidity: a systematic review and meta-analysis of randomized controlled trials.

Purpose: To optimize patients prior to bariatric surgery, very low energy diets (VLEDs) are often employed for 2-4 weeks preoperatively. They are known to result in preoperative weight loss, decrease liver volume, and decrease surgeon-perceived operative difficulty. Their impact on postoperative morbidity has been less extensively studied. We performed a focused systematic review and meta-analysis with the aim of comparing preoperative VLEDs prior to bariatric surgery with controls in terms of overall postoperative morbidity. Methods: MEDLINE, Embase, and CENTRAL were searched from database inception to February 2023. Articles were eligible for inclusion if they were randomized controlled trials (RCTs) comparing postoperative morbidity in adult patients (i.e., over the age of 18) receiving a VLED with liquid formulation to those receiving a non-VLED control prior to elective bariatric surgery. Outcomes included overall 30-day postoperative morbidity and preoperative weight loss. An inverse variance meta-analysis was performed with GRADE assessment of the quality of evidence. Results: After reviewing 2,525 citations, four RCTs with 294 patients receiving preoperative VLEDs with liquid formulation and 294 patients receiving a non-VLED control met inclusion. Patients receiving VLED experienced significantly more preoperative weight loss than patients receiving control (mean difference (MD) 3.38 kg, 95% confidence interval (CI) 1.06-5.70, p = 0.004, I2 = 95%). According to low certainty evidence, there was a non-significant reduction in 30-day postoperative morbidity in patients receiving VLED prior to bariatric surgery (risk ratio (RR) 0.67, 95%CI 0.39-1.17, p = 0.16, I2 = 0%). Conclusion: The impact of preoperative VLEDs on postoperative outcomes following bariatric surgery remains unclear. It is possible that VLEDs may contribute to decreased postoperative morbidity, but further larger prospective trials are required to investigate the signal identified in this study.

HEmoRhoidal disease management with Band ligation versus polidocanol Sclerotherapy: a systematic review and meta-analysis (the HerBS Review).

PURPOSE: Symptomatic internal hemorrhoids affect up to 40% of people in Western society. Patients with grade I-III hemorrhoids, who fail lifestyle and medical management, may benefit from office-based procedures. As per the American Society of Colon and Rectum Surgeons (ASCRS), rubber band ligation (RBL) is the first-line office-based treatment. Polidocanol sclerotherapy is a relatively new approach for these patients. The aim of this systematic review is to compare the efficacy of RBL and polidocanol sclerotherapy with the treatment of symptomatic grade I-III internal hemorrhoids. METHODS: The systematic review was completed by searching MEDLINE, Embase, and CENTRAL databases from inception to August 2022 for prospective studies comparing RBL and polidocanol sclerotherapy or evaluating the efficacy of polidocanol sclerotherapy alone for adult (> 18 years) patients with grade I-III internal hemorrhoids. Treatments were evaluated for therapeutic success and post-procedure morbidity. RESULTS: Of 155 citations obtained, 10 studies (3 comparative and 7 single-arm studies) and 4 abstracts (2 comparative and 2 single arm) were included in the study. The patients undergoing sclerotherapy had a 93% (151/163) therapeutic success rate compared to 75% (68/91) in the RBL group (OR 3.39, 95% CI 1.48-7.74, p < 0.01). The post-procedure morbidity was 8% (17/200) in the sclerotherapy group and 18% (23/128) in the RBL group (OR 0.53, 95% CI 0.15-1.82, p = 0.31). CONCLUSION: This study highlights that polidocanol sclerotherapy may be associated with higher therapeutic success in patients with symptomatic grade I-III internal hemorrhoids. Further evaluations in the form of randomized trials are required to evaluate patient populations, which may benefit more from sclerotherapy.

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.

Patient reported symptom burden amongst immigrant and Canadian long-term resident women undergoing breast cancer surgery.

PURPOSE: Immigrants are susceptible to marginalization due to social isolation, economic disadvantage and systemic bias. Our goal was to compare symptom burden between immigrant and long-term resident women undergoing breast cancer surgery in Ontario, Canada. METHODS: A population-level retrospective cohort-study using administrative databases was conducted. Women who underwent surgery for newly diagnosed breast cancer and were treated at regional cancer centers between 2010 and 2016 were included. The primary outcome was a moderate or severe (≥ 4) symptom score on the Edmonton Symptom Assessment System Scale (ESAS). RESULTS: There were 12,250 (87.2%) long-term Canadian residents and 1,806(12.8%) immigrants. Immigrants were younger (mean age 53 vs. 61 years); had a higher proportion residing in a lowest income quintile neighbourhood (22.2% vs 15.4%); were less often on a primary-care physician roster (83.7% vs. 90.4%); and were less often diagnosed with Stage I/II disease (80.9% vs. 84.6%) (all p < 0.01). The proportion of women with scores ≥ 4 was significantly higher amongst immigrant women for 7/9 symptom categories; with the largest differences for depression (24.9% vs. 20.2%, p < 0.01) and pain (28.0% vs. 22.4%, p < 0.01). On multivariable regression analysis, immigration status was associated with scores ≥ 4 for pain (OR 1.13, 95% CI 1.02-1.23). There was an association between moderate/severe pain and region of origin, but not length of stay in Canada or immigration class. CONCLUSIONS: This is the first study comparing symptom burden amongst immigrant and non-immigrant women with breast cancer at a population-level. Immigrant women with breast cancer undergoing surgery were found to have a higher burden of pain.

Total Abdominal Colectomy Versus Diverting Loop Ileostomy and Antegrade Colonic Lavage for Fulminant Clostridioides Colitis: Analysis of the National Inpatient Sample 2016-2019.

BACKGROUND: When surgery is indicated for fulminant Clostridioides difficile infection (CDI), total abdominal colectomy (TAC) is the most common approach. Diverting loop ileostomy (DLI) with antegrade colonic lavage has been introduced as a colon-sparing surgical approach. Prior analyses of National Inpatient Sample (NIS) data suggested equivalent postoperative outcomes between groups but did not evaluate healthcare resource utilization. As such, we aimed to analyze a more recent NIS cohort to compare these two approaches in terms of both postoperative outcomes and healthcare resource utilization. METHODS: A retrospective analysis of the NIS from 2016 to 2019 was conducted. The primary outcome was postoperative in-hospital morbidity. Secondary outcomes included postoperative in-hospital mortality, system-specific postoperative complications, total admission cost, and length of stay (LOS). Univariable and multivariable regressions were utilized to compare the two operative approaches. RESULTS: In total, 886 patients underwent TAC and 409 patients underwent DLI with antegrade colonic lavage. Adjusted analyses demonstrated no difference between groups in postoperative in-hospital morbidity (aOR 0.96, 95%CI 0.64-1.44, p = 0.851) or in-hospital mortality (aOR 1.15, 95%CI 0.81-1.64, p = 0.436). Patients undergoing TAC experienced significantly decreased total admission cost (MD $79,715.34, 95%CI 133,841-25,588, p = 0.004) and shorter postoperative LOS (MD 4.06 days, 95%CI 6.96-1.15, p = 0.006). CONCLUSIONS: There are minimal differences between TAC and DLI with antegrade colonic lavage for fulminant CDI in terms of postoperative morbidity and mortality. Healthcare resource utilization, however, is significantly improved when patients undergo TAC as evidenced by clinically important decreases in total admission cost and postoperative LOS.