The impact of COVID-19 pandemic on patient selection and access to care, approach type, and postoperative outcomes in bariatric surgery.

BACKGROUND: The COVID-19 pandemic had affected the health systems across the world since early 2020 with a concern about access to medical care during the first wave of COVID-19 pandemic. OBJECTIVES: The objective of this study was to examine how the COVID-19 pandemic influenced patient selection, approach type, and postoperative outcomes in elective bariatric surgery. SETTING: United States. METHODS: Data from the MBSAQIP database for the years 2016-2020 were queried. Wilcoxon rank-sum test and Fisher's exact test were employed for continuous and categorical variables, respectively. Postoperative outcomes within 30 days were assessed separately and based on the Clavien-Dindo (CD) classification of III-V. χ2 test and logistic regression were used to compare outcomes between procedure and approach types, as well as surgical operation periods. RESULTS: A total of 741,620 patients underwent robotic and laparoscopic sleeve gastrectomy and Roux-en-Y gastric-bypass. The cases performed in 2020 exhibited lower comorbidities and postoperative complications compared to prepandemic years, regardless of the approach type. Notably, the proportion of White patients decreased during the pandemic, while there was an increase in the number of African American and Hispanic patients who had bariatric surgery. CONCLUSIONS: Patients who underwent bariatric surgery during the COVID-19 pandemic appeared to be healthier with fewer comorbidities and experienced fewer adverse postoperative outcomes compared to those who had surgery prior to the pandemic. This study highlights the limited access to bariatric surgery for high-risk patients during the pandemic.

Readability of online patient education material for foregut surgery.

INTRODUCTION: Health literacy is the ability of individuals to use basic health information and services to make well-informed decisions. Low health literacy among surgical patients has been associated with nonadherence to preoperative and/or discharge instructions as well as poor comprehension of surgery. It likely poses as a barrier to patients considering foregut surgery which requires an understanding of different treatment options and specific diet instructions. The objective of this study was to assess and compare the readability of online patient education materials (PEM) for foregut surgery. METHODS: Using Google, the terms "anti-reflux surgery, "GERD surgery," and "foregut surgery" were searched and a total of 30 webpages from universities and national organizations were selected. The readability of the text was assessed with seven instruments: Flesch Reading Ease formula (FRE), Gunning Fog (GF), Flesch-Kincaid Grade Level (FKGL), Coleman Liau Index (CL), Simple Measure of Gobbledygook (SMOG), Automated Readability Index (ARI), and Linsear Write Formula (LWF). Mean readability scores were calculated with standard deviations. We performed a qualitative analysis gathering characteristics such as, type of information (preoperative or postoperative), organization, use of multimedia, inclusion of a version in another language. RESULTS: The overall average readability of the top PEM for foregut surgery was 12th grade. There was only one resource at the recommended sixth grade reading level. Nearly half of PEM included some form of multimedia. CONCLUSIONS: The American Medical Association and National Institute of Health have recommended that PEMs to be written at the 5th-6th grade level. The majority of online PEM for foregut surgery is above the recommended reading level. This may be a barrier for patients seeking foregut surgery. Surgeons should be aware of the potential gaps in understanding of their patients to help them make informed decisions and improve overall health outcomes.

Disparities in hepatocellular carcinoma incidence among Hispanic and non-Hispanic adults in Arizona: Trends between 2009-2017.

BACKGROUND: Hepatocellular carcinoma (HCC) is a highly lethal cancer with few treatment options available to patients. Most HCC cases in Arizona, a state with a high proportion of Hispanic adults, have not been included in recent reports of HCC incidence. This study describes trends in HCC incidence and stage at diagnosis among Arizona residents between 2009-2017 and reports on racial and ethnic disparities for these outcomes. METHODS: The Arizona Cancer Registry was used to identify Arizonans aged 19 or older diagnosed with liver cell carcinoma diagnosed between 2009-2017. A total of 5043 cases were examined. Adjusted annual and 3-year HCC incidence rates (per 100,000) were examined for non-Hispanic White (NHW) and Hispanic adults. RESULTS: The total age-adjusted HCC incidence rate increased significantly between 2009-2012 and then declined significantly between 2012-2017. Across nearly all years, age-adjusted HCC incidence in Hispanic adults was twice that of NHW adults. Hispanic adults were more likely to be diagnosed at a later stage across all time periods. The disparity in 3-year age-adjusted HCC incidence rate between NHW and Hispanic adults decreased between 2009-2017. CONCLUSION: Whe total age-adjusted HCC incidence rate increased significantly between 2009-2012 and then declined significantly between 2012-2017. Across nearly all years, age-adjusted HCC incidence in Hispanic adults was twice that of NHW adults. Hispanic adults were more likely to be diagnosed at a later stage across all time periods. The disparity in 3-year age-adjusted HCC incidence rate between NHW and Hispanic adults decreased between 2009-2017.

Follow-up compliance in patients undergoing abdominal aortic aneurysm repair at Veterans Affairs hospitals.

OBJECTIVE: The Society for Vascular Surgery guidelines recommend annual imaging surveillance following endovascular aneurysm repair (EVAR) and every 5 years following open surgical repairs (OSR) of abdominal aortic aneurysms (AAAs). Adherence to these guidelines is low outside of clinical trials, and compliance at Veterans Affairs (VA) hospitals is not yet well-established. We examined imaging follow-up compliance and mortality rates after AAA repair at VA hospitals. METHODS: We queried the VA Surgical Quality Improvement Program database for elective infrarenal AAA repairs, EVAR and OSR, then merged in follow-up imaging and mortality information. Mortality rate over time was derived using Kaplan-Meier estimation. Generalized estimating equation with a logit link and a sandwich standard error estimate was performed to compare the probability of having annual follow-up imaging over time between procedure types and to identify variables associated with follow-up imaging for EVAR patients. RESULTS: Our analysis included 11,668 patients who underwent EVAR and 4507 patients who underwent OSR at VA hospitals between the years 2000 and 2019. The 30-day mortality rate for EVAR and OSR was 0.37% and 0.82%, respectively. OSR was associated with lower long-term mortality after adjusting age, sex, American Society of Anesthesiologists classification and preoperative renal failure with an adjusted hazard ratio of 0.88 (95% confidence interval, 0.84-0.92; P < .01). Of surviving patients, the follow-up imaging rate was 69.1% by 1 year post-EVAR. The follow-up rate after 5 years was 45.6% post-EVAR compared with 63.6% post-OSR of surviving patients. A history of smoking or drinking, baseline hypertension, and known cardiac disease were independently associated with poor follow-up after EVAR. CONCLUSIONS: Patients undergoing elective open AAA repair in the VA hospital system had lower long-term mortality compared with patients who underwent endovascular repair. Compliance with post-EVAR imaging is low. Patient factors associated with poor post-EVAR imaging surveillance were smoking within the last year, excess alcohol consumption, and cardiac risk factors including hypertension, prior myocardial infarction, and congestive heart failure.

The impact of gender, race, and ethnicity on bariatric surgery outcomes.

BACKGROUND: The rates of postoperative complications can vary among specific patient populations. OBJECTIVES: The aim of this study is to examine how gender, race, and ethnicity can affect short-term postoperative complications in bariatric surgery patients. SETTING: United States. METHODS: Patients who underwent bariatric surgery between the years 2016 and 2021 were included and stratified based on gender, race/ethnicity, and procedure type. The 30-day outcomes were assessed using Clavien-Dindo (CD) classification of III-V. Wilcoxon rank-sum test was performed to compare continuous variables among groups and Chi-squared test for categorical variables. Logistic regression was performed to examine the effects of gender, race/ethnicity on CD classification ≥ III complications by the procedure type. RESULTS: A total of 975,642 bariatric surgery patients were included. Descriptive univariate analysis showed that CD ≥ III complications were higher among non-Hispanic blacks (NHB) and lowest in Hispanic patients, regardless of their gender, except in the duodenal switch DS group, where non-Hispanic whites (NHW) had the lowest complication rate. There was no difference between male and female patients with regards to postoperative complications, except in the sleeve gastrectomy (SG) group, where NHW males had more complications than NHW females. Sleeve gastrectomy showed the lowest complication rates followed by gastric bypass and DS in all groups. In multivariate logistic regression model, for both females and males NHBs had higher odds of postoperative complications compared to NHWs in sleeve gastrectomy (Female aOR:1.31, 95% CI: [1.23-1.40]; Male aOR:1.24, 95% CI: [1.08-1.43], P < .001) and gastric bypass (Female aOR:1.24, 95% CI: [1.16-1.33]; Male aOR:1.25, 95% CI: [1.06-1.48], P < .01). CONCLUSIONS: Non-Hispanic Black patients are at a higher rate of developing CD ≥ III complications compared to non-Hispanic Whites after bariatric surgery. The male gender was not a significant risk factor for serious postoperative complications. Among the different types of bariatric procedures, sleeve gastrectomy has the lowest rates of severe complications, followed by gastric bypass and duodenal switch. These results highlight the significance of considering gender, race, ethnicity, and procedure type during preoperative evaluation, surgical planning, and postoperative care.

Neighborhood social vulnerability and disparities in time to kidney cancer surgical treatment and survival in Arizona.

BACKGROUND: Hispanics and American Indians (AI) have high kidney cancer incidence and mortality rates in Arizona. This study assessed: (1) whether racial and ethnic minority patients and patients from neighborhoods with high social vulnerability index (SVI) experience a longer time to surgery after clinical diagnosis, and (2) whether time to surgery, race and ethnicity, and SVI are associated with upstaging to pT3/pT4, disease-free survival (DFS), and overall survival (OS). METHODS: Arizona Cancer Registry (2009-2018) kidney and renal pelvis cases (n = 4592) were analyzed using logistic regression models to assess longer time to surgery and upstaging. Cox-regression hazard models were used to test DFS and OS. RESULTS: Hispanic and AI patients with T1 tumors had a longer time to surgery than non-Hispanic White patients (median time of 56, 55, and 45 days, respectively). Living in neighborhoods with high (≥75) overall SVI increased odds of a longer time to surgery for cT1a (OR 1.54, 95% CI: 1.02-2.31) and cT2 (OR 2.32, 95% CI: 1.13-4.73). Race and ethnicity were not associated with time to surgery. Among cT1a patients, a longer time to surgery increased odds of upstaging to pT3/pT4 (OR 1.95, 95% CI: 0.99-3.84). A longer time to surgery was associated with PFS (HR 1.52, 95% CI: 1.17-1.99) and OS (HR 1.63, 95% CI: 1.26-2.11). Among patients with cT2 tumor, living in high SVI neighborhoods was associated with worse OS (HR 1.66, 95% CI: 1.07-2.57). CONCLUSIONS: High social vulnerability was associated with increased time to surgery and poor survival after surgery.

Carotid Revascularization is Associated with Improved Mood in Patients with Advanced Carotid Disease.

OBJECTIVE: To investigate the impact of carotid interventions on patients' mental condition in patients with carotid stenosis. SUMMARY BACKGROUND DATA: Ongoing research highlights the impact of carotid interventions on neurocognitive function in patients with advanced carotid atherosclerosis. However, data regarding the impact of carotid revascularization on mood is scarce. METHODS: A total of 157 patients undergoing carotid revascularization were prospectively recruited. The primary outcome was depression, evaluated pre-operatively, and at 1-,6- and 12-month post-intervention using the long form of the geriatric depression scale (GDS-30) questionnaire. Other tests were also used to assess cognition at the respective timepoints. Statistical analyses were performed to assess the postoperative outcomes compared to baseline. RESULTS: Baseline depression (GDS>9) was observed in 49(31%) subjects, whereas 108(69%) patients were not depressed (GDS≤9). The average pre-operative GDS score was 15.42 ± 4.40(14.2-16.7) and 4.28 ±2.9(3.7-4.8) in the depressed and non-depressed groups, respectively. We observed a significant improvement in GDS scores within the depressed group at 1-month (P=0.002), 6-months (P=0.027), and 1-year (P<0.001) post-intervention compared to preop, whereas the non-depressed group had similar post-op GDS scores at all time points compared to baseline. Significant improvement in measures of executive function was seen in non-depressed patients at all three timepoints whereas depressed patients showed an improvement at 1-year follow-up. CONCLUSIONS: Our study highlights improvement in mood among patients with advanced carotid disease who screened positive for depression at baseline. Further studies with larger sample sizes are warranted to investigate the association between depression, carotid disease, and carotid intervention.

First Assistant In Bariatric Surgery: A Comparison Between Laparoscopic And Robotic Approaches: A 4-Year Analysis of the MBSAQIP Database (2016-2019).

PURPOSE: The first assistant (FA) plays an important role in the operating room for bariatric surgery. The aim of this study was to examine the relationship between the type of FA and operative time (OT) and postoperative outcomes comparing robotic and laparoscopic approaches in bariatric surgery. METHODS AND MATERIALS: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data for 2016-2019 was queried. Log-normal regression was performed to evaluate the association of FAs and OT variations within and between groups. We used logistic regression to examine the relationship between the type of FA and 30-day outcomes across all procedures and approaches. RESULTS: A total of 691,789 patients who underwent robotic (R), and laparoscopic (L) sleeve gastrectomy (SG), Roux-en-Y gastric-bypass (RYGB), and duodenal switch (DS) were included. The percentage variation of OT was higher in the laparoscopic group (L-SG: 8.18%, L-RYGB: 9.88%, and L-DS: 15.00%) compared to the robotic group (R-SG: 2.43%, R-RYGB: 5.76%, and R-DS: 0.80%). There was not a significant difference in 30-day outcomes between laparoscopic and robotic approaches for the same procedures. CONCLUSIONS: The FA was associated with a decreased variability in OT in the robotic cohort compared to the laparoscopic group with no significant difference in complication rates. These results suggest that the robotic approach may decrease the need for skilled FAs in bariatric procedures.

Cognitive effects of carotid revascularization in octogenarians.

BACKGROUND: Cognitive impairment is the epitome of cerebrovascular diseases, causing a significant economic burden on our health care system. Growing evidence has indicated the benefits of carotid interventions in patients with severe carotid atherosclerosis. However, the neurocognitive outcome of carotid revascularization in octogenarians is not clearly understood. We aim to evaluate postintervention cognitive changes in seniors older than 80 years. METHODS: We prospectively recruited 170 patients undergoing carotid interventions. Neurocognitive testing was performed preoperatively and at 1, 6, and 12 months postoperatively. Episodic memory was assessed with Rey's Auditory Verbal Learning Test. Other executive functions and language measures were also evaluated at individual time points. Raw test scores were converted to z-scores or scaled scores adjusted for age and education. The sample was divided into 2 groups based on age: octogenarian (≥80 years) and nonoctogenarian (<80 years old). Postoperative cognitive scores were compared to baseline within each subcohort. RESULTS: A total of 23 subjects (13%) were octogenarians, and 147 (87%) were younger than 80 years. Younger patients demonstrated significant cognitive improvements up to 12 months postop compared to the baseline. However, octogenarians exhibited a lack of improvement in verbal memory, measures of executive function, and language at all 3 postintervention time points. CONCLUSION: Carotid interventions improve cognitive functions in younger patients with carotid occlusive atherosclerosis. However, no cognitive benefits were seen in male seniors older than 80 years. Further investigations are warranted to better understand the postinterventional cognitive changes in octogenarians.

Gemcitabine as first-line therapy for high-grade non-muscle invasive bladder cancer: results from a tertiary center in the contemporary BCG-shortage era.

Background: To evaluate the safety profile and efficacy of intravesical gemcitabine as first-line adjuvant therapy for non-muscle invasive bladder cancer (NMIBC) in the setting of ongoing Bacillus Calmette-Guérin (BCG) shortage. Methods: We performed an institutional, retrospective review of patients treated with intravesical gemcitabine induction and maintenance therapy from March 2019 to October 2021. Patients with intermediate or high-risk NMIBC who were BCG-naïve or experienced a high-grade (HG) recurrence after 12 months since the last dose of BCG were included in the analysis. The primary endpoint was complete response (CR) rate at the 3-month visit. Secondary endpoints were recurrence-free survival (RFS) and assessment of adverse events. Results: A total of 33 patients were included. All had HG disease and 28 (84.8%) were BCG-naive. The median follow-up was 21.4 months (range, 4.1-39.4). Tumor stages were cTa in 39.4%, cT1 in 54.5%, and cTis in 6.1% of patients. Most patients (90.9%) were in the AUA high-risk category. The 3-month CR was 84.8%. Among patients who achieved CR with adequate follow-up, 86.9% (20/23) remained disease-free at 6 months. The 6-month and 12-month RFS were 87.2% and 76.5%, respectively. The estimated median RFS was not reached. Approximately 78.8% of patients were able to complete full induction. Common adverse events (incidence ≥10%) included dysuria and fatigue/myalgia. Conclusions: Intravesical gemcitabine for intermediate and high-risk NMIBC in areas where BCG supply is limited was safe and feasible at short-term follow-up. Larger prospective studies are needed to better ascertain the oncologic efficacy of gemcitabine.

Robotic Bariatric Surgery in Older Adults, Is It Safer Than the Laparoscopic Approach? A 7-Year Analysis of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Database.

BACKGROUND: Utilization of the robotic platform in bariatric surgery has increased over the past several years. The population of older adults who benefit from bariatric surgery is also growing. This study evaluated the safety of robotic-assisted bariatric surgery in older adults using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Database. METHODS: Adults who underwent gastric bypass or sleeve gastrectomy and were ≥ 65 years old between the years 2015 and 2021 were included. The 30-day outcomes were assessed and stratified based on Clavien-Dindo (CD) classification of III-V. Univariable and multivariable logistic regressions were performed to identify predictors of CD ≥ III complications. RESULTS: A total of 62,973 bariatric surgery patients were included. Most of the patients (90%) underwent laparoscopic surgery, and the remainder (10%) underwent robotic surgery. Robotic sleeve gastrectomy (R-SG) was associated with lower odds of developing CD ≥ III complications compared to three other procedures (adjusted odds ratio (aOR), 0.741; confidence interval (CI), 0.584-0.941; p 0.014). CONCLUSIONS: Bariatric surgery using a robotic approach is considered safe for older patients. Robotic sleeve gastrectomy (R-SG) has the lowest morbidity and mortality rates compared to laparoscopic sleeve gastrectomy (L-SG), laparoscopic Roux-en-Y gastric bypass (L-RYGB), and robotic Roux-en-Y gastric bypass (R-RYGB). The findings of this study can help surgeons and their elderly patients to make informed decisions regarding the safety of different bariatric surgical approaches.

Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.

OBJECTIVES: To determine the feasibility (as measured by tolerability and safety) and efficacy of topical 5-fluorouracil (5-FU) and imiquimod for the treatment of cervical intraepithelial neoplasia (CIN) 2/3. METHODS: This pilot prospective study was conducted in women aged 18-45 years with p16+ CIN 2/3. Participants underwent an 8-week alternating regimen of self-applied 5% 5-FU on weeks 1, 3, 5, and 7 and physician-applied imiquimod on weeks 2, 4, 6, and 8. Adverse events (AEs) were collected by symptom diary and clinical exam. Feasibility was measured by tolerability and safety (AEs) of the study intervention. Tolerability was assessed as the number of participants able to apply 50% or more of the treatment doses. The safety outcome was calculated as the number of participants who experienced "specified AEs" defined as possibly, probably, or definitely related grade 2 or worse AE or grade 1 genital AEs (blisters, ulcerations, or pustules) lasting more than 5 days. The efficacy of the intervention was determined by histology and high-risk human papillomavirus (hrHPV) testing was done after treatment. RESULTS: The median age of the 13 participants was 27 ± 2.9 years. Eleven (84.61%) participants applied 50% or more of the treatment. All participants reported grade 1 AEs; 6 (46.15%) reported grade 2 AEs; and 0 reported grade 3/4 AEs. Three (23.08%) participants had specified AEs. Histologic regression to normal or CIN 1 among those completing 50% or more of the treatment doses was observed in 10 (90.91%) participants, and 7 (63.63%) tested negative for hr-HPV at the end of the study. CONCLUSIONS: Topical treatment for CIN 2/3 with 5-FU/imiquimod is feasible, with preliminary evidence of efficacy. Topical therapies need further investigation as adjuncts or alternatives to surgical therapy for CIN 2/3.

Gastric Cancer Surgery in the US: a Contemporary Trend Analysis of Lymphadenectomy and the Impact of Minimally Invasive Approaches.

BACKGROUND: The National Comprehensive Cancer Network guidelines recommend harvesting 16 or more lymph nodes for the adequate staging of gastric adenocarcinoma. This study examines the rate of adequate lymphadenectomy over recent years, its predictors, and its impact on overall survival(OS). STUDY DESIGN: The National Cancer Database was utilized to identify patients who underwent surgical treatment for gastric adenocarcinoma between 2006-2019. Trend analysis was performed for lymphadenectomy rates during the study period. Logistic regression, Kaplan-Meier survival plots, and Cox proportional hazard regression were utilized. RESULTS: A total of 57,039 patients who underwent surgical treatment for gastric adenocarcinoma were identified. Only 50.5% of the patients underwent a lymphadenectomy of ≥ 16 nodes. Trend analysis showed that this rate significantly improved over the years, from 35.1% in 2006 to 63.3% in 2019 (p < .0001). The main independent predictors of adequate lymphadenectomy included high-volume facility with ≥ 31 gastrectomies/year (OR: 2.71; 95%CI:2.46-2.99), surgery between 2015-2019 (OR: 1.68; 95%CI: 1.60-1.75), and preoperative chemotherapy (OR:1.49; 95%CI:1.41-1.58). Patients with adequate lymphadenectomy had better OS than patients who did not: median survival: 59 versus 43 months (Log-Rank: p < .0001). Adequate lymphadenectomy was independently associated with improved OS (HR:0.79; 95%CI:0.77-0.81). Laparoscopic and robotic gastrectomies were independently associated with adequate lymphadenectomy compared to open, OR: 1.11, 95%CI:1.05-1.18 and OR: 1.24, 95%CI:1.13-1.35, respectively. CONCLUSION: Although the rate of adequate lymphadenectomy improved over the study period, a large number of patients still lacked adequate lymph node dissection, negatively impacting their OS despite multimodality therapy. Laparoscopic and robotic surgeries were associated with a significantly higher rate of lymphadenectomy ≥ 16 nodes.

HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine.

OBJECTIVES: A single dose of human papillomavirus (HPV) vaccine would simplify logistics and reduce costs of vaccination programs worldwide. We conducted a phase IIa trial to determine the stability of HPV type-specific antibody responses after a single dose of the nonavalent HPV vaccine, Gardasil9. METHODS: Two hundred-and-one healthy 9 to 11-year-old girls and boys were enrolled at 2 centers in the United States to receive a prime dose of the nonavalent vaccine at baseline, a delayed dose at month 24, and an optional third dose at month 30. Blood samples were collected to measure HPV type-specific antibodies at baseline and at 6, 12, 18, 24, and 30 months after the prime dose. The primary outcomes were serum HPV16 and HPV18 antibody responses. RESULTS: In both girls and boys, geometric mean concentrations of HPV16 and HPV18 antibodies increased at 6 months, declined between months 6 to 12, and then remained stable and high (at 20- and 10-times those at baseline for HPV16 and HPV18, respectively) throughout months 12, 18, and 24 (prebooster) visits. Both HPV16 and HPV18 antibody responses demonstrated anamnestic boosting effect at 30-months after the delayed (24-month) booster dose. CONCLUSIONS: A single dose of the nonavalent HPV vaccine induced persistent and stable HPV16 and HPV18 antibody responses up to 24 months. This study contributes important immunogenicity data to inform feasibility of the single dose HPV vaccination paradigm. Further research is needed to assess the long-term antibody stability and individual clinical and public health benefit of the single dose schedule.

Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial.

BACKGROUND: Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines. OBJECTIVE: This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation. METHODS: This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment. RESULTS: Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027. CONCLUSIONS: The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48898.

Post Treatment Mastalgia is a Common Complaint but not an Indication of Recurrence or Second Primary Breast Cancer.

BACKGROUND: Post-treatment mastalgia is a common complaint in up to 68% of patients after treatment. This symptom is worrisome to patients as many believe it is a sign of recurrence. The current study was performed to evaluate if post-treatment mastalgia is associated with a second breast cancer diagnosis. MATERIALS AND METHODS: Patients included were seen from January 1, 2000 to December 31, 2020. All patients who were treated for breast cancer and then presented with breast pain during follow up were considered to have post-treatment mastalgia. All patients who were diagnosed with a second breast cancer but did not experience post-treatment mastalagia were also evaluated. RESULTS: 1799 patients had a mean age 52.9 years. 36% of patients experienced post-treatment mastalgia. Of patients who complained of post-treatment mastalgia, 19 were diagnosed with a chest wall recurrence (CW), ipsilateral breast tumor recurrence (IBTR), or contralateral breast cancer (CBC). 17 of the 19 patients had breast pain after the second diagnosis and treatment were completed. The average duration between their second diagnosis and initial complaint of breast pain was 6.2 years. The two patients who complained of breast pain prior to their second diagnosis did not have mastalgia at the time of their second diagnosis. Local recurrence or contralateral breast cancer were more common in patients without post treatment mastalgia (10.1% vs 0.3%, p < 0.0001) during follow up. CONCLUSION: Post treatment mastalgia is not associated with recurrence. Interval or repeat imaging does not appear necessary and instead patient education and reassurance are important in its management.

Three-port laparoscopic cholecystectomy is safe and efficient in the treatment of surgical biliary disease: a retrospective cohort study.

Multiple studies have suggested that three-port laparoscopic cholecystectomy is both feasible and safe. However, this approach has failed to gain acceptance outside of clinical trials, leaving adopters of this approach vulnerable to medico-legal scrutiny. We hypothesized that the three-port approach to laparoscopic cholecystectomy (LC) is safe and efficient in experienced hands. All LC (including robotic) cases were performed on patients 18 years and older between November 2018 and March 2020. Operations utilizing three ports were compared to those performed using more than three ports. The primary outcomes measured were total operative time, conversion-to-open rate, and the complication rate. A two-sample test was performed to compare operative times, and a Fisher's exact test was used to compare conversion-to-open and complication rates. Linear regression models were used to account for the effect of confounders. 924 total LCs were performed by 30 surgeons in the study period (71 three-port, 853 four or more ports). The mean operative time was 10 min shorter in the three-port group in comparison (64.1 ± 1.4 min vs. 74.4 ± 1.8 min, p < 0.01), despite a threefold higher rate of intraoperative cholangiogram in these cases (23.0% vs. 7.9%, p < 0.001). There was no significant difference in either the conversion-to-open rate (1.6% vs. 5.1%, p = 0.35), or the overall complication rate (7.1% vs. 8.7%, p = 0.82). Operative time for LC performed through three ports was significantly less than those performed through the traditional four port approach, despite utilizing intraoperative cholangiogram nearly three times as often. There was no difference in the conversion-to open rate or complication rate. These results provide considerable evidence that three-port laparoscopic cholecystectomy is comparable to four-port laparoscopic cholecystectomy in operative duration, conversion-to-open rate, and complication rate.

Genome-Wide Association Study of Metachronous Colorectal Adenoma Risk among Participants in the Selenium Trial.

Genetic variants related to colorectal adenoma may help identify those who are at highest risk of colorectal cancer development or illuminate potential chemopreventive strategies. The purpose of this genome-wide association study was to identify genetic variants that are associated with risk of developing a metachronous colorectal adenoma among 1,215 study participants of European descent from the Selenium Trial. Associations of variants were assessed with logistic regression analyses and validated in an independent case-control study population of 1,491 participants from the Colorectal Cancer Study of Austria (CORSA). No statistically significant genome-wide associations between any variant and metachronous adenoma were identified after correction for multiple comparisons. However, an intron variant of FAT3 gene, rs61901554, showed a suggestive association (P = 1.10 × 10-6) and was associated with advanced adenomas in CORSA (P = 0.04). Two intronic variants, rs12728998 and rs6699944 in NLRP3 were also observed to have suggestive associations with metachronous lesions (P = 2.00 × 10-6) in the Selenium Trial and were associated with advanced adenoma in CORSA (P = 0.03). Our results provide new areas of investigation for the genetic basis of the development of metachronous colorectal adenoma and support a role for FAT3 involvement in the Wnt/ß-catenin pathway leading to colorectal neoplasia.Trial Registration number: NCT00078897 (ClinicalTrials.gov).

A Phase 2, Double-blind, Randomized Controlled Trial of PROSTVAC in Prostate Cancer Patients on Active Surveillance.

BACKGROUND: There is an unmet clinical need for interventions to prevent disease progression in patients with localized prostate cancer on active surveillance (AS). OBJECTIVE: To determine the immunologic response to the PROSTVAC vaccine and the clinical indicators of disease progression in patients with localized prostate cancer on AS. DESIGN, SETTING, AND PARTICIPANTS: This was a phase 2, double-blind, randomized controlled trial in 154 men with low- or intermediate-risk prostate cancer on AS. INTERVENTION: Participants were randomized (2:1) to receive seven doses of subcutaneous PROSTVAC, a vaccinia/fowlpox viral vector-based immunotherapy containing a prostate-specific antigen (PSA) transgene and three T-cell co-stimulatory molecules, or an empty fowlpox vector (EV) over 140 d. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the change from baseline in CD4 and CD8 T-cell infiltration in biopsy tumor tissue. Key secondary outcomes were safety and changes in prostate biopsy tumor pathology, peripheral antigen-specific T cells, and serum PSA. Continuous variables were compared using nonparametric tests. Categorical variables were compared using Fisher's exact test. RESULTS AND LIMITATIONS: The PROSTVAC/EV vaccination was well tolerated. All except one participant completed the vaccination series. Changes in CD4 or CD8 density in biopsy tumor tissue did not differ between the PROSTVAC and EV arms. The proportions of patients with Gleason upgrading to grade group 3 after treatment was similar between the arms. There were no differences in postvaccination peripheral T-cell responses or the PSA change from baseline to 6-mo post-treatment follow-up between the groups. CONCLUSIONS: In this first-of-kind trial of immunotherapy in patients on AS for prostate cancer, PROSTVAC did not elicit more favorable prostate tissue or peripheral T-cell responses than the EV. There was no difference between the arms in clinicopathologic effects. Despite the null findings, this is the first study reporting the feasibility and acceptability of an immunotherapy intervention in the AS setting. PATIENT SUMMARY: We looked at responses after an experimental prostate cancer vaccine in patients with prostate cancer on active surveillance (AS). Participants who received the vaccine did not show more favorable outcomes than those receiving the control. Despite these findings, this is the first report showing the feasibility and acceptability of immunotherapy for prostate cancer in patients on AS.

A systematic review of robotic surgery curricula using a contemporary educational framework.

BACKGROUND: There has been a rising trend in robotic surgery. Thus, there is demand for a robotic surgery curriculum (RSC) for training surgical trainees and practicing surgeons. There are limited data available about current curricular designs and the extent to which they have incorporated educational frameworks. Our aim was to study the existing robotic surgery curricula using Kern's 6-step approach in curriculum development. METHODS: A systematic review was conducted using PubMed, PubMed Central, Cochrane, Embase, and Scopus (we searched studies from 2001 to 2021). PRISMA Guidelines was used to guide the search. Curriculum designed for general surgery and its subspecialties were included. Urology and gynecology were excluded. The articles were reviewed by five reviewers. RESULTS: Our review yielded 71 articles, including 39 curricula at 9 different settings. Using Kern's framework, we demonstrated that the majority of robotic surgery curricula contained all the elements of Kern's curricular design. However, there were significant deficiencies in important aspects of these curricula i.e., implementation, the quality of assessment tools for measurement of performance and evaluation of the educational value of these interventions. Most institutions used commercial virtual reality simulators (VRS) as the main component of their RSC and 23% of curricula only used VRS. CONCLUSIONS: Although majority of these studies contained all the elements of Kern's framework, there are critical deficiencies in the components of existing curricula. Future curricula should be designed using established educational frameworks to improve the quality of robotic surgery training.