Survival and cancer recurrence after short-course perioperative probiotics in a randomized trial.

BACKGROUND & AIMS: The long-term impact of perioperative probiotics remains understudied while mounting evidence links microbiome and oncogenesis. Therefore, we analyzed overall survival and cancer recurrence among patients enrolled in a randomized trial of perioperative probiotics. METHODS: 6-year follow-up of surgical patients participating in a randomized trial evaluating short-course perioperative oral probiotic VSL#3 (n = 57) or placebo (n = 63). RESULTS: Study groups did not differ in age, preoperative hemoglobin, ASA status, and Charlson comorbidity index. There was a significant difference in preoperative serum albumin (placebo group 4.0 ± 0.1 vs. 3.7 ± 0.1 g/dL in the probiotic group, p = 0.030). Thirty-seven deaths (30.8 %) have occurred during a median follow-up of 6.2 years. Overall survival stratified on preoperative serum albumin and surgical specialty was similar between groups (p = 0.691). Age (aHR = 1.081, p = 0.001), serum albumin (aHR = 0.162, p = 0.001), and surgical specialty (aHR = 0.304, p < 0.001) were the only predictors of overall survival in the multivariate model, while the placebo/probiotic group (aHR = 0.808, p = 0.726) was not predictive. The progression rate among cancer patients was similar in the probiotic group (30.3 %, 10/33) compared to the placebo group (21.2 %, 7/33; p = 0.398). The progression-free survival was not significantly different (unstratified p = 0.270, stratified p = 0.317). CONCLUSIONS: Perioperative short-course use of VSL#3 probiotics does not influence overall or progression-free survival after complex surgery for visceral malignancy.

The Future of Interventions for Stage IV Colorectal Cancers.

Future options for the management of stage IV colorectal cancer are primarily focused on personalized and directed therapies. Interventions include precision cancer medicine, utilizing nanocarrier platforms for directed chemotherapy, palliative pressurized intraperitoneal aerosol chemotherapy (PIPAC), adjunctive oncolytic virotherapy, and radioembolization techniques. Comprehensive genetic profiling provides specific tumor-directed therapy based on individual genetics. Biomimetic magnetic nanoparticles as chemotherapy delivery systems may reduce systemic side effects of traditional chemotherapy by targeting tumor cells and sparing healthy cells. PIPAC is a newly emerging option for patients with peritoneal metastasis from colorectal cancer and is now being used internationally, showing promising results as a palliative therapy for colorectal cancer. Oncolytic virotherapy is another emerging potential treatment option, especially when combined with standard chemotherapy and/or radiation, as well as immunotherapy. And finally, radioembolization with yttrium-90 ( 90 Y) microspheres has shown some success in treating patients with unresectable liver metastasis from colorectal cancer via selective arterial injection.

Differences in Resident Self-Evaluation and Clinical Competency Committee Evaluation Using ACGME Milestone Versions 1.0 and 2.0.

OBJECTIVE: Intentionally self-driven professional development of surgical resident physicians is a hallmark of surgical training and is expected to gain further traction as Entrustable Professional Activities (EPAs) become the new paradigm for surgical education. We aimed to analyze how surgical residents rate themselves as compared to the evaluation of the Clinical Competency Committee using ACGME Milestones Version 1 (M1.0) and Version 2 (M2.0). DESIGN: We asked 22 general surgical trainees for self-evaluation of Milestones (both M1.0 and M2.0) from 2017 semiannually to 2022. ACGME-required Milestone evaluations by the Clinical Competency Committee (CCC) were independently performed after the time window for resident self-evaluation. Neither trainees nor CCC were aware of the other party's evaluations. There were 1552 paired data available for evaluating individual competencies by both trainees and CCC. Paired Wilcoxon signed-rank tests were then performed among the corresponding pairs. SETTING: MercyOne Des Moines Medical Center, Des Moines, IA; Teaching tertiary referral center. PARTICIPANTS: Twenty-two general surgical trainees at this hospital and 28 faculty surgeons participated in this study. RESULTS: The average self-evaluation of surgical residents was lower in the M1.0 cohort compared to the corresponding CCC evaluation (1.96 ± 0.72 vs. 2.11 ± 0.67; p < 0.001). M1.0 self-assessments and CCC-assessments were statistically similar for ICS (p = 0.548) and PROF (p = 0.554) competencies and differed for MK (p < 0.001), PBLI (p < 0.001), PC (p < 0.001), SBP (p = 0.008). On the contrary, the M2.0 cohort demonstrated higher average self-evaluation of surgical residents compared to the corresponding CCC evaluation (2.75 ± 0.87 vs. 2.12 ± 0.97; p < 0.001). Significant differences were observed for all 6 ACGME competencies using M2.0 self-assessments and CCC-assessments (all p < 0.001). Multivariate regression modeling (p < 0.001, R2 = 0.255) predicted the degree of discordance between self-assessment and CCC-assessed achievement of competencies with a significant effect of gender (baseline male: coef = -0.232, p < 0.001), PGY level (-0.083 per year, p < 0.001) and Milestone version (0.831, p < 0.001). A significant interaction exists for all gender/Milestone combinations except for the female trainees with M1.0. CONCLUSIONS: The difference between self-evaluated Milestone achievement and faculty-driven CCC evaluation of surgical resident physician performance is more evident in Milestones 2.0 than in Milestones 1.0. Residents self-evaluate higher compared to faculty using Milestones 2.0. This discrepancy is seen among both genders and is more pronounced among male residents overestimating core competencies with M2.0 self-evaluation than formal CCC assessment.

Preliminary Reference Interval for 5-Alpha Reductase in Normal Male Children and Its Association with Hypospadias.

BACKGROUND: 5-alpha reductase (5-AR) enzyme is responsible for conversion of testosterone to dihydrotestosterone (DHT) in humans, which subserves various functions. The aim of the study was to establish a normal reference interval (RI) for blood levels of the enzyme 5-AR. METHODS: We conducted a prospective study on 150 boys, 75 of whom underwent circumcision for various benign conditions or for religious reasons (Group A/controls) and 75 suffering from hypospadias of variable severity (Group B/cases). The plasma levels of 5-AR were measured by enzyme-linked immunosorbent assay (ELISA) in all 150 boys and correlated with the severity of hypospadias. RESULTS: The 5-AR levels in Group A ranged from 14.6 to 17.3 ng/mL. The enzyme levels decreased in value with increasing severity of hypospadias in Group B (P-value <0.01 - statistically significant). The levels of the enzyme in this group ranged from 0.6 ng/mL (in the most severe variety of hypospadias) to 11.5 ng/mL (mild variety of hypospadias). CONCLUSIONS: There is no record of RI values of 5-AR in the literature. The RI of 5-AR needs to be determined by conducting more studies globally. Its levels falls considerably with clinical severity of hypospadias, reinforcing the importance of the enzyme in the development of male external genitalia.

Impact of Medicaid Expansion on the Diagnosis, Treatment, and Outcomes of Stage II and III Rectal Cancer Patients.

BACKGROUND: Insurance status has been associated with disparities in stage at cancer diagnosis. We examined how Medicaid expansion (ME) impacted diagnoses, surgical treatment, use of neoadjuvant therapies (NCRT), and outcomes for Stage II and III rectal cancer. STUDY DESIGN: We used 2010-2017 American College of Surgeons National Cancer Database (NCDB) to identify patients ages 18-65, with Medicaid as primary form of payment, and were diagnosed with Stage II or III rectal cancer. Patients were stratified based on Census bureau division's ME adoption rates of High, Medium, Low. Overall trends were examined, and patient characteristics and outcomes were compared before and after ME date of 1/1/2014. RESULTS: Over 8 years of NCDB data examined, there was an increasing trend of Stage II and III rectal cancer diagnoses, surgical resection, and use of NCRT for Medicaid patients. We observed an increase in age, proportion of White Medicaid patients in Low ME divisions, and proportion of fourth income quartile patients in High ME divisions. Univariate analysis showed decreased use of open surgery for all 3 categories after ME, but adjusted odds ratios (aOR) were not significant based on multivariate analysis. NCRT utilization increased after ME for all 3 ME adoption categories and aOR significantly increased for Low and High ME divisions. ME significantly decreased 90-day mortality. CONCLUSIONS: Medicaid expansion had important impacts on increasing Stage II and III rectal cancer diagnoses, use of NCRT, and decreased 90-day mortality for patients with Medicaid. Our study supports increasing health insurance coverage to improve Medicaid patient outcomes in rectal cancer care.

Analysis of Patterns of Compliance with Accreditation Standards of National Accreditation Program for Rectal Cancer.

BACKGROUND: We identified commonly deficient standards across rectal cancer programs that underwent accreditation review by the National Accreditation Program for Rectal Cancer to evaluate for patterns of noncompliance. STUDY DESIGN: With the use of the internal database of the American College of Surgeons, programs that underwent accreditation review from 2018 to 2020 were evaluated. The occurrence and frequency of noncompliance with the standards, using the 2017 standards manual, were evaluated. Programs were further stratified based on the year of review, annual rectal cancer volume, and Commission on Cancer classification. RESULTS: A total of 25 programs with annual rectal cancer volume from 14 to more than 200 cases per year underwent accreditation review. Only 2 programs achieved 100% compliance with all standards. Compliance with standards ranged from 48% to 100%. The 2 standards with the lowest level of compliance included standard 2.5 and standard 2.11 that require all patients with rectal cancer to be discussed at a multidisciplinary team meeting before the initiation of definitive treatment and within 4 weeks after definitive surgical therapy, respectively. Patterns of noncompliance persisted when programs were stratified on the basis oof the year of survey, annual rectal cancer volume, and Commission on Cancer classification. The corrective action process allowed all programs to ultimately become successfully accredited. CONCLUSION: During this initial phase of the National Accreditation Program for Rectal Cancer accreditation, the majority of programs undergoing review did not achieve 100% compliance and went through a corrective action process. Although the minimal multidisciplinary team meeting attendance requirements were simplified in the 2021 revised standards, noncompliance related to presentation of all patients at the multidisciplinary team meeting before and after definitive treatment highlights the need for programs seeking accreditation to implement optimized and standardized workflows to achieve compliance.