United States-Based Colorectal Cancer Surgical Trials Lack Representation and Adequate Reporting of Racially and Ethnically Diverse Participants: Systematic Review and Regression Analysis.

BACKGROUND: Despite the established National Institute of Health Revitalization Act, which aims to include ethnic and racial minority representation in surgical trials, racial and ethnic enrollment disparities persist. OBJECTIVE: To assess the proportion of patients from minority races and ethnicities that are included in colorectal cancer surgical trials and reporting characteristics. DATA SOURCES: Search was performed using MEDLINE (Ovid), Embase, Web of Science, and Cochrane Central. STUDY SELECTION: Inclusion criteria included 1) trials performed in the United States between January 1, 2000, and May 30, 2022; 2) patients with colorectal cancer diagnosis; and 3) surgical intervention, technique, or postoperative outcome. Trials evaluating chemotherapy, radiotherapy, or other nonsurgical interventions were excluded. INTERVENTIONS: Pooled proportion and regression analysis was performed to identify the proportion of patients by race and ethnicity included in surgical trials and the association of year of publication and funding source. MAIN OUTCOME MEASURES: Proportion of trials reporting race and ethnicity and proportion of participants by race and ethnicity included in surgical trials. RESULTS: We screened 10,673 unique publications, of which 80 were examined in full text. Fifteen studies met our inclusion criteria. Ten (66.7%) trials did not report race, 3 reported races as a proportion of White participants only, and 3 reported 3 or more races. There was no description of ethnicity in 11 (73.3%) trials, with 2 describing "non-Caucasian" as ethnicity and 2 describing only Hispanic ethnicity. Pooled proportion of White participants was 81.3%, of Black participants was 6.2%, of Asian participants was 3.6%, and of Hispanic participants was 3.5%. LIMITATIONS: A small number of studies was identified that reported racial or ethnic characteristics of their participants. CONCLUSIONS: Both race and ethnicity are severely underreported in colorectal cancer surgical trials. To improve outcomes and ensure the inclusion of vulnerable populations in innovative technologies and novel treatments, reporting must be closely monitored.

Role of Age as a Predictor of Major Complications After Elective Surgery for Ulcerative Colitis.

BACKGROUND: The incidence of ulcerative colitis (UC) in the elderly population is increasing. The aim of this study was to assess the degree to which age and other factors increase the risk of developing major complications in patients undergoing elective surgery for UC. METHODS: Using the ACS-NSQIP database from 2016 to 2020, patients undergoing elective surgery for UC were divided into four categories: younger than 30, 30-49, 50-69, and 70 or older. A composite outcome was created including major complications and multivariable analysis was performed to identify factors associated with composite major complications. RESULTS: 5946 patients diagnosed with ulcerative colitis who underwent elective surgery were included in the analysis. 14.1% of all patients developed a major complication. For patients with UC, factors associated with the development of a major complication were age 50-69 (OR 1.31, P = .034), male sex (OR 1.38, P < .001), Black race (OR 1.47, P = .049), dependent status (OR 2.06, P = .028), hypoalbuminemia (OR 1.92, P < .001), preoperative steroid treatment (OR 1.27, P = .038), preoperative transfusion (OR 1.91, P < .001), open surgical approach (OR 1.44, P = .002), and partial colectomy (OR 1.51, P = .007). Specifically in patients aged 70 or older, hypoalbuminemia (OR 3.20, P < .001) and preoperative transfusion (OR 2.78, P = .019) were associated with a major complication. CONCLUSION: Age is a risk factor for the development of a major complication in UC patients undergoing elective surgery. However, it is not the only risk factor nor is it the one that increases the risk the most.

Impact of neoadjuvant chemotherapy for locally advanced colon cancer on postoperative complications.

PURPOSE: Although not considered standard therapy, neoadjuvant chemotherapy (NAC) is an encouraging alternative for selected patients with locally advanced colon cancer (LAC). The aim of this study was to compare 30-day postoperative outcomes between patients undergoing upfront surgery and those undergoing NAC for LAC. METHODS: Using the ACS-NSQIP data from 2016 to 2020, 11,498 patients with LAC were divided into those who underwent upfront colectomy (96.2%) and those who received NAC (3.8%). The primary outcome was a composite outcome encompassing 30-day major postoperative complications. Propensity score matched (PSM) analysis and multivariable logistic regression were performed. RESULTS: After PSM analysis, there was no statistically significant difference in the development of a major complication. NAC was not significantly associated with the primary outcome. Risk factors for postoperative complications were T4 stage, older age, male sex, black race, smoking, dependent status, severe COPD, hypoalbuminemia, and preoperative transfusion. Laparoscopic and robotic surgery was protective. CONCLUSION: NAC did not increase the odds of developing a major complication.

Is the Sars-CoV-2 virus a possible trigger agent for the development of achalasia?

BACKGROUND: Achalasia is an autoimmune disease whose probable causal agent is a neurotropic virus that chronically infects the myenteric plexus of the esophagus and induces the disease in a genetically susceptible host. The association between achalasia and coronaviruses has not been reported. AIMS: To evaluate the presence of the SARS-CoV-2 virus, the ACE2 expression, the tissue architecture, and immune response in the lower esophageal sphincter muscle (LESm) of achalasia patients who posteriorly had SARS-CoV-2 (achalasia-COVID-19) infection before laparoscopic Heller myotomy (LHM) and compare the findings with type II achalasia patients and transplant donors (controls) without COVID-19. METHODS: The LESm of 7 achalasia-COVID-19 patients (diagnosed by PCR), ten achalasia patients, and ten controls without COVID-19 were included. The presence of the virus was evaluated by in situ PCR and immunohistochemistry. ACE2 receptor expression and effector CD4 T cell and regulatory subsets were determined by immunohistochemistry. KEY RESULTS: Coronavirus was detected in 6/7 patients-COVID-19. The SARS-CoV-2 was undetectable in the LESm of the achalasia patients and controls. ACE2 receptor was expressed in all the patients and controls. One patient developed achalasia type II post-COVID-19. The percentage of Th22/Th17/Th1/pDCreg was higher in achalasia and achalasia-COVID-19 pre-HLM vs. controls. The Th2/Treg/Breg cell percentages were higher only in achalasia vs. controls. CONCLUSION & INFERENCES: SARS-CoV2 and its receptor expression in the LESm of achalasia patients who posteriorly had COVID-19 but not in the controls suggests that it could affect the myenteric plexus. Unlike achalasia, patients-COVID-19 have an imbalance between effector CD4 T cells and the regulatory mechanisms.

Predictive factors associated with the persistence of chest pain in post-laparoscopic myotomy and fundoplication in patients with achalasia.

Background: Episodic angina-like retrosternal pain is a prevalent symptom for achalasia patients pre- and post-treatment. The cause of postoperative chest pain remains poorly understood. Moreover, there are no reports on their predictive value for chest pain in the long-term post-treatment. The effect of laparoscopic Heller myotomy (LHM) and fundoplication techniques (Dor vs. Toupet) is unclear. Methods: We analyzed a cohort of 129 achalasia cases treated with LHM and randomly assigned fundoplication technique. All the patients were diagnosed with achalasia by high-resolution manometry (HRM). Patients were followed up at 1-, 6-, 12-, and 24-month post-treatment. We implemented unadjusted and adjusted logistic regression analyses to evaluate the predictive significance of pre- and post-operative clinical factors. Results: Preoperative chest pain with every meal was associated with an increased risk of occasional postoperative chest pain [unadjusted model: odds ratio (OR) = 12, 95% CI: 2.2-63.9, P = 0.006; adjusted model: OR = 26, 95% CI: 2.6-259.1, P = 0.005]. In type II achalasia, hypercontraction was also associated with an increased risk of chest pain (unadjusted model: OR = 2.6 e9 in all the patients). No significant differences were associated with age, type of achalasia, dysphagia, esophageal shape, and integrated relaxation pressure (IRP) with an increased risk of occasional postoperative chest pain. Also, there was no significant difference between fundoplication techniques or surgical approaches (e.g., length of myotomy). Conclusion: Preoperative chest pain with every meal was associated with a higher risk of occasionally postoperative chest pain.