Evaluating the impact of delayed study startup on accrual in cancer studies.

Background: Drug development in cancer medicine depends on high-quality clinical trials, but these require large investments of time to design, operationalize, and complete; for oncology drugs, this can take 8-10 years. Long timelines are expensive and delay innovative therapies from reaching patients. Delays often arise from study startup, a process that can take 6 months or more. We assessed how study-specific factors affected the study startup duration and the resulting overall success of the study. Method: Data from The University of Kansas Cancer Center (KUCC) were used to analyze studies initiated from 2018 to 2022. Accrual percentage was computed based on the number of enrolled participants and the desired enrollment goal. Accrual success was determined by comparing the percentage of enrollments to predetermined threshold values (50%, 70%, or 90%). Results: Studies that achieve or surpass the 70% activation threshold typically exhibit a median activation time of 140.5 days. In contrast, studies that fall short of the accrual goal tend to have a median activation time of 187 days, demonstrating the shorter median activation times associated with successful studies. Wilcoxon rank-sum test conducted for the study phase (W=13607, p-value=0.001) indicates that late-phase projects took longer to activate compared to early-stage projects. We also conducted the study with 50% and 90% accrual thresholds; our findings remained consistent. Conclusions: Longer activation times are linked to reduced project success, and early-phase studies tend to have higher success than late-phase studies. Therefore, by reducing impediments to the approval process, we can facilitate quicker approvals, increasing the success of studies regardless of phase.

Predictors of cytomegalovirus reactivation after allogeneic hematopoietic cell transplantation: Insights from a real-world experience.

BACKGROUND: We aimed to investigate factors associated with cytomegalovirus (CMV) viremia and CMV disease and its impact on post-transplant outcomes including overall survival (OS) following allogeneic hematopoietic stem cell transplantation (Allo-SCT). METHODS: We conducted a single-center retrospective study including 452 Allo-SCT recipients (matched unrelated donor, MUD 61%; haploidentical, haplo 39%) from 2016 to 2021. Data were analyzed using SPSS v28. Descriptive (chi-square and t-test), Kaplan-Meier and regression analyses were conducted. RESULTS: The median age was 57 years. Sixty-one percent were males and 84.3% were Caucasians. CMV serostatus was positive in 59.1% of recipients. The median follow-up was 24.4 months. CMV viremia and CMV disease were observed in 181 (40%) and 32 (7%) patients, respectively. Among CMV seropositive recipients, 65% developed CMV viremia and 11% were noted to have CMV disease compared to 4% and 1% in seronegative recipients, respectively (p < 0.001). Patients with CMV disease had significantly lower OS than those without CMV disease (median 14.1 months vs. not reached, p = 0.024); however, OS was not associated with CMV viremia (median not reached in both groups, p = 0.640). Letermovir prophylaxis was used in 66% (n = 176/267) of CMV seropositive recipients, but no impact was observed on the incidence of CMV viremia or CMV disease and OS. CONCLUSIONS: CMV disease leads to significantly inferior survival after an allogeneic hematopoietic cell transplantation. Recipient CMV seropositive status was associated with the risk of CMV viremia and CMV disease, and this was not abrogated with the use of Letermovir prophylaxis.

When Should We Operate on the Elderly with Acute Pancreatitis Requiring Emergency Surgery? A 10-Year Study of a National Inpatient Sample Using a Generalized Additive Model of 110,289 Patients.

INTRODUCTION: Elderly patients with acute pancreatitis have longer hospital length of stay (HLOS) and higher mortality compared to adult patients. We aimed to assess the optimal timing to operate for acute pancreatitis and to evaluate the relationship between HLOS and mortality. MATERIALS AND METHODS: This was a retrospective cohort study of 110,289 elderly patients diagnosed with acute pancreatitis requiring emergency admission using the National Inpatient Sample (NIS) between 2005-2014. The ICD9 code 577.0 was used to select patients with a diagnosis of acute pancreatitis. Stratified analysis was performed to compare male versus female, survived versus deceased, and no operation versus operation. Multivariable logistic regression models were created to assess independent risk factors of mortality. Generalized additive models (GAM) were created to assess the linearity of the relationship between HLOS and in-hospital mortality. RESULTS: The mean age of the cohort was 76 years old, and 56.3% were female. The mean frailty index was 1.65. Twenty-five percent of patients underwent an operation, with a mean time to operation being 3.44 days for females and 3.77 days for males. Overall mortality was 2.3%. For patients who had an operation, each additional day of delay until operation increased the odds of mortality by 8.8%. Each additional point for the modified frailty index increased the odds of mortality by 30.2%. HLOS had a non-linear relationship with mortality, with an estimated degree of freedom of 22.05 and a nadir at three to seven days. Each additional day in hospital after day seven increased the odds of mortality by 6.7%. CONCLUSIONS: In those who required an operation, every day of delay in operation increased the odds of mortality by almost 9%. The lowest mortality for elderly patients with acute pancreatitis occurred with a hospital length of stay of three to seven days. After seven days, each additional day increased the odds of mortality by 6.7%.

Gallbladder cancer: Historical treatment and new management options.

Gallbladder cancer is a rare, aggressive malignancy that has a poor overall prognosis. Effective treatment consists of early detection and surgical treatment. With the wide spread treatment of gallbladder disease with minimally invasive techniques, the rate of incidental gallbladder cancer has seen an equitable rise along with stage migration towards earlier disease. Although the treatment remains mostly surgical, newer modalities such as regional therapy as well as directed therapy based on molecular medicine has led to improved outcomes in patients with advanced disease. We aim to summarize the management of gallbladder cancer along with the newer developments in this formidable disease process.

Robotic Inguinal Hernias Performed at a Community Hospital: a Case Series of 292 Patients.

BACKGROUND: Robotic inguinal hernia repair has become more common and has replaced the laparoscopic approach in many hospitals in the US. We present a retrospective review of 416 consecutive inguinal hernia repairs using the robotic transabdominal preperitoneal approach in an academic community hospital. METHODS: This is a retrospective review of 416 consecutive robotic inguinal hernia repairs in 292 patients performed from October 2015 to March 2021 by two surgeons. The demographics, intra-operative findings, and postoperative outcomes were analyzed. The results for patients during the initial 25 cases (which were considered to be during the learning curve for each surgeon) were compared to their subsequent cases. A multivariable logistic regression analysis was used to determine independent risk factors for postoperative complications. RESULTS: Overall, 292 patients underwent 416 inguinal hernia repairs, of whom 124 (42.5%) had bilateral hernias. The mean age was 61 years and the mean BMI was 26.96 kg/m2. Of the bilateral hernias, 31.5% were unsuspected pre-operatively. Femoral hernias were found in 20.5% of patients, including in 18.4% of men, which were also unsuspected. Post-operatively, 89% of patients were discharged home the same day. The most common post-operative complication was seroma, which occurred in 13%. Three patients required re-intervention: one had deep SSI (infected mesh removal), one had a needle aspiration of a hematoma (SSORI), and one was operated on for small bowel volvulus related to adhesions. On short-term follow-up, there was only one early recurrence (0.2%). When cases during the learning curve period were compared to subsequent surgeries, there were no major differences in post-operative complications or operating time. Patients aged ≥55 years had a 2.456-fold (p=0.023) increased odds of post-operative complications. CONCLUSIONS: Robotic inguinal hernia repair can be safely performed at a community hospital with few early post-operative complications and very low early recurrence rates. The robotic approach also allows for the detection of a significant number of unsuspected contralateral inguinal hernias and femoral hernias, especially in male patients. Age ≥55 years was an independent risk factor for postoperative complications.

Simultaneous Robot Assisted Colon and Liver Resection for Metastatic Colon Cancer.

INTRODUCTION: Simultaneous robot assisted colon and liver resections are being performed more frequently at present due to the expanded adoption of the robotic platform for surgical management of metastatic colon cancer. However, this approach has not been studied in detail with only case series available in the literature. The aim of this systematic review was to evaluate the current body of evidence on the feasibility of performing simultaneous robotic colon and liver resections. METHODS: A systematic review was performed through PubMed to identify relevant articles describing simultaneous colon and liver resections for metastatic colon cancer. RESULTS: A total of 28 patients underwent simultaneous resections robotically with an average operative time of 420.3 minutes and average blood loss of 275.6 ml. Postoperative stay was 8.6 days on average with all cases achieving negative surgical margins. CONCLUSIONS: Robotic simultaneous resection of colorectal cancer with liver metastases is technically feasible and seems oncologically equivalent to open or laparoscopic surgery. Further studies are urgently needed to assess benefits of robotic surgery in the patient population.

Early Abdominal Wall Reconstruction with Biologic Mesh is Feasible after Catastrophic Abdominal Wall Disruption from Blunt Trauma.

INTRODUCTION: Traumatic abdominal wall hernias (TAWHs) after blunt trauma, while rare, are typically associated with severe injuries, particularly those involved with the seatbelt triad of abdominal wall disruption. The aim of this study is to present a case series of patients with TAWHs that were managed at an early stage post injury with a biological mesh. MATERIALS AND METHODS: Patients with TAWH undergoing complex abdominal wall reconstruction (CAWR) between 2017 and 2020 were identified from our institutional database. All patients underwent definitive reconstruction using advanced surgical techniques including a posterior component separation with biological mesh (STRATTICE™, Allergan, Inc., Dublin, Ireland) placed in a sublay fashion. RESULTS: Seven patients underwent definitive TAWH repair during their index admission: the median age was 56 years (range 20-77) and the median Injury Severity Score (ISS) was 34 (29-50). The most common mechanism of injury was motor vehicle crash (MVC) at 86%, while the most common intra-abdominal concomitant injury was small bowel. Traumatic hernia location was on the right side of the abdominal wall in three patients, left in three patients, and bilaterally in one patient. There were no hernia recurrences or deaths in this small cohort. CONCLUSION: Traumatic abdominal wall disruption can be safely reconstructed using advanced surgical techniques with a biological mesh during the acute phase or same index hospitalization.

Complex Abdominal Wall Reconstruction in Neutropenic Patients.

The aim of our study was to determine whether patients with neutropenia (absolute neutrophil count (ANC) ≤1,500 cells/µL) had higher rates of surgical site infection after elective abdominal wall reconstruction. This was a case series from a prospective complex abdominal wall reconstruction cohort describing the surgical outcomes of 4 neutropenic patients (ANC ≤1,500 cells/µL) within 48 hours of index operation. Median age was 55 years, 3 patients were female. All patients had liver cirrhosis as a comorbidity: 2 patients as a result of alcohol abuse and 2 patients secondary to cryptogenic and nonalcoholic fatty liver disease, respectively. All patients underwent a posterior component separation with transversus abdominis release and retro-rectus biologic mesh. None of the 4 patients developed a surgical site infection 90 days postoperatively. Complex abdominal wall reconstruction in neutropenic patients could be safe.

Independent Predictors for Surgical Site Infections in Patients Undergoing Complex Abdominal Wall Reconstruction.

INTRODUCTION: Complex abdominal wall reconstruction (CAWR) in patients with large abdominal defects have become a common procedure. The aim of this study was to identify independent predictors of surgical site infections (SSI) in patients undergoing CAWR. MATERIALS AND METHODS: This was an ambidirectional cohort study of 240 patients who underwent CAWR with biologic mesh between 2012 and 2020 at an academic tertiary/quaternary care center. Prior superficial SSI, deep SSI, organ space infections, enterocutaneous fistulae, and combined abdominal infections were defined as prior abdominal infections. Univariable and multivariable logistic regression models were performed to determine independent risk factors for SSI. RESULTS: There were a total of 39 wound infections, with an infection rate of 16.3%. Forty percent of patients who underwent CAWR in this study had a history of prior abdominal infections. In the multivariable regression models not weighted for length of stay (LOS), prior abdominal infection (odds ratio [OR]: 2.49, p=0.013) and higher body mass index (BMI) (OR: 1.05, p=0.023) were independent predictors of SSI. In the multivariable regression model weighted for LOS, prior abdominal infection (OR: 2.2, p=0.034), higher BMI (OR: 1.05, p=0.024), and LOS (OR: 1.04, p=0.043) were independent predictors of SSI. CONCLUSION: The history of prior abdominal infections, higher BMI, and increased LOS are important independent predictor of SSI following CAWR.

Robotic duodenal (D3) resection with Roux-en-Y duodenojejunostomy reconstruction for large GIST tumor: Step by step with video.

BACKGROUND: Duodenal gastrointestinal stromal tumors (GISTs) are uncommon, making up only 3-5% of all GISTs. [1,2] Historically, the treatment of choice for duodenal GIST tumors was pancreaticoduodenectomy. [3]Currently, newer surgical intervention methods including local resection via laparotomy, endoscopic resection, and robotic resection are feasible. When doing a local resection, the defect can be closed either primarily or via a Roux-en-Y duodenojejunostomy. [3] Case presentation: Our patient is a 64-year- old female who presented initially with shortness of breath and was found to have a pulmonary embolism. She then developed upper GI bleeding from anticoagulation and was found to have an ulcerated GIST tumor in the anti-mesenteric border of the third portion of the duodenum (D3). Initial surgery was postponed due to high pulmonary artery pressure from the pulmonary embolism. The patient underwent argon beam coagulation of the bleeding mass to control the bleeding, followed by localized radiotherapy plus Gleevec. Unfortunately, the tumor grew in size during follow-up. The patient was then taken to the OR for a robot-assisted partial duodenal resection (D3) with Roux-en-Y duodenojejunostomy to reconstruct the large defect. She did well post operatively and her final pathology showed a GIST tumor, c-kit and DOG1 positive, 3.5 cm in size, with negative margins. CONCLUSION: Robotic duodenal resection is a new technique currently being used to resect duodenal GIST tumors. Our video demonstrates the feasibility of D3 partial resection with Roux-en-Y duodenojejunostomy. Duodenal GIST tumor robotic resection offers both decreased morbidity and adequate oncologic outcomes.

A Multicenter Prospective Non-Randomized Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization for Prolapsed, Nonincarcerated, Reducible Hemorrhoids: A Study Protocol.

INTRODUCTION: Current evidence suggests that transanal hemorrhoidal dearterialization (THD) is associated with less postoperative pain and faster recovery than Ferguson hemorrhoidectomy. However, there is some uncertainty regarding the durability of the therapeutic effect in terms of recurrent disease. Objective and significance: The aim of this study will be to evaluate the outcome of THD compared to Ferguson hemorrhoidectomy in terms of recurrence rate at 1-year follow-up. METHODS: This is a multicenter, parallel-arm, non-randomized prospective study comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rate at one year. The primary endpoint is recurrence rate at one year defined as prolapsing internal hemorrhoids at physical examination. Secondary endpoints include the following postoperative complications: urinary retention, constipation (requiring laxative or emergency room visit), dysuria, pruritis ani, anal pain, anal stenosis, unhealed wound, fissure, fecal urgency, and flatus or stool incontinence. Adults older than 18 years with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination will be included in one of the study arms: Ferguson hemorrhoidectomy and THD. Surgeons with proven expertise in hemorrhoids surgery will enroll patients undergoing Ferguson hemorrhoidectomy and THD (not both). Each participating surgeon will enroll a maximum of 10 patients. Ethics and Dissemination: This study was approved by the Institutional Review Boards of Stony Brook University (previously) and New York Medical College (currently), and registered in ClinicalTrials.gov (NCT03245086). The findings of the study will be published in a peer-reviewed journal.

Use of Direct Peritoneal Resuscitation for Intra-Abdominal Catastrophes: A Technical Note.

Direct peritoneal resuscitation (DPR) involves instilling 2.5% dextrose peritoneal dialysate into the abdomen in an attempt to both resuscitate the patient and decrease systemic inflammation; 800cc are instilled in the first hour and 400cc/h are instilled each subsequent hour. DPR has been shown to decrease systemic inflammation, increase the rate of primary abdominal closure, lower the rate of intra-abdominal infections, and lower the rate of complications. It also increases blood flow to the intestines, helping to prevent ischemia and re-perfusion injury. We present the technique used for DPR in a patient with an intra-abdominal catastrophe, as well as the use of Kerecis® Omega3 Wound graft (Kerecis, Arlington, VA) and wound vacuum-assisted closure (VAC) for creation of a floating stoma.

Evolution of the Circular Stapler in Rectal Cancer Surgery.

The circular stapler has played a critical role in fashioning colorectal anastomoses following low anterior resection for rectal cancer. One of the greatest benefits of the circular stapler has been the feasibility of constructing ultra-low anastomoses, thereby decreasing permanent colostomy rates. A notable US innovation to the original design was the addition of disposable cartridges of various sizes, which greatly decreased assembly time and made the instrument more versatile. Another important modification was the ability to detach the anvil from the stapler shaft. This markedly simplified the construction of anastomoses by negating the need for a double purse-string and avoiding an open rectal stump. An additional modification to facilitate transanal stapler extraction was the tilted-top anvil, which flipped parallel to the shaft once the stapler was fired. The circular stapler continues to evolve while maintaining the basic elements of Hültl's brilliant concept from over a century ago.

Timing and Type of Bacteria In Surgical Site Infections Following Complex Abdominal Wall Reconstruction.

PURPOSE: The goal of this study was to assess the bacteriology of surgical site infections (SSIs) in patients undergoing complex abdominal wall reconstruction (CAWR) with biologic mesh. METHODS: This was a prospective cohort study of all patients who developed SSI following CAWR with biologic mesh between 2017-2020 at an academic tertiary/quaternary care center. The patients were subdivided into six overlapping groups: infections found during hospitalization vs. infections found after discharge, sensitive bacteria vs. resistant bacteria, and nosocomial bacteria vs. intestinal bacteria. RESULTS: Of the 194 patients who underwent CAWR during the study period, 33 (17%) developed SSI. SSI was more commonly discovered after discharge than during hospitalization. These SSIs were vancomycin-resistant Enterococcus (VRE) or methicillin-resistant Staphylococcus aureus (MRSA) rather than sensitive bacteria, and required re-operation, which were more frequently found following elective procedures. VRE and MRSA infections were more common with clean wounds than with clean/contaminated, contaminated, or dirty wounds, while SSIs with intestinal flora were more common following fistula and stoma takedown. CONCLUSIONS: Surgical site infections with resistant bacteria manifest more frequently post-discharge and require more re-admissions and re-operations.

Toward Implementing Primary Care at Chairside: Developing a Clinical Decision Support System for Dental Hygienists.

INTRODUCTION: The goal of this project was to use the Consolidated Framework for Implementation Research (CFIR) as the theoretical foundation for developing a web-based clinical decision support system (CDSS) for primary care screening and care coordination by dental hygienists at chairside. METHODS: First, we appraised New York State education and scope of practice requirements for dental hygienists with input from health experts who constituted a Senior Advisory Board for the project, and reviewed current professional guidelines and best practices for tobacco use, hypertension and diabetes screening, and nutrition counseling at chairside. Second, we created algorithms for these four health issues (tobacco, hypertension, diabetes, and nutrition) using evidence-based guidelines endorsed by authoritative professional bodies. Third, an information technology specialist incorporated the algorithms into a tool using an iterative process to refine the CDSS, with input from dental hygienists, dentists, Senior Advisory Board members and research staff. RESULTS: An evidence-based CDSS for use by dental hygienists at chairside for tobacco use, hypertension and diabetes screening, and nutrition counseling was developed with the active participation of the individuals involved in the implementation process. CONCLUSIONS: CDSS technology may potentially be leveraged to enhance primary care screening and coordination by dental hygienists at chairside, leading to improved patient care. Using the CFIR as a pragmatic structure for implementing this intervention across multiple settings, the developed CDSS is available for downloading and adaptation to diverse dental settings and other primary care sensitive conditions.