SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Current Nonoperative Therapeutic Interventions for Lower Gastrointestinal Hemorrhage.

Lower gastrointestinal hemorrhage remains a common cause of hospitalization, with significant health care costs. Initial management should include aggressive resuscitation followed by localization of bleeding with nuclear scintigraphy, colonoscopy, or computed tomography (CT) angiography. If bleeding does not resolve spontaneously, expeditious intervention with minimally invasive endoscopic or angiographic methods is necessary with surgical intervention as a last resort.

Surgical Treatment of Diverticulitis: Hand-Assisted Laparoscopic Resection Is Predominantly Used for Complex Cases and Is Associated With Increased Postoperative Complications and Prolonged Hospitalization.

Introduction Laparoscopic (LAP) colectomy is now the "gold" standard for diverticulitis; the role of hand-assisted LAP (HAL) and Open methods today is unclear. This study assessed the elective use of these methods for diverticulitis. Methods A retrospective review of demographic, comorbidity (Carlson Comorbidity Index [CCI]), resection type, and short-term outcomes was carried out. Results There were 125 (44.5%) LAP, 125 (44.5%) HAL, and 31 (11%) Open cases (overall N = 281). The mean age, body mass index, and percentage of high-risk patients (CCI score >2) of the HAL group were greater (P < .05) than the LAP group (vs Open, P = ns). The Open group's mean age and percent with CCI >2 was greater when compared with the LAP group (P < .05). More Open (P < .05) and HAL patients had complex disease (Open, 63%; HAL, 40%, LAP, 22%) and were diverted (Open, 35%; HAL, 10%; LAP, 3%). Time to bowel movement was not different; however, there was a stepwise increase in median length of stay (LOS; days) from the LAP (5 days) to HAL (6 days) to Open group (7 days) (P < .05 for all). The LAP complication rate (22.4%) was lower (P < .05) than the HAL (42.4%) or Open groups' (45.2%) rates. The LAP surgical site infection rate (5.6%) was lower (P < .05) than the HAL (12.8%) or Open groups (19.6%). Conclusion The HAL and Open groups had more high risk, complex disease, diverted, and older patients than the LAP group; likewise, the overall complication rate and LOS was higher in the HAL and Open groups. Use of HAL methods likely contributed to the high minimally invasive surgery utilization rate (89%).

The effects of viewing axis on laparoscopic performance: a comparison of non-expert and expert laparoscopic surgeons.

BACKGROUND: While the ideal relationship of telescope viewing axis and instrument working axis in laparoscopic surgery is co-axial, it is often necessary to deviate view of the surgical field from the direction of working instruments with potentially negative implications to performance. The objectives of this study are to (1) characterize performance effects of working progressively further off telescope viewing axis and (2) compare the ability of expert laparoscopic surgeons and non-expert surgeons to compensate for the psychomotor problems imposed by off-axis viewing. METHODS: Subjects included Baystate Medical Center surgical residents between PGY 1 and PGY 5 training years and attending surgeons. Expert subjects (>250 basic and >50 advanced laparoscopic cases, N = 6) and non-expert subjects (N = 11) performed the FLS peg transfer task in a box trainer configured to accept a laparoscope inserted at 0°, 45°, 90°, 135°, and 180° viewing angles relative to axis of working instruments. Performance measures included time to task completion (seconds), errors (# dropped objects), and percent completed transfers. Statistical analysis took into account repeated measures within each subject for each performance measure. Trends were assessed using linear contrasts for trend (p-trend). Differences between experts and non-experts were evaluated using an interaction term (p-interaction). RESULTS: Overall there was increased time to completion (p < 0.001), increased number of dropped pegs (p < 0.001), and decreased percentage of completed transfers (<0.001) as the viewing axis relative to working instruments increased from 0° to 180°. Overall, expert laparoscopic surgeons demonstrated significantly shorter time to completion (p < 0.0027), fewer dropped pegs (p < 0.001), and higher percentage of completed peg transfers (p < 0.0001) compared to non-expert surgeons. CONCLUSIONS: Surgeon performance degrades as viewing axis increases from 0° to 180° relative to working instruments. Expert laparoscopic surgeons perform better than non-expert surgeons when working off the laparoscope viewing axis.

EHR-Driven Delivery of EPA Assessments Significantly Improves Participation.

INTRODUCTION: Digital education tools are a cornerstone in the evolution to CBME through EPAs. Successful implementation requires understanding the variable impacts of EHR-driven delivery of EPAs, flexible digital device access to EPAs, and user-behavior trends. METHODS: Through a HIPAA compliant, flexible-device accessible, surgical education platform, general surgery training programs at 21 institutions collected EPA from July 2023 to April 2024. At 5 EHR-integrated institutions (EHR+), EPA were created for clinical activities based on the OR schedule, automatically pushed to attendings and residents with built in completion reminders. At 16 institutions without EHR integration (EHR-), EPA were initiated manually. To improve user experience, care phases were bundled (cEPA). We compared the EHR+ and EHR- groups, computing descriptive statistics on the cEPAs completed and user behavior metrics. RESULTS: We collected 4187 cEPAs in total, with 82% at EHR+ institutions and 18% at EHR- institutions. Platform triggering dramatically drove cEPA completion for both faculty and residents, 88% and 81%, respectively. Only 3% were initiated by the faculty or resident. Faculty at EHR+ institutions strongly preferred the automated OR-triggered workflow to start their EPAs (Chi-squared test, p ≈ 0). Faculty completed all 3 care phases nearly 80% of the time. Time reminders specifically drive EPA completion for residents and faculty on weekdays and build habits on weekends. 71% of cEPAs completed were by computer, and 29% by phone. More comments were provided when computers were used. Residents reviewed feedback with a median lag of 1 hour and 29 min after results were available. CONCLUSIONS: EHR-driven delivery of EPA leads to a 4.6-fold increase in EPAs completed. EPA initiation is the most critical phase in the workflow and EHR-data driven alerts drive this action. These alerts are also effective drivers of habit formation. Flexible device access is important to increase EPAs completed and improve the usefulness through comments for residents.

The Whiteboard Time Out: A Novel Tool to Improve Resident Learning in the Operating Room.

OBJECTIVE: "Flipping the classroom" is a strategy that has been implemented in various educational environments to create a student-centered learning environment. Within this model of teaching, "first exposure" occurs prior to the classroom in a lower form of cognitive demand, allowing students to employ higher forms of cognition within the classroom. Surgical education has evolved over recent years to incorporate different modalities of learning; however, optimal educational approaches within the operating room (OR) have not been clearly defined. The Whiteboard Time Out (WBTO) utilizes the idea of "flipping the classroom" to make learning within the OR more resident centered. Residents complete most of the preoperative work prior to the case with a focus on the indications, steps of the procedure, and potential complications associated with the procedure. Residents then utilize a whiteboard located in the OR to outline, diagram, and discuss this information with the attending. Aims of the study are to enhance higher level intraoperative resident learning and attending teaching and improve resident knowledge and the ability to communicate surgical steps. DESIGN: Faculty and residents completed a preimplementation questionnaire aligned to the Student Evaluation of Educational Quality (SEEQ) in July 2021. Participants were assigned 3 digit codes to ensure anonymity. The questionnaire was composed of 6 questions with a 5-point Likert scale. Whiteboards were mounted in every operating room, 19 total, in both the general OR and an ambulatory surgical center. The residents were expected to go to the OR, prior to scrubbing the case, and use the whiteboard to outline the indications, key steps and potential complications. After the resident completed the white board, the resident and attending reviewed the white board together prior to the start of the case. After the procedure, residents uploaded a picture of the whiteboard with a self-evaluation and faculty provided resident feedback via an online Wufoo Survey link. The start of the utilization of the whiteboards occurred after the initial survey in July 2021. The SEEQ questionnaire was again administered in October 2021, 3 months post-WBTO implementation, to assess resident and attending satisfaction. SEEQ questionnaire results were compared using a t-test. PARTICIPANTS: Participants included surgical residents and attendings at Maimonides Medical Center (MMC). MMC is a 700-bed university-affiliated, academic, tertiary medical center in Brooklyn, New York. The General Surgery Residency is approved for up to 5 graduates annually. RESULTS: A total of 17 attendings and 17 residents filled out the questionnaire. The average number of whiteboards completed was highest amongst the PGY1 class with an average of 18 whiteboards per resident. However, the average number of whiteboards completed declined amongst more senior residents. There was a statistically significant increase in overall SEEQ survey score amongst residents and attendings after implementation of the WBTO suggesting that whiteboards were useful (p < 0.03 and p < 0.02, respectively). Residents found that the whiteboard was an effective means of teaching surgical education compared to the current curriculum (p < 0.04). CONCLUSIONS: The whiteboard timeout is a tool created to enhance resident education in the OR. This idea is centered on a "flipped classroom," an educational strategy to increase student engagement. Our data demonstrates that the whiteboard timeout is an effective method of intraoperative teaching.

Painful Anal Ulcers in an HIV-Negative Young Woman: An Atypical Presentation of Syphilis.

Anorectal syphilis is relatively uncommon and diagnostically challenging given the wide differential diagnosis for anal lesions. Risk factors, such as men who have sex with men or HIV-positive status, are especially important to elicit from patients during the clinical history. In this report, we present a rare case of painful anal syphilis diagnosed in an HIV-negative woman by tissue biopsy.

Management Options of Giant Colonic Lipomas.

Colonic lipomas are rare, benign neoplasms, typically asymptomatic, and predominantly found incidentally during autopsy or routine surveillance. Symptomatic lesions are usually those greater than 2 cm in diameter while "giant" lesions are characterized as those over 4 cm. Presentations can vary from asymptomatic to more severe sequelae, including obstruction, gastrointestinal bleeding, or intussusception. Resection of these lesions has historically been restricted to large or symptomatic lesions. However, recent reports suggest lipomas may retain the ability to grow and can become symptomatic over time despite being inconsequential initially. This series provides a review of the clinical manifestations of colonic lipomas, radiographic characteristics, and a treatment recommendation for management of these lesions using minimally invasive surgical techniques whilst advocating for consideration of resection prior to the development of symptoms or more emergent complications.

Overcoming Systems Factors in Case Logging with Artificial Intelligence Tools.

INTRODUCTION: Case logs are foundational data in surgical education, yet cases are consistently under-reported. Logging behavior is driven by multiple human and systems factors, including time constraints, ease of case data retrieval, access to data-entry tools, and procedural code decision tools. METHODS: We examined case logging trends at three mid-sized, general surgery training programs from September 2016-October 2020, January 2019-October 2020 and May 2019-October 2020, respectively. Across the programs we compared the number of cases logged per week when residents logged directly to ACGME versus via a resident education platform with machine learning-based case logging assistance tools. We examined case logging patterns across 4 consecutive phases: baseline default ACGME logging prior to platform access (P0 "Manual"), full platform logging assistance (P1 "Assisted"), partial platform assistance requiring manual data entry without data integrations (P2 "Notebook"), and resumed fully integrated platform with logging assistance (P3 "Resumed"). RESULTS: 31,385 cases were logged utilizing the platform since 2016 by 171 residents across the 3 programs.Intelligent case logging assistance significantly increased case logging rates, from 1.44 ± 1.48 cases by manual entry in P0 to 4.77 ± 2.45 cases per resident per week via the platform in P1 (p-value < 0.00001). Despite the burden of manual data entry when the platform's data connectivity was paused, the tool helped to increase overall case logging into ACGME to 2.85 ± 2.37 cases per week (p-value = 0.0002). Upon resuming the data connectivity, case logging levels rose to 4.54 ± 3.33 cases per week via the platform, equivalent to P1 levels (insignificant difference, p-value = 0.57). CONCLUSIONS: Mapping the influence of systems and human factors in high-quality case logs allows us to target interventions to continually improve the training of surgical residents. System level factors such as access to alternate automation-drive tools and operative schedule integrated platforms to assist in ACGME case log has a significant impact on the number of cases captured in logs.

The Attending Meritocracy: Implementation of a Novel Team-Based Approach to Provide Effective Resident Feedback.

OBJECTIVE: Providing timely quality feedback is an essential responsibility of teaching faculty and is critical for resident assessment and development throughout training. Numerous evaluation platforms have been created to provide immediate and big picture end-of-rotation feedback. Faculty suffer burnout from electronic documentation demands and workload and as a result, evaluation activity is relegated to a lower priority leading to poor compliance. We implemented a novel team-based Attending Meritocracy (AM)1 program that encompasses monetary, automated reminder, and punitive components, while adding a competition element to further engage faculty. The aim of this study is to determine effectiveness of AM in increasing compliance with resident feedback. DESIGN, SETTING AND PARTICIPANTS: Surgical faculty (n = 36) were divided into 5 teams according to service and subspecialty. Points could be earned by completing surgical (Firefly, MiniCEX) or rotation (New Innovations) evaluations, leaving comments, and other educational tasks. A prize for the highest scoring team was identified as a dinner financed by the non-winning teams. Data from evaluation platforms was extracted. Continuous variables were compared using Mann-Whitney-U test, and categorical variables using chi-squared test. RESULTS: When comparing July 2019 to February 2020 (control period) with July 2020 to February 2021(initial implementation period), we found a 237% increase in submitted NI evaluations (n = 111-374) and a 42.5% decrease in median time to completion from 60.4 (33.2-106.9) days to 34.7 (24.0-64.5) days, (p = 0.001).2 We observed an increase in operative evaluations completed (Mini CEX n = 4-97, Firefly n = 150-1284). CONCLUSIONS: Implementation of a team-based attending meritocracy program is an effective budget neutral method to increase completion of resident evaluations. Further investigation is needed to assess improvement in quality of feedback as well as to explore it's impact on progression of resident autonomy.

Rapid Adoption of an Interdisciplinary Care Team Model for Surgical Residents Managing Coronavirus Disease-19.

Introduction: Patients infected with SARS-Cov-2, the causative virus behind the coronavirus disease-19 (COVID-19) pandemic, have been increasing rapidly in New York City. New York City has the highest incidence in the United States and fully 45% of all deaths from COVID-19. Our medical center is located within a high-density region of cases in south Brooklyn and, in fact, three of our neighborhood zip codes are in the top seven in New York in incidence. As a result, our center has experienced a dramatic increase in hospitalizations, particularly respiratory distress secondary to COVID-19, which rapidly exceeded the capacity of our internal medicine service. This necessitated the formation of new COVID-19 units throughout the hospital, replacing all former service lines. These units employed management teams composed of residents from many medical and surgical disciplines, including general surgery residents. Methods: Our general surgery residency program established a surgical COVID-19 (SCOVID) management team. Initially, 4 surgical residents (2 senior and 2 junior), 1 attending surgeon, and 1 attending internal medicine physician were allocated to the initial SCOVID team. On day 3 of implementation, to achieve more rapid competence in the complex management of these patients, a senior medicine resident with direct experience in the care of COVID-19 patients was added in an advisory capacity. Results: The addition of an experienced senior medical resident and attending allowed for the quick adoption of uniform management protocols by surgical residents and attendings. Discussion: We describe a protocol for the establishment of COVID-19 management teams staffed with general surgical residents, as well as a strategy for the achievement of rapid increases in competency. The addition of a senior internal medicine resident and attending to our SCOVID team allowed for rapid achievement of competency in the care of COVID-19 patients in our large institution at the epicenter of the COVID-19 pandemic.

A rare case of perianal apocrine adenocarcinoma.

Apocrine adenocarcinoma is a rare primary cutaneous malignancy that arises from areas with high apocrine gland density, most frequently described in the axilla. There have only been three previously reported cases of apocrine adenocarcinoma in the anal/perianal region. A 72-year-old female presented for evaluation of a perianal lesion with persistent drainage that she had noticed for over a year. The patient proceeded with surgical excision of the perianal nodule. Diagnosis was made based on pathology demonstrating areas of mixed solid and trabecular areas with large nuclei and many prominent mitotic figures, which stained positive for periodic acid-Schiff-diastase, cytokeratin 7 and gross cystic disease fluid protein 15. We are reporting just the fourth such case of apocrine adenocarcinoma in the anal/perianal region. It is important to consider apocrine adenocarcinoma in our differential, because though apocrine adenocarcinoma has a benign clinical presentation, it can have a high incidence of lymph invasion on presentation.

Loss of signal transducer and activator of transduction 4 or 6 signaling contributes to immune cell morbidity and mortality in sepsis.

OBJECTIVE: The role of signal transducer and activator of transduction (STAT) 4 vs. 6 has been assessed thus far only in a model of high mortality strongly driven by proinflammation alone. Their role in a low-mortality (LD25) model of sepsis remains unclear. DESIGN AND SETTING: Prospective controlled animal study in a research laboratory. SUBJECTS: STAT4 and STAT6 knockout mice. INTERVENTIONS: We induced sepsis by cecal ligation and puncture (CLP) or sham CLP in three groups of mice: (a) STAT4-/-, (b) STAT6-/-, (c) BALB/c. Splenic T cells or macrophages were then harvested 24 h after CLP, and their ability to produce cytokines was assessed. RESULTS: Following CLP T-cells from BALB/c mice were suppressed in the ability to release the Th1 cytokines interleukin (IL) 2 and interferon gamma. The release of Th2 cytokine IL-10 was increased. The Th1 response of STAT4-deficient animals was not only markedly lower in shams but was further suppressed by CLP. The Th2 cytokine response was elevated even more than that of the septic BALB/c. This was associated with lower survival than in the BALB/c. STAT6 deficiency resulted in a stronger Th1 response and a suppressed Th2 response to CLP. A similar difference between IL-12 and IL-10 release was seen in macrophages from these mice. Interestingly, while this resulted in improved survival, compared to STAT4-/- mice, the STAT6-/- animals still had a higher mortality than the BALB/c. CONCLUSIONS: These data suggest that contributions from both STAT4 driven processes as well as STAT6 responses are needed in a balanced fashion to maximize the animals' ability to survive septic challenge.

Inhibition of CD1d activation suppresses septic mortality: a role for NK-T cells in septic immune dysfunction.

BACKGROUND: Studies indicate that following septic insult there is development of generalized immune dysfunction in T cells, B cells and phagocytes, which is thought to contribute to morbidity and mortality. Specifically, there is a shift in the lymphocytes of septic animals toward an increased release of Th2 cytokines. NK-T cells have been shown to contribute to propagation of the Th2 response. The influence of NK-T cells on the immune response to septic challenge is poorly understood. In this study, we examine whether NK-T cells contribute to the immune dysfunction seen following the onset of polymicrobial sepsis, as produced by cecal ligation and puncture (CLP). MATERIALS AND METHODS: Male 129S1/SvImJ mice were pretreated with either rat IgG (isotypic control) or monoclonal antibody to CD1d (clone 1B1) (0.5 mg), which blocks signaling/antigen presentation via the CD1d cell surface receptor, thereby, ablating the activation and differentiation of the NK-T cells. Septic survival with and without anti-CD1d (CLP/CD1d) pretreatment was assessed. Mice sacrificed 24 h after CLP were assessed for change in splenic %NK-T cell (via flourescense activated cell sector) and for splenic, hepatic, and lymphoid/macrophage production of pro-inflammatory or anti-inflammatory cytokines (via enzyme-linked immunosorbent assay). RESULTS: Administration of anti-CD1d reduced septic mortality 35% at 6-10 d (n = 23 mice/group) (P <.05). There was a consistent increase in the %CD3(+) NK1.1(+) cell population (NK-T cells) in septic mice (1.706%), which was markedly suppressed by pretreatment with anti-CD1d (0.592%). IL-6 and IL-10 levels were suppressed by anti-CD1d in the spleen and blood. CONCLUSIONS: Together these findings imply not only that NK-T cells may play a role in mediating the immune suppression seen in bacterial sepsis, but that inhibition of their activation promotes survival to septic challenge.

PATHOLOGICAL ASPECTS OF THE ANTI-INFLAMMATORY/IMMUNE SUPPRESSIVE RESPONSE IN SEPSIS AND SHOCK.

Despite the recent advances in contemporary therapeutic, operative as well as supportive care sepsis and its associated co-morbidity/mortality are still a common occurrence in the critically ill trauma/surgical patient. Thus, it remains important to continue to expand our understanding of pathological components which drive the development of immune dysfunction contributing to subsequent multiple organ failure. Here we overview some of the immuno-pathological processes, cells and mediators which may play a role in the development of this immune dysfunctional condition.