A multi-national, video-based qualitative study to refine training guidelines for assigning an "unsafe" score in laparoscopic cholecystectomy critical view of safety.

BACKGROUND: The critical view of safety (CVS) was incorporated into a novel 6-item objective procedure-specific assessment for laparoscopic cholecystectomy (LC-CVS OPSA) to enhance focus on safe completion of surgical tasks and advance the American Board of Surgery's entrustable professional activities (EPAs) initiative. To enhance instrument development, a feasibility study was performed to elucidate expert surgeon perspectives regarding "safe" vs. "unsafe" practice. METHODS: A multi-national consortium of 11 expert LC surgeons were asked to apply the LC-CVS OPSA to ten LC videos of varying surgical difficulty using a "safe" vs. "unsafe" scale. Raters were asked to provide written rationale for all "unsafe" ratings and invited to provide additional feedback regarding instrument clarity. A qualitative analysis was performed on written responses to extract major themes. RESULTS: Of the 660 ratings, 238 were scored as "unsafe" with substantial variation in distribution across tasks and raters. Analysis of the comments revealed three major categories of "unsafe" ratings: (a) inability to achieve the critical view of safety (intended outcome), (b) safe task completion but less than optimal surgical technique, and (c) safe task completion but risk for potential future complication. Analysis of reviewer comments also identified the potential for safe surgical practice even when CVS was not achieved, either due to unusual anatomy or severe pathology preventing safe visualization. Based upon findings, modifications to the instructions to raters for the LC-CVS OPSA were incorporated to enhance instrument reliability. CONCLUSIONS: A safety-based LC-CVS OPSA has the potential to significantly improve surgical training by incorporating CVS formally into learner assessment. This study documents the perspectives of expert biliary tract surgeons regarding clear identification and documentation of unsafe surgical practice for LC-CVS and enables the development of training materials to improve instrument reliability. Learnings from the study have been incorporated into rater instructions to enhance instrument reliability.

Laparoscopic cholecystectomy critical view of safety (LC-CVS): a multi-national validation study of an objective, procedure-specific assessment using video-based assessment (VBA).

BACKGROUND: A novel 6-item objective, procedure-specific assessment for laparoscopic cholecystectomy incorporating the critical view of safety (LC-CVS OPSA) was developed to support trainee formative and summative assessments. The LC-CVS OPSA included two retraction items (fundus and infundibulum retraction) and four CVS items (hepatocystic triangle visualization, gallbladder-liver separation, cystic artery identification, and cystic duct identification). The scoring rubric for retraction consisted of poor (frequently outside of defined range), adequate (minimally outside of defined range) and excellent (consistently inside defined range) and for CVS items were "poor-unsafe", "adequate-safe", or "excellent-safe". METHODS: A multi-national consortium of 12 expert LC surgeons applied the OPSA-LC CVS to 35 unique LC videos and one duplicate video. Primary outcome measure was inter-rater reliability as measured by Gwet's AC2, a weighted measure that adjusts for scales with high probability of random agreement. Analysis of the inter-rater reliability was conducted on a collapsed dichotomous scoring rubric of "poor-unsafe" vs. "adequate/excellent-safe". RESULTS: Inter-rater reliability was high for all six items ranging from 0.76 (hepatocystic triangle visualization) to 0.86 (cystic duct identification). Intra-rater reliability for the single duplicate video was substantially higher across the six items ranging from 0.91 to 1.00. CONCLUSIONS: The novel 6-item OPSA LC CVS demonstrated high inter-rater reliability when tested with a multi-national consortium of LC expert surgeons. This brief instrument focused on safe surgical practice was designed to support the implementation of entrustable professional activities into busy surgical training programs. Instrument use coupled with video-based assessments creates novel datasets with the potential for artificial intelligence development including computer vision to drive assessment automation.

A Crucial Moment for Reflection on the Importance of Ethical Leadership in Academic Medicine.

The extreme disturbances caused by the COVID -19 pandemic on our academic medical centers compounded by a recurrent surge of violence against people of color have reopened our wounds exposing fragility, inequality, and continued racial disparities in society and health. At the center of this severe institutional disruption, leaders will be compelled to take action to keep their constituents and patients safe and their hospitals and departments afloat during and after a pandemic, all while simultaneously addressing and implementing the cultural changes required to eliminate systemic racism and discrimination. Organizational disruptions of this magnitude will naturally test one's principles, loyalties and responsibilities while challenging the practical burdens of leadership. If the goal of responding to these upheavals is to bring them to resolution and ultimately to bring about organizational change for the better, ethical leadership is critical. Applying ethical principles allows leaders to chart clear paths to solutions both in the short and long term. We review the principles of ethical leadership exemplified by a case illustration and provide a novel resource to help ensure ethical leadership in academic medicine and beyond.

Ethical considerations for allocation of scarce resources and alterations in surgical care during a pandemic.

The COVID-19 pandemic caused by SARS-CoV-2 is unprecedented in modern history. Its effects on social behavior and health care delivery have been dramatic. The resultant burden of disease and critical illness has outpaced the diagnostic, therapeutic, and health care professional resources of many clinics and hospitals. It continues to do so globally. The allocation of hospital beds and ventilators, personal protective equipment, investigational therapeutics, and other scarce resources has required difficult decisions. Clinical and surgical practices which are standard in normal times may not be standard or safe during the COVID-19 crisis. How can we best adapt as physicians and surgeons? What foundational ethical principles and systems of principle application can help guide our decision-making? Fortunately, a large body of work in medical ethics addresses these questions. Unfortunately, many surgeons and other health care professionals are probably not as familiar with these concepts. This brief communication is intended to provide a concise explanation of ethical considerations which readers may find helpful when addressing allocation of scarce resources and alterations in surgical care brought on by the current pandemic.

Correction to: International Scholarship Programs of the American College of Surgeons: Expansion of the Global Surgical Network.

In the original article, the top of Fig. 1 was inadvertently cut off. The original article has been corrected. The publisher regrets the error.

International Scholarship Programs of the American College of Surgeons: Expansion of the Global Surgical Network.

BACKGROUND: The American College of Surgeons has always promoted education and collaborations with other countries and their scientific organizations. The International Guest Scholarship program was established in 1968 to support the travel of foreign surgeons to medical Institutions in the USA and Canada. The program has grown substantially over time and now includes different categories of scholarships and surgeons. The objective of this article is to describe the experiences gained by the international scholars who visited US and Canadian institutions through these ACS programs. STUDY DESIGN: In order to collect information regarding these scholarships from the surgeons who have already participated in the program, an Internet-based survey was e-mailed to alumni. The surveys were constructed to gather career information on former scholars and to analyze the perceived impact of these programs on their careers. RESULTS: Among the international scholarships alumni, most are now Fellows of the American College of Surgeons. The majority of respondents maintained contact with their host surgeons in the USA or Canada; they began or continued research, surgical education and surgical quality improvement initiatives in their country of origin based upon their experiences as international scholars. Most of the alumni reported that the experience they had during the scholarship was inspiring, opened their minds and broadened their horizons. CONCLUSIONS: The overall effect of ACS international scholarship program should be considered as positive, as 80-90% of respondent alumni consider their experience very helpful and feel that it provided them with opportunities that would not have been possible without it. It is incumbent upon the ACS to continue along this path by identifying funding and donation sources, as well as enriching the content and goals.

Ethical Issues in the Introduction of New Technologies: From Mis to POEM.

The ethical debate regarding the introduction of new technologies in the surgical health care environment is discussed in this manuscript, with a special emphasis on minimally invasive and NOTES procedures for the treatment of esophageal achalasia. It offers an overview of the ethical principles and considerations about the implementation of new techniques and technologies.

Diagnóstico y tratamiento de la pancreatitis aguda en la Argentina. Resultados de un estudio prospectivo en 23 centros.

In Argentina there are no multicenter studies evaluating the management of patients with acute pancreatitis (AP) nationwide. OBJECTIVES: The main objective of this study is to know how the patients with AP are treated in Argentina. The secondary objective is to assess whether the results comply with the recommendation of the American College of Gastroenterology Guide. MATERIAL AND METHODS: Twenty three center participated in the study. They include in a database hosted online consecutive patients with acute pancreatitis from june 2010 to june 2013. RESULTS: 854 patients entered the study. The average age was 46.6 years and 495 (58%) belonged to the female sex. The most common cause (88.2%) of AP was biliary. Some prognostic system was used in 99 % of patients and the most used was Ranson (74.5%). Were classified as mild 714 (83.6%) patients and severe 140 (16.4%). Systemic complications occurred in 43 patients and local complications in 21. 86 patients underwent dynamic CT scans and 73 patients had pancreatic and / or peripancreatic necrosis. Mortality was 1.5%. There was no difference in mortality in relation to the size, complexity or affiliation of the center. The comply of key recommendations of the American College of Gastroenterology Guide was over 80%. CONCLUSIONS: The diagnosis and treatment of patients with AP in 23 health centers located throughout the country was optimal. The management complied with most of the recommendations of the American College of Gastroenterology Guide.

Ethical issues of expert witness testimony.

Being a surgical expert witness (EW) in professional liability claims implies ethical responsibilities, which are usually unknown to the parties who try to obtain such testimony as well as to the surgeons involved in providing the expert opinion required by the courts. Giving medical testimony can be included in the field of surgery since (1) being an expert medical witness and judge the performance of another surgeon means that the witness must have a medical license and preferably be board-certified as a surgeon, and (2) the EW opinion sets the standard of care to be applied in each particular case. Thus, the role of the surgeon EW in the legal arena must have the same degree of integrity as the surgeon in his practice with direct patient care and it should be reviewed and subject to regulation.

The extent of surgical patients' understanding.

The notion that consent to surgery must be informed implies not only that information should be provided by the surgeon but also that the information should be understood by the patient in order to give a foundation to his or her decision to accept or refuse treatment and thus, achieve autonomy for the patient. Nonetheless, this seems to be an idyllic situation, since most patients do not fully understand the facts offered and thus the process of surgical informed consent, as well as the patient's autonomy, may be jeopardized. Informed consent does not always mean rational consent.

Ethical and legal issues regarding artificial intelligence (AI) and management of surgical data.

The advent of AI in surgical practice is representing a major innovation. As its role expands and due to its several implications, strict compliance with ethical, legal and regulatory good practices is mandatory. Observance of ethical principles and legal rules will be a professional imperative for the application of AI in surgical practice, both clinically and scientifically.

Surgical Antibiotic Prophylaxis: A Proposal for a Global Evidence-Based Bundle.

In the multimodal strategy context, to implement healthcare-associated infection prevention, bundles are one of the most commonly used methods to adapt guidelines in the local context and transfer best practices into routine clinical care. One of the most important measures to prevent surgical site infections is surgical antibiotic prophylaxis (SAP). This narrative review aims to present a bundle for the correct SAP administration and evaluate the evidence supporting it. Surgical site infection (SSI) prevention guidelines published by the WHO, CDC, NICE, and SHEA/IDSA/APIC/AHA, and the clinical practice guidelines for SAP by ASHP/IDSA/SIS/SHEA, were reviewed. Subsequently, comprehensive searches were also conducted using the PubMed®/MEDLINE and Google Scholar databases, in order to identify further supporting evidence-based documentation. The bundle includes five different measures that may affect proper SAP administration. The measures included may be easily implemented in all hospitals worldwide and are based on minimal drug pharmacokinetics and pharmacodynamics knowledge, which all surgeons should know. Antibiotics for SAP should be prescribed for surgical procedures at high risk for SSIs, such as clean-contaminated and contaminated surgical procedures or for clean surgical procedures where SSIs, even if unlikely, may have devastating consequences, such as in procedures with prosthetic implants. SAP should generally be administered within 60 min before the surgical incision for most antibiotics (including cefazolin). SAP redosing is indicated for surgical procedures exceeding two antibiotic half-lives or for procedures significantly associated with blood loss. In principle, SAP should be discontinued after the surgical procedure. Hospital-based antimicrobial stewardship programmes can optimise the treatment of infections and reduce adverse events associated with antibiotics. In the context of a collaborative and interdisciplinary approach, it is essential to encourage an institutional safety culture in which surgeons are persuaded, rather than compelled, to respect antibiotic prescribing practices. In that context, the proposed bundle contains a set of evidence-based interventions for SAP administration. It is easy to apply, promotes collaboration, and includes measures that can be adequately followed and evaluated in all hospitals worldwide.

Broad clinical utilization of NOTES: is it safe?

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has been the focus of several studies as a less invasive alternative to conventional laparoscopy to access and treat intracavitary organs. For the last 5 years, much has been accomplished with animal studies, yet the clinical utilization of this novel technique is still modest. After 2 years of experience in the laboratory, we started our clinical experience. We report our experience with clinical utilization of NOTES procedures from 2007 to 2010. METHODS: Under UCSD institutional review board-approved trials, 104 patients were enrolled under seven different NOTES protocols from 2007 to 2010, where a NOTES procedure was offered as an alternative to conventional treatments. The treated pathologies were cholelithiasis, biliary dyskinesia, acute and chronic appendicitis, ventral hernias, morbid obesity, and achalasia. The access routes included transgastric (TG), transvaginal (TV), transesophageal (TE), and perirectal (PR). RESULTS: Among the 104 patients enrolled, 103 underwent a surgical procedure starting with diagnostic laparoscopy, and 94 cases were deemed appropriate to proceed via a NOTES approach. There were 9 aborted NOTES procedures at the time of the initial peritoneoscopy before creating a NOTES access route. The reasons to not proceed with a NOTES procedure in the TV cholecystectomy group (n = 5) were a large amount of pelvic adhesions in 4 patients and a severe inflammation of the gallbladder in 1 patient. In the TG cholecystectomy group (n = 1), it was severe inflammation of the gallbladder. In the TG appendectomy group (n = 1), it was the presence of localized peritonitis. In the TE endoscopic myotomy group (n = 2), it was the presence of megaesophagus with an inability to clean the esophagus of food debris. The NOTES procedures performed were 48 TV cholecystectomies, 4 TV appendectomies, 8 TG cholecystectomies, 2 PR peritoneoscopies, 3 TG appendectomies, 3 TV ventral hernia repairs, 5 TE endoscopic myotomies, 3 TV sleeve gastrectomies, and 18 TG sleeve gastrectomies. The average body mass indexes for those in the sleeve gastrectomy group was 42.1 kg/m(2) (TG route) and 40.6 kg/m(2) (TV route). There were no intraoperative complication and no conversions to standard laparoscopy during these procedures. The average hospital stay was 1-2 days. One patient who underwent TV cholecystectomy required an emergency department visit for nausea and vomiting. To date, 3 patients who underwent TV cholecystectomy have become pregnant and delivered normally. CONCLUSIONS: NOTES is safe, feasible, and reproducible with previous training in the laboratory and a consistent team at a high-volume center. Prospective randomized studies of a large patient population are necessary to assess long-term results.

Ethical debate: the ethics of not performing extended lymphadenectomy in patients with gastrointestinal cancer.

The ethical debate about performing-or not-extended lymphadenectomy in patients with a gastrointestinal malignancy is approached in this work. It offers a thorough overview of the ethical principles. Problem-solving tools are provided to assist in framing the issues and resolving the conflicts.

Clinical experience with a multifunctional, flexible surgery system for endolumenal, single-port, and NOTES procedures.

BACKGROUND: Single-port and incisionless surgical approaches hold the promise of fewer complications, reduced pain, faster recovery, and improved cosmesis compared with traditional open or laparoscopic approaches. The ability to select an access approach (i.e., endolumenal, single-port, transvaginal, or transgastric) with one platform may be important to optimization of individual patient results. The authors report their results using these four separate surgical approaches tailored to three different therapeutic procedures, all with the use of a single flexible platform, the Incisionless Operating Platform (IOP). METHODS: After institutional review board approval, the IOP was used to perform nine cholecystectomies via transvaginal (TV) (n=4), transgastric (TG) (n=4), and single-port transumbilical (TU) (n=1) access. Two appendectomies were performed via TG access. Endolumenal access was used for 18 gastric pouch and stoma reductions after Roux-en-Y gastric bypass. The TG and TV procedures involved the use of one to three trocars. The recorded data included safety, procedural success, operative time, patient pain assessment (on a 0-10 scale) at discharge, and length of hospital stay. RESULTS: Procedural success was achieved for 16 of 18 endolumenal procedures, 1 of 1 single-port procedure, and 10 of 10 NOTES procedures. For 5 of 10 NOTES procedures, only one small trocar was required. The mean operative times were 79 min for pouch with stoma reduction, 171 min for cholecystectomy, and 274 min for appendectomy. Of 29 patients, 27 were discharged in 24 h or less. The average pain scores were 0.44 for pouch with stoma reduction, 1.3 for cholecystectomy, and 2.5 for appendectomy. No significant complications occurred. The ergonomics of IOP allowed the surgeon to interface with the system using an endoscopic or laparoscopic orientation. CONCLUSION: Availability of a multifunctional, flexible surgery platform provides a choice of a single-port or incisionless surgical approach with the potential to reduce complications, pain, and recovery time while improving cosmesis.

Natural orifice surgery: initial clinical experience.

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience. METHODS: Under an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance. RESULTS: Nine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred. CONCLUSION: The limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.