Characteristics and contributing factors of diagnostic error in surgery: analysis of closed medico-legal cases and complaints in Canada.

BACKGROUND: Diagnostic errors lead to patient harm; however, most research has been conducted in nonsurgical disciplines. We sought to characterize diagnostic error in the pre-, intra-, and postoperative surgical phases, describe their contributing factors, and quantify their impact related to patient harm. METHODS: We performed a retrospective analysis of closed medico-legal cases and complaints using a database representing more than 95% of all Canadian physicians. We included cases if they involved a legal action or complaint that closed between 2014 and 2018 and involved a diagnostic error assigned by peer expert review to a surgeon. RESULTS: We identified 387 surgical cases that involved a diagnostic error. The surgical specialties most often associated with diagnostic error were general surgery (n = 151, 39.0%), gynecology (n = 71, 18.3%), and orthopedic surgery (n = 48, 12.4%), but most surgical specialties were represented. Errors occurred more often in the postoperative phase (n = 171, 44.2%) than in the pre- (n = 127, 32.8%) or intra-operative (n = 120, 31.0%) phases of surgical care. More than 80% of the contributing factors for diagnostic errors were related to providers, with clinical decision-making being the principal contributing factor. Half of the contributing factors were related to the health care team (n = 194, 50.1%), the most common of which was communication breakdown. More than half of patients involved in a surgical diagnostic error experienced at least moderate harm, with 1 in 7 cases resulting in death. CONCLUSION: In our cohort, diagnostic errors occurred in most surgical disciplines and across all surgical phases of care; contributing factors were commonly attributed to provider clinical decision-making and communication breakdown. Surgical patient safety efforts should include diagnostic errors with a focus on understanding and reducing errors in surgical clinical decision-making and improving communication.

Feasibility and Safety of a "Shared Care" Model in Complex Hepatopancreatobiliary Surgery: A 5-year Observational Study of Outcomes in Pancreaticoduodenectomy.

OBJECTIVE: To determine the safety of a fully functioning shared care model (SCM) in hepatopancreatobiliary surgery through evaluating outcomes in pancreaticoduodenectomy. BACKGROUND: SCMs, where a team of surgeons share in care delivery and resource utilization, represent a surgeon-level opportunity to improve system efficiency and peer support, but concerns around clinical safety remain, especially in complex elective surgery. METHODS: Patients who underwent pancreaticoduodenectomy between 2016 and 2020 were included. Adoption of shared care was demonstrated by analyzing shared care measures, including the number of surgeons encountered by patients during their care cycle, the proportion of patients with different consenting versus primary operating surgeon (POS), and the proportion of patients who met their POS on the day of surgery. Outcomes, including 30-day mortality, readmission, unplanned reoperation, sepsis, and length of stay, were collected from the institution's National Surgical Quality Improvement Program (NSQIP) database and compared with peer hospitals contributing to the pancreatectomy-specific NSQIP collaborative. RESULTS: Of the 174 patients included, a median of 3 surgeons was involved throughout the patients' care cycle, 69.0% of patients had different consenting versus POS and 57.5% met their POS on the day of surgery. Major outcomes, including mortality (1.1%), sepsis (5.2%), and reoperation (7.5%), were comparable between the study group and NSQIP peer hospitals. Length of stay (10 day) was higher in place of lower readmission (13.2%) in the study group compared with peer hospitals. CONCLUSIONS: SCMs are feasible in complex elective surgery without compromising patient outcomes, and wider adoption may be encouraged.

Intraoperative injuries from abdominopelvic surgery: an analysis of national medicolegal data.

Background: Intraoperative injuries during abdominopelvic surgery can be associated with substantial patient harm. The objective of this study was to describe abdominopelvic intraoperative injuries and their contributing factors among medicolegal cases. Methods: This study was a descriptive analysis of medicolegal matters reported to a national body, with subgroup analyses by type of surgery. We reviewed medicolegal matters involving a population-based sample of physicians who were subject to a civil legal action or complaint to a regulatory authority that was closed between 2013 and 2017 in Canada. Results: Our analysis included 181 civil legal cases and 88 complaints to a regulatory authority. Among legal cases, 155 patients (85.6%) (median age 47 yr) underwent elective procedures. The most common injury site was the bowel (53 cases [29.3%]). Injuries frequently occurred during dissection (79 [43.6%]) and ligation (38 [21.0%]), were identified postoperatively (138 [76.2%]) and necessitated further surgery (139 [76.8%]). Many patients experienced severe harm (55 [30.4%]) or died (25 [13.8%]). Peer experts in nongynecologic cases were more likely than those in gynecologic cases to include criticisms of a provider in a harmful incident (79 [71.2%] v. 30 [42.9%], p < 0.01). Peer expert criticisms often related to clinical evaluation, decision-making and misidentification of anatomy. Criticisms of nontechnical skills identified documentation and communication deficiencies. Conclusion: This study confirms the importance of provider and team training to improve clinical evaluation and decision-making, documentation and communication. Effective protocols may help support clinicians in providing safer surgical care.

Contexte: Les blessures survenant durant une chirurgie abdominopelvienne peuvent être associées à d'importants préjudices chez les patients. La présente étude avait pour but de décrire les blessures peropératoires abdominopelviennes faisant l'objet d'enquêtes médicolégales et à connaître leurs facteurs contributifs. Méthodes: Cette étude comprend une analyse descriptive d'affaires médicolégales signalées à un organisme de réglementation national, ainsi que des analyses par sousgroupes selon le type de chirurgie. Nous avons examiné des cas impliquant un échantillon de médecins canadiens représentatifs de la population qui avaient fait l'objet d'une poursuite au civil ou d'une plainte auprès d'un organisme de réglementation. Toutes les poursuites et plaintes étudiées ont été résolues entre 2013 et 2017. Résultats: Notre analyse comprenait 181 poursuites au civil et 88 plaintes auprès d'un organisme de réglementation. En ce qui concerne les poursuites au civil, 155 patients (85,6 %) (âge médian 47 ans) avaient subi une intervention non urgente. Les blessures déclarées touchaient généralement les intestins (53 cas [29,3 %]). Elles sont fréquemment survenues durant la dissection (79 cas [43,6 %]) et la ligature (38 cas [21,0 %]), ont été repérées en période postopératoire (138 cas [76,2 %]) et ont nécessité une autre chirurgie (139 cas [76,8 %]). De nombreux patients ont subi de graves préjudices (55 cas [30,4 %]) ou sont décédés (25 cas [13,8 %]). Les pairs experts dans un domaine autre que la gynécologie étaient plus susceptibles que ceux experts en gynécologie de critiquer un fournisseur en cas d'incident avec préjudice (79 cas [71,2 %] c. 30 cas [42,9 %]; p < 0,01). Les critiques formulées par les pairs experts portaient souvent sur l'évaluation clinique, la prise de décision et les erreurs d'identification des structures anatomiques. Les critiques visant les habiletés non techniques avaient trait aux lacunes dans la documentation et la communication. Conclusion: Cette étude vient confirmer l'importance que revêt la formation des fournisseurs et de leur équipe dans l'amélioration de la prise de décision, de la documentation et de la communication. Des protocoles efficaces pourraient soutenir l'offre de soins chirurgicaux sûrs par les professionnels de la santé.

Efficacy of a Dual-ring Wound Protector for Prevention of Surgical Site Infections After Pancreaticoduodenectomy in Patients With Intrabiliary Stents: A Randomized Clinical Trial.

OBJECTIVE: To evaluate the efficacy of a dual-ring wound protector for preventing incisional surgical site infection (SSI) among patients with preoperative biliary stents undergoing pancreaticoduodenectomy (PD). METHODS AND ANALYSIS: This study was a parallel, dual-arm, double-blind randomized controlled trial. Adult patients with a biliary stent undergoing elective PD at 2 tertiary care institutions were included (February 2013 to May 2016). Patients were randomly assigned to receive a surgical dual-ring wound protector or no wound protector, and also the current standard of care. The main outcome measure was incisional SSI, as defined by the Centers for Disease Control and Prevention criteria, within 30 days of the index operation. RESULTS: A total of 107 patients were recruited (mean age 67.2 years; standard deviation 12.9; 65% male). No significant differences were identified between the intervention and control groups (age, sex, body mass index, preoperative comorbidities, American Society of Anesthesiologists class, prestent cholangitis). There was a significant reduction in the incidence of incisional SSI in the wound protector group (21.1% vs 44.0%; relative risk reduction 52%; P = 0.010). Patients with completed PD also displayed a decrease in incisional SSI with use of the wound protector compared with those palliated surgically (27.3% vs 48.7%; P = 0.04). Multivariate analysis did not identify any significant modifying factor relationships (estimated blood loss, duration of surgery, hospital site, etc.) (P > 0.05). CONCLUSION: Among adult patients with intrabiliary stents, the use of a dual-ring wound protector during PD significantly reduces the risk of incisional SSI.

Clinical and pathological features of intraductal papillary neoplasm of the biliary tract and gallbladder.

BACKGROUND: Intraductal papillary neoplasms of the biliary tract (IPNB) and intracholecystic papillary neoplasms (ICPN) are rare tumours characterized by intraluminal papillary growth that can be associated with invasive carcinoma. Their natural history remains poorly understood. This study examines clinicopathological features and outcomes. METHODS: Patients who underwent surgery for IPNB/ICPN (2008-2014) were identified. Descriptive statistics and survival data were generated. RESULTS: Of 23 patients with IPNB/ICPN, 10 were male, and the mean age was 68 years. The most common presentations were abdominal pain (n = 10) and jaundice (n = 9). Tumour locations were: intrahepatic (n = 5), hilar (n = 3), the extrahepatic bile duct (n = 8) and the gallbladder (n = 7). Invasive cancer was found in 20/23 patients. Epithelial subtypes included pancreatobiliary (n = 15), intestinal (n = 7) and gastric (n = 1). The median follow-up was 30 months. The 5-year overall (OS) and disease-free survivals (DFS) were 51% and 57%, respectively. Decreased OS (P = 0.09) and DFS (P = 0.05) were seen in patients with tumours expressing MUC1 on immunohistochemistry (IHC). CONCLUSION: IPNB/ICPN are rare precursor lesions that can affect the entire biliary epithelium. At pathology, the majority of patients have invasive carcinoma, thus warranting a radical resection. Patients with tumours expressing MUC1 appear to have worse OS and DFSs.

Patterns of recurrence following selective intraoperative radiofrequency ablation as an adjunct to hepatic resection for colorectal liver metastases.

BACKGROUND AND OBJECTIVES: The purpose of this study was to analyze the patterns of recurrence following intraoperative radiofrequency ablation (RFA) combined with hepatic resection for patients with colorectal liver metastases (CLM). METHODS: Patients undergoing liver resection (with or without RFA) for CLM were examined. Rates and patterns of disease recurrence, as well as overall survival were assessed using Kaplan-Meier and Cox analyses. RESULTS: A total of 174 patients underwent liver resection for CLM (150 without and 24 with intraoperative RFA). RFA was used to treat 41 tumors (median 1.6 cm). The 3-year overall survival was 65.5% and 61.4% (adjusted HR 1.02, 95% CI 0.55-1.88). Median recurrence-free survival was 7.4 versus 12.7 months with RFA versus non-RFA, respectively (adjusted HR 1.51, 95% CI 0.94-4.42). On multivariate analysis, neither survival nor recurrence-free survival was significantly associated with RFA. In total, there were two RFA ablation zone local failures. An ablation site recurrence was the sole site in one patient (4.2%). CONCLUSION: RFA was used as an adjunct to resection in patients with greater disease burden. Despite this, RFA was not significantly associated with a higher risk of local failure and was not associated with worse survival, when compared with liver resection alone.

The management of hepatobiliary cystadenomas: lessons learned.

BACKGROUND: Mucinous cystic neoplasms of the liver (hepatobiliary cystadenomas) are rare neoplastic lesions. Such cysts are often incorrectly diagnosed and managed, and carry a risk of malignancy. The objective of this study was to review the surgical experience with these lesions over 15 years. METHODS: A retrospective chart review identified consecutive patients undergoing surgery for liver cystadenomas from 1997-2011. Clinical data were collected and summarized. RESULTS: Thirteen patients (mean age 51 years, 12/13 females) with cysts 4.6-18.1 cm were identified. Most cysts were located in the left lobe/centrally (11/12) and had septations (8/13). Mural nodularity was infrequent (3/13). Nine patients had liver resection/enucleation, whereas four had unroofing. Frozen section analysis had a high false-negative rate (4/6). All patients had cystadenomas, of which two had foci of invasive carcinoma (cystadenocarcinoma) within mural nodules. There was no 90-day mortality. All but one patient (myocardial infarction) were alive at a median follow-up of 23.1 months. No patient with unroofing has developed malignancy to date. CONCLUSIONS: Non-invasive hepatobiliary cystadenomas present as large central/left-sided cysts in young or middle-aged women. Associated malignancy was relatively uncommon and found within mural nodules. Intra-operative frozen section analysis was ineffective at ruling out cystadenomas. Complete excision is recommended, but close follow-up might be considered in patients with a prohibitive technical or medical risk, in the absence of nodularity on high-quality imaging.

The making of a (new) surgeon: Opportunities for repeated messaging on NOTSS in the Canadian medical system.

Proficiency in nontechnical skills (NTS) contributes to reduction in critical safety incidents and improvement in patient safety outcomes. Despite evidence demonstrating the importance of NTS in patient safety, there remains limited NTS specific curricula and formal teaching in Canadian surgical programs. We propose a three-stage longitudinal approach to education surrounding NTS using the Nontechnical skills for surgeons (NOTSS) framework.

Evaluating agreement regarding the resectability of colorectal liver metastases: a national case-based survey of hepatic surgeons.

BACKGROUND: The resectability of colorectal liver metastases is in part largely based on the surgeon's assessment of cross-sectional imaging. This process, while guided by principles, is subjective. The objective of the present study was to assess agreement between hepatic surgeons regarding the resectability of colorectal liver metastases. METHODS: Forty-six hepatic surgeons across Canada were invited. A patient with biologically favourable disease was presented after having received neoadjuvant chemotherapy. The scenario was matched with 10 different scrollable abdominal CT scans representing a maximum response after six cycles of chemotherapy. Surgeons were asked to offer an opinion on resectability of liver metastases, and whether they would use adjunct modalities to hepatic resection. RESULTS: Twenty-six surgeons participated. Twenty responses were complete. The median number of scenarios deemed resectable was 6/10 (range 3-8). Two control scenarios demonstrated perfect agreement. Agreement on resectability was poor for 4/8 test scenarios, of which one scenario demonstrated complete disagreement. Among resectable cases, the pattern of use of adjunct modalities was variable. A median ratio of 0.87 adjunct modality per resectable scenario per surgeon was used (range 0.25-1.75). CONCLUSION: A significant lack of agreement was identified among surgeons on the resectability and use of adjunct modalities in the treatment of colorectal liver metastases.

Defining healthcare never events to effect system change: A protocol for systematic review.

INTRODUCTION: A never event is the most egregious of patient safety incidents. It refers to events that should theoretically never happen, such amputating the wrong limb. The term "never event" is used around the world by a variety of medical and patient safety organizations and is synonymous with sentinel events and serious reportable events. Unfortunately, there is little consensus about which events, in particular, are never events. These differing lists hinder potential collaboration or large-scale analyses. A recent systematic review by Hegarty et al. (2020) identified the need for a standardized definition for serious reportable events. The objective of our systematic review is to build on this by identifying which events are consistently or frequently identified as never events in order to isolate those which are core never events. MATERIALS AND METHODS: A systematic review will be conducted using Medline, Medline in Process, Scopus, PsychINFO, Embase via OVID, and CINAHL via EBSCO databases, as well as grey literature. We will include articles of any study design that discuss never events or one of its synonymous terms in the context of medical care. Four independent reviewers will conduct the title and abstract as well as the full-text screening, and 2 reviewers will abstract data. Data will be analyzed using narrative synthesis. Results will be categorized by year and geographic location, and by other factors determined during full-text screening. DISCUSSION AND CONCLUSION: The lack of consensus regarding never events hinders progress in reducing their occurrence. Differing data sources makes comparison challenging, and limits the ability for patient safety groups to work collaboratively and share learnings with others. Identifying a core set of never events will serve as a first step to focus our efforts to reduce these harmful incidents.

The Inter-Rater Reliability of Technical Skills Assessment and Retention of Rater Training.

BACKGROUND: The inter-rater reliability (IRR) of laparoscopic skills assessment is usually determined in the context of motivated raters from a single subspecialty practice group with significant experience using similar tools. The purpose of this study was to determine the IRR among attending surgeons of different experience and practices, the extent of rater training that is necessary to achieve good IRR, and if rater training is retained over periods of nonuse. METHODS: In Part 1, 5 surgeons of different practice backgrounds assessed 3 laparoscopic cholecystectomy videos using the Global Operative Assessment of Laparoscopic Skills instrument. In Part 2, 2 of the surgeons assessed a total of 33 videos over 5 scoring sessions distributed across 6 months. They participated in 2 different training sessions, and retention was tested in the other 3 sessions. IRR was calculated for Parts 1 and 2 with an intraclass correlation (ICC) in a 2-way random-effects model. RESULTS: The ICC for Part 1 was poor (ICC = 0.26). In Part 2, the ICC was highest after each training session (scoring #1 ICC = 0.76, scoring #3 ICC = 0.74). The ICC was not retained 1.5 months after the brief video-based training session (scoring #2 ICC = -0.17). The ICC was retained 2.5 months after the in-depth discussion training session (scoring #4 ICC = 0.70), but not 4.5 months later (scoring #5 ICC = 0.04). CONCLUSIONS: Good IRR is not implicit among surgeons with varying backgrounds and experience. Good IRR can be achieved with different types of rater training, but the impact of rater training is lost in periods of nonuse. This suggests the need for further study of the IRR of technical skills assessment when performed by the wide variety of surgeon raters as is commonly encountered in the environment of postgraduate resident assessment.

Paraduodenal pancreatitis as an uncommon cause of gastric outlet obstruction: A case report and review of the literature.

INTRODUCTION: Paraduodenal pancreatitis (PP) is an under-recognized form of focal chronic or recurrent pancreatitis. Since PP presents with non-specific symptoms and shares radiological and histopathological features with other entities, it can be challenging to diagnose. PRESENTATION OF CASE REPORT: Herein, a case of a 64 year-old Caucasian male with PP presenting with recurrent gastric outlet obstruction (GOO) is detailed. Over the course of two years, he underwent multiple balloon dilatations for symptom management. His diagnostic course was complicated by inconclusive and misleading biopsies. CONCLUSION: PP can rarely present as GOO in otherwise asymptomatic patients. A preoperative pathologic diagnosis can be difficult to obtain, and in this case delayed definitive surgical management. The case is discussed in detail, and a concise review the current literature was undertaken.

Safety and feasibility of phlebotomy with controlled hypovolemia to minimize blood loss in liver resections.

BACKGROUND: Liver resection can be associated with significant blood loss and transfusion. Whole blood phlebotomy is an under-reported technique, distinct from acute normovolemic hemodilution, the goal of which is to minimize blood loss in liver operation. This work sought to report on its safety and feasibility and to describe technical considerations. METHODS: Consecutive patients who had an elective liver resection and concurrent phlebotomy between 2013 and 2016 were examined prospectively. Formal Inclusion and exclusion criteria were defined a priori. All surgical indications were allowed. All procedures were carried out with a stated goal of low central venous pressure anesthesia (<5 cm H2O). The target phlebotomy volume was 7-10 mL/kg of patient body weight. The removed blood was not replaced by intravenous fluid. Removed blood was returned back to the patient after parenchymal transection. Safety end points were examined. A historic cohort (2010-2014) of major resections was included for comparison. RESULTS: A total of 37 patients underwent liver resection with phlebotomy (86% major) and 101 without. Half had metastatic colorectal cancer. The median phlebotomy volume was 7.2 mg/kg (4.7-10.2), yielding a median drop in central venous pressure of 3 cm H2O (0-15). Median blood loss was 400 vs 700 mL (P = .0016), and the perioperative transfusion rate was 8.1% vs 32% (P = .0048). There was no difference between the 2 groups in overall complications, mortality, intensive care admission, duration of stay, or end-organ ischemic complications. CONCLUSION: Whole blood phlebotomy with controlled hypovolemia prior to liver resection seems to be safe and feasible. Comparative studies are required to determine its effectiveness.

Role of fine-needle aspiration in the surgical management of pancreatic neuroendocrine tumors: utility and limitations in light of the new World Health Organization classification.

CONTEXT: Pancreatic neuroendocrine tumors (Panc-NETs) are rare and tend to get overshadowed by their more prevalent and aggressive ductal adenocarcinoma counterparts. The biological behavior of PancNETs is unpredictable, and thus management is controversial. However, the new World Health Organization classification has significantly contributed to the prognostic stratification of these patients. Concurrently, there have been advances in surgical techniques for benign or low-grade pancreatic tumors. These procedures include minimally invasive and parenchyma-sparing operations such as laparoscopy and enucleation. OBJECTIVE: To report on the utility and limitations of fine-needle aspiration in the preoperative evaluation and management of PancNETs. DESIGN: This was a retrospective review of our institutional tumor database from 2002 to 2012. There were 25 cases of PancNETs that were localized and staged by medical imaging and diagnosed by fine-needle aspiration. RESULTS: Fourteen patients underwent laparotomy, with some requiring only limited surgery; 4 had laparoscopic resections; 4 were serially observed without surgical intervention; and another 3 were inoperable. After a mean follow-up of 37 months, more than half of the patients had no evidence of disease, including most of those who underwent minimally invasive surgery. CONCLUSIONS: Fine-needle aspiration is a useful diagnostic adjunct to medical imaging in the preoperative evaluation and management of PancNETs. However, there are limitations with regard to grading PancNETs using this technique.

Technique for salvage ERCP with gastric bypass anatomy and severe intra-abdominal adhesions.

BACKGROUND: Choledocholithiasis is a complex problem in patients with Roux-en-Y gastric bypass anatomy. Several techniques of biliary clearance have been described, but these can be limited by intra-abdominal adhesions. PATIENT AND METHODS: A 36-French surgical gastrostomy was created and was allowed to mature for 10 weeks. It was exchanged for a 15-mm laparoscopic surgery trocar under fluoroscopic guidance. Endoscopic retrograde cholangiopancreatography (ERCP) was carried out using the trocar as a stable access point. Complete biliary clearance was achieved in one sitting using sphincterotomy, large-diameter biliary orifice balloon dilation, and balloon/basket sweeps. RESULTS: Total endoscopy time was 120 minutes. There were no complications associated with the procedure. The postprocedure length of stay was 2 days. The total bilirubin level at discharge was 1.2 mg/dL (20 µmol/L). CONCLUSIONS: In patients with gastric bypass anatomy and severe adhesions, successful salvage therapeutic ERCP can be achieved using a gastrostomy tract and a large-bore laparoscopy trocar for access to the defunctioned stomach.

Comparison of CT duodeno-cholangiopancreatography to ERCP for assessing biliary obstruction.

The authors have developed a CT protocol, CT duodeno-cholangiopancreatography (CDCP), which is performed during a single contrast-enhanced phase, proceeding cranially, allowing enhancement of the pancreas during its parenchymal phase followed by enhancement of the liver during its portal-venous phase. This retrospective pilot study evaluates CDCP compared with endoscopic retrograde cholangiopancreatography (ERCP) as a diagnostic tool for assessing the cause and level of biliary obstruction. Forty-one patients with jaundice underwent CDCP and ERCP between October 2002 and May 2004. Pathologic confirmation was obtained in 31 of the 41 (76%) patients. The sensitivity, specificity, and kappa values of CDCP and ERCP compared with pathology were calculated for tumors and stones. Pathology-proven cases included 7 cases of stones, 23 tumors, and 1 other cause of obstruction. The overall level of agreement of diagnoses between CDCP and pathology was 29 of 31 (93.5%); that between CDCP and ERCP was 36 of 41 (88%). Comparing CDCP to pathology for tumors, the sensitivity was 100%, the specificity was 89%, and the kappa was 0.92 (95% CI 0.76-1.0). For stone detection, CDCP had a sensitivity of 86%, a specificity of 100%, and a kappa value of 0.90 (95% CI 0.72-1.0). For level of obstruction of the common bile duct, comparing CDCP to ERCP, observations agreed in 31 of the 36 (86%) cases; for the pancreatic duct, observations agreed in 24 of the 25 (96%) cases. CDCP is a noninvasive diagnostic tool that can be used to assess the cause and level of obstruction. A blinded prospective study would be valuable to further assess the merits of CDCP.