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Importance: Tranexamic acid reduces bleeding and blood transfusion in many types of surgery, but its effect in patients undergoing liver resection for a cancer-related indication remains unclear. Objective: To determine whether tranexamic acid reduces red blood cell transfusion within 7 days of liver resection. Design, Setting, and Participants: Multicenter randomized clinical trial of tranexamic acid vs placebo conducted from December 1, 2014, to November 8, 2022, at 10 hepatopancreaticobiliary sites in Canada and 1 site in the United States, with 90-day follow-up. Participants, clinicians, and data collectors were blinded to allocation. A volunteer sample of 1384 patients undergoing liver resection for a cancer-related indication met eligibility criteria and consented to randomization. Interventions: Tranexamic acid (1-g bolus followed by 1-g infusion over 8 hours; n = 619) or matching placebo (n = 626) beginning at induction of anesthesia. Main Outcomes and Measures: The primary outcome was receipt of red blood cell transfusion within 7 days of surgery. Results: The primary analysis included 1245 participants (mean age, 63.2 years; 39.8% female; 56.1% with a diagnosis of colorectal liver metastases). Perioperative characteristics were similar between groups. Red blood cell transfusion occurred in 16.3% of participants (n = 101) in the tranexamic acid group and 14.5% (n = 91) in the placebo group (odds ratio, 1.15 [95% CI, 0.84-1.56]; P = .38; absolute difference, 2% [95% CI, -2% to 6%]). Measured intraoperative blood loss (tranexamic acid, 817.3 mL; placebo, 836.7 mL; P = .75) and total estimated blood loss over 7 days (tranexamic acid, 1504.0 mL; placebo, 1551.2 mL; P = .38) were similar between groups. Participants receiving tranexamic acid experienced significantly more complications compared with placebo (odds ratio, 1.28 [95% CI, 1.02-1.60]; P = .03), with no significant difference in venous thromboembolism (odds ratio, 1.68 [95% CI, 0.95-3.07]; P = .08). Conclusions and Relevance: Among patients undergoing liver resection for a cancer-related indication, tranexamic acid did not reduce bleeding or blood transfusion but increased perioperative complications. Trial Registration: ClinicalTrials.gov Identifier: NCT02261415.
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Background: Those with cirrhosis who require emergency colorectal surgery are at risk for poor outcomes. Although risk predictions models exists, these tools are not specific to colorectal surgery, nor were they developed in a contemporary setting. Thus, the objective of this study was to assess the outcomes in this population and determine whether cirrhosis etiology and/or the Model for End Stage Liver Disease (MELD-Na) is associated with mortality. Methods: This population-based study included those with cirrhosis undergoing emergent colorectal surgery between 2009 and 2017. All eligible individuals in Ontario were identified using administrative databases. The primary outcome was 90-day mortality. Results: Nine hundred and twenty-seven individuals (57%) (male) were included. The most common cirrhosis etiology was non-alcoholic fatty liver disease (NAFLD) (50%) and alcohol related (32%). Overall 90-day mortality was 32%. Multivariable survival analysis demonstrated those with alcohol-related disease were at increased risk of 90-day mortality (hazards ratio [HR] 1.53, 95% confidence interval [CI] 1.2-2.0 vs. NAFLD [ref]). Surgery for colorectal cancer was associated with better survival (HR 0.27, 95%CI 0.16-0.47). In the subgroup analysis of those with an available MELD-Na score (n = 348/927, 38%), there was a strong association between increasing MELD-Na and mortality (score 20+ HR 6.6, 95%CI 3.9-10.9; score 10-19 HR 1.8, 95%CI 1.1-3.0; score <10 [ref]). Conclusion: Individuals with cirrhosis who require emergent colorectal surgery have a high risk of postoperative complications, including mortality. Increasing MELD-Na score is associated with mortality and can be used to risk stratify individuals.
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BACKGROUND: Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting. METHODS: We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants' satisfaction with the consent discussion. RESULTS: We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen's d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen's effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen's effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants' self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149). CONCLUSION: The addition of digital education platform to standard verbal consent significantly improves patient's early and delayed understanding of risks and benefits of LC in an acute care setting.
Subject(s)
Cholecystectomy, Laparoscopic , Informed Consent , Patient Education as Topic , Humans , Female , Cholecystectomy, Laparoscopic/education , Male , Middle Aged , Prospective Studies , Patient Education as Topic/methods , Adult , Aged , Patient Satisfaction , Surveys and QuestionnairesABSTRACT
Those with cirrhosis who develop colorectal cancer (CRC) are an understudied group who may tolerate treatments poorly and are at risk of worse outcomes. This is a retrospective cohort study of 842 individuals from Ontario, Canada, with a pre-existing diagnosis of cirrhosis who underwent surgery for CRC between 2009 and 2017. Practice patterns, overall survival, and short-term morbidity and mortality were assessed. The most common cirrhosis etiology was non-alcoholic fatty liver disease (NAFLD) (52%) and alcohol-associated liver disease (29%). The model for end-stage liver disease score (MELD-Na) was available in 42% (median score of 9, IQR7-11). Preoperative radiation was used in 62% of Stage II/III rectal cancer patients, while postoperative chemotherapy was used in 42% of Stage III colon cancer patients and 38% of Stage II/III rectal cancer patients. Ninety-day mortality following surgery was 12%. Five-year overall survival was 53% (by Stages I-IV, 66%, 55%, 50%, and 11%, respectively). Those with alcohol-associated cirrhosis (HR 1.8, 95% CI 1.5-2.2) had lower survival than those with NAFLD. Those with a MELD-Na of 10+ did worse than those with a lower MELD-Na score (HR 1.9, 95% CI 1.4-2.6). This study reports poor survival in those with cirrhosis who undergo treatment for CRC. Caution should be taken when considering aggressive treatment.
Subject(s)
Colonic Neoplasms , End Stage Liver Disease , Non-alcoholic Fatty Liver Disease , Rectal Neoplasms , Humans , End Stage Liver Disease/complications , Retrospective Studies , Non-alcoholic Fatty Liver Disease/complications , Severity of Illness Index , Liver Cirrhosis/complications , Liver Cirrhosis/surgery , Ontario/epidemiologyABSTRACT
INTRODUCTION: Liver resection patients may be at an increased risk of local anesthetic (LA) toxicity because the liver is essential for metabolizing LA and producing proteins (mainly α1-acid glycoprotein (AAG)) that bind to it and reduce the free (and pharmacologically active/toxic) levels in circulation. The liver resection itself, manipulation during surgery, and pre-existing liver disease may all interfere with normal hepatic protein synthesis and result in an attenuation of the increased AAG (a positive acute-phase protein) that normally occurs postoperatively. The purpose of this study was to determine whether the AAG response is attenuated postoperatively following liver resection and whether patients approach toxicity thresholds with continuous postoperative epidural infusion of bupivacaine. METHODS: Prospective, observational study with blood drawn preoperatively, in the postanesthetic care unit, on postoperative day (POD) 2, and prior to discontinuation of epidural analgesia on POD3/POD4. Plasma was analyzed for total and unbound bupivacaine via liquid chromatography-mass spectrometry and AAG via ELISA. Signs/symptoms of local anesthetic systemic toxicity (LAST), pain, and sedation scores were also recorded. RESULTS: For the 19 patients completed, total plasma bupivacaine was correlated with total administered, but unbound levels were not associated with the total administered. Unlike non-hepatectomy surgery where unbound LA plasma levels remain stable (or decrease) with continuous postoperative epidural administration, we observed an overall increase. Several patients approached toxicity thresholds and 47% reported at least one symptom of LAST, but no epidurals were discontinued because of LAST. In contrast to the AAG response reported following major non-liver surgery where AAG levels increase twofold, we observed a reduction until POD2 and the magnitude was proportional to resection weight. DISCUSSION: Our results are supported by the literature in suggesting that major liver resection patients may be at an increased vulnerability for LAST. Factors such as the extent of liver disease, resection and intraoperative blood loss should be considered when using continuous postoperative epidural infusion of bupivacaine and vigilance should be used in monitoring, for signs/symptoms of LAST, even for those subtle and non-specific. Future research will be required to verify these findings. TRIAL REGISTRATION NUMBER: NCT03145805.
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BACKGROUND: Abdominal surgery and chemotherapy are well-established risk factors for venous thromboembolism (VTE) in patients with cancer, but their specific contribution in patients with esophageal and gastric cancer is unclear. We aim to quantify the risk of VTE, identify risk factors associated with VTE, and determine the association between VTE and survival in patients undergoing surgery for esophageal or gastric cancer. METHODS: A retrospective, population-based cohort study was conducted using linked administrative healthcare databases. We used the Ontario Cancer Registry to identify patients with esophageal or gastric cancer between January 1, 2007 and December 31, 2016 who underwent surgical resection. Incidence of first VTE event was identified using International Classification of Diseases 9 and 10 codes. VTE incidence was calculated at clinically relevant time points 180 days before and after surgery. Logistic regression was used to identify factors associated with VTE with odds ratios (OR) and 95% confidence intervals (CI) reported. Cox proportional hazards regression models were used to estimate associations between covariates and survival. Kaplan-Meier method was used to compare overall (OS) and cancer-specific survival (CSS) by VTE status. RESULTS: A total of 4894 patients had esophagectomy or gastrectomy, of which 8% (n = 383/4894) had VTE. VTE risk was 2.5% (n = 123/4894) 180 days before surgery, 2.8% (n = 138/4894) within 30 days of surgery, and 2.5% (n = 122/4894) from 31 to ≤ 180 days after surgery. Of the patients with VTE within 30 days of surgery, 34% (n = 47/138) were diagnosed after discharge from hospital. Receipt of preoperative chemotherapy was associated with VTE 180 days before surgery (odds ratio [OR] 3.84, 95% confidence interval [CI] 2.41, 6.11). Increased hospital length of stay (LOS) was associated with VTE 30 days after surgery (OR 1.08, 95% CI 1.02, 1.14, per week). Patients with VTE had inferior median OS and CSS (2.2 vs. 3.7 years; 2.3 vs. 4.4 years, respectively). In adjusted models VTE was associated with inferior OS (HR 1.36, 95% CI 1.13, 1.63) and CSS (HR 1.42, 95% CI 1.16, 1.75). CONCLUSIONS: The highest risk of VTE is within 30 days of surgery with one third of patients diagnosed after discharge from hospital. Longer hospital LOS and receipt of preoperative chemotherapy are associated with increased risk of VTE. VTE is an independent risk factor for inferior survival in patients with esophageal or gastric cancer.
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INTRODUCTION: Despite use of operative and non-operative interventions to reduce blood loss during liver resection, 20%-40% of patients receive a perioperative blood transfusion. Extensive intraoperative blood loss is a major risk factor for postoperative morbidity and mortality and receipt of blood transfusion is associated with serious risks including an association with long-term cancer recurrence and overall survival. In addition, blood products are scarce and associated with appreciable expense; decreasing blood transfusion requirements would therefore have health system benefits. Tranexamic acid (TXA), an antifibrinolytic, has been shown to reduce the probability of receiving a blood transfusion by one-third for patients undergoing cardiac or orthopaedic surgery. However, its applicability in liver resection has not been widely researched. METHODS AND ANALYSIS: This protocol describes a prospective, blinded, randomised controlled trial being conducted at 10 sites in Canada and 1 in the USA. 1230 eligible and consenting participants will be randomised to one of two parallel groups: experimental (2 g of intravenous TXA) or placebo (saline) administered intraoperatively. The primary endpoint is receipt of blood transfusion within 7 days of surgery. Secondary outcomes include blood loss, postoperative complications, quality of life and 5-year disease-free and overall survival. ETHICS AND DISSEMINATION: This trial has been approved by the research ethics boards at participating centres and Health Canada (parent control number 177992) and is currently enrolling participants. All participants will provide written informed consent. Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT02261415.
Subject(s)
Antifibrinolytic Agents , Tranexamic Acid , Antifibrinolytic Agents/therapeutic use , Blood Loss, Surgical/prevention & control , Blood Transfusion , Humans , Liver , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic , Tranexamic Acid/therapeutic useABSTRACT
BACKGROUND: The extent of resection required in advanced gallbladder cancer is controversial. We aimed to describe the management and outcomes in patients with resected stage T2 and T3 gallbladder cancer. METHODS: In this population-based study, all T2 and T3 gallbladder cancer cases from Jan. 1, 2002, to Mar. 31, 2012, were identified from the Ontario Cancer Registry; pathology reports were linked and abstracted. The type of resection was classified as extended (cholecystectomy + liver resection, with or without bile duct resection) or simple (cholecystectomy only). We used Kaplan-Meier survival analysis to model time to death and evaluated factors associated with overall survival using the Cox proportional hazards regression model. RESULTS: A total of 370 patients were included, 232 with T2 disease and 138 with T3 disease. The proportions who underwent extended resection were 24.1% (56/232) and 37.0% (51/138), respectively. The unadjusted 5-year overall survival rates for simple and extended resection were 39.7% and 49.5%, respectively, for T2 disease (p = 0.03), and 13.5% and 22.8%, respectively, for T3 disease (p = 0.05). In adjusted analysis, extended resection significantly improved overall survival among patients with T2 disease (hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.30-0.97), whereas higher grade of differentiation, presence of lymphovascular invasion and positive lymph nodes led to worse survival. Extended resection was not associated with improved survival in the T3 group; however, in subgroup analysis stratified by lymph node status, a trend toward improved overall survival with extended resection was seen in node-negative patients (HR 0.20, 95% CI 0.03-1.06). CONCLUSION: Extended resection improved overall survival in T2 disease regardless of nodal status but appeared most beneficial in node-negative T3 disease. The finding that extended resection was offered only to a small proportion of eligible patients highlights the need for improved knowledge translation at national surgical meetings.
Subject(s)
Cholecystectomy/statistics & numerical data , Gallbladder Neoplasms/pathology , Gallbladder Neoplasms/surgery , Hepatectomy/statistics & numerical data , Outcome and Process Assessment, Health Care/statistics & numerical data , Registries , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Neoplasm Staging , Ontario , Proportional Hazards Models , Retrospective Studies , Young AdultABSTRACT
BACKGROUND: Appropriate patient selection for liver resection in hepatocellular carcinoma (HCC) is critical to mitigation of major liver-related postoperative complications. Currently, no standard prognostic tool exists to predict the risk of postoperative liver decompensation events (POLDEs) after partial hepatectomy for patients with cirrhosis and HCC. This study aimed to identify independent preoperative predictors of POLDEs for future development of prognostic tools to improve surgical decision-making. METHODS: This population-based, retrospective cohort study investigated patients with cirrhosis and incident HCC between 2007 and 2017, identified using administrative health data from Ontario, Canada. The occurrence of a POLDE or death within 2 years after surgery was described. Multivariable Cox regression identified independent predictors of POLDE-free survival, as well as cause-specific hazards for POLDEs and death. RESULTS: Among 611 patients with cirrhosis and HCC who underwent liver resection, 160 (26.2%) experienced at least one POLDE, and 189 (30.9%) died within 2 years after surgery. Diabetes, cirrhosis etiology, major liver resection, and previous non-malignant decompensation were independent predictors of POLDE-free survival. Except for extent of resection, the same risk factors were associated with POLDEs in the cause-specific analysis. In contrast, only age and history of previous non-malignant decompensation were independent predictors of mortality. CONCLUSIONS: Among patients with cirrhosis undergoing resection for HCC, patient and disease-related factors are associated with POLDEs and POLDE-free survival. These factors can be used both to inform clinical practice and to advance the development of preoperative prognostic tools, which may lead to improved outcomes for this population.
Subject(s)
Carcinoma, Hepatocellular , Liver Neoplasms , Carcinoma, Hepatocellular/surgery , Humans , Liver Cirrhosis/complications , Liver Neoplasms/surgery , Ontario/epidemiology , Retrospective StudiesABSTRACT
BACKGROUND: Incidence of venous thromboembolism (VTE) following hepatectomy for colorectal cancer (CRC) metastases is unclear. These patients may represent a vulnerable population due to increased tumour burden. We aim to identify the risk of VTE development in routine clinical practice among patients with resected CRC liver metastases, the associated risk factors, and its impact on survival. METHODS: We conducted a population-based retrospective cohort study of Ontario patients undergoing hepatectomy for CRC metastases between 2002 and 2009 using linked universal healthcare databases. Multivariable logistic regression was used to estimate the association between patient characteristics and VTE risk at 30 and 90-days after surgery. Cox proportional-hazards regression was used to estimate the association between VTE and adjusted cancer specific (CSS) and overall survival (OS). RESULTS: 1310 patients were included with a mean age of 63 ± 11. 62% were male. 51% had one metastatic deposit. Major hepatectomy occurred in 64%. VTE occurred in 4% within 90 days of liver resection. Only longer length of stay was associated with VTE development (OR 6.88 (2.57-18.43), p <0.001 for 15-21 days versus 0-7 days). 38% of VTEs were diagnosed after discharge, comprising 1.52% of the total cohort. VTE was not associated with inferior CSS or OS. CONCLUSIONS: Risk of VTE development in this population is similar to those undergoing hepatectomy for other indications, and to the risk following other cancer site resections where post-operative extended VTE prophylaxis is currently recommended. The number of VTEs occurring after discharge suggests there may be a role for extended VTE prophylaxis.
Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Venous Thromboembolism , Aged , Cohort Studies , Colorectal Neoplasms/surgery , Hepatectomy/adverse effects , Humans , Incidence , Liver Neoplasms/surgery , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiologyABSTRACT
BACKGROUND: Post-operative pancreatic fistula (POPF) is the most significant cause of morbidity following distal pancreatectomy. Hemopatch™ is a thin, bovine collagen-based hemostatic sealant. We hypothesized that application of Hemopatch™ to the pancreatic stump following distal pancreatectomy would decrease the incidence of clinically-significant POPF. METHODS: We conducted a prospective, single-arm, multicentre phase II study of application of Hemopatch™ to the pancreatic stump following distal pancreatectomy. The primary outcome was clinically-significant POPF within 90 days of surgery. A sample size of 52 patients was required to demonstrate a 50% relative reduction in Grade B/C POPF from a baseline incidence of 20%, with a type I error of 0.2 and power of 0.75. Secondary outcomes included incidence of POPF (all grades), 90-day mortality, 90-day morbidity, re-interventions, and length of stay. RESULTS: Adequate fixation Hemopatch™ to the pancreatic stump was successful in all cases. The rate of grade B/C POPF was 25% (95%CI: 14.0-39.0%). There was no significant difference in the incidence of grade B/C POPF compared to the historical baseline (p = 0.46). The 90-day incidence of Clavien-Dindo grade ≥3 complications was 26.9% (95%CI: 15.6-41.0%). CONCLUSION: The use of Hemopatch™ was not associated with a decreased incidence of clinically-significant POPF compared to historical rates. (NCT03410914).
Subject(s)
Pancreatectomy , Pancreatic Fistula , Animals , Cattle , Humans , Pancreas , Pancreatectomy/adverse effects , Pancreatic Fistula/epidemiology , Pancreatic Fistula/etiology , Pancreatic Fistula/prevention & control , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Prospective Studies , Retrospective StudiesABSTRACT
Summary: Competency-based education (CBE) is currently being implemented by the Royal College of Physicians and Surgeons of Canada across all residency programs. This shift away from time-based residency is proposed to be the answer to maximize training opportunity in the era of work hour restrictions and growing concerns regarding accountability in medical education. A Web-based survey was conducted to obtain feedback from Canadian general surgery residents on their experience and perception of competence within core procedures, as well as attitudes toward CBE. A total of 244 residents completed the survey. For most procedures, more than 50% of residents felt they could perform the procedure with no guidance after completing 11-30 cases. Generally, residents were welcoming of CBE; however, medium-sized programs reported some concerns regarding inadequate exposure to cases and risk of training less well-rounded surgeons. This is valuable resident feedback for programs to consider during the implementation process.
Subject(s)
Competency-Based Education , Internship and Residency , Surgeons , Surgical Procedures, Operative , Attitude of Health Personnel , Canada , Health Care Surveys , HumansABSTRACT
BACKGROUND: Few reports have evaluated prognostic modelling studies of tools used for surgical decision-making. This systematic review aimed to describe and critically appraise studies that have developed or validated multivariable prognostic models for post-operative liver decompensation following partial hepatectomy. METHODS: This study was designed using the CHARMS checklist. Following a comprehensive literature search, two reviewers independently screened candidate references for inclusion and abstracted relevant study details. Qualitative assessment was performed using the PROBAST tool. RESULTS: We identified 36 prognostic modelling studies; 25 focused on development only, 3 developed and validated models, and 8 validated pre-existing models. None compared routine use of a prognostic model against standard clinical practice. Most studies used single-institution, retrospective cohort designs, conducted in Eastern populations. In total, 15 different outcome definitions for post-operative liver decompensation events were used. Statistical concerns surrounding model overfitting, performance assessment, and internal validation led to high risk of bias for all studies. CONCLUSIONS: Current prognostic models for post-operative liver decompensation following partial hepatectomy may not be valid for routine clinical use due to design and methodologic concerns. Landmark resources and reporting guidelines such as the TRIPOD statement may assist researchers, and additionally, model impact assessment studies represent opportunities for future research.
Subject(s)
Hepatectomy , Liver , Bias , Hepatectomy/adverse effects , Humans , Prognosis , Retrospective StudiesABSTRACT
Background: Research on informed consent (IC) has traditionally focused on the documentation of the discussion with patients of potential complications. We sought to examine the completeness of documentation for all elements of IC for laparoscopic cholecystectomy (LC): potential complications, alternatives to LC and details of the procedure. Differences in the documentation of IC for elective and emergent LC were examined. Methods: A retrospective chart review of patients undergoing LC at our institution between 2015 and 2017 was performed. Completeness of documentation was defined as documentation of all 3 elements of IC in the clinic note, the operating room note or the consent form itself. Data were analyzed descriptively. We compared documention for emergent and elective cases as well as documentation by residents and attending physicians using t tests. Results: A total of 270 patients were included in the analysis. Only 5 (2%) had complete documentation of all elements of IC. Documentation of potential complications was noted in 232 cases (86%), of which 58 (25%) were elective and 174 (75%) were emergent. Details were noted in 28 (10%) cases, of which 21 (75%) were elective and 7 (25%) were emergent. Alternatives were documented the least frequently: they were documented in 23 cases (9%), of which 20 (87%) were elective and 3 (13%) were emergent. Residents performed better than attending physicians in documenting IC discussions in clinic notes and on consent forms, but not in operating room notes. Conclusion: Documentation of the elements of IC for LC was poor. Potential complications were the most frequently documented element of IC; alternatives and details were often omitted. Future studies comparing audiotaped IC conversations with the documentation of IC are warranted. The use of procedure-specific consent forms for LC may facilitate documentation.
Contexte: La recherche sur le consentement éclairé (CÉ) s'est longtemps intéressée surtout à la consignation du contenu des discussions avec les patients au sujet des complications potentielles. Nous avons voulu examiner l'exhaustivité de la consignation de tous les éléments du CÉ pour la cholécystectomie laparoscopique (CL) : complications potentielles, solutions de rechange à la CL et détails de l'intervention. Nous avons observé des différences dans la consignation des éléments du CÉ pour la CL urgente et non urgente. Méthodes: Nous avons procédé à un examen rétrospectif des dossiers de patients soumis à une CL dans notre établissement entre 2015 et 2017. La consignation au dossier était jugée complète lorsque les 3 éléments du CÉ étaient présents dans la note clinique, la note opératoire ou le formulaire de consentement lui-même. Nous avons effectué une analyse descriptive des données, et nous avons comparé la consignation des éléments pour les cas urgents et non urgents, effectuée par les résidents et les médecins traitants au moyen de tests t. Résultats: Au total, 270 patients ont été inclus dans l'analyse. Tous les éléments du CÉ étaient adéquatement consignés pour seulement 5 (2 %) d'entre eux. Les complications potentielles ont été consignées dans 232 cas (86 %), dont 58 (25 %) étaient non urgents et 174 (75 %) étaient urgents. Les détails de l'intervention ont été notés dans 28 cas (10 %), dont 21 (75 %) étaient non urgents et 7 (25 %) étaient urgents. Ce sont les solutions de rechange qui ont été le moins souvent consignées : elles ont été notées dans 23 cas (9 %), dont 20 (87 %) étaient non urgents et 3 (13 %) étaient urgents. Les résidents ont mieux fait que les médecins traitants pour ce qui est de consigner les discussions sur le CÉ dans les notes cliniques et les formulaires de CÉ, mais non dans les notes opératoires. Conclusion: La consignation des éléments du CÉ pour la CL a été faible. Les complications potentielles ont été l'élément du CÉ le plus souvent consigné au dossier; les solutions de rechange et les détails de l'intervention ont souvent été omis. Il faudra procéder à d'autres études pour comparer le contenu des discussions sur le CÉ enregistrées sur bande audio et sa consignation. L'utilisation de formulaires de CÉ spécifiques aux interventions pourrait faciliter la consignation de leurs éléments.
Subject(s)
Cholecystectomy, Laparoscopic , Documentation/statistics & numerical data , Informed Consent , Academic Medical Centers , Consent Forms , Female , Humans , Internship and Residency , Male , Medical Staff, Hospital , Middle Aged , Postoperative Complications , Retrospective StudiesABSTRACT
PURPOSE: Clinical trials have shown that palliative chemotherapy (PC) improves survival in patients with incurable esophageal and gastric cancer; however, outcomes achieved in routine practice are unknown. We describe treatment patterns and outcomes among patients treated in the general population of Ontario, Canada. METHODS: The Ontario Cancer Registry was used to identify patients with esophageal or gastric cancer from 2007 to 2016, and data were linked to other health administrative databases. Patients who received curative-intent surgery or radiotherapy were excluded. Factors associated with the receipt of PC were determined using logistic regression. First-line PC regimens were categorized, and trends over time were reported. Survival was determined using the Kaplan-Meier method. RESULTS: The cohort included 9,848 patients; 22% (2,207 of 9,848) received PC. Patients receiving PC were younger (mean age, 63 v 74 years; P < .0001) and more likely male (71% v 65%; P < .0001). Thirty-seven percent of non-PC patients saw a medical oncologist in consultation. Over the study period, utilization of PC increased (from 11% in 2007 to 19% in 2016; P < .0001), whereas the proportion of patients receiving triplet regimens decreased (65% in 2007 to 56% in 2016; P = .04). In the PC group, the median overall and cancer-specific survival from treatment initiation was 7.2 months. CONCLUSION: One fifth of patients with incurable esophageal and gastric cancer in the general population receive PC. Median survival of patients treated in routine practice is inferior to that in clinical trials. Only one third of patients not treated with PC had consultation with a medical oncologist. Further work is necessary to understand low utilization of PC and medical oncology consultation in this patient population.
Subject(s)
Esophageal Neoplasms , Stomach Neoplasms , Aged , Antineoplastic Combined Chemotherapy Protocols , Esophageal Neoplasms/drug therapy , Female , Humans , Male , Middle Aged , Ontario/epidemiology , Palliative Care , Stomach Neoplasms/drug therapyABSTRACT
BACKGROUND: Prior work has shown associations between blood transfusion (BT) and inferior outcomes during resection for colorectal cancer liver metastases (CRLM). Herein, we describe short and long-term outcomes relating to perioperative BT in routine clinical practice. METHODS: All CRLM resections in Ontario, Canada from 2002 to 2009 were identified using the Ontario Cancer Registry. Log-binomial regression and Cox regression were used to explore factors associated with receipt of BT and the association of BT with 5-year cancer specific (CSS) and overall survival (OS), respectively. RESULTS: The study included 1310 patients; 31% (403/1310) had perioperative BT. Transfused patients had longer median length of stay (9 vs. 7 days, p < 0.001), higher 90-day mortality (9% vs. 1%, p < 0.001), greater 90-day readmission (28% vs. 16%, p < 0.001), and inferior 5-year CSS (41% vs. 48%, p = <0.001) and OS (38% vs. 47%, p < 0.001). Transfusion was independently associated with inferior CSS (HR = 1.35, 95% CI: 1.11-1.63) and OS (HR = 1.30, 95% CI: 1.10-1.53), however, excluding 90-day postoperative deaths showed these associations were no longer significant. CONCLUSION: Perioperative BT is common in patients undergoing resection of CRLM. While transfusion is associated with greater morbidity, mortality, and inferior survival, after excluding early postoperative deaths, BT does not appear to be independently associated with CSS or OS.
Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Blood Transfusion , Hepatectomy/adverse effects , Humans , Liver Neoplasms/surgery , Ontario , Retrospective Studies , Survival RateABSTRACT
BACKGROUND: There is an elevated risk of venous thromboembolism in patients treated for colon cancer. Postoperative venous thromboembolism has been studied previously, but no large study has compared the risks during different stages of treatment. OBJECTIVE: This study aimed to quantify and compare the risks of venous thromboembolism before surgery, after surgery, during adjuvant chemotherapy, and up to 365 days after surgery among patients with resected colon cancer. DESIGN: This is a population-based retrospective cohort study. SETTING: This study was conducted in a single-payer, universal health care setting (Ontario) between 2002 and 2008. PATIENTS: A total of 6806 patients with stage I to III colon cancer treated with surgical resection were included. INTERVENTIONS: Phases of treatment were evaluated, including preoperative, in-hospital, postoperative, during adjuvant chemotherapy, and 365 days postoperatively. MAIN OUTCOME MEASURES: Venous thromboembolism, as defined using diagnostic codes from administrative data sources, was the primary outcome measured. RESULTS: Of the 6806 patients included, 327 (5%) developed venous thromboembolism. Patients receiving adjuvant chemotherapy had a higher risk versus surgery-alone patients (6% vs 4%, p < 0.001). Of the 327 who developed venous thromboembolism, 32% (1.6% overall) were diagnosed during hospital admission and 13.5% (0.6% overall) were diagnosed between discharge and 30 days after surgery. The majority of venous thromboembolisms diagnosed in patients receiving adjuvant chemotherapy (53%, 3.1% of all patients receiving adjuvant chemotherapy) were diagnosed within 180 days of starting adjuvant chemotherapy. Venous thromboembolism was an independent risk factor for worse 5-year overall survival (HR, 1.65; 95% CI, 1.43-1.91; p < 0.001). LIMITATIONS: This study was limited by the potential for misclassification of venous thromboembolism and unknown compliance with prophylaxis recommendations. CONCLUSION: Patients who undergo treatment for stage I to III colon cancer are at considerable risk of developing venous thromboembolism. The risk is elevated in those who require adjuvant chemotherapy, and venous thromboembolism is associated with worse long-term outcomes. There may be a role of venous thromboembolism prophylaxis during all phases of treatment, including both after surgery and during adjuvant chemotherapy. See Video Abstract at http://links.lww.com/DCR/B123. UN ESTUDIO DE COHORTE POBLACIONAL DE LAS TASAS DE TROMBOEMBOLISMO VENOSO DESPUÉS DE CIRUGÍA Y DURANTE QUIMIOTERAPIA ADYUVANTE EN PACIENTES CON CÁNCER DE COLON: Existe un riesgo elevado de tromboembolismo venoso en pacientes tratados por cáncer de colon. El tromboembolismo venoso postoperatorio se ha estudiado previamente, pero ningún estudio grande ha comparado los riesgos durante las diferentes etapas del tratamiento.Cuantificar y comparar los riesgos de tromboembolismo venoso antes de la cirugía, después de la cirugía, durante quimioterapia adyuvante y hasta 365 días después de cirugía en pacientes con cáncer de colon resecado.Estudio retrospectivo de cohorte poblacional.Escenario de atención médica universal con pagador único (Ontario) entre 2002-2008.6,806 pacientes con cáncer de colon en estadio I-III tratados con resección quirúrgica.Fase de tratamiento, incluyendo preoperatorio, hospitalización, postoperatorio, durante quimioterapia adyuvante y 365 días después de la operación.Tromboembolismo venoso, tal como se define utilizando códigos de diagnóstico de fuentes de datos administrativos.Se incluyeron 6,806 pacientes, con 327 (5%) que desarrollaron tromboembolismo venoso. Los pacientes que recibieron quimioterapia adyuvante tuvieron un mayor riesgo en comparación con los pacientes con cirugía solamente (6% vs 4%, p <0.001). De los 327 que desarrollaron tromboembolismo venoso, 32% (1.6% en general) fueron diagnosticados durante el ingreso hospitalario y 13.5% (0.6% en general) fueron diagnosticados entre el alta y 30 días después de la cirugía. La mayoría de los tromboembolismos venosos diagnosticados en pacientes que recibieron quimioterapia adyuvante (53%, 3.1% de todos los pacientes con quimioterapia adyuvante) fueron diagnosticados dentro de los 180 días de comenzar la quimioterapia adyuvante. El tromboembolismo venoso fue un factor de riesgo independiente para una peor supervivencia general a 5 años (Hazard Ratio (cociente de riesgo) 1.65, IC 95% 1.43-1.91, p <0.001).Potencial de clasificación errónea del tromboembolismo venoso, cumplimiento desconocido de las recomendaciones de profilaxis.Los pacientes que se someten a tratamiento para el cáncer de colon en estadio I-III tienen un riesgo considerable de desarrollar tromboembolismo venoso. El riesgo es elevado en aquellos que requieren quimioterapia adyuvante y el tromboembolismo venoso se asocia con peores resultados a largo plazo. La profilaxis del tromboembolismo venoso puede desempeñar un papel durante todas las fases del tratamiento, incluyendo tanto el periodo posquirúrgico como durante la quimioterapia adyuvante. Consulte Video Resumen en http://links.lww.com/DCR/B123.
Subject(s)
Chemotherapy, Adjuvant , Colectomy , Colonic Neoplasms/therapy , Postoperative Complications/epidemiology , Venous Thromboembolism/epidemiology , Aged , Colonic Neoplasms/pathology , Female , Humans , Male , Middle Aged , Neoplasm Staging , Ontario/epidemiology , Registries , Retrospective Studies , Risk FactorsABSTRACT
BACKGROUND: There is variation in the clinical management of intestinal obstruction (IO) in patients with cancer. We describe the management of cancer-associated IO near the end of life in a population-based cohort with universal health coverage. METHODS: Patients who died of gastric, colorectal, ovarian, and pancreatic cancers from 2002 to 2015 were identified from the Ontario Cancer Registry. Those with ≥1 hospital admission for IO in the final year of life were identified from administrative data. Management of IO at index admission was categorized as surgery, gastrostomy, stent, feeding jejunostomy, and medical management. Trends in management over the study period were assessed by the Cochran-Armitage test. RESULTS: The cohort included 57 378 patients (gastric [n = 7448, 13%], colorectal [n = 30 577 53%], ovarian [n = 6273, 11%], and pancreatic [n = 13 080, 23%] cancers). Of those, 7618 (13%) patients had ≥1 admission for IO in the final year of life. Of these patients, 2657 (35%) patients were managed with a surgical/procedural intervention at index admission (surgery [86%], gastrostomy [8%], stent [6%], and jejunostomy [0.4%]); the remaining patients (n = 4961, 65%) received medical management. Over the study period, there was a small but statistically significant increase in the use of stents (0% in 2002 to 5% in 2015, P < .0001) and gastrostomy tubes (2% in 2002 to 4% in 2015, P = .002) and a large decrease in the use of surgery (41% in 2002 to 28% in 2015, P = .04). CONCLUSIONS: Management of IO has changed over time with the increased use of stents and gastrostomy tubes and decreased use of surgery.
Subject(s)
Intestinal Obstruction/etiology , Intestinal Obstruction/therapy , Neoplasms/complications , Terminal Care , Aged , Aged, 80 and over , Female , Gastrostomy , Humans , Male , Middle Aged , Ontario , Registries , StentsABSTRACT
INTRODUCTION: The symptom profile in cancer patients and the association between palliative care (PC) and symptoms has not been studied in the general population. We addressed these gaps in gastrointestinal (GI) cancer patients in the final year of life. METHODS: Patients dying of esophageal, gastric, colon, and anorectal cancers during 2003-2015 were identified. Symptom scores were recorded in the year before death using the Edmonton Symptom Assessment System (ESAS), which includes scores from 0 to 10 in nine domains. Symptom severity was categorized as none-mild (≤ 3) or moderate-severe (≥ 4-10). Adjusted associations between outpatient PC and moderate-severe ESAS scores were determined, and the effect of PC initiation on ESAS scores was estimated. RESULTS: The cohort included 11,242 patients who died (esophageal [17%], gastric [20%], colon [38%], and anorectal [26%] cancers). Fifty percent experienced moderate-severe scores in tiredness, lack of well-being, and lack of appetite earlier (weeks 18 to 12 before death), whereas 50% experienced moderate-severe scores in drowsiness, pain, and shortness of breath later (weeks 5 to 2 before death) in the disease course. Outpatient PC was associated with an increased likelihood of moderate-severe scores in all domains, with the highest score in pain (odds ratio [OR] 1.86, 95% confidence interval [CI] 1.68-2.05). In PC-naïve patients with moderate-severe scores, initiation of outpatient PC was associated with a 1- to 3-point decrease in subsequent scores, with the greatest reductions in pain (OR - 1.91, 95% CI - 2.11 to - 1.70) and nausea (OR - 3.01, 95% CI - 3.31 to - 2.71). CONCLUSION: GI cancer patients experience high symptom burden in the final year of life. Outpatient PC initiation is associated with a decrease in symptoms.