Association between Complications and Death within 30 days after General Surgery: A Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) substudy.

OBJECTIVE: To determine the epidemiology of post-operative complications among general surgery patients, inform their relationships with 30-day mortality, and determine the attributable fraction of death of each postoperative complication. BACKGROUND: The contemporary causes of post-operative mortality among general surgery patients are not well characterized. METHODS: VISION is a prospective cohort study of adult non-cardiac surgery patients across 28 centres in 14 countries, who were followed for 30 days after surgery. For the subset of general surgery patients, a cox proportional hazards model was used to determine associations between various surgical complications and post-operative mortality. The analyses were adjusted for preoperative and surgical variables. Results were reported in adjusted hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: Among 7950 patients included in the study, 240 (3.0%) patients died within 30 days of surgery. Five post-operative complications (myocardial injury after non-cardiac surgery [MINS], major bleeding, sepsis, stroke, and acute kidney injury resulting in dialysis) were independently associated with death. Complications associated with the largest attributable fraction (AF) of post-operative mortality (i.e., percentage of deaths in the cohort that can be attributed to each complication, if causality were established) were major bleeding (n=1454, 18.3%, HR 2.49 95%CI 1.87-3.33, P<0.001, AF 21.2%), sepsis (n=783, 9.9%, HR 6.52, 95%CI 4.72-9.01, P<0.001, AF 15.6%), and MINS (n=980, 12.3%, HR 2.00, 95%CI 1.50-2.67, P<0.001, AF 14.4%). CONCLUSION: The complications most associated with 30-day mortality following general surgery are major bleeding, sepsis, and MINS. These findings may guide the development of mitigating strategies, including prophylaxis for perioperative bleeding.

Robotic Versus Laparoscopic Liver Resection in Various Settings: An International Multicenter Propensity Score Matched Study of 10.075 Patients.

OBJECTIVE: To compare the perioperative outcomes of robotic liver surgery (RLS) and laparoscopic liver surgery (LLS) in various settings. BACKGROUND: Clear advantages of RLS over LLS have rarely been demonstrated, and the associated costs of robotic surgery are generally higher than those of laparoscopic surgery. Therefore, the exact role of the robotic approach in minimally invasive liver surgery remains to be defined. METHODS: In this international retrospective cohort study, the outcomes of patients who underwent RLS and LLS for all indications between 2009 and 2021 in 34 hepatobiliary referral centers were compared. Subgroup analyses were performed to compare both approaches across several types of procedures: (1) minor resections in the anterolateral (2, 3, 4b, 5, and 6) or (2) posterosuperior segments (1, 4a, 7, 8), and (3) major resections (≥3 contiguous segments). Propensity score matching was used to mitigate the influence of selection bias. The primary outcome was textbook outcome in liver surgery (TOLS), previously defined as the absence of intraoperative incidents ≥grade 2, postoperative bile leak ≥grade B, severe morbidity, readmission, and 90-day or in-hospital mortality with the presence of an R0 resection margin in case of malignancy. The absence of a prolonged length of stay was added to define TOLS+. RESULTS: Among the 10.075 included patients, 1.507 underwent RLS and 8.568 LLS. After propensity score matching, both groups constituted 1.505 patients. RLS was associated with higher rates of TOLS (78.3% vs 71.8%, P < 0.001) and TOLS+ (55% vs 50.4%, P = 0.026), less Pringle usage (39.1% vs 47.1%, P < 0.001), blood loss (100 vs 200 milliliters, P < 0.001), transfusions (4.9% vs 7.9%, P = 0.003), conversions (2.7% vs 8.8%, P < 0.001), overall morbidity (19.3% vs 25.7%, P < 0.001), and microscopically irradical resection margins (10.1% vs. 13.8%, P = 0.015), and shorter operative times (190 vs 210 minutes, P = 0.015). In the subgroups, RLS tended to have higher TOLS rates, compared with LLS, for minor resections in the posterosuperior segments (n = 431 per group, 75.9% vs 71.2%, P = 0.184) and major resections (n = 321 per group, 72.9% vs 67.5%, P = 0.086), although these differences did not reach statistical significance. CONCLUSIONS: While both produce excellent outcomes, RLS might facilitate slightly higher TOLS rates than LLS.

Model to predict major complications following liver resection for HCC in patients with metabolic syndrome.

BACKGROUND: Metabolic syndrome (MS) is rapidly growing as risk factor for HCC. Liver resection for HCC in patients with MS is associated with increased postoperative risks. There are no data on factors associated with postoperative complications. AIMS: The aim was to identify risk factors and develop and validate a model for postoperative major morbidity after liver resection for HCC in patients with MS, using a large multicentric Western cohort. MATERIALS AND METHODS: The univariable logistic regression analysis was applied to select predictive factors for 90 days major morbidity. The model was built on the multivariable regression and presented as a nomogram. Performance was evaluated by internal validation through the bootstrap method. The predictive discrimination was assessed through the concordance index. RESULTS: A total of 1087 patients were gathered from 24 centers between 2001 and 2021. Four hundred and eighty-four patients (45.2%) were obese. Most liver resections were performed using an open approach (59.1%), and 743 (68.3%) underwent minor hepatectomies. Three hundred and seventy-six patients (34.6%) developed postoperative complications, with 13.8% major morbidity and 2.9% mortality rates. Seven hundred and thirteen patients had complete data and were included in the prediction model. The model identified obesity, diabetes, ischemic heart disease, portal hypertension, open approach, major hepatectomy, and changes in the nontumoral parenchyma as risk factors for major morbidity. The model demonstrated an AUC of 72.8% (95% CI: 67.2%-78.2%) ( https://childb.shinyapps.io/NomogramMajorMorbidity90days/ ). CONCLUSIONS: Patients undergoing liver resection for HCC and MS are at high risk of postoperative major complications and death. Careful patient selection, considering baseline characteristics, liver function, and type of surgery, is key to achieving optimal outcomes.

Quality of life following perioperative optimization with nutritional supplements in patients undergoing gastrointestinal surgery for cancer: A randomized, placebo-controlled feasibility clinical trial.

BACKGROUND: Up to two thirds of patients presenting for abdominal cancer surgery are malnourished pre-operatively. Perioperative nutritional supplementation has been proposed to improve surgical outcomes, though its effect on quality of life (QoL) is not yet understood. METHODS: A randomized controlled feasibility trial for perioperative nutrition among patients undergoing major abdominal cancer surgery was conducted. Participants in the intervention group received supplements for 30 days before surgery. Participants completed two QoL questionnaires (EORTC-QLQ-C-30 and FACT-G) at baseline, then 4 and 12 weeks postoperatively. Participants were compared between and within groups at baseline, Weeks 4, and 12 using t tests. Minimal clinically important differences (MCIDs) were considered as a 10-point worsening from baseline. RESULTS: Sixty-six participants were available for analysis in this study, including 33 in the intervention and 30 in the control arms. Baseline demographics were balanced between groups except for different rates of pancreas cancer (36% intervention vs. 9% control) and colorectal cancer (19% intervention vs. 34% control). At baseline, participants in the intervention group had lower overall QoL (59% vs. 77%, p = 0.01), role functioning (72% vs 88%, p = 0.045), and cognitive functioning (79% vs 90%, p = 0.047). Following surgery, role and physical functioning worsened in the control group, without significant differences between groups. Role functioning was persistently worsened at 12 weeks in the control group. The rates of MCIDs were similar between both intervention and control groups. DISCUSSION: Perioperative nutrition was associated with preservation of QoL in the postoperative period following major abdominal cancer surgery compared to placebo. SUMMARY: Among patients undergoing surgery for cancer, the majority present at high risk for malnutrition. In this placebo-controlled randomized trial among patients undergoing major abdominal surgery for cancer, preoperative nutrition supplementation was associated with the preservation of QoL in the postoperative period.

Comparing cefazolin/ metronidazole, piperacillin-tazobactam, or c efoxitin as surgical antibiotic prophylaxis in patients undergoing pancreaticoduodenectomy: A retrospective cohort study.

BACKGROUND: Preoperative antibiotic options for pancreaticoduodenectomy (PD) include cefoxitin (CX), piperacillin-tazobactam (PT), or combined cefazolin and metronidazole (CM). Recent studies suggest the superiority of PT over CX, but evidence for CM is unclear. OBJECTIVE: To explore the impact of preoperative antibiotic selection (CM vs. PT and CX vs. PT) on the development of surgical site infections (SSI). METHODS: Consecutive adult patients at one institution who underwent PD from November 2017 to December 2021 and received either CM, PT, or CX preoperatively, were included. The primary outcome was SSI. Secondary outcomes included postoperative infections and clinically significant postoperative pancreatic fistula (POPF). Logistic regression models were used. RESULTS: Among 127 patients included in the study, PT, CM, and CX were administered in 46 (36.2%), 44 (34.6%), and 37 (29.4%) patients, respectively. There were 32 (27.1%) SSI, 20 (36.1%) infections, and 21 (22.9%) POPF events. PT use was associated with reduced risk of SSI compared to CX (OR: 0.32, 95% CI: 0.11-0.89, p = 0.03), but there was no difference as compared to CM (OR: 0.75, 95% CI: 0.27-2.13, p = 0.59). There were no differences in secondary outcomes. CONCLUSION: PT reduced SSI rates compared to CX but was no different to CM among patients undergoing PD at our center.

Minimally Invasive Versus Open Liver Resections for Hepatocellular Carcinoma in Patients With Metabolic Syndrome.

OBJECTIVE: To compare minimally invasive (MILR) and open liver resections (OLRs) for hepatocellular carcinoma (HCC) in patients with metabolic syndrome (MS). BACKGROUND: Liver resections for HCC on MS are associated with high perioperative morbidity and mortality. No data on the minimally invasive approach in this setting exist. MATERIAL AND METHODS: A multicenter study involving 24 institutions was conducted. Propensity scores were calculated, and inverse probability weighting was used to weight comparisons. Short-term and long-term outcomes were investigated. RESULTS: A total of 996 patients were included: 580 in OLR and 416 in MILR. After weighing, groups were well matched. Blood loss was similar between groups (OLR 275.9±3.1 vs MILR 226±4.0, P =0.146). There were no significant differences in 90-day morbidity (38.9% vs 31.9% OLRs and MILRs, P =0.08) and mortality (2.4% vs 2.2% OLRs and MILRs, P =0.84). MILRs were associated with lower rates of major complications (9.3% vs 15.3%, P =0.015), posthepatectomy liver failure (0.6% vs 4.3%, P =0.008), and bile leaks (2.2% vs 6.4%, P =0.003); ascites was significantly lower at postoperative day 1 (2.7% vs 8.1%, P =0.002) and day 3 (3.1% vs 11.4%, P <0.001); hospital stay was significantly shorter (5.8±1.9 vs 7.5±1.7, P <0.001). There was no significant difference in overall survival and disease-free survival. CONCLUSIONS: MILR for HCC on MS is associated with equivalent perioperative and oncological outcomes to OLRs. Fewer major complications, posthepatectomy liver failures, ascites, and bile leaks can be obtained, with a shorter hospital stay. The combination of lower short-term severe morbidity and equivalent oncologic outcomes favor MILR for MS when feasible.

Textbook outcomes and benchmarks of minimally invasive left lateral sectionectomy across North America.

BACKGROUND: Minimally invasive approach represents the gold standard for the resection of the left lateral section of the liver. Recently, the American Minimally Invasive Liver Resection (AMILES) registry has become available to track outcomes of laparoscopic and robotic liver resection in the Americas. The aim of the present study is to determine the benchmark performance of MILLS throughout the AMILES database. METHODS: The AMILES registry was interrogated for cases of minimally invasive left lateral sectionectomies (MILLS). Centers with best practices according to the achievement of textbook outcomes (TOs) were identified and were used to define benchmark performances. RESULTS: Seven institutions from US and Canada entered 1665 minimally invasive liver resections, encompassing 203 MILLS. Overall, 49% of cases of MILLS satisfied contemporarily all textbook outcomes. While all centers obtained TOs with different rates of success, the outcomes of the top-ranking centers were used for benchmarking. Benchmark performance metrics of MILLS across North America are: conversion rate ≤ 3.7%, blood loss ≤ 200 ml, OR time ≤ 199 min, transfusion rate ≤ 4.5%, complication rate ≤ 7.9%, LOS ≤ 4 days. CONCLUSION: Benchmark performances of MILLS have been defined on a large multi-institutional database in North America. As more institutions join the collaboration and more prospective cases accrue, benchmark for additional procedures and approaches will be defined.

Circumstances and implications of conversion from minimally invasive to open liver resection: a multi-center analysis from the AMILES registry.

BACKGROUND: Minimally invasive approaches to liver resection (MILR) are associated with favorable outcomes. The aim of this study was to determine the implications of conversion to an open procedure on perioperative outcomes. METHODS: Patients who underwent MILR at 10 North American institutions were identified from the Americas Minimally Invasive Liver Resection (AMILES) database. Outcomes of patients who required conversion were compared to those who did not. Additionally, outcomes after conversion due to unfavorable findings (poor visualization/access, lack of progress, disease extent) versus intraoperative events (bleeding, injury, cardiopulmonary instability) were compared. RESULTS: Of 1675 patients who underwent MILR, 102 (6.1%) required conversion. Conversion rate ranged from 4.4% for left lateral sectionectomy to 10% for right hepatectomy. The primary reason for conversion was unfavorable findings in 67 patients (66%) and intraoperative adverse events in 35 patients (34%). By multivariable analysis, major resection, cirrhosis, prior liver surgery, and tumor proximity to major vessels were identified as risk factors for conversion (p < 0.05). Patients who required conversion had higher blood loss, transfusion requirements, operative time, and length of stay, (p < 0.05). They also had higher major complication rates (23% vs. 5.2%, p < 0.001) and 30-day mortality (8.8% vs. 1.3%, p < 0.001). When compared to those who required conversion due to unfavorable findings, patients who required conversion due to intraoperative adverse events had significantly higher major complication rates (43% vs. 14%, p = 0.012) and 30-day mortality (20% vs. 3.0%, p = 0.007). CONCLUSIONS: Conversion from MILR to open surgery is associated with increased perioperative morbidity and mortality. Conversion due to intraoperative adverse events is rare but associated with significantly higher complication and mortality rates, while conversion due to unfavorable findings is associated with similar outcomes as planned open resection. High-risk patients may benefit from early conversion in a controlled fashion if difficulties are encountered or anticipated.

Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.

Importance: Despite improvements in perioperative mortality, the incidence of postoperative surgical site infection (SSI) remains high after pancreatoduodenectomy. The effect of broad-spectrum antimicrobial surgical prophylaxis in reducing SSI is poorly understood. Objective: To define the effect of broad-spectrum perioperative antimicrobial prophylaxis on postoperative SSI incidence compared with standard care antibiotics. Design, Setting, and Participants: Pragmatic, open-label, multicenter, randomized phase 3 clinical trial at 26 hospitals across the US and Canada. Participants were enrolled between November 2017 and August 2021, with follow-up through December 2021. Adults undergoing open pancreatoduodenectomy for any indication were eligible. Individuals were excluded if they had allergies to study medications, active infections, chronic steroid use, significant kidney dysfunction, or were pregnant or breastfeeding. Participants were block randomized in a 1:1 ratio and stratified by the presence of a preoperative biliary stent. Participants, investigators, and statisticians analyzing trial data were unblinded to treatment assignment. Intervention: The intervention group received piperacillin-tazobactam (3.375 or 4 g intravenously) as perioperative antimicrobial prophylaxis, while the control group received cefoxitin (2 g intravenously; standard care). Main Outcomes and Measures: The primary outcome was development of postoperative SSI within 30 days. Secondary end points included 30-day mortality, development of clinically relevant postoperative pancreatic fistula, and sepsis. All data were collected as part of the American College of Surgeons National Surgical Quality Improvement Program. Results: The trial was terminated at an interim analysis on the basis of a predefined stopping rule. Of 778 participants (378 in the piperacillin-tazobactam group [median age, 66.8 y; 233 {61.6%} men] and 400 in the cefoxitin group [median age, 68.0 y; 223 {55.8%} men]), the percentage with SSI at 30 days was lower in the perioperative piperacillin-tazobactam vs cefoxitin group (19.8% vs 32.8%; absolute difference, -13.0% [95% CI, -19.1% to -6.9%]; P < .001). Participants treated with piperacillin-tazobactam, vs cefoxitin, had lower rates of postoperative sepsis (4.2% vs 7.5%; difference, -3.3% [95% CI, -6.6% to 0.0%]; P = .02) and clinically relevant postoperative pancreatic fistula (12.7% vs 19.0%; difference, -6.3% [95% CI, -11.4% to -1.2%]; P = .03). Mortality rates at 30 days were 1.3% (5/378) among participants treated with piperacillin-tazobactam and 2.5% (10/400) among those receiving cefoxitin (difference, -1.2% [95% CI, -3.1% to 0.7%]; P = .32). Conclusions and Relevance: In participants undergoing open pancreatoduodenectomy, use of piperacillin-tazobactam as perioperative prophylaxis reduced postoperative SSI, pancreatic fistula, and multiple downstream sequelae of SSI. The findings support the use of piperacillin-tazobactam as standard care for open pancreatoduodenectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT03269994.

Use of population-based electronic databases for the identification of patients with synchronous colorectal cancer and liver metastases potentially eligible for a surgical trial.

BACKGROUND: Some population-based recruitment methods, such as registries and databases, have been used to increase enrolment in clinical trials by identifying eligible participants based on baseline characteristics; however; these methods have not been tested in surgical trials, in which accrual occurs before surgery. We evaluated the use of population-based electronic databases to identify patients who potentially could be accrued to the Simultaneous Resection of Colorectal Cancer with Synchronous Liver Metastases (RESECT) trial and compared it to the traditional methods used to accrue patients (e.g., multidisciplinary rounds, letters to community surgeons) for that same trial during the same period. METHODS: An electronic database (ePath) was interrogated every 2 weeks for patients diagnosed with colorectal cancer from Feb. 1, 2017, to Mar. 30, 2019. A radiologic image database (OneView) was reviewed to identify those with liver metastases (level 1 screening). Reports were interrogated to identify potentially eligible patients for the RESECT trial (level 2 screening). A hepatobiliary surgeon reviewed radiology images to identify eligible patients for the trial (level 3 screening). The primary outcome was patient eligibility for the ongoing RESECT trial. RESULTS: The population-based method identified 90 (11.2%) of 803 patients diagnosed with colorectal cancer over the study period. Among the 90 patients, level 2 screening identified 60 (67%) potentially eligible patients for the RESECT trial. Of the 90 patients, 18 (20%) were eligible after radiographic image review (level 3 screening). Traditional accrual methods identified 38 patients with liver metastases, 27 (71%) of whom were identified as potentially eligible on level 2 screening, and 14 (37%) of whom were deemed to be eligible on level 3 screening. Twenty-six patients were identified by both methods. Twelve patients were identified by population-based methods alone, and 8 patients by traditional methods alone. Six eligible patients were identified by both methods. Baseline characteristics were similar between the 2 groups. CONCLUSION: A population-based electronic database method of patient accrual was able to identify eligible participants for the RESECT trial. However, optimal accrual likely requires the use of traditional methods as well.

Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study.

BACKGROUND: Due to lack of data, direct oral anticoagulants are not considered by guidelines for venous thromboembolism (VTE) prophylaxis after cancer surgery. Adherence to low-molecular-weight heparin injections in this setting is sometimes poor. AIM: Analysis of adherence to oral apixaban for extended thromboprophylaxis. METHODS: Consecutive patients discharged after major surgery for abdominal/pelvic cancer and considered eligible for extended prophylaxis were offered apixaban 2.5 mg twice daily. Primary outcomes were adherence metrics-proportion of prescriptions filled, persistence (not prematurely discontinued), proportion of days covered (PDC) based on apixaban pill counts, and modified Morisky medication adherence scale at Days 28-30. Secondary outcomes were bleeding, VTE, and serious adverse events until Day 90. RESULTS: We included 53 patients, 51 were analyzed. Of 45 patients with prescriptions all had it filled (95% confidence interval [CI], 92%-100%). Persistence was 98% (95% CI, 90%-100%). PDC was ≥80% for 48 patients (94%; 95% CI, 84%-99%). We found good adherence (0/6 answers "yes") in 75% and moderate (1/6 answers "yes") in 25%. No major bleed or VTE occurred while on apixaban. CONCLUSION: Our results support good adherence with apixaban for VTE prophylaxis up to 28 days after major abdominal or pelvic cancer surgery.

Evaluating compliance of extended venous thromboembolism prophylaxis following abdominopelvic surgery for cancer: A multidisciplinary quality improvement project.

BACKGROUND AND OBJECTIVES: Despite quality evidence supporting postoperative extended venous thromboembolism prophylaxis (eVTEp) following abdominopelvic cancer surgery, baseline use of eVTEp at our institution was 3%. Our project aim was to improve the proportion of patients prescribed eVTEp following surgery for gynecologic, hepatobiliary, and colorectal cancers by a 30% absolute increase. METHODS: We performed an interrupted time series study using quality improvement methodology. Postoperative order sets, pre-printed prescriptions, process checklists, and multimodal education were introduced. Process and outcome data were collected and analyzed on statistical process control charts. RESULTS: We included 324 patients with gynecologic and hepatobiliary cancers. Despite efforts to include them, the colorectal team did not participate. The monthly mean order set-use was 58% (SD = 14%), by specialty: gynecology 79%, hepatobiliary 47%. The proportion of patients prescribed eVTEp increased from 3% to 70% (SD = 14%). The target goal was surpassed and sustained by both cohorts. Patient compliance was 73% (n = 117/160, SD = 16%). Of those who stopped eVTEp early, 45% (n = 14/31) objected because of the injectable nature. Bleeding events were infrequent (0.6%, n = 2/324). CONCLUSIONS: Three process changes and multimodal education resulted in a significant increase in eVTEp use. Failure to identify improvement champions limited project expansion to colorectal patients. Patient compliance was largely limited by the injectable nature of the medication.

Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial.

BACKGROUND AND OBJECTIVES: We tested the feasibility of a simultaneous resection clinical trial in patients with synchronous colorectal cancer liver metastases to obtain the necessary information to plan a randomized trial. METHODS: Multicenter feasibility single-arm trial enrolling patients with synchronous colorectal cancer liver metastases eligible for simultaneous resection. Prespecified criteria for feasibility were: proportion of eligible patients enrolled ≥66%, and the proportion of enrolled patients who completed simultaneous resection ≥75%. The prespecified 90-day major postoperative complication rate was 30%. RESULTS: Of 61 eligible patients from February 2017 to August 2019, 41 were enrolled (67%; 95% confidence interval [CI], 55%-78%), 32 underwent simultaneous resection (78%; 95% CI, 63%-88%). Four patients were not enrolled due to the surgeon's preference, three were due to the complexity of resection (right hepatectomy and low anterior resection). Intraoperative complications during liver resection (n = 4) and progression of disease (n = 4) were the main reasons for not undergoing simultaneous resection. The 90-day incidence of major complications was 41% (95% CI, 16%-58%) and the 90-day postoperative mortality was 6% (95% CI, 1.7%-20%). CONCLUSION: According to prespecified criteria, enrolling patients with synchronous colorectal cancer liver metastases to a trial of simultaneous resection is feasible; however, it is associated with higher than anticipated 90-day postoperative complications.

Prognostic factors of overall survival in patients with recurrent disease following liver resection for colorectal cancer metastases: A multicenter external validation study.

BACKGROUND: The clinical course of patients experiencing recurrence following hepatectomy for colorectal cancer metastases (CRM) is poorly defined. Previous studies associated shorter time to recurrence (TTR) in months, node-positive primary tumor, and more than one site of recurrence with worse outcomes. METHODS: We conducted a retrospective cohort study across four Canadian institutions to externally validate previously established prognostic factors of overall survival (OS). We included consecutive adult patients who had a recurrence following curative-intent liver resection for CRM. Prognostic factors were explored using a multivariable Cox regression model. Risk group cutoffs were identified through recursive partitioning. OS between low- and high-risk groups was compared using the Kaplan-Meier method. RESULTS: This study included 471 patients. Shorter TTR in months (hazard ratio [HR]: 0.95, 95% confidence interval [CI]: 0.93-0.97), presence of extrahepatic disease at first hepatectomy (HR: 2.54, 95% CI: 1.18-5.50), and larger tumor size in millimetres (HR: 1.01, 95% CI: 1.00-1.02) were associated with worse OS. Median OS in the high- and low-risk groups were 40.5 (95% CI: 34.0-45.7 months) versus 64.7 months (95% CI: 57.9-72.3 months; p < 0.001), respectively. CONCLUSIONS: We externally validated the prognostic significance of shorter TTR (<8.5 months) as a predictor of worse OS in patients who recur the following hepatectomy for CRM.

Frailty Predicts Postoperative Complications following Pancreaticoduodenectomy.

INTRODUCTION: Frailty is a clinically recognizable state of decreased reserve and function across physiologic systems, characterized by an inability to cope with acute stressors. A validated modified frailty index (mFI) was used to evaluate the impact of frailty on postoperative complications following pancreaticoduodenectomy. METHODS: Data from consecutive patients undergoing pancreaticoduodenectomy from 2011 to 2020 were collected retrospectively at a high-volume tertiary care hepatopancreatobiliary hospital. Based on an 11-item mFI, patients were grouped by high (≥0.27) and low mFI. The main outcome was postoperative complications (Clavien-Dindo classification). The impact of frailty on complications was analyzed by evaluating baseline and operative characteristics using multivariable logistic regression. Secondary outcomes included postoperative mortality, length of hospital stay, and intensive care unit (ICU) admission, which were analyzed using univariable logistic regression. RESULTS: There were 64/554 patients (12%) with high mFI. Low and high mFI had similar characteristics, including proportion of pancreatic adenocarcinoma (low mFI = 247/490 [50%] vs. high mFI = 31/64 [48%], p = 0.767), intermediate or hard pancreatic texture (low mFI = 75/191 [39%] vs. high mFI = 6/19 [32%], p = 0.512), operative room time (low mFI = 370 min vs. high mFI = 368 min, p = 0.630), and drain placement (low mFI = 355/490 [72%] vs. high mFI = 48/64 [75%], p = 0.642). The mFI score was an independent predictor for the development of any type of postoperative complications (OR 1.44, 95% CI 1.02-2.10) and major postoperative complications (OR 1.44, 95% CI 1.05-1.98) by multivariable analysis. High mFI patients had a higher 90-day mortality rate (high mFI = 7/64 [11%] vs. low mFI = 20/490 [4.1%], p = 0.017), a longer median length of hospital stay (high mFI = 11 days vs. low mFI = 8 days, p = 0.016), and a higher rate of ICU admission (high mFI = 47/64 [73%] vs. low mFI = 211/490 [43%], p < 0.001). CONCLUSION: Among patients who are considered surgical candidates, the mFI can identify those at high risk of developing postoperative complications. This tool can be used to accurately discuss postoperative risk with patients undergoing pancreaticoduodenectomy.

Weight Loss Following Hepatopancreatobiliary Surgery. How Much is Too Much? A Retrospective Cohort Study.

Background & Aims. Postoperative weight loss is common following hepato-pancreato-biliary (HPB) surgical resections; however, the extent of weight loss and the association with poor outcomes have not been well described. We assessed the average percentage of weight loss and risk factors associated with sustained postoperative weight loss. Materials and Methods. We enrolled patients undergoing major HPB surgical resections from 2011-2016 at a single institution. We evaluated percent change in weight postoperatively, incidence of complications, and nutritional clinical markers at 1, 3, and 6 months postoperatively compared to preoperative baseline. We used multiple logistic regression to evaluate factors associated with significant weight loss (>10% from baseline) at 3 months from surgery. Results. Among 262 patients undergoing HPB surgery, liver surgery patients lost 2.5% of baseline weight at 3 months postoperatively but regained baseline weight by 6 months. Pancreatic surgery patients lost 7.7% at 3 months and were unable to recover their baseline weights at 6 months. Forty-three (16%) patients had major postoperative complications including abdominal abscess (5.3%) and anastomotic leak (3.8%). Patients who experienced major postoperative complications had a greater percentage weight loss at 3 months compared to those without major complications: median 11% (interquartile range (IQR): 7%-15%) vs 4% (IQR: 0%-8%), P < .001. In the multivariable analysis, major postoperative complications were associated with significant weight loss at 3 months (OR 3.39, 95% CI 1.38-8.33). Conclusions. Due to the association of weight loss and major postoperative complications, patients who experience significant weight loss (>10% from baseline) may benefit from nutritional assessment for dietary intervention.

PATCH-DP: a single-arm phase II trial of intra-operative application of HEMOPATCH™ to the pancreatic stump to prevent post-operative pancreatic fistula following distal pancreatectomy.

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).

Enthusiasm, Opinion Leaders, Comparative Advantage, and the Uptake Of Laparoscopic Resection For Colorectal Cancer Liver Metastases in Ontario, Canada: A Population-Based Cohort Study.

BACKGROUND: Numerous factors likely influence adoption of surgical innovations in large regions. We considered the role of comparative advantage, surgeon enthusiasm, and opinion leaders on uptake of minimally invasive liver resection (MILR) for colorectal cancer (CRC) metastases in Ontario. METHODS: We used administrative data for patients undergoing liver resection for CRC metastases from years 2006-2015. Fourteen regions were divided into three groups based on overall rate of MILR for CRC metastases. Outcomes included postoperative complications, length of hospital stay (LOS), operative mortality, and 1-year survival. We evaluated uptake of MILR among groups and within groups between opinion leader and nonopinion leader surgeons. RESULTS: There were 2675 patients in the low-rate (n = 937), medium-rate (n = 919), and high-rate (n = 819) groups. In these same groups, the number of opinion leader surgeons was six, five, and six. Patient outcomes were similar among groups, except in the low-rate group LOS was 1 day greater (7 vs. 6 and 6; p = 0.017). The rate of MILR for CRC metastases did not change significantly among opinion leaders in any group. This rate among nonopinion leader surgeons was steady and low in the low-rate group (1.7-8.0%, p = 0.80) and increased in the mid-rate group (2.4-31.8%, p = 0.0026) and in the high-rate group (7.7-40.9%, p < 0.001). CONCLUSIONS: Greater use of MILR was associated with a 1-day shorter LOS. Relative enthusiasm for MILR for CRC metastases among a small number of opinion leader surgeons likely facilitated or dampened uptake of this complex innovation.

Incidence of Splanchnic Vein Thrombosis After Abdominal Surgery: A Systematic Review and Meta-analysis.

BACKGROUND: Abdominal surgery may increase the risk of splanchnic vein thrombosis (SVT). We determined the incidence of SVT after abdominal surgery and identified groups at highest risk. MATERIALS AND METHODS: MEDLINE and Embase were searched for clinical studies evaluating the incidence of postoperative SVT after abdominopelvic surgery. Study selection, data abstraction, and risk of bias assessment were carried out independently by two reviewers. Clinical heterogeneity was explored by subgroup analyses (i.e., type of intra-abdominal procedure and organ group). RESULTS: Of 5549 abstracts screened, 48 were analyzed. Pooled incidence of SVT (n = 50,267) was 2.68% [95% confidence interval (CI), 2.24 to 3.11] (1347 events), I2 = 96%. Pooled incidence of SVT in high-risk procedures were splenectomy with devascularization (24%), hepatectomy in patients with cirrhosis (9%), and pancreatectomy with venous resection (5%). Pooled incidence of symptomatic and asymptomatic SVT was 1.02% (95% CI: 0.97% to 1.07%) and 0.98% (95% CI 0.88% to 1.07%), respectively. Most common causes of SVT-related mortality were irreversible thrombosis, bowel ischemia, liver failure, and gastrointestinal bleed. Most studies included were at a high risk of bias due to lack of prospective data collection and lack of SVT screening for all participants. CONCLUSIONS: Incidence of SVT after abdominal surgery is low but remains a relevant complication. Patients undergoing procedures involving surgical manipulation of the venous system and splenectomy are at the highest risk. Given the life-threatening risks associated with SVT, there is a need for larger prospective studies on the incidence and impact of SVT after abdominal surgery.

Effect of PET-CT on disease recurrence and management in patients with potentially resectable colorectal cancer liver metastases. Long-term results of a randomized controlled trial.

BACKGROUND: Preoperative evaluation of resectable colorectal cancer liver metastases with positron emission tomography (PET) combined with computed tomography (PET-CT) is used extensively. The PETCAM trial evaluated the effect of PET-CT (intervention) vs no PET-CT (control) on surgical management. PET-CT resulted in 8% change in surgical management, therefore, we aimed to compare long-term outcomes (disease-free [DFS], overall survival [OS]). METHODS: Trial recruitment (2005-2010) had prospective follow-up until 2013. Events from 2013 to 2017 were collected retrospectively. Survival was described by the Kaplan-Meier method and compared with log-rank test. Oncologic risk factors were calculated using Cox proportional hazard models. RESULTS: Among 404 patients randomized, there were no differences in DFS (hazard ratio [HR] = 1.13; 95% confidence interval [CI], 0.89 to 1.43) or OS (HR, 1.02; 95% CI, 0.78-1.32) between groups. For all patients randomized, median DFS (PET-CT vs no PET-CT) was 16 months (95% CI, 13-18) and 15 months (95% CI, 11-22), P = .33. For patients who underwent liver resection (n = 368), DFS (17 vs 16 months, P = .51) and OS (58 months vs 52 months, P = .90) were similar between groups, respectively. Risk factors for DFS and OS were age, tumor size, node-positive disease, extrahepatic metastases and disease-free duration. CONCLUSION: Preoperative PET-CT changes surgical management in a small percentage of cases, without effect on recurrence rates or long-term survival.