Importance:Explanatory trials suggest that prehabilitation has efficacy in improving surgical outcomes. The effectiveness of offering home-based prehabilitation across multiple centers and for older adults with frailty remains unknown. Objective:To evaluate the effectiveness of offering coach-supported, home-based prehabilitation to older surgical patients with frailty. Design, Setting, and Participants:This study is a pragmatic, parallel-arm, multicenter randomized clinical trial with embedded qualitative assessment. Clinicians and assessors were fully blinded; participants were partially blinded in that the control arm received publicly available activity and nutritional guidelines. From March 2, 2020, to February 8, 2024, participants aged 60 years and older with frailty (Clinical Frailty Scale score ≥4) scheduled for elective, inpatient noncardiac surgery were recruited from surgeon's offices at 13 centers in Canada. Data analysis was completed from October 3, 2024, to December 5, 2024. Intervention:Assignment to a home-based, multimodal program of exercise and personalized nutritional recommendations, remotely supported by coaches using a theory-based approach to enhance adherence. Main Outcomes and Measures:The coprimary outcomes were patient-reported disability 30 days after surgery using the World Health Organization Disability Assessment Schedule 2.0 and the incidence of any postoperative complication during the surgical hospitalization. Barriers to adherence were identified using the Theoretical Domains Framework. Secondary outcomes were intervention-attributable safety events, health-related quality of life, survival, falls, complication severity, activities of daily living, length of stay, discharge disposition, lower limb function, and readmission. Analysis was by mixed-effects regression, adjusting for stratification and prespecified prognostic factors. Results:Of 992 eligible participants, 847 (85.4%) were randomized (423 to prehabilitation and 424 to usual care), and 705 participants had their planned surgery (353 in the prehabilitation group and 352 in the usual care group). A total of 452 participants (53.4%) were female, and mean (SD) participant age was 71.7 (7.1) years. A median (IQR) of 4 weeks (3-7) of prehabilitation enrollment was achieved. Preoperative safety outcomes did not differ between groups. Participants assigned to prehabilitation reported a mean (SD) postoperative disability score of 23.5 (21.8) compared to 24.7 (23.8) for usual care (adjusted mean difference, -1.4; 97.5% CI, -4.9 to 2.0; P = .36). Complications occurred in 177 participants (50.1%) assigned to prehabilitation and 168 control participants (47.7%) (adjusted odds ratio, 1.05; 97.5% CI, 0.73-1.49; P = .78). Participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation (mean difference, -4.9; 97.5% CI, -9.8 to -0.01; P = .02), but there was no significant difference in complications (odds ratio, 1.06; 97.5% CI, 0.67-1.67; P = .79). Primary barriers to adherence were competing priorities and motivation. Conclusions and Relevance:In this randomized clinical trial among older adults with frailty scheduled for surgery, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications. Trial Registration:ClinicalTrials.gov Identifier: NCT04221295.
QuestionCan home-based prehabilitation improve patient-centered outcomes after surgery for older adults living with frailty?FindingsIn this pragmatic randomized clinical trial that included 847 older adults living with frailty, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications. However, participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation.MeaningAssignment to home-based prehabilitation with structured coaching did not improve patient-centered outcomes across all participants; given promising findings in adherent participants, intervention design and delivery require further optimization to overcome barriers to adherence. ImportanceExplanatory trials suggest that prehabilitation has efficacy in improving surgical outcomes. The effectiveness of offering home-based prehabilitation across multiple centers and for older adults with frailty remains unknown.ObjectiveTo evaluate the effectiveness of offering coach-supported, home-based prehabilitation to older surgical patients with frailty.Design, Setting, and ParticipantsThis study is a pragmatic, parallel-arm, multicenter randomized clinical trial with embedded qualitative assessment. Clinicians and assessors were fully blinded; participants were partially blinded in that the control arm received publicly available activity and nutritional guidelines. From March 2, 2020, to February 8, 2024, participants aged 60 years and older with frailty (Clinical Frailty Scale score >= 4) scheduled for elective, inpatient noncardiac surgery were recruited from surgeon's offices at 13 centers in Canada. Data analysis was completed from October 3, 2024, to December 5, 2024.InterventionAssignment to a home-based, multimodal program of exercise and personalized nutritional recommendations, remotely supported by coaches using a theory-based approach to enhance adherence.Main Outcomes and MeasuresThe coprimary outcomes were patient-reported disability 30 days after surgery using the World Health Organization Disability Assessment Schedule 2.0 and the incidence of any postoperative complication during the surgical hospitalization. Barriers to adherence were identified using the Theoretical Domains Framework. Secondary outcomes were intervention-attributable safety events, health-related quality of life, survival, falls, complication severity, activities of daily living, length of stay, discharge disposition, lower limb function, and readmission. Analysis was by mixed-effects regression, adjusting for stratification and prespecified prognostic factors.ResultsOf 992 eligible participants, 847 (85.4%) were randomized (423 to prehabilitation and 424 to usual care), and 705 participants had their planned surgery (353 in the prehabilitation group and 352 in the usual care group). A total of 452 participants (53.4%) were female, and mean (SD) participant age was 71.7 (7.1) years. A median (IQR) of 4 weeks (3-7) of prehabilitation enrollment was achieved. Preoperative safety outcomes did not differ between groups. Participants assigned to prehabilitation reported a mean (SD) postoperative disability score of 23.5 (21.8) compared to 24.7 (23.8) for usual care (adjusted mean difference, -1.4; 97.5% CI, -4.9 to 2.0; P = .36). Complications occurred in 177 participants (50.1%) assigned to prehabilitation and 168 control participants (47.7%) (adjusted odds ratio, 1.05; 97.5% CI, 0.73-1.49; P = .78). Participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation (mean difference, -4.9; 97.5% CI, -9.8 to -0.01; P = .02), but there was no significant difference in complications (odds ratio, 1.06; 97.5% CI, 0.67-1.67; P = .79). Primary barriers to adherence were competing priorities and motivation.Conclusions and RelevanceIn this randomized clinical trial among older adults with frailty scheduled for surgery, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications.Trial RegistrationClinicalTrials.gov Identifier: NCT04221295 This multicenter randomized clinical trial evaluates the effectiveness of offering coach-supported, home-based prehabilitation to older patients with frailty scheduled for surgery.
TPS4268 Background: Resectable pancreatic ductal adenocarcinoma (PDAC) comprises < 20% of cases and remains associated with poor outcomes despite surgery and adjuvant chemotherapy. PDAC features a hypoxic, immunosuppressive and “cold” tumor microenvironment (TME). CD73 has emerged as a prognostic biomarker in PDAC, with high expression linked to poor survival. CD73 on tumor cells impairs antitumor T-cell responses and results in tumor immune escape. Inhibition of CD73 could reverse immune suppression by the TME. Preliminary data from the phase I combination trial of durvalumab (anti-PD-L1 antibody) and oleclumab (anti-CD73 antibody) has shown modest antitumor activity in patients in PDAC, colon cancer, and non-small cell lung cancer. A window-of-opportunity (WOO) study allows for rapid early identification of biological activity. We therefore designed a WOO trial to assess the impact of CD73 and PD-L1 blockade in resectable PDAC to test the hypothesis that this strategy would increase CD8+ T cell infiltration and reduce suppressive immune cells as assessed by digital spatial profiling and image mass cytometry. Methods: DORA (NCT06060405) is a prospective phase II multicentre WOO trial evaluating the immune activity of combined CD73 and PD-L1 blockade in upfront resectable PDAC. Eligible patients must have ECOG 0–1, histologically confirmed NCCN resectable PDAC, and be immunotherapy-naïve. Patients undergo an upfront EUS for histological diagnosis and for correlative studies, and then receive a single dose of durvalumab 1500 mg IV and oleclumab 3000 mg IV x 2 doses every two weeks prior to surgical resection. Patients receive standard-of-care adjuvant systemic therapy following surgery. The primary objective is to determine the increase in immune cell infiltration, specifically CD8+ T cells, between the paired pre-treatment and surgical resection specimens. Secondary objectives include the percent change in other immune cell populations (CD3/CD45RA/RO T cells, M1 vs. M2 macrophage), and the dynamic changes in immune cell populations as measured by flow cytometry/CyTOF. A total of 22 patients will be enrolled to ensure 20 evaluable subjects who undergo surgical resection. With 20 patients, this provides 80% power to detect an effect size of 0.66 using a two-sided alpha of 0.05. Planned correlatives include serial ctDNA analysis and whole genome and transcriptome sequencing of all surgical resections. This study was activated in January 2024. Clinical trial information: NCT06060405 .
Background The optimal surgical technique for hepatocellular carcinoma (HCC) remains debated, particularly regarding the balance between perioperative morbidity and long-term oncological outcomes when comparing anatomical resection (AR) with non-anatomical resection (NAR). Methods This international, retrospective multicenter study included patients undergoing resection for solitary HCC ≤5 cm. Patients undergoing major hepatectomy (≥3 segments), two-stage hepatectomy, portal vein embolization, or non-curative procedures were excluded. After propensity score matching (PSM), perioperative outcomes, disease-free survival (DFS), and overall survival (OS) were analyzed, with subgroup analyses by surgical approach and tumour size. Results After propensity score matching, 442 patients were included in each group. NAR was associated with more favourable perioperative outcomes, including shorter operative time, lower blood loss, and lower rates of severe morbidity. DFS did not differ between groups. AR was associated with improved OS in the overall matched cohort (5-year OS: 77.2% vs. 67.2%; p = 0.041), in patients with larger tumours (≥3.6 cm; 81.3% vs. 61.3%; p = 0.022), and in those undergoing minimally invasive liver resection (74.5% vs. 63.2%; p = 0.001). No significant OS difference was observed in patients with smaller tumours (≤3.5 cm). Conclusion NAR was associated with better perioperative outcomes, whereas AR was associated with improved OS in selected analyses. As DFS did not differ between groups and subgroup findings were exploratory, these results should be interpreted cautiously. Overall, the findings support an individualized, tumour-tailored surgical approach.
Background:The contemporary causes of postoperative mortality in orthopedic surgery are not well characterized. Objective:This study aimed to describe the epidemiology of postoperative complications among adult patients who underwent orthopedic surgery and inform their relationships with 30-day mortality. Methods:Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) was a prospective cohort study involving 40,004 adult patients who underwent noncardiac surgery across 28 centers in 14 countries. For the subset of patients who underwent orthopedic surgery, a Cox proportional hazards model was used to determine time-dependent associations between various surgical complications and 30-day postoperative mortality. Analyses were adjusted for preoperative and surgical variables. Results:Among 8385 patients who underwent an orthopedic surgery in VISION, 1.6% (n=132) died within 30 days of surgery. Of the 132 deaths, 63.6% (n=84) occurred in hospital during the index hospitalization, while 36.4% (n=48) occurred after discharge. The incidence of death across the subcategories of orthopedic surgery was above-knee amputation (30/221, 13.6%), internal fixation of femur (29/750, 3.9%), lower leg amputation (9/252, 3.6%), major hip or pelvic surgery (49/2898, 1.7%), major spine surgery (8/1405, 0.6%), and knee arthroplasty (7/2876, 0.2%). A total of 6 postoperative complications (myocardial injury after noncardiac surgery [MINS], major bleeding, infection without sepsis, sepsis, stroke, and atrial fibrillation) were associated with death in adjusted analyses. The greatest attributable fractions of postoperative mortality (ie, proportion of deaths in the cohort that can be attributed to each complication, if causality were established) were from MINS (1454/8385, 17.3%; hazard ratio [HR] 2.08, 95% CI 1.38-3.14; P<.001; attributable fraction=20.6%), major bleeding (2422/8385, 28.9%; HR 1.95, 95% CI 1.34-2.85; P<.001; attributable fraction=16.5%), and sepsis (318/8385, 3.8%; HR 6.24, 95% CI 3.85-10.12; P<.001; attributable fraction=9.7%). Conclusions:The complications most attributable to 30-day mortality following orthopedic surgery were MINS, major bleeding, and sepsis. These findings highlight areas for further study to mitigate perioperative mortality in orthopedic surgery. MINS demonstrated the highest attributable fraction for mortality (20.6%), emphasizing the importance of appropriate MINS screening, diagnosis, and management.
Among patients with pancreatic cancer deemed resectable on computed tomography (CT), approximately 41% have more advanced disease that is not detected by CT. Diagnostic staging laparoscopy is used preoperatively either routinely or selectively in patients with high-risk features and may reduce unnecessary laparotomies by more than 20%. However, it remains an invasive procedure that requires general anesthesia and, when possible, should be avoided if metastatic disease is already evident on preoperative imaging. CT remains the standard imaging modality for staging pancreatic cancer and determining its resectability, but recent studies have demonstrated the added benefit of other radiological modalities in reducing unnecessary surgeries. Magnetic resonance imaging (MRI) is recommended for patients with high risk features to detect extra-pancreatic metastases or for those with indeterminate liver lesions on CT. Accordingly, at a population-level, we evaluated whether patients diagnosed with pancreatic adenocarcinoma and receiving preoperative abdominal MRI, in lieu of or combined with CT, had a lower likelihood of laparotomy and/or laparoscopy.
Introduction Poor cardiopulmonary fitness is an important risk factor for postoperative complications, yet a feasible, objective and prognostically accurate method to assess preoperative fitness has not been established. The 6 min walk test (6MWT) is a simple, inexpensive and widely applicable measure that shows promise for predicting postoperative risk. However, robust data are lacking on whether the 6MWT accurately predicts complications, provides incremental prognostic value beyond routinely collected clinical factors or outperforms simpler alternatives such as questionnaires, cardiac biomarkers or grip strength testing. The Functional Assessment for Surgery by a Timed Walk (FAST Walk) study is designed to address these knowledge gaps by evaluating whether the 6MWT improves prediction of key postoperative outcomes compared with clinical factors and simpler measures of fitness.Methods and analysis The FAST Walk study is an international multicentre prospective cohort study of 1672 adults (≥40 years) undergoing major elective non-cardiac surgery at centres in Canada, Hong Kong, Australia, Spain and the Netherlands. Participants complete a preoperative 6MWT and baseline assessments of comorbidities, self-reported cardiopulmonary fitness (MET: Re-evaluation for Perioperative Cardiac Risk questionnaire), biomarkers (N-terminal pro-B-type natriuretic peptide) and grip strength. The primary outcome is 30-day death or major postoperative complication, defined as Clavien-Dindo grade II or higher. Secondary outcomes are (1) death or new significant disability at 90 days after surgery and (2) days alive and out of hospital at 30 days after surgery. Disability is measured using the short-form WHO Disability Assessment Schedule 2.0 instrument. Multivariable regression models and complementary metrics of prediction performance will be used to determine whether 6MWT distance adds prognostic value beyond routinely collected clinical factors and simpler measures of fitness.Ethics and dissemination The FAST Walk study has received research ethics board approval at all participating sites. Recruitment commenced in June 2024, with completion of participant follow-up expected in 2026. Findings will be disseminated through peer-reviewed publications and conference presentations, with the primary results anticipated in 2027.Trial registration number NCT06412367.
BACKGROUND:Conversion to open surgery forfeits any potential benefits of minimally invasive liver surgery (MILS), however, it remains uncertain whether the conversion itself introduces additional risk. The impact may differ depending on urgency (emergency or elective) and surgical approach (robotic or laparoscopic liver resection). This study aimed to evaluate outcomes of emergency and elective conversions in robotic liver resection (RLR) and laparoscopic liver resection (LLR). PATIENTS AND METHODS:Data from 34 international centers of patients undergoing converted MILS procedures (stratified for conversion urgency) were retrospectively compared with patients who underwent elective open liver surgery using propensity score matching. Additionally, RLR and LLR conversions were compared. Conversion risk factors were identified using multivariable logistic regression in RLR and LLR separately. RESULTS:Among 10,548 MILS procedures (n = 1626 RLR and n = 8922 LLR), 719 (6.8%) were converted. Both emergency (n = 226) and elective (n = 472) conversions were associated with longer operative time and more Pringle use compared with open surgery. Emergency conversions additionally showed higher blood loss, transfusion rates, severe morbidity, and even mortality. Matched analysis of 40 pairs of RLR and LLR conversions identified no significant differences in perioperative outcomes, although mortality following RLR conversion was remarkably high (7.7%). RLR conversion risk factors were bilobar disease and anatomically major resection; whereas LLR risk factors included cirrhosis, history of previous liver surgery, tumor size, technically complex, and anatomically major resection. CONCLUSIONS:Emergency conversions in MILS are associated with worse outcomes, whereas elective conversions appear safe, highlighting the importance of timely, controlled conversion. Further investigation into the safety of robotic conversions is warranted.
BACKGROUND:Liver transplant is indicated in patients with Wilson's disease for acute hepatic failure, advanced cirrhosis, and disease refractory to chelation therapy. This study aims to systematically review data about overall morbidity, hepatic, neuropsychiatric, and survival outcomes following liver transplantation for Wilson disease. METHODS:MEDLINE, Embase, and Central were searched from inception until July 2023. Peer-reviewed articles and published abstracts evaluating patients diagnosed with Wilson's disease and undergoing any type of liver transplant as a result of the disease were eligible for inclusion. A restricted maximum likelihood random effects model was used to generate the pooled proportion of each outcome. The risk of bias for each included observational study was assessed using the Methodological Index for Non-Randomized Studies tool. RESULTS:A total of 39 studies met all inclusion criteria. All studies were observational. Specific indications for liver transplant were most commonly acute liver failure (36.73%), chronic liver failure (45.02%), and acute-on-chronic liver failure (8.35%). The pooled proportions of mortality at 30 days, 1, and 5 years were 0.10 (95% CI 0.08, 0.13; I2 = 16%), 0.11 (95% CI 0.09, 0.14; I2 = 37%), and 0.15 (95% CI 0.11, 0.20; I2 = 81%), respectively. The postoperative complication with the greatest prevalence was biopsy-proven acute rejection with a pooled proportion of 0.20 (95% CI 0.12, 0.31; I2 = 84%). The mean MINORS score for risk of bias for all studies was 8.19. CONCLUSION:Overall, reporting quality and consistency of outcomes included in the studies was poor as assessed using the MINORS score. Pooled proportions for 30-day, 1- and 5-year mortality are similar, suggesting most postoperative deaths are acute in nature. Future research should incorporate objective measures and the reporting of standardized parameters to allow more robust comparisons between studies.
Importance:Perioperative bleeding is common in general surgery. The POISE-3 (Perioperative Ischemic Evaluation-3) trial demonstrated efficacy of prophylactic tranexamic acid (TXA) compared with placebo in preventing major bleeding without increasing vascular outcomes in noncardiac surgery. Objective:To determine the safety and efficacy of prophylactic TXA, specifically in general surgery. Design, Setting, and Participants:Subgroup analyses were conducted that compared randomized treatment with TXA vs placebo according to whether patients underwent general surgery or nongeneral surgery in the POISE-3 blinded, international, multicenter randomized clinical trial. Participants were 45 years or older, were undergoing noncardiac surgery, had increased cardiovascular risk, and were expected to require at least an overnight hospital admission after surgery. Among 26 581 eligible patients identified, 17 046 were excluded, resulting in 9535 patients randomized to the POISE-3 trial. Participants were enrolled from June 2018 through July 2021. The data were analyzed during December 2023. Intervention:Prophylactic, 1-g bolus of intravenous TXA or placebo at the start and end of surgery. Main Outcomes and Measures:The primary efficacy outcome was a composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ. The primary safety outcome was a composite of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism at 30 days. Cox proportional hazards models were conducted, incorporating tests of interaction. Results:Among 9535 POISE-3 participants, 3260 underwent a general surgery procedure. Mean age was 68.6 (SD, 9.6) years, 1740 were male (53.4%), and 1520 were female (46.6%). Among general surgery patients, 8.0% and 10.5% in the TXA and placebo groups, respectively, had the primary efficacy outcome (hazard ratio [HR], 0.74; 95% CI, 0.59-0.93; P = .01) and 11.9% and 12.5% in the TXA and placebo groups, respectively, had the primary safety outcome (HR, 0.95; 95% CI, 0.78-1.16; P = .63). There was no significant interaction by type of surgery (general surgery vs nongeneral surgery) on the primary efficacy (P for interaction = .81) and safety (P for interaction = .37) outcomes. Across subtypes of general surgery, TXA decreased the composite bleeding outcome in hepatopancreaticobiliary surgery (HR, 0.55; 95% CI, 0.34-0.91 [n = 332]) and colorectal surgery (HR, 0.67; 95% CI, 0.45-0.98 [n = 940]). There was no significant interaction across subtypes of general surgery (P for interaction = .68). Conclusions and Relevance:In this study, TXA significantly reduced the risk of perioperative bleeding without increasing cardiovascular risk in patients undergoing general surgery procedures. Trial Registration:ClinicalTrials.gov Identifier: NCT03505723.
BACKGROUND:Laparoscopic liver resection has been associated with less morbidity than, and similar global outcomes to, open liver resection. There is no robust evidence that these outcomes lead to similar clinical outcomes in patients aged over 80 years. The aim of this study was to analyse the short-term outcomes between open and laparoscopic liver resection in patients over 80 years old. METHODS:A retrospective analysis was undertaken. The study population comprised patients aged ≥ 80 years who underwent laparoscopic or open liver resection between January 2014 and December 2019, and who presented with resectable malignant tumours. The primary outcome was postoperative morbidity, according to Dindo-Clavien grading. Cox regression models were used to compute hazard ratios and 95% confidence intervals. Propensity score matching (1 : 1) was performed to balance the two groups according to independent prognostic factors for morbidity. RESULTS:A total of 988 patients were analysed from 34 centres (16 from Asia, 14 from Europe and 4 from America): 487 in the open group and 501 in the laparoscopic group. Independent risk factors associated with severe morbidity were the open approach (hazard ratio 1.59, 95% confidence interval 1.19 to 2.11; P < 0.001), Charlson Co-morbidity Index score > 7 (HR 1.69, 1.26 to 2.27; P < 0.001), more than one resected tumour (hazard ratio 1.55, 1.13 to 2.11; P = 0.006), major hepatectomy (hazard ratio 1.86, 1.22 to 2.83; P = 0.003), and Iwate score ≥ 7 (hazard ratio 1.43, 1.02 to 2.01; P = 0.03). Before propensity score matching, severe morbidity, length of intensive care unit stay, 90-day mortality, length of hospital stay, and readmission were better in the laparoscopic group (P < 0.050). These observations were confirmed after propensity score matching. CONCLUSION:The laparoscopic approach is a safe procedure for elderly patients, with better morbidity and mortality outcomes than the open approach, and should be considered as a default option.
BACKGROUND:Older adults aged 65 years and older considering major surgery often prioritise functional and cognitive outcomes over survival. Therefore, we conducted a prospective cohort study that aimed to characterise the incidence, effect, and predictors of new postoperative disability in older adults. METHODS:The Functional Improvement Trajectories After Surgery multicentre prospective cohort study enrolled older adults (ie, those aged ≥65 years) undergoing major elective non-cardiac surgery at 17 hospitals across Canada. Endovascular, joint replacement, intra-cranial, and palliative procedures were excluded. The WHO Disability Assessment Schedule was used to assess disability preoperatively and at 1, 3, 6, 9, and 12 months postoperatively. The primary outcome was 6-month significant new disability or death. The secondary outcome was this composite outcome at 12 months. Multivariable logistic regression models were used to estimate associations of baseline characteristics with outcomes. FINDINGS:Between Dec 16, 2019, and April 26, 2023, we enrolled 2007 patients (median age 72 years [IQR 68-76]; 853 [42·5%] were female), of whom 1988 (99·1%) lived at home and 868 (43·3%) lived with frailty. By 6 months after surgery, 16·5% patients had significant new disability and death, increasing to 20·7% by 1 year. Patients with new disability at 6 months had higher risks of concurrent depression (risk difference 36·7%, 95% CI 31·9-41·6) and decisional regret (9·9%, 5·1-14·7). At 12 months, the higher risks of depression (33·6%, 28·2-39·0) and decisional regret (12·9%, 7·9-17·8) persisted. Multivariable modelling identified baseline frailty, cognitive impairment, mobility aids, open surgery, smoking, and possibly unmet social supports as associated with increased risks of postoperative new disability or death. INTERPRETATION:One in six older adults in this cohort experienced new disability or death at 6 months following major surgery, increasing to one in five patients by 1 year. Preoperative assessment of frailty, cognitive status, and social supports could enhance shared decision making, care planning, and functional recovery. FUNDING:Canadian Institutes of Health Research, PSI Foundation, Ontario Ministry of Health Innovation Fund, and the Elizabeth A and Richard J Currie, OC Chair in Translational Anesthesia Research at St Michael's Hospital and the University of Toronto.
Minimally invasive liver resection (MILR) is associated with fewer postoperative complications compared to open liver resection. Eastern Cooperative Oncology Group (ECOG) performance status (PS) is a fast, reproducible patient selection tool used to guide therapy. We compared patient outcomes after MILR by ECOG PS. Non-cirrhotic patients undergoing MILR resection at one of 14 North American healthcare centers were identified from the Americas Minimally Invasive Liver Surgery (AMILES) database (2010–2024). Perioperative outcomes were compared between ECOG1 and ECOG2 patients. Multivariable analysis (MVA) was used to identify factors independently associated with postoperative complications. Of 4,181 patients, 486 met our inclusion criteria. Median patient age was 62 years. Four-hundred twenty-eight patients (88.1
BACKGROUND:Despite the popularity of minimally invasive liver surgery (MILS), the optimal approach for incision dominant hepatectomy remains unclear. METHODS:We used the Americas Minimally Invasive Liver Resection Database (AMILES)to compare outcomes in patients undergoing incision-dominant hepatectomy (IDH) via different minimally invasive surgical (MIS) approaches. RESULTS:We identified 197 patients across 15 centers undergoing resection of segment VII and/or VIII. Of these patients, 138 patients underwent laparoscopic hepatectomy (LapH), 28 underwent hand-assisted laparoscopic hepatectomy (Hand-LapH), and 31 underwent robotic hepatectomy (RoboH). Our analysis indicated that there were no differences in outcomes in terms of post-operative complications (14.8 % LapH vs. 22.2 % Hand-LapH vs. 22.6 % RoboH, p = 0.400), ICU admission (10.2 % LapH vs. 11.1 % Hand-LapH vs. 19.4 % RoboH, p = 0.347) or achievement of R0 resection (86.2 % LapH vs. 100 % Hand-LapH vs. 83.9 % RoboH, p = 0.193). However, Hand-LapH was associated with significantly greater EBL (475 mL Hand-LapH vs. 200 mL RoboH vs. 100 mL LapH, p = 0.001) and LOS (median 4 days Hand-LapH vs. 3 days LapH vs. 2 days RoboH, p = 0.003) compared to other approaches. DISCUSSION:Our results demonstrate that MIS IDH can be performed safely, with some differences in outcomes across each technique.
Objective: To determine the epidemiology of postoperative 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 postoperative mortality among general surgery patients are not well characterized. Methods: VISION is a prospective cohort study of adult non-cardiac surgery patients across 28 centers 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 postoperative 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 postoperative 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 postoperative mortality (ie, 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, 9.8%, 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%). Conclusions: 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.
INTRODUCTION:In moderate to high-risk surgical procedures, 15-25% of patients develop a postoperative surgical site infection. Intraoperative incisional wound irrigation has the potential to reduce surgical site infections, and additional randomised controlled trials are required to provide evidence of effectiveness. METHODS AND ANALYSIS:This protocol describes a pragmatic, adaptive, participant and adjudicator-blinded trial at 13 sites in Canada in up to 2500 participants. Participants planned for surgery with an abdominal or groin incision, who are eligible and provide verbal consent through an integrated consent model, are randomised to receive intraoperative incisional wound irrigation with povidone-iodine, saline or no irrigation. The primary outcome is surgical site infection within 30 days postoperatively. Secondary outcomes include quality of life measured 30 days postoperatively and morbidity, mortality and healthcare utilisation within 90 days postoperatively. ETHICS AND DISSEMINATION:This trial has been approved by the research ethics board at the participating centres and stopped enrolling participants on May 23, 2025. All participants will provide verbal consent. Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov. TRIAL REGISTRATION NUMBER:The study is registered with http://clinicaltrial.gov (NCT04548661; 14 September 2020).
BACKGROUND:Timing to surgery for acute cholecystitis remains variable, ranging from early (< 7 d) to delayed surgery (> 7 d). Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine the feasibility of a trial comparing accelerated surgery with standard care among patients with calculous acute cholecystitis. METHODS:We conducted a multicentre pilot randomized controlled trial. We randomly assigned adult patients with acute cholecystitis to receive accelerated surgery (i.e., goal of surgery within 6 hours of diagnosis) or standard care. The primary feasibility outcome included recruitment of 60 patients, randomly assigning the equivalent of 1 patient per site per month, and 95% follow-up at 90 days. RESULTS:Sixty patients (mean age 61.7, standard deviation [SD] 13.5, yr; 27 [45%] female) were randomly assigned to accelerated surgery (n = 31) or standard care (n = 29) from December 2019 to December 2021, with 2 recruitment pauses due to the COVID-19 pandemic. The median time from diagnosis to surgery was 5.8 (interquartile range [IQR] 4.4-11.1) hours in the accelerated care arm and 20.3 (IQR 6.8-26.8) hours in the standard care arm. Across 4 sites, 4.6 patients per month were randomly assigned. All patients completed the 90-day follow up. CONCLUSION:In our pilot trial, we found that accelerated cholecystectomy was achievable. These results show the feasibility of a trial comparing accelerated and standard care among patients requiring surgery for acute cholecystitis and support a definitive trial. TRIAL REGISTRATION:ClinicalTrials.gov, no. NCT04033822.
BACKGROUND:Robotic liver resections (RLR) are increasingly adopted, but their clinical advantages over laparoscopic liver resections (LLR) remain unclear. This study compared intraoperative and postoperative outcomes between RLR and LLR across surgical difficulty levels and institutions. METHODS:We analyzed 1683 patients (456 RLR [27.1 %] and 1227 LLR [72.9 %]) from the Americas Minimally Invasive Liver Resection (AMILES) database (2011-2024). Mixed-effects regression models accounted for institutional clustering. Outcomes included operative time, estimated blood loss, use of Pringle maneuver, intraoperative transfusion, length of stay, and postoperative complications. Subgroup analyses were performed by IWATE difficulty. RESULTS:RLR was associated with longer operative times than LLR (227 vs. 157 min; p = 0.004). In advanced-difficulty resections, RLR was associated with fewer major postoperative complications (1.7 % vs. 7.7 %; p = 0.013). Interaction testing demonstrated that the effect of surgical approach on transfusion risk and overall complications differed significantly by difficulty. Between-site heterogeneity in the effect of RLR was observed for operative time, use of Pringle maneuver, and intraoperative transfusion. CONCLUSION:RLR was associated with longer operative times overall, but in advanced-difficulty cases, RLR achieved lower rates of major complications. These findings highlight difficulty- and institution-specific variation that may guide adoption of RLR.