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result(s) for
"Surgical Procedures, Operative - mortality"
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National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training
by
Bilimoria, Karl Y
,
Hedges, Larry V
,
Mellinger, John D
in
Accreditation
,
Clinical outcomes
,
Continuity of Patient Care
2016
In this randomized trial comparing ACGME duty-hour policies with more flexible policies for surgical residents, the flexible policies resulted in noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality.
In response to concerns about patient safety and resident well-being, the Accreditation Council for Graduate Medical Education (ACGME) introduced national regulations in 2003 that limited resident duty periods to 80 hours per week, capped overnight shift lengths, and mandated minimum time off between shifts.
1
,
2
Concerns persisted,
3
and in 2011, the ACGME implemented further restrictions to shorten maximum shift lengths for interns and increase time off after overnight on-call duty for residents.
1
,
4
,
5
Although most observers agree that some duty-hour regulation was necessary, critics cite a weak evidence base for the 2003 and 2011 reforms.
3
,
6
,
7
Several retrospective . . .
Journal Article
Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial
2021
AbstractObjectiveTo determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic.DesignMulticentre randomised controlled trial.Setting8 acute care hospitals in Canada.Participants905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up.InterventionParticipants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre’s usual care. Patients, healthcare providers, and data collectors were aware of patients’ group allocations. Outcome adjudicators were blinded to group allocation.Main outcome measuresThe primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation.ResultsAll 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval −0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (−0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation.ConclusionVirtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function.Trial registrationClinicalTrials.gov NCT04344665.
Journal Article
Aspirin in Patients Undergoing Noncardiac Surgery
by
Berwanger, Otavio
,
Srinathan, Sadeesh
,
Villar, Juan Carlos
in
Aged
,
Aspirin
,
Aspirin - adverse effects
2014
In this trial, administering aspirin before surgery and during the early postsurgical period did not affect the rate of death or nonfatal MI but increased the risk of major bleeding. This was true in patients who had not been taking aspirin and in those on a long-term aspirin regimen.
Myocardial infarction is the most common major vascular complication that occurs after noncardiac surgery.
1
–
3
Noncardiac surgery is associated with platelet activation,
4
and coronary-artery thrombus may be a mechanism of perioperative myocardial infarction.
5
,
6
Aspirin inhibits platelet aggregation,
7
and the perioperative administration of aspirin may prevent major vascular complications by inhibiting thrombus formation.
8
In a meta-analysis of data from large, randomized trials involving more than 110,000 patients who were not undergoing surgery, the use of aspirin was shown to prevent myocardial infarction and major vascular events.
9
High-dose aspirin has not been shown to be superior to low-dose aspirin in preventing . . .
Journal Article
Clonidine in Patients Undergoing Noncardiac Surgery
by
Berwanger, Otavio
,
Srinathan, Sadeesh
,
Villar, Juan Carlos
in
Adrenergic alpha-2 Receptor Agonists - adverse effects
,
Adrenergic alpha-2 Receptor Agonists - therapeutic use
,
Aged
2014
In this trial, clonidine, an α2-adrenergic agonist, did not reduce the rate of death or MI among patients undergoing noncardiac surgery. Clonidine did increase the risk of perioperative hypotension, bradycardia, and nonfatal cardiac arrest.
Myocardial infarction is the most common major vascular complication of surgery and is associated with substantial mortality.
1
During and after noncardiac surgery, there is marked activation of the sympathetic nervous system, which can lead to a mismatch between the supply of and demand for myocardial oxygen and to subsequent myocardial infarction.
2
–
4
We previously reported that perioperative administration of a high-dose, long-acting beta-blocker (initiated 2 to 4 hours before surgery and continued after surgery) reduced the risk of myocardial infarction but increased the risk of death, stroke, and clinically important hypotension.
5
Clonidine, an α
2
-adrenergic agonist, blunts central sympathetic . . .
Journal Article
A Randomized, Controlled Trial of the Use of Pulmonary-Artery Catheters in High-Risk Surgical Patients
by
Hull, Russell Douglas
,
Brant, Rollin Frederick
,
Passerini, Louise
in
Aged
,
Catheterization, Swan-Ganz - adverse effects
,
Catheters
2003
In this large trial, elderly, high-risk patients were randomly assigned before surgery to goal-directed therapy guided by a pulmonary-artery catheter or to standard care without the use of such a catheter. There was no significant difference between the groups in mortality in the hospital or at 6 or 12 months. Pulmonary embolism was more frequent in the catheter group.
These findings argue against the routine use of this catheter during and after surgery.
The clinical value of data obtained from pulmonary-artery catheters remains unproven. The light, flexible, balloon-tipped, flow-directed pulmonary-artery catheter was introduced clinically three decades ago,
1
and its use has continued without definitive evidence of decreased morbidity or mortality.
2
More than 1.5 million pulmonary-artery catheters are inserted into medical and surgical patients in North America annually,
3
despite calls for a moratorium
4
,
5
on the use of this invasive technology because observational studies have suggested an association with increased mortality.
6
–
8
Proponents argue that physiological measurements provided by the use of a pulmonary-artery catheter permit refinements of treatment that improve patients' outcomes. This . . .
Journal Article
Does Obstructive Sleep Apnea Affect Perioperative Complications? A Retrospective Study Using a Modified NSQIP Database
2020
Background
Obstructive sleep apnea (OSA) has been linked to increased perioperative complications. The National Surgical Quality Improvement Project (NSQIP), which is the leading outcomes-based patient database, does not report OSA as a comorbidity. Therefore, we started recording the patient's OSA status as part of Lahey Hospital and Medical Center’s (LHMC) NSQIP database in an effort to study the effect of OSA on perioperative complications.
Methods
Starting July 2013 we have been including patients’ OSA status in our hospital's NSQIP database. We conducted chart review of all patients who underwent any surgical intervention at LHMC between 2013 and 2016 and identified those who had OSA as part of their medical history. We then compared their perioperative mortality and complications to a matched sample.
Results
A total of 7872 patients were examined. In total, 739 patients had OSA bringing our prevalence to 9.4%. In total, 631 were matched to patients without OSA after adjusting for age, gender, BMI and multiple other comorbidities. We found no statistically significant difference in 30-day mortality (0.1 vs 0%), unplanned intubation (2.6 vs 1.1%), pulmonary embolism (0.5 vs 0.2%), respiratory failure requiring mechanical ventilation (2.3 vs 1.4%), cardiac arrest (0.5 vs 0.3%), myocardial infarction (0.4 vs 0.5%), surgical site infections (4.6 vs 4.3%), sepsis (2.4 vs 1.9%) and average length of stay (3.8 vs 4.2).
Conclusion
Patients with OSA did not have any statistically significant difference in post-op complications or mortality when compared to patients without OSA. This is the first study that tracked OSA status as part of the NSQIP database and studied its effect on perioperative complications. Randomized controlled studies are needed to conclude whether OSA status affects perioperative outcomes.
Journal Article
Trimetazidine offers myocardial protection in elderly coronary artery disease patients undergoing non-cardiac surgery: a randomized, double-blind, placebo-controlled trial
2021
Background
Trimetazidine (TMZ) pretreatment protects cardiomyocytes during cardiac surgery. TMZ may protect elderly patients with ischaemic heart disease (IHD) undergoing non-cardiac surgery.
Methods
This was a randomized, double-blind, placebo-controlled trial (registration #ChiCTR1900025018) of patients with IHD scheduled to undergo non-cardiac surgery at Shenzhen People’s Hospital (Shenzhen, Guangdong Province, China) between June 2014 and September 2015, randomized to 60 mg TMZ or placebo 12 h before surgery. The primary endpoint was the occurrence of in-hospital cardiovascular events. The secondary endpoints were myocardial ischaemia on five-lead electrocardiogram (cECG), cardiac troponin I (cTnI) elevation, cardiac death, acute coronary events, heart failure, and arrhythmia requiring treatments.
Results
Compared with the placebo group, the TMZ group showed a lower occurrence of in-hospital cardiovascular events (primary endpoint, 20.0% vs. 37.5%,
P
= 0.02), myocardial ischaemia (15.0% vs. 32.5%,
P
< 0.01), cTnI elevation (2.5% vs. 10%,
P
< 0.01), acute coronary events (10.0% vs. 20.0%,
P
< 0.05), heart failure (0% vs. 2.5%,
P
< 0.05), and arrhythmia requiring treatment (17.5% vs. 35.0%,
P
< 0.05). There was no acute myocardial infarction during the 30-day postoperative period.
Conclusions
In elderly patients with IHD undergoing non-cardiac surgery, TMZ pretreatment was associated with myocardial protective effects.
Trial registration
The trial was prospectively registered at
http://www.chictr.org.cn/showproj.aspx?proj=41909
with registration number [ChiCTR1900025018] (7/8/2019).
Journal Article
TRACE (Routine posTsuRgical Anesthesia visit to improve patient outComE): a prospective, multicenter, stepped-wedge, cluster-randomized interventional study
2018
Background
Perioperative complications occur in 30–40% of non-cardiac surgical patients and are the leading cause of early postoperative morbidity and mortality. Regular visits by trained health professionals may decrease the incidence of complications and mortality through earlier detection and adequate treatment of complications. Until now, no studies have been performed on the impact of routine postsurgical anesthesia visits on the incidence of postoperative complications and mortality.
Methods
TRACE is a prospective, multicenter, stepped-wedge cluster randomized interventional study in academic and peripheral hospitals in the Netherlands. All hospitals start simultaneously with a control phase in which standard care is provided. Sequentially, in a randomized order, hospitals cross over to the intervention phase in which patients at risk are routinely followed up by an anesthesia professional at postoperative days 1 and 3, aiming to detect and prevent or treat postoperative complications. We aim to include 5600 adult patients who are at high risk of developing complications. The primary outcome variable is 30-day postoperative mortality. Secondary outcomes include incidence of postoperative complications and postoperative quality of life up to one year following surgery.
Statistical analyses will be performed to compare the control and intervention cohorts with multilevel linear and logistic regression models, adjusted for temporal trends and for clusters (hospitals). The time horizon of the economic (cost-effectiveness) evaluation will be 30 days and one year following surgery.
Discussion
TRACE is the first to study the effects of a routine postoperative visit by an anesthesia healthcare professional on mortality and cost-effectiveness of surgical patients. If the intervention proves to be beneficial for the patient and cost-effective, the stepped-wedge design ensures direct implementation in the participating hospitals.
Trial registration
Nederlands Trial Register/Netherlands Trial Registration,
NTR5506
. Registered on 02 December 2015.
Journal Article
Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study
2020
The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection.
This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation.
This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p<0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p<0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p<0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047).
Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery.
National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research.
Journal Article
Comparison of postoperative outcomes among patients treated by male and female surgeons: a population based matched cohort study
by
Wallis, Christopher JD
,
Coburn, Natalie
,
Ravi, Bheeshma
in
Adult
,
Age Factors
,
Ambulatory care
2017
Objective To examine the effect of surgeon sex on postoperative outcomes of patients undergoing common surgical procedures.Design Population based, retrospective, matched cohort study from 2007 to 2015.Setting Population based cohort of all patients treated in Ontario, Canada.Participants Patients undergoing one of 25 surgical procedures performed by a female surgeon were matched by patient age, patient sex, comorbidity, surgeon volume, surgeon age, and hospital to patients undergoing the same operation by a male surgeon.Interventions Sex of treating surgeon.Main outcome measure The primary outcome was a composite of death, readmission, and complications. We compared outcomes between groups using generalised estimating equations.Results 104 630 patients were treated by 3314 surgeons, 774 female and 2540 male. Before matching, patients treated by female doctors were more likely to be female and younger but had similar comorbidity, income, rurality, and year of surgery. After matching, the groups were comparable. Fewer patients treated by female surgeons died, were readmitted to hospital, or had complications within 30 days (5810 of 52 315, 11.1%, 95% confidence interval 10.9% to 11.4%) than those treated by male surgeons (6046 of 52 315, 11.6%, 11.3% to 11.8%; adjusted odds ratio 0.96, 0.92 to 0.99, P=0.02). Patients treated by female surgeons were less likely to die within 30 days (adjusted odds ratio 0.88; 0.79 to 0.99, P=0.04), but there was no significant difference in readmissions or complications. Stratified analyses by patient, physician, and hospital characteristics did not significant modify the effect of surgeon sex on outcome. A retrospective analysis showed no difference in outcomes by surgeon sex in patients who had emergency surgery, where patients do not usually choose their surgeon.Conclusions After accounting for patient, surgeon, and hospital characteristics, patients treated by female surgeons had a small but statistically significant decrease in 30 day mortality and similar surgical outcomes (length of stay, complications, and readmission), compared with those treated by male surgeons. These findings support the need for further examination of the surgical outcomes and mechanisms related to physicians and the underlying processes and patterns of care to improve mortality, complications, and readmissions for all patients.
Journal Article