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result(s) for
"Intraoperative Complications - epidemiology"
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Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke
2021
In a randomized trial, 4811 patients with atrial fibrillation were assigned to undergo or not undergo left atrial appendage occlusion during cardiac surgery for another indication. At 3 years, 77% of the patients continued to receive oral anticoagulation. At 3.8 years, the risk of ischemic stroke or systemic embolism was significantly lower with occlusion than without it.
Journal Article
Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer
by
Collet, Denis
,
Meunier, Bernard
,
Mabrut, Jean-Yves
in
Abdomen
,
Adenocarcinoma - surgery
,
Adult
2019
Open esophagectomy involves laparotomy and thoracotomy. Laparoscopic abdominal surgery may be useful for reducing complications, but does it control the cancer? A trial suggests that morbidity is lower and cancer outcomes are at least as good with the hybrid procedure as with the open procedure.
Journal Article
A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair
by
Nager, Charles W
,
Kenton, Kim
,
Amundsen, Cindy L
in
Aged
,
Biological and medical sciences
,
Bladder
2012
Women undergoing surgery for vaginal prolapse are at risk for urinary incontinence. In this randomized trial, women who received a midurethral sling had lower rates of incontinence at 3 and 12 months but higher rates of adverse events than those who received sham incisions.
One in five women will undergo surgery for pelvic-organ prolapse in her lifetime,
1
and urinary incontinence commonly occurs with pelvic-organ prolapse. In previously continent women with pelvic-organ prolapse, urinary incontinence develops in approximately a quarter of them after prolapse repair; this phenomenon is referred to as occult, latent, de novo, iatrogenic, or potential stress urinary incontinence.
2
In 2006, the Colpopexy and Urinary Reduction Efforts (CARE) trial
2
showed that adding a bladder-neck suspension at the time of abdominal prolapse surgery in women without preoperative stress incontinence significantly reduced the risk of postoperative stress urinary incontinence (23.8%, vs. 44.1% in the control . . .
Journal Article
Retropubic versus Transobturator Midurethral Slings for Stress Incontinence
by
Nager, Charles W
,
Richter, Holly E
,
Brubaker, Linda
in
Biological and medical sciences
,
Comparative Effectiveness Research
,
Female
2010
This randomized trial comparing retropubic and transobturator slings for the treatment of stress urinary incontinence showed equivalent rates of treatment success according to objective criteria; the rates of treatment success in the two groups according to subjective criteria were similar but did not meet the criteria for equivalence. Complications differed in the two groups, with more voiding dysfunction requiring surgery in the retropubic-sling group and more neurologic symptoms in the transobturator-sling group.
In this randomized trial, two surgical approaches for the treatment of stress urinary incontinence had similar cure rates, although the complications differed by group.
Urinary incontinence affects up to 50% of women, resulting in substantial medical, social, and economic burdens.
1
,
2
Among U.S. women with urinary incontinence, 15 to 80% have a component of stress incontinence,
3
which results in leakage of urine during physical exertion, sneezing, and coughing.
4
Of these women, 4 to 10% undergo surgery.
5
In 1996, Ulmsten et al.
6
introduced a procedure that involved the placement of a retropubic midurethral mesh sling for the treatment of stress incontinence; this procedure was less invasive than the Burch colposuspension and the autologous rectus fascial sling procedures that were the reference standards at the time. . . .
Journal Article
Safety and feasibility of intraoperative high PEEP titrated to the lowest driving pressure during anesthesia for minimally invasive abdominal surgery – Interim analysis of GENERATOR
by
Hollmann, Markus W.
,
Neto, Ary Serpa
,
Germann, Reinhard
in
Abdomen
,
Abdomen - surgery
,
Abdominal surgery
2025
The optimal level of positive end–expiratory pressure (PEEP) during minimally invasive abdominal surgery is uncertain. Intraoperative ventilation with individualized high PEEP and recruitment maneuvers can be used to keep the driving pressure (ΔP) low, but can also lead to hypotension. In addition, the resulting ΔP and feasibility of individualized high PEEP in minimally invasive abdominal surgery is unclear.
Planned interim analysis on safety and feasibility of ‘Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery’ (GENERATOR), an ongoing randomized clinical trial that compares individualized high PEEP, titrated to the lowest ΔP, with a standard low PEEP ventilation strategy with respect to postoperative pulmonary complications. The primary endpoint for this analysis was the proportion of patients with intraoperative hypotension. Secondary endpoints were other intraoperative complications, ventilation variables and feasibility parameters.
From December 2023 to July 2024, 181 patients were enrolled. Data for analysis were available for 177 patients, of which 87 patients were randomized to individualized high PEEP and 90 to standard low PEEP. Intraoperative hypotension was similar between the individualized high PEEP vs standard low PEEP group (11.5 vs 11.1 %, relative risk ratio 1.0 [95 % CI 0.5–2.4], p = 1.00), while vasopressor use was higher in the intervention group. The median difference in ΔP between both groups was 6 cm H2O. Protocol compliance was 81.6 % in the individualized high PEEP group vs 97.8 % in the standard low PEEP group; most instances of non–compliance in the individualized high PEEP group concerned a level of PEEP that was too high.
In minimally invasive abdominal surgery, a ventilation strategy using individualized high PEEP was not associated with a higher incidence of hypotension, but did show an increased use of vasopressors. The intervention was highly feasible, and led to a lower ΔP. These interim findings warrant confirmation in the main analysis of GENERATOR.
This research was funded by ZonMW, grant number 10390012110091.
•Individualized high PEEP ventilation is feasible in minimally invasive abdominal surgery.•Intraoperative hypotension is similar between individualized high PEEP and standard low PEEP.•Vasopressors were used in higher doses with individualized high PEEP compared to standard low PEEP.•Driving pressure was lower with individualized high PEEP compared to standard low PEEP.
Journal Article
Perioperative goal-directed therapy with artificial intelligence to reduce the incidence of intraoperative hypotension and renal failure in patients undergoing lung surgery: A pilot study
by
Alkoudmani, Ibrahim
,
Denn, Sara Marie
,
Schneck, Emmanuel
in
Acute kidney injury
,
Acute Kidney Injury - epidemiology
,
Acute Kidney Injury - etiology
2025
The aim of this study was to investigate whether goal-directed treatment using artificial intelligence, compared to standard care, can reduce the frequency, duration, and severity of intraoperative hypotension in patients undergoing single lung ventilation, with a potential reduction of postoperative acute kidney injury (AKI).
single center, single-blinded randomized controlled trial.
University hospital operating room.
150 patients undergoing lung surgery with single lung ventilation were included.
Patients were randomly assigned to two groups: the Intervention group, where a goal-directed therapy based on the Hypotension Prediction Index (HPI) was implemented; the Control group, without a specific hemodynamic protocol.
The primary outcome measures include the frequency, duration of intraoperative hypotension, furthermore the Area under MAP 65 and the time-weighted average (TWA) of MAP of 65. Other outcome parameters are the incidence of AKI and myocardial injury after non-cardiac surgery (MINS).
The number of hypotensive episodes was lower in the intervention group compared to the control group (0 [0–1] vs. 1 [0–2]; p = 0.01), the duration of hypotension was shorter in the intervention group (0 min [0–3.17] vs. 2.33 min [0–7.42]; p = 0.01). The area under the MAP of 65 (0 mmHg * min [0−12] vs. 10.67 mmHg * min [0–44.16]; p < 0.01) and the TWA of MAP of 65 (0 mmHg [0–0.08] vs. 0.07 mmHg [0–0.25]; p < 0.01) were lower in the intervention group.
The incidence of postoperative AKI showed no differences between the groups (6.7 % vs.4.2 %; p = 0.72). There was a trend to lower incidence of MINS in the intervention group (17.1 % vs. 31.8 %; p = 0.07). A tendency towards reduced postoperative infection was seen in the intervention group (16.0 % vs. 26.8 %; p = 0.16).
The implementation of a treatment algorithm based on HPI allowed us to decrease the duration and severity of hypotension in patients undergoing lung surgery. It did not result in a significant reduction in the incidence of AKI, however we observed a tendency towards lower incidence of MINS in the intervention group, along with a slight reduction in postoperative infections.
•What is known?•Hypotension is associated with worse outcomes, especially acute kidney injury and myocardial injury.•The hypotension prediction index (HPI), along with an algorithm, can predict and prevent hypotension in general surgery.•What is new?•The HPI was not employed to investigate the clinical outcomes in patients undergoing lung surgery.•An algorithm utilizing the HPI can reduce hypotensive episodes during lung surgery and a slight reduction in myocardial injury and infections was observed.
Journal Article
Effect of remimazolam induction on hemodynamics in patients undergoing valve replacement surgery: A randomized, double‐blind, controlled trial
Background The stability of hemodynamics during anesthesia induction in patients undergoing valve replacement surgery is particularly important. Remimazolam is a new type of benzodiazepine drug, with supposed advantages of rapid induction, rapid recovery, stable hemodynamics, and mild respiratory inhibition. Aim To evaluate the effect of remimazolam anesthesia induction on hemodynamics in patients undergoing valve replacement surgery. Methods This randomized, double‐blind, controlled trial enrolled consecutive patients undergoing mitral valve replacement (MVR)/aortic valve replacement (AVR)/double‐valve replacement (DVR) surgery on cardiopulmonary bypass (CPB). The study was conducted according to the Consolidated Standards of Reporting Trials statement. Participants were randomly assigned to receive either remimazolam or propofol induction of 30 patients each. All patients, data collectors, and data analyzers were blinded to the group allocation. The primary outcomes were the fluctuations in hemodynamic parameters (the difference of maximum or minimum heart rate to baseline, ▲HR, the difference of maximum or minimum mean arterial pressure to baseline, ▲MAP), the occurrence of cardiovascular events (hypotension, severe bradycardia), and the cumulative norepinephrine doses used per patient, averaged per group during induction. The secondary outcomes were hemodynamic parameters (heart rate, HR, mean arterial pressure, MAP, bispectral index, BIS, plasma lactic acid, Lac, and blood glucose, Glu values). Results A total of 60 patients with heart valve replacement were included in the final analysis, with 30 patients in each group. The ▲MAP was significantly lower in the remimazolam group than in the propofol group during induction (p < .05). The incidences of hypotension and the cumulative norepinephrine doses used per patient, averaged per group during induction were significantly lower in the remimazolam group than in the propofol group (p < .05). Conclusion Remimazolam may be safe and effective for induction and may as an alternative to propofol during anesthesia induction in patients undergoing valve replacement surgery. Remimazolam may be safe and effective for induction in patients undergoing valve replacement surgery.
Journal Article
Randomized Trial of Endoscopist-Controlled vs. Assistant-Controlled Wire-Guided Cannulation of the Bile Duct
by
Sahakian, Ara
,
Leonor, Paul
,
Laine, Loren
in
Adult
,
Bile Ducts - injuries
,
Bile Ducts - surgery
2016
Biliary cannulation is frequently the most difficult component of endoscopic retrograde cholangiopancreatography (ERCP). Techniques employed to improve safety and efficacy include wire-guided access and the use of sphincterotomes. However, a variety of options for these techniques are available and optimum strategies are not defined. We assessed whether the use of endoscopist- vs. assistant-controlled wire guidance and small vs. standard-diameter sphincterotomes improves safety and/or efficacy of bile duct cannulation.
Patients were randomized using a 2 × 2 factorial design to initial cannulation attempt with endoscopist- vs. assistant-controlled wire systems (1:1 ratio) and small (3.9Fr tip) vs. standard (4.4Fr tip) sphincterotomes (1:1 ratio). The primary efficacy outcome was successful deep bile duct cannulation within 8 attempts. Sample size of 498 was planned to demonstrate a significant increase in cannulation of 10%. Interim analysis was planned after 200 patients-with a stopping rule pre-defined for a significant difference in the composite safety end point (pancreatitis, cholangitis, bleeding, and perforation).
The study was stopped after the interim analysis, with 216 patients randomized, due to a significant difference in the safety end point with endoscopist- vs. assistant-controlled wire guidance (3/109 (2.8%) vs. 12/107 (11.2%), P=0.016), primarily due to a lower rate of post-ERCP pancreatitis (3/109 (2.8%) vs. 10/107 (9.3%), P=0.049). The difference in successful biliary cannulation for endoscopist- vs. assistant-controlled wire guidance was -0.5% (95% CI-12.0 to 11.1%) and for small vs. standard sphincerotome -0.9% (95% CI-12.5 to 10.6%).
Use of the endoscopist- rather than assistant-controlled wire guidance for bile duct cannulation reduces complications of ERCP such as pancreatitis.
Journal Article
Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial
2024
Maintaining hemodynamic stability during cardiac ablation under general anesthesia is challenging. Remimazolam, a novel ultrashort-acting benzodiazepine, is characterized by maintaining comparatively stable blood pressure and does not influence the cardiac conduction system, which renders it a reasonable choice for general anesthesia for cardiac ablation. We aimed to evaluate whether remimazolam is associated with a decreased incidence of intraoperative hypotension compared with desflurane.
In this single-centre, parallel-group, prospective, single-blind, randomized clinical trial, we randomized patients (1:1) into a remimazolam group (remimazolam-based total intravenous anesthesia) or desflurane group (propofol-induced and desflurane-maintained inhalational anesthesia) during cardiac ablation procedures for arrhythmia. The primary outcome was the incidence of intraoperative hypotensive events, defined as mean arterial pressure of < 60 mm Hg at any period.
Overall, we enrolled 96 patients between 2 August 2022 and 19 May 2023 (47 and 49 patients in the remimazolam and desflurane groups, respectively). The remimazolam group showed a significantly lower incidence of hypotensive events (14/47, 30%) than the desflurane group (29/49, 59%; relative risk [RR], 0.5; 95% confidence interval [CI], 0.31 to 0.83; P = 0.004). Remimazolam was associated with a lower requirement for bolus or continuous vasopressor infusion than desflurane was (23/47, 49% vs 43/49, 88%; RR, 0.56; 95% CI, 0.41 to 0.76; P < 0.001). No between-group differences existed in the incidence of perioperative complications such as nausea, vomiting, oxygen desaturation, delayed emergence, or pain.
Remimazolam was a viable option for general anesthesia for cardiac ablation. Remimazolam-based total intravenous anesthesia was associated with significantly fewer hypotensive events and vasopressor requirements than desflurane-based inhalational anesthesia was, without significantly more complications.
ClinicalTrials.gov (NCT05486377); first submitted 1 August 2022.
Journal Article
Determinants of postoperative complications in high-risk noncardiac surgery patients optimized with hemodynamic treatment strategies: A post-hoc analysis of a randomized multicenter clinical trial
by
El Amine, Younes
,
Lorne, Emmanuel
,
Fischer, Marc-Olivier
in
Acute kidney injury
,
Acute Kidney Injury - epidemiology
,
Acute Kidney Injury - etiology
2024
This post-hoc analysis of a randomized controlled trial was undertaken to establish the determinants of postoperative complications and acute kidney injury in high-risk noncardiac surgery patients supported with hemodynamic treatment strategies.
We conducted a post-hoc analysis of patients enrolled in the OPtimization Hemodynamic Individualized by the respiratory QUotiEnt (OPHIQUE) trial.
Operating rooms in four university medical centers and one non-university hospital from December 26, 2018, to September 9, 2021.
We enrolled 350 patients with a high risk of postoperative complications undergoing high-risk noncardiac surgery lasting 2 h or longer under general anesthesia.
All patients were treated according to hemodynamic treatment strategies which included cardiac output optimization by titration of fluid challenge and targeted systolic blood pressure to remain within ±10% of the reference value.
We assessed the association between pre-operative and intra-operative exposure of interest with a composite primary outcome of major complications or death within seven days following surgery using a multivariable logistic regression model. We also assessed the association between these exposures of interest and acute kidney injury.
The data of 341 patients were analyzed. In multivariate analysis, the factors independently associated with the primary outcome were age (OR = 1.04 (1.01–1.06), P = 0.002), preoperative hemoglobin concentration (OR = 0.85 (0.75–0.96), P = 0.012), non-vascular surgery (OR = 0.30 (0.17–0.53), P < 0.0001), and intraoperative surgical complications (OR = 2.08 (1.02–4.24), P = 0.046). The factors independently associated with postoperative acute kidney injury were age (OR = 1.04 (1.01–1.08), P = 0.008), preoperative creatinine concentration (OR = 1.01 (1.00–1.01), P = 0.049), non-vascular surgery (OR = 0.36 (0.20–0.66), P = 0.001), and intraoperative surgical complications (OR = 3.36 (1.50–7.55), P = 0.031).
Surgical complications, a lower preoperative hemoglobin concentration, age, and vascular surgery were associated with postoperative complications in a high-risk noncardiac surgery population supported with hemodynamic treatment strategies.
•The prevalence of complications was high for patients treated according to hemodynamic treatment strategy.•factors associated with complications in this population were age, the preoperative hemoglobin and surgical complications.•These factors were associated with outcome in this population treated according to hemodynamic treatment strategy.•Neither blood pressure, cardiac output, intraoperative volume, nor norepinephrine dose were associated with complications.
Journal Article