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Prospective, randomized clinical trial comparing use of intraoperative transesophageal echocardiography to standard care during radical cystectomy.

ABSTRACT: Purpose:Our prospective, randomized clinical study aims to evaluate the utility of intraoperative transesophageal echocardiography (TEE) in patients undergoing radical cystectomy. Materials and Methods:Eighty patients were randomized to a standard of care group or the intervention group that received continuous intraoperative TEE. Data are presented as means ± standard deviations, median (25th percentile, 75th percentile), or numbers and percentages. Characteristics were compared between groups using independent sample t-tests, Wilcoxon-Mann-Whitney tests or Chi-square tests, as appropriate. All tests were two-sided and P < 0.05 was considered to indicate statistical significance. Results:Both groups had similar preoperative demographic characteristics. There was a significant difference between central line insertion with all insertions in the control group (15%, 6 vs. 0%, 0; P < 0.003). Of all the perioperative complications, 80% occurred in the control group versus 20% in the TEE group, with 21% of controls experiencing a cardiac or pulmonary complication compared to 5% in the TEE group (8 vs. 2, P < 0.04). The control group patients were more likely to have adverse cardiac complications than the TEE group (15%, 6 vs. 3%, 1; P < 0.040). Postoperative cardiac arrhythmia was observed only in the control group (13%, 5 vs. 0%, 0; P <.007). Prolonged intubation was only observed in the control group (10%, 4 vs. 0%, 0; P < 0.017). Conclusion:TEE can be a useful monitoring tool in patients undergoing radical cystectomy, limiting the use of central line insertion and potentially translating into earlier extubation and decreased postoperative cardiac morbidities.

SUBMITTER: Dhawan R

PROVIDER: S-EPMC6078029 | biostudies-literature | 2018 Jul-Sep

REPOSITORIES: biostudies-literature

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Prospective, randomized clinical trial comparing use of intraoperative transesophageal echocardiography to standard care during radical cystectomy.

Dhawan Richa R Shahul Sajid S Roberts Joseph Devin JD Smith Norm D ND Steinberg Gary D GD Chaney Mark A MA

Annals of cardiac anaesthesia 20180701 3

<h4>Purpose</h4>Our prospective, randomized clinical study aims to evaluate the utility of intraoperative transesophageal echocardiography (TEE) in patients undergoing radical cystectomy.<h4>Materials and methods</h4>Eighty patients were randomized to a standard of care group or the intervention group that received continuous intraoperative TEE. Data are presented as means ± standard deviations, median (25<sup>th</sup> percentile, 75<sup>th</sup> percentile), or numbers and percentages. Characte ...[more]

PMID: 30052211

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Project description:Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk.To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques.A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively.Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach.Primary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score.The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings.This trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique.Of 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups.ClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.

Project description:PurposeRadical cystectomy/urinary diversion is a high risk procedure. Intraoperative stents are commonly utilized to decrease ureteroenteric anastomosis related complications. Institutionally some surgeons routinely use intraoperative stents while others do not, providing an opportunity to compare complication differences.Materials and methodsWe queried a prospective database of 283 patients enrolled in a randomized controlled trial evaluating 30-day perioperative complications with goal directed fluid therapy following open radical cystectomy/urinary diversion between 2014 and 2018. Ureteroenteric anastomosis specific complications (ureteral obstruction, urinary leak, urinary infections/sepsis and intra-abdominal abscess) were compared between groups (intraoperative stent vs nonintraoperative stent group) using Fisher exact test and quantified using logistic regression.ResultsThe nonintraoperative stent group (77 of 283 patients, 27%) was older (median 72 vs 69 years) and was more likely to receive neoadjuvant chemotherapy (53% vs 40%), have baseline renal insufficiency (43% vs 30%) and undergo an ileal conduit (92% vs 53%). However, despite higher comorbidity, the nonintraoperative stent group had a significantly lower rate of ureteroenteric anastomosis complications (14% vs 32%, p=0.004). Since continent diversions may be associated with higher complications, the nonintraoperative stent group with ileal conduit was also compared to intraoperative stent cohorts with ileal conduit, and ureteroenteric anastomosis complications remained lower in the nonintraoperative stent group (14% vs 28%, p=0.043). Multivariable logistic regression showed significantly increased odds of urinary complications with intraoperative stent use (OR 3.55, 95% CI 2.93-4.31; p <0.0001). Importantly there was no obstruction and only 1 leak (1.3%) in the nonintraoperative stent group.ConclusionsContrary to conventional belief, we found intraoperative stent use in radical cystectomy/urinary diversion was associated with significantly higher infectious complications and urgent care visits, and significantly increased the odds of 30-day ureteroenteric anastomosis associated complications.

Project description:BackgroundPostoperative ileus is a common complication of intraabdominal surgeries, including radical cystectomy with reported rates as high as 32%. Perioperative fluid administration has been associated with improvement in postoperative ileus rates, but it is difficult to generalize because earlier studies lacked standardized definitions of postoperative ileus and other relevant outcomes. The hypothesis was that targeted individualized perioperative fluid management would improve postoperative ileus in patients receiving radical cystectomy.MethodsThis is a parallel-arm, double-blinded, single-center randomized trial of goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy. The primary outcome was postoperative ileus, and the secondary outcome was complications within 30 days post-surgery. Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation. The intervention in the goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring.ResultsBetween August 2014 and April 2018, 283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy) were included in the analysis. Postoperative ileus occurred in 25% (36 of 142) of patients in the goal-directed fluid therapy arm and 21% (30 of 141) of patients in the standard arm (difference in proportions, 4.1%; 95% CI, -5.8 to 13.9; P = 0.418). There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).ConclusionsGoal-directed fluid therapy may not be an effective strategy for lowering the risk of postoperative ileus in patients undergoing open radical cystectomy.

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Prospective, randomized clinical trial comparing use of intraoperative transesophageal echocardiography to standard care during radical cystectomy.

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Prospective, randomized clinical trial comparing use of intraoperative transesophageal echocardiography to standard care during radical cystectomy.

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