Dataset Information

Postoperative Ecchymosis and Edema After Creation of Subperiosteal Tunnels in Rhinoplasty: A Randomized Clinical Trial.

ABSTRACT:

Importance

Periorbital ecchymosis and edema are commonly associated with rhinoplasty and are the principal limiting factors for return to daily activities after rhinoplasty. Several methods have been evaluated to minimize these sequelae including creation of subperiosteal tunnels, which involves elevating the vascular periosteal layer, preserving it from trauma when creating osteotomies.

Objective

To assess the efficacy of the creation of subperiosteal tunnels prior to lateral osteotomies during rhinoplasty for reducing postoperative ecchymosis and edema.

Design, setting, and participants

A randomized, blinded, matched-paired, prospective, clinical trial took place between April 1 and August 30, 2015, in a private practice in a stand-alone clinic and surgical center. All patients who were undergoing aesthetic rhinoplasty requiring bilateral lateral osteotomies were offered inclusion in the trial. All 34 enrolled patients completed the follow-up requirements.

Intervention

Creation of subperiosteal tunnels prior to lateral osteotomies on 1 randomly selected side.

Main outcomes and measures

Three blinded evaluators independently graded the degree of ecchymosis and edema on a visual analog scale of 0 to 10 on each side of the nose on postoperative days 2 and 7. Each patient had 1 side that was randomly selected to undergo creation of subperiosteal tunnels. A difference in mean score between sides of the nose was calculated for each patient using a paired t test.

Results

Of the 34 patients (28 females and 6 males; mean [SD] age, 27.3 [9.2]), the mean (SD) difference in ecchymosis scores between sides on day 2 was -0.05 (1.94) (95% CI, -0.43 to 0.33) and on day 7 was -0.22 (1.23) (95% CI, -0.47 to 0.02), favoring the side without tunnels. The mean (SD) difference in edema scores on day 2 was -0.21 (1.66) (95% CI, 0.53-0.12) and on day 7 was -0.29 (1.11) (95% CI, -0.51 to -0.07). There were no clinically significant differences between sides in terms of postoperative ecchymosis and edema.

Conclusions and relevance

Ecchymosis and edema can have significant postoperative practical, emotional, and financial effects on patients. Creation of subperiosteal tunnels prior to lateral osteotomies showed no clinically significant differences in edema and ecchymosis after the procedure.

Level of evidence

Trial registration

isrctn.org Identifier: ISRCTN42741475.

SUBMITTER: Chan DS

PROVIDER: S-EPMC6439794 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Postoperative Ecchymosis and Edema After Creation of Subperiosteal Tunnels in Rhinoplasty: A Randomized Clinical Trial.

Chan David S DS Roskies Michael M Jooya Alex Alborz AA Samaha Mark M

JAMA facial plastic surgery 20190301 2

<h4>Importance</h4>Periorbital ecchymosis and edema are commonly associated with rhinoplasty and are the principal limiting factors for return to daily activities after rhinoplasty. Several methods have been evaluated to minimize these sequelae including creation of subperiosteal tunnels, which involves elevating the vascular periosteal layer, preserving it from trauma when creating osteotomies.<h4>Objective</h4>To assess the efficacy of the creation of subperiosteal tunnels prior to lateral ost ...[more]

PMID: 30589927

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Project description:ImportanceEvidence has emerged on the efficacy of tranexamic acid to control blood loss and postoperative complications after rhinoplasty.ObjectiveTo investigate the results of tranexamic acid use to reduce intraoperative bleeding, postoperative eyelid edema, and periorbital ecchymosis in rhinoplasty.Data sources and study selectionFor this systematic review of randomized clinical trials, searches were performed in PubMed, Cochrane Central Register of Controlled Trials, Web of Science, SCOPUS, Science Direct, Google Scholar, OpenThesis, and ClinicalTrials.gov from inception to December 23, 2017. Key words included tranexamic acid, rhinoplasty, and nasal surgical procedures. The following elements were used to define eligibility criteria: (1) population: patients undergoing rhinoplasty surgery; (2) intervention and controls: tranexamic acid vs placebo solution or no-treatment control group; (3) outcomes: intraoperative bleeding, postoperative eyelid edema and periorbital ecchymosis, and thromboembolic events; and (4) study type: randomized clinical trials.Data extraction and synthesisTwo reviewers extracted data and assessed study quality according to the Cochrane guidelines for randomized clinical trials. Treatment effects were defined as weighted mean difference (WMD) and 95% CIs. The strength of evidence was analyzed using the Grading of Recommendations Assessment, Development, and Evaluation rating system.Main outcomes and measuresIntraoperative bleeding, postoperative eyelid edema and periorbital ecchymosis. To calculate the effect sizes, means and SDs were obtained for each study group and outcome of interest.ResultsFive studies comprising 276 patients were included in the systematic review: 177 patients (64.1%) were women, and mean age was 26.8 (range, 16-42) years. Four studies comprising 246 patients estimated the amount in intraoperative bleeding as a primary outcome and were included in the meta-analysis. Eyelid edema and ecchymosis were evaluated as outcomes in 2 studies. Tranexamic acid was associated with reduced bleeding during rhinoplasty was found (WMD, -42.28 mL; 95% CI, -70.36 to -14.21 mL), with differences (P?=?.01) between oral (WMD, -61.70 mL; 95%?CI, -83.02 to -40.39 mL; I2?=?0%) and intravenous (WMD, -23.88 mL; 95% CI, -45.19 to -2.58 mL; I2?=?56%) administration. Eyelid edema and ecchymosis scores in patients receiving tranexamic acid were significantly lower compared with the control group within the first postoperative week: lower eyelid edema, WMD, -0.76; 95% CI, -1.04 to -0.49 and lower eyelid ecchymosis, WMD, -0.94; 95% CI, -1.80 to -0.08. No cases of thromboembolic events were reported.Conclusions and relevanceCurrent available evidence suggests that preoperative administration of tranexamic acid is safe and may reduce intraoperative bleeding as well as postoperative eyelid edema and ecchymosis in patients undergoing rhinoplasty.

Project description:ObjectiveTo provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME).DesignRandomized phase II clinical trial.ParticipantsOne hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320.InterventionsRandom assignment to 1 of 5 groups: (A) focal photocoagulation at baseline (n = 19), (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks (n = 22), (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and 6 weeks (n = 24), (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at 6 weeks (n = 22), or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (n = 22).Main outcome measuresCentral subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks.ResultsAt baseline, median CST was 411 mum and median Snellen VA equivalent was 20/50. Compared with group A, groups B and C had a greater reduction in CST at 3 weeks and about 1 line better median VA over 12 weeks. There were no meaningful differences between groups B and C in CST reduction or VA improvement. A CST reduction > 11% (reliability limit) was present at 3 weeks in 36 of 84 (43%) bevacizumab-treated eyes and 5 of 18 (28%) eyes treated with laser alone, and at 6 weeks in 31 of 84 (37%) and 9 of 18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in 1 eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (n = 2), congestive heart failure (n = 1), elevated blood pressure (n = 3), and worsened renal function (n = 3).ConclusionThese results demonstrate that intravitreal bevacizumab can reduce DME in some eyes, but the study was not designed to determine whether treatment is beneficial. A phase III trial would be needed for that purpose.

Project description:Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results.To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME.Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment.Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME.Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study.Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P < .001) or ranibizumab (+13.6 [8.5]; 95% CI, +0.7 to +6.0; P = .009). When VA was 20/50 or worse at baseline, bevacizumab reduced CST less than the other agents at 1 year, but at 2 years the differences had diminished. In subgroups stratified by baseline VA, anti-VEGF agent, and whether focal/grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P < .001).Although post hoc analyses should be viewed with caution given the potential for bias, in eyes with a VA of 20/50 or worse, aflibercept has the greatest improvement in VA over 2 years. Focal/grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years.clinicaltrials.gov Identifier NCT01627249.

Project description:Delirium is a neurobehavioural syndrome that frequently develops in the postoperative setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 10 to 80% (Schonauer et al., J Pept Sci. 2017). Delirium was first described more than half a century ago in the cardiac surgery population (Blachy and Starr, Am J Psychiatry 121:371-5, 1964), where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population (Sessler et al., Am J Respir Crit Care Med 166:1338-44, 2002). This long-term experience with delirium suggests a high socioeconomic burden and has been a focus of many studies (Nishio et al., Crit Care Med 5:953-7, 1997; Ehlenbach et al., JAMA 303:763-70, 2010; Jahangir et al., World J Cardiol 3:383-7, 2011; Abegunde et al., Lancet 370:1929-1938, 2007; Darmon et al., Intensive Care Med 43:829-840, 2017; Marino et al., J Nephrol 28:717-24, 2015; Ng LL et al., J Am Coll Cardiol 69:56-69, 2017; Sezen et al., J Pharmacol Exp Ther 287:238-45, 1998; Kim et al., Ann Lab Med 37:388-97, 2017). Due to the multifactorial origin of delirium, we have several but no incontestable options for prevention and symptomatic treatment. Overall, delirium represents a high burden not only for patient and family members, but also for the medical care team that aims to prevent postoperative delirium to avoid serious consequences associated with it. The purpose of this study is to determine whether postoperative delirium can be prevented by the combination of established preventive agents. In addition, measured levels of pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100? will be used to investigate dynamics of these parameters in delirious and non-delirious patients after surgery.The Baden PRIDe Trial is an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial for the prevention of delirium with haloperidol, ketamine, and the combination of both vs. placebo in 200 patients scheduled for surgery. We would like to investigate superiority of one of the three treatment arms (i.e., haloperidol, ketamine, combined treatment) to placebo.There is limited but promising evidence that haloperidol and ketamine can be used to prevent delirium. Clinical care for patients might improve as the results of this study may lead to better algorithms for the prevention of delirium.ClinicalTrials.gov, NCT02433041 . Registered on 7 April 2015. Swiss National Clinical Trial Portal, SNCTP000001628. Registered on 9 December 2015.

Dataset Information

Postoperative Ecchymosis and Edema After Creation of Subperiosteal Tunnels in Rhinoplasty: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Intervention

Main outcomes and measures

Results

Conclusions and relevance

Level of evidence

Trial registration

Publications

Postoperative Ecchymosis and Edema After Creation of Subperiosteal Tunnels in Rhinoplasty: A Randomized Clinical Trial.

Similar Datasets

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