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COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial.

ABSTRACT: INTRODUCTION:Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for the evacuation of cSDH leads to higher patient satisfaction with the aesthetical result at 90 days postoperative, without worsening disability outcomes or increasing the complication rate. METHODS AND ANALYSIS:This is a prospective, single-blinded, randomised, controlled, investigator-initiated clinical trial enrolling 80 adult patients with first-time unilateral or bilateral cSDH in Switzerland. The primary outcome is the difference in satisfaction with the aesthetic result of the scar, comparing patients allocated to the intervention (burr hole cover) and control (no burr hole cover) group, measured on the Aesthetic Numeric Analogue scale at 90 days postoperative. Secondary outcomes include differences in the rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative. ETHICS AND DISSEMINATION:The institutional review board (Kantonale Ethikkommission Zürich) approved this study on 29 January 2019 under case number BASEC 2018-01180. This study determines, whether a relatively minor modification of a standard surgical procedure can improve patient satisfaction, without worsening functional outcomes or increasing the complication rate. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years. TRIAL REGISTRATION NUMBER:NCT03755349.

SUBMITTER: Stienen MN

PROVIDER: S-EPMC6924766 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial.

Stienen Martin N MN Akeret Kevin K Vasella Flavio F Velz Julia J Jehli Elisabeth E Scheffler Pierre P Voglis Stefanos S Bichsel Oliver O Smoll Nicolas Roydon NR Bozinov Oliver O Regli Luca L Germans Menno R MR

BMJ open 20191206 12

<h4>Introduction</h4>Outcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for ...[more]

PMID: 31811007

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Project description:BackgroundChronic subdural haematoma (CSDH) is one of the most common types of intracranial haematoma, and often occurs in older people. Burr-hole craniostomy, which is an evacuation through one or two burr holes drilled over the site of the haematoma, has been widely accepted as the most effective way to manage CSDH. Recurrences are a major problem and need reoperation, sometimes repeatedly.ObjectivesTo assess the effects and safety of the use of external drains versus no drains after burr-hole evacuation for the treatment of CSDH in adults.Search methodsWe ran our first search on 27 November 2014. We searched the Cochrane Injuries Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE (OvidSP), Embase Classic+Embase (OvidSP), PubMed, ISI WOS (SCI-EXPANDED, SSCI, CPCI-S and CPSI-SSH), Chinese databases, and clinical trials registers, and screened reference lists. In compliance with the MECIR conduct standard 37, the Cochrane Injuries Group Information Specialist ran an update search within 12 months of publication (25 April 2016). We have screened these results but not incorporated the findings into the current review; as a result of the update search, one trial is awaiting classification.Selection criteriaWe included randomized controlled trials (RCTs) that compared external subdural drains with no drains after burr-hole evacuation for the treatment of CSDH in adults.Data collection and analysisTwo review authors identified potential articles from the literature search, extracted data independently using a data extraction form and assessed risk of bias using the Cochrane 'Risk of bias' tool. For dichotomous data, where statistical heterogeneity was low, we calculated summary risk ratios with 95% confidence intervals using a fixed-effect model.Main resultsNine RCTs, including a total of 968 participants, reported outcomes specified by this review. Only one RCT reported the use of an adequate method of allocation concealment; this trial was a large, single-centre, high quality study and was adequately reported. All included trials reported a reduced recurrence of CSDH with external subdural drains. We found a significant reduction in the risk of recurrence with subdural drains (RR 0.45, 95% CI 0.32 to 0.61, I(2) = 38%; 9 studies, 968 participants; moderate-quality evidence). There was no strong evidence of any increase in complications (RR 1.15; 95% CI 0.77 to 1.72, I(2) = 0%; 7 studies, 710 participants; low-quality evidence), mortality (RR 0.78, 95% CI 0.45 to 1.33, I(2) = 22%; 5 studies, 539 participants; low-quality evidence), or poor functional outcome (which included deaths) (RR 0.68, 95% CI 0.44 to 1.05, I(2) = 31%; 5 studies, 490 participants; low-quality evidence).Authors' conclusionsThere is some evidence that postoperative drainage is effective in reducing the symptomatic recurrence of CSDH. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Due to the low quality of the evidence for the secondary outcomes, the effect of drainage on the occurrence of surgical complications, mortality and poor functional outcome is uncertain. This uncertainty can be clarified with data from high-quality studies which may be conducted in the future. There is no strong evidence of any increase in complications when drains are used.

Project description:BackgroundThe aesthetic outcome after burr hole trepanation for the evacuation of chronic subdural hematomas (cSDH) is often unsatisfactory, as the bony skull defects may cause visible skin depressions. The purpose of this study was to evaluate the efficacy of burr hole cover placement to improve the aesthetic outcome.MethodsWe reviewed consecutive patients treated by burr hole trepanation for cSDH with or without placement of burr hole covers by a single surgeon between October 2016 and May 2018. The clinical data, including complications, were derived from the institution's prospective patient registry. The primary endpoint was the aesthetic outcome, as perceived by patients on the aesthetic numeric analog (ANA) scale, assessed by means of a standardized telephone interview. Secondary endpoints were skin depression rates and wound pain, as well as complications.ResultsFrom n = 33, outcome evaluation was possible in n = 28 patients (n = 24 male; mean age of 70.4 ± 16.1 years) with uni- (n = 20) or bilateral cSDH (n = 8). A total of 14 burr hole covers were placed in 11 patients and compared to 50 burr holes that were not covered. Patient satisfaction with the aesthetic outcome was significantly better for covered burr holes (mean ANA 9.3 ± 0.74 vs. 7.9 ± 1.0; p < 0.001). Skin depressions occurred over 7% (n = 1/14) of covered and over 92% (n = 46/50) of uncovered burr holes (p < 0.001). There was no difference in wound pain (p = 0.903) between covered and uncovered sites. No surgical site infection, cSDH recurrence, or material failure was encountered in patients who had received a burr hole plate.ConclusionsIn this retrospective series, placement of burr hole covers was associated with improved aesthetic outcome, likely due to reduction of skin depressions. A randomized controlled trial is developed to investigate whether adding burr hole covers results in superior aesthetic outcomes, without increasing the risk for complications.

Project description:Objective:Chronic subdural hematoma (CSDH) is a common disease. Atorvastatin calcium can increase CSDH absorption. However, whether atorvastatin can increase hematoma absorption and reduce recurrence at high altitudes is not clear. Methods:After burr-hole drainage, CSDH patients were divided into an atorvastatin group and a control group. Follow-up computed tomography (CT) was performed on day 1, months 1, 2, and 3 after surgery. Then, the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, and Markwalder grading scale score (MGSS) were calculated, and related risk factors were analyzed. Results:The non-recurrent and recurrent patients in the control group differed significantly in terms of the hemoglobin concentration (HB) [176.24 ± 16.43 vs. 194.25 ± 12.34 (g/L), p < 0.01], CT value [41.92 ± 10.76 vs. 34.12 ± 8.78 (Hu), p < 0.01], and low-density time [3.88 ± 1.04 vs. 5.50 ± 0.87 (d), p < 0.01]. The non-recurrent and recurrent patients in the atorvastatin group differed significantly in terms of the HB [172.66 ± 16.41 vs. 190.45 ± 10.23 (g/L), p < 0.01], CT value [38.91 ± 7.16 vs. 29.50 ± 8.61 (Hu), p < 0.01], and mixed [2 vs. 4 (n), p < 0.05] and low-density time [4.09 ± 0.75 vs. 5.45 ± 1.12 (d), p < 0.01]. The logistic regression analysis showed that HB [odds ratio, 1.14; 95% confidence interval (CI), 1.04-1.25 in the control group, odds ratio, 1.13; 95% CI, 1.03-1.23 in the atorvastatin group] and low-density time (odds ratio, 3.53; 95% CI, 1.42-8.74 in the control group, odds ratio, 2.53; 95% CI, 1.10-5.80 in the atorvastatin group) were possible risk factors for the two groups. The receiver operating characteristic curves showed that the area under the receiver operating characteristic curve values for the HB, CT value (Hu), and low-density time were 0.812, 0.702, and 0.755 for all subjects; 0.812, 0.719, and 0.790 for the control group; and 0.807, 0.682, and 0.756 for the atorvastatin group, respectively. The postoperative follow-up results showed that there was no significant difference in the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, or MGSS between the two groups. Conclusion:The effect of atorvastatin was not significant after the operation. The risk factors for CSDH recurrence were the HB and low-density time. The HB was the most specific and sensitive predictor of CSDH recurrence.

Dataset Information

COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial.

Publications

COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial.

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