Dataset Information

Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial.

ABSTRACT:

Background

Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is generally removed after 48 h, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In our retrospective study, postoperative hematoma volume was found to significantly increase the risk of recurrence. Based on these results, an exhaustive drainage strategy is conducted to minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes.

Methods

This is a prospective, multicenter, open-label, blinded endpoint randomized controlled trial designed to include 304 participants over the age of 18-90 years presenting with a symptomatic CSDH verified on cranial computed tomography or magnetic resonance imaging. Participants will be randomly allocated to perform exhaustive drainage (treatment group) or fixed-time drainage (control group) after a one-burr hole craniostomy. The primary endpoint will be recurrence indicating a reoperation within 6 months.

Discussion

This study will validate the effect and safety of exhaustive drainage after one-burr hole craniostomy in reducing recurrence rates and provide critical information to improve CSDH surgical management.

Trial registration

Clinicaltrials.gov, NCT04573387. Registered on October 5, 2020.

SUBMITTER: Wu L

PROVIDER: S-EPMC10029260 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial.

Wu Liang L Ou Yunwei Y Zhu Bingcheng B Guo Xufei X Yu Xiaofan X Xu Long L Li Jinping J Feng Enshan E Li Huaqing H Wang Xiaodong X Chen Huaqun H Sun Zhaosheng Z Liu Zaofu Z Yang Dawei D Zhang Hongbing H Liu Zhigang Z Tang Jie J Zhao Shangfeng S Zhang Guobin G Yao Jiemin J Ma Dongming D Sun Zelin Z Zhou Hui H Liu Baiyun B Liu Weiming W

Trials 20230320 1

<h4>Background</h4>Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is generally removed after 48 h, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In our retrospective study, postoperative hematoma volume was fou ...[more]

PMID: 36941714

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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.

Project description:Background and objectivesEnhanced recovery programs may be especially useful in patients with chronic subdural hematoma or hygroma (cSDH), who frequently exhibit frailty and multimorbidity. We aim to evaluate the real-world safety and effectiveness of an enhanced recovery protocol in this population.MethodsFrom a prospective registry, burr hole evacuations for cSDH carried out under the protocol (including early thromboprophylaxis, no flat bed rest, early mobilization without drain clamping, and early resumption of antithrombotic medication) were extracted, along with those procedures carried out within the past year before protocol change. Propensity score-based matching was carried out. A range of clinical and imaging outcomes were analyzed, including modified Rankin Scale as effectiveness and Clavien-Dindo adverse event grading as safety primary end points.ResultsPer group, 91 procedures were analyzed. At discharge, there was no significant difference in the modified Rankin Scale among the standard and enhanced recovery groups (1 [1; 2] vs 1 [1; 3], P = .552), or in Clavien-Dindo adverse event grading classifications of adverse events (P = .282) or occurrence of any adverse events (15.4% vs 20.9%, P = .442). There were no significant differences in time to drain removal (2.00 [2.00; 2.00] vs 2.00 [1.25; 2.00] days, P = .058), time from procedure to discharge (4.0 [3.0; 6.0] vs 4.0 [3.0; 6.0] days, P = .201), or total hospital length of stay (6.0 [5.0; 9.0] vs 5.0 [4.0; 8.0] days, P = .113). All-cause mortality was similar in both groups (8.8% vs 4.4%, P = .289), as was discharge disposition (P = .192). Other clinical and imaging outcomes were similar too (all P > .05).ConclusionIn a matched cohort study comparing perioperative standard of care with a novel enhanced recovery protocol focusing on evidence-based drainage, mobilization, and thromboprophylaxis regimens as well as changes to the standardized reuptake of oral anticoagulants and antiaggregants, no differences in safety or effectiveness were observed after burr hole evacuation of cSDH.

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.

Dataset Information

Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial.

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