Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

Official title

Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial, URANUS

Overview

Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.

Detailed description

Chronic subdural hematoma (CSDH) is a common disease in neurosurgery. It is generally considered to be a closed fluid collection situated between the dura mater and arachnoid mater, formed by blood or blood degradation products. This collection causes a local mass effect, compressing adjacent brain tissue and leading to varying degrees of neurological dysfunction. In severe cases, it can induce brain herniation, endangering the patient's life. In recent years, despite the availability of various pharmacological and surgical treatment options for CSDH, the efficacy and long-term prognosis of these treatment methods and strategies remain not entirely clear, and a standardized treatment approach has yet to be established. Neuroendoscopy-assisted hematoma drainage is one of the treatment methods for CSDH, but its current application is not widespread. The core of this method involves neurosurgeons directly observing the hematoma structure during surgery with the assistance of a neuroendoscope, enabling them to thoroughly irrigate and aspirate the hematoma under direct vision and sever hematoma septations. This approach enhances the hematoma clearance rate, ultimately reducing the amount of postoperative hematoma residue. Compared with conventional burr-hole drainage, neuroendoscopy-assisted burr-hole drainage reduces the recurrence rate of CSDH and shortens the duration of postoperative drainage. This study aims to conduct a multicenter randomized controlled trial comparing neuroendoscopy-assisted hematoma drainage with burr-hole drainage, with the objective of scientifically and rigorously determining the optimal clinical treatment strategy for CSDH.

Interventions

• Procedure Endoscope-assisted hematoma drainage
  The procedure of endoscope-assisted hematoma drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as shown on CT scan. A bone flap measuring 2.0 cm × 2.0 cm is then created using a milling cutter. Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated. A subdural drainage tube is inserted, and postoperatively,
• Procedure Burr hole hematoma drainage
  The procedure of burr hole drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as indicated by CT scan. A subdural drainage tube is then inserted. The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear. Postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the d

Primary outcome measures

• Recurrence rate within 3 months after operation [Time frame: From operation up to 3 months postoperatively]

Secondary outcome measures (7)

• Mortality rate within 3 months after operation [Time frame: From operation up to 3 months postoperatively]
• Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation [Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation]
• Change of Markwalder Grading Scale (MGS) between groups from baseline to 3 months after operation [Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation]
• Change of Quality of life assessment (EQ-5D-5L) between groups from baseline to 3 months after operation [Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation]
• Rate of complications and adverse events between groups within 3 months [Time frame: From operation up to 3 months postoperatively]
• Postoperative drainage time [Time frame: immediately after the procedure]
• Length of hospitalization [Time frame: immediately after the procedure]

Eligibility criteria

Inclusion criteria

• Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
• CSDH verified on cranial computed tomography or magnetic resonance imaging.
• Written informed consent from patients or their next of kin according to the patient's cognitive status.

Exclusion criteria

• No clinical symptoms correlating with chronic subdural hematoma.
• Lack of mass effect and midline shift < 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.
• Previous surgery for CSDH during the past 6 months.
• Previous intracranial surgery for any other neurological disorder.
• Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed.
• Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio > 3.0; absolute platelet count < 100×109/L).
• Postoperative compliance is suspected to be insufficient for 3-month follow-up visit.
• Reproductive-age women without verified negative pregnancy testing.
• Participating in another research.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 24 centers

• Beijing Tiantan Hospital, Capital Medical University — Beijing
• First Affiliated Hospital of Xiamen University — Xiamen
• Jiangmen Central Hospital — Jiangmen
• Shantou central hosital — Shantou
• People's Hospital of Longhua, Shenzhen — Shenzhen
• Liuzhou worker's Hospital — Liuzhou
• The Second Affiliated Hospital of Guangxi Medical University — Nanning
• Nanning First People's Hospital — Nanning
• … and 16 more centers

Publications

• Abouzari M, Rashidi A, Rezaii J, Esfandiari K, Asadollahi M, Aleali H, Abdollahzadeh M. The role of postoperative patient posture in the recurrence of traumatic chronic subdural hematoma after burr-hole surgery. Neurosurgery. 2007 Oct;61(4):794-7; discussion 797. doi: 10.1227/01.NEU.0000298908.94129.67. PMID 17986941
• Asghar M, Adhiyaman V, Greenway MW, Bhowmick BK, Bates A. Chronic subdural haematoma in the elderly--a North Wales experience. J R Soc Med. 2002 Jun;95(6):290-2. doi: 10.1258/jrsm.95.6.290. PMID 12042376
• Bakheet MF, Pearce LA, Hart RG. Effect of addition of clopidogrel to aspirin on subdural hematoma: meta-analysis of randomized clinical trials. Int J Stroke. 2015 Jun;10(4):501-5. doi: 10.1111/ijs.12419. Epub 2014 Dec 3. PMID 25472690
• Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. doi: 10.1161/01.STR.0000258355.23810.c6. Epub 2007 Feb 1. PMID 17272767
• Brennan PM, Kolias AG, Joannides AJ, Shapey J, Marcus HJ, Gregson BA, Grover PJ, Hutchinson PJ, Coulter IC; British Neurosurgical Trainee Research Collaborative. The management and outcome for patients with chronic subdural hematoma: a prospective, multicenter, observational cohort study in the United Kingdom. J Neurosurg. 2017 Mar 17:1-8. doi: 10.3171/2016.8.JNS16134.test. Online ahead of print. PMID 28306417
• Frati A, Salvati M, Mainiero F, Ippoliti F, Rocchi G, Raco A, Caroli E, Cantore G, Delfini R. Inflammation markers and risk factors for recurrence in 35 patients with a posttraumatic chronic subdural hematoma: a prospective study. J Neurosurg. 2004 Jan;100(1):24-32. doi: 10.3171/jns.2004.100.1.0024. PMID 14743908
• Jablawi F, Kweider H, Nikoubashman O, Clusmann H, Schubert GA. Twist Drill Procedure for Chronic Subdural Hematoma Evacuation: An Analysis of Predictors for Treatment Success. World Neurosurg. 2017 Apr;100:480-486. doi: 10.1016/j.wneu.2017.01.037. Epub 2017 Jan 19. PMID 28109862
• Kudo H, Kuwamura K, Izawa I, Sawa H, Tamaki N. Chronic subdural hematoma in elderly people: present status on Awaji Island and epidemiological prospect. Neurol Med Chir (Tokyo). 1992 Apr;32(4):207-9. doi: 10.2176/nmc.32.207. PMID 1378564

Identifiers

NCT: NCT07144423 · HX-A-2025027

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗