RecruitingNot ApplicableNCT07144423

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

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


Sponsor

Beijing Tiantan Hospital

Enrollment

770 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Burr hole hematoma drainage and a procedure called Endoscope-assisted hematoma drainage for people with chronic subdural hematoma. The study is currently recruiting participants at 24 locations. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscope-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, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

PROCEDUREBurr 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 drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.


Locations(24)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Shantou central hosital

Shantou, Guangdong, China

People's Hospital of Longhua, Shenzhen

Shenzhen, Guangdong, China

Liuzhou worker's Hospital

Liuzhou, Guangxi, China

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Nanning First People's Hospital

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

Nanning, Guangxi, China

Wuzhou Gongren Hospital

Wuzhou, Guangxi, China

Hebei University of Engineering Affiliated Hospital

Handan, Hebei, China

Xingtai Central Hospital

Xingtai, Hebei, China

Changde First People's Hospital

Changde, Hunan, China

People's Hospital of Xiangxi Prefecture, Hunan Province

Jishou, Hunan, China

Yueyang Central Hospital

Yueyang, Hunan, China

Heji Hospital affiliated with Changzhi Medical College

Changzhi, Shanxi, China

Linfen People's Hospital

Linfen, Shanxi, China

Shanxi Provincial People's Hospital,Shanxi Medical University

Taiyuan, Shanxi, China

The Second Affiliated Hospital of Xi'an Medical University

Xi’an, Shanxi, China

Mianyang 404 Hospital

Mianyang, Sichuan, China

the First People'S Hospital of Yibin

Yibin, Sichuan, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Pu'er People's Hospital

Pu'er, Yunnan, China

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT07144423


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