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RECRUITING
NCT07144423
NA

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

770

Start Date

2025-11-19

Completion Date

2027-12-31

Last Updated

2026-02-09

Healthy Volunteers

No

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, 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.

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 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

Liuchow, 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