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Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH). The target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT/MRI). The main questions this study is designed to answer are: * Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months * Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures) There are two groups, researchers will compare: * Group A: patients receiving puncture at the frontal region vs. * Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other. Participants will: * undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence; * receive closed-system drainage after a twist-drill puncture; * complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence; * have safety monitoring throughout the study period to record any complications or adverse events.
Trial Details
NCT Number NCT07731620
Lead Sponsor The Second Hospital of Anhui Medical University
Collaborators: Yangzhou University, Huai'an First People's Hospital
Conditions
(from sponsor)
Chronic Subdural Hematoma
Related terms Hematoma, Subdural, Chronic
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov