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Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

NCT07731620 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Subdural Hematoma

Interventions

PROCEDURE

Frontal-region puncture drainage

Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).

PROCEDURE

Parietal Eminence region puncture drainage

Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

Sponsors & Collaborators

  • Yangzhou University

    collaborator OTHER

  • Huai'an First People's Hospital

    collaborator OTHER

  • The Second Hospital of Anhui Medical University

    lead OTHER

Principal Investigators

  • qi li, MD · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731620 on ClinicalTrials.gov