Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

Официальное название

Frontal Versus Parietal Eminence Twist-Drill Drainage for Chronic Subdural Hematoma

Обзор

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.

Подробное описание

This is a (multi-center) prospective, randomized, parallel-group, assessor-blinded clinical trial in eligible patients with unilateral chronic subdural hematoma (cSDH) to compare the effects of puncture-site location on outcomes after minimally invasive drainage: participants will be randomly assigned 1:1 to Group A (frontal twist-drill puncture drainage) or Group B (parietal eminence twist-drill puncture drainage), with both groups receiving standardized closed-system subdural drainage and postoperative management; random allocation will be concealed using a secure electronic randomization system or sealed opaque envelopes prepared by a researcher not involved in surgery or outcome assessment. The primary outcome is the rate of ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery (recurrence defined as symptomatic re-accumulation or enlargement confirmed by imaging and judged by the treating team to require repeat intervention). Secondary outcomes include postoperative residual hematoma maximum thickness and volume at 24-48 hours, pneumocephalus volume at 24-48 hours, reduction in midline shift, brain re-expansion rate, drainage duration, length of hospital stay, postoperative complications, Markwalder grading and modified Rankin Scale (mRS) scores at 30 days/3 months, and mortality at 30 days and 3 months; although surgeon blinding is not feasible, radiological and clinical outcome assessors and statisticians will be blinded whenever possible, with anonymized postoperative CT images assessed independently by trained reviewers.

Вмешательства

• Процедура Frontal-region puncture drainage
  Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
• Процедура Parietal Eminence region puncture drainage
  Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

Первичные конечные точки

• Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery [Срок оценки: 3 months]

Вторичные конечные точки (9)

• Residual hematoma maximum thickness [Срок оценки: "Day 2", "Month 1", "Month3" after operation]
• Residual hematoma volume [Срок оценки: "Day 2", "Month 1", "Month3" after operation]
• Intra-cranial pneumocephalus volume [Срок оценки: "Day 2", "Month 1" after operation]
• Improvement in midline shift [Срок оценки: "Day 2", "Month 1", "Month3" after operation]
• Drain duration / catheter indwelling time [Срок оценки: immediately after the procedure]
• Postoperative complications [Срок оценки: From operation up to 3 months postoperatively]
• Markwalder grade at 7days, 30 days and 3 months [Срок оценки: "Day 7", "Month 1", "Month3" after operation]
• Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months [Срок оценки: "Day 7", "Month 1", "Month3" after operation]
• Mortality rate within 3 months after operation [Срок оценки: From operation up to 3 months postoperatively]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
• Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.
• Radiological indication for surgery, defined as one of the following:

Maximum hematoma thickness ≥ 10 mm, and/or Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon.

• Plan to undergo twist-drill puncture drainage with a closed drainage system.
• Written informed consent signed by the participant or their legally authorized representative.

Критерии исключения

• Bilateral cSDH requiring simultaneous bilateral surgery.
• Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.
• Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.
• Previous surgery on the ipsilateral side for cSDH.
• Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.
• Severe coagulation disorder that cannot be corrected before surgery.
• Life expectancy < 6 months.
• Pregnancy.
• Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй
• Huai'an First People's Hospital — Huai'an
• Yangzhou University Affiliated Hospital — Yangzhou

Идентификаторы

NCT: NCT07731620 · SAHAMU-CSDH-RCT-002 · 202512022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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