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Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

25 de julho de 2026 atualizado por: Jie Shen, The Second Hospital of Anhui Medical University

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

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

440

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University
        • Contato:
          • Jie Shen, MD
          • Número de telefone: +8613515515154
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Huai'an first people's hospital
        • Contato:
      • Yangzhou, Jiangsu, China, 225009
        • Yangzhou University Affiliated Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
  3. Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.

  4. 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.

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

Exclusion Criteria:

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage)
The puncture point is selected within the anterior coverage region of the hematoma area-typically within the frontal bone region anterior to the coronal suture-avoiding the frontal sinus, obvious cortical veins, and key functional areas. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment.
Procedimento: Frontal-region puncture drainage
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Comparador Ativo: Parietal Eminence Burr Hole Puncture Group(twist-drill drainage)
The puncture point is selected at the vertex (crown vertex) region within the hematoma area. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment.
Procedimento: Parietal Eminence region puncture drainage
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
Prazo: 3 months
Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention.
3 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Residual hematoma maximum thickness
Prazo: "Day 2", "Month 1", "Month3" after operation
Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.
"Day 2", "Month 1", "Month3" after operation
Residual hematoma volume
Prazo: "Day 2", "Month 1", "Month3" after operation
Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.
"Day 2", "Month 1", "Month3" after operation
Intra-cranial pneumocephalus volume
Prazo: "Day 2", "Month 1" after operation
Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity).
"Day 2", "Month 1" after operation
Improvement in midline shift
Prazo: "Day 2", "Month 1", "Month3" after operation
Assessed on follow-up imaging by comparing the midline shift against baseline/protocol-defined preoperative value; reported as the degree of improvement.
"Day 2", "Month 1", "Month3" after operation
Drain duration / catheter indwelling time
Prazo: immediately after the procedure
Time from catheter placement to catheter removal, reported as hours/days per protocol.
immediately after the procedure
Postoperative complications
Prazo: From operation up to 3 months postoperatively

Any adverse events occurring postoperatively, including (but not limited to):

acute subdural hematoma, intracerebral hemorrhage, seizure, infection, tension pneumocephalus, and drain/catheter misplacement.
From operation up to 3 months postoperatively
Markwalder grade at 7days, 30 days and 3 months
Prazo: "Day 7", "Month 1", "Month3" after operation
Neurological symptom severity scored using the Markwalder scale at the specified follow-up time points.
"Day 7", "Month 1", "Month3" after operation
Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months
Prazo: "Day 7", "Month 1", "Month3" after operation
Functional status measured by mRS at the specified follow-up time points.
"Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation
Prazo: From operation up to 3 months postoperatively
Death from any cause assessed at 3 months after surgery.
From operation up to 3 months postoperatively

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Second Hospital of Anhui Medical University

Colaboradores

Yangzhou University
Huai'an First People's Hospital

Investigadores

  • Diretor de estudo: qi li, MD, The Second Hospital of Anhui Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de junho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

22 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de julho de 2026

Primeira postagem (Real)

28 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SAHAMU-CSDH-RCT-002
  • 202512022 (Número de outro subsídio/financiamento: Anhui Provincial International Joint Research Center for Advanced Technology in Medical Imaging, Anhui University)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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