Template-Guided Burr-Hole Drainage With Middle Meningeal Artery Coagulation for Chronic Subdural Hematoma (3D-MMA-cSDH Tr)
Three-Dimensional Printed Template-Guided Burr-Hole Drainage Combined With Intraoperative Middle Meningeal Artery Coagulation for Preventing Recurrence of Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
Chronic subdural hematoma is a common neurosurgical disease, especially in older adults. Burr-hole drainage with closed-system drainage is widely used as standard surgical treatment. However, recurrence after surgery remains an important clinical problem and may require repeat invasive treatment.
The middle meningeal artery is believed to contribute to the blood supply of the outer membrane of chronic subdural hematoma. Interruption of middle meningeal artery flow may reduce repeated microbleeding and fluid exudation from the hematoma membrane. Endovascular middle meningeal artery embolization has shown promising results, but it requires angiographic equipment, interventional expertise, embolic materials, and additional cost.
This study evaluates a surgical strategy that combines patient-specific 3D-printed template guidance with burr-hole drainage and intraoperative middle meningeal artery coagulation. Preoperative thin-slice computed tomography images will be used to plan the burr-hole location and design a 3D-printed template. The template is intended to help surgeons locate a burr-hole site related to the expected course of the middle meningeal artery(frontal branch) while still allowing effective hematoma drainage.
Participants with symptomatic chronic subdural hematoma requiring burr-hole drainage will be randomly assigned to receive either standard burr-hole drainage or 3D-printed template-guided burr-hole drainage with attempted intraoperative middle meningeal artery coagulation when safely feasible.
The study will test whether this approach can reduce recurrence requiring repeat invasive treatment within 3 months after surgery. It will also assess clinical recovery, radiological changes, complications, resource use, and the feasibility and safety of template-guided localization and intraoperative artery coagulation.Patient safety will take priority over completion of the coagulation step. If the middle meningeal artery or a related branch cannot be clearly identified or safely coagulated during surgery, coagulation will not be performed, and standard hematoma drainage will be completed.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: jie shen, MD
- Número de telefone: +8613515515154
- E-mail: efy126405@fy.ahmu.edu.cn
Locais de estudo
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Anhui
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Hefei, Anhui, China, 230601
- The Second Affiliated Hospital of Anhui Medical University
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Contato:
- jie shen, MD
- Número de telefone: +8613515515154
- E-mail: efy126405@fy.ahmu.edu.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria
- Patients diagnosed with chronic subdural hematoma based on clinical symptoms and cranial CT or MRI.
- Patients scheduled to undergo burr-hole drainage surgery.
- Age 18 years or older.
- Written informed consent obtained from the patient or legal representative. Exclusion Criteria
- Acute subdural hematoma or other intracranial lesions requiring different surgical management.
- Previous surgery for the same episode of chronic subdural hematoma.
- Severe coagulation disorder or other contraindications to surgery.
- Severe systemic disease making the patient unsuitable for participation.
- Refusal or inability to provide informed consent.
Plano de estudo
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 |
|---|---|
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Comparador Ativo: Standard Burr-Hole Drainage
Participants assigned to this arm will undergo standard burr-hole drainage for chronic subdural hematoma according to routine clinical practice.
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Standard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.
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Experimental: 3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation
Participants assigned to this arm will undergo 3D-printed template-guided burr-hole drainage combined with attempted intraoperative middle meningeal artery coagulation for chronic subdural hematoma.
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Burr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery
Prazo: Within 3 months after surgery
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Recurrence is defined as radiologically confirmed recurrent chronic subdural hematoma requiring repeat surgical intervention within 3 months after the initial surgery (e.g., repeat burr-hole drainage, craniotomy, endoscopic treatment, and/or MMA embolization).
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Within 3 months after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of cSDH Recurrence (Hematoma Progression)
Prazo: Within 3 months after surgery
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Incidence of cSDH Recurrence (Hematoma Progression): Hematoma progression will be defined as radiological increase in ipsilateral and/or bilateral subdural hematoma on follow-up imaging compared with the predefined postoperative baseline.
Hematoma progression (Yes/No) will be considered present if any of the following criteria are met: (1) increase in maximal subdural hematoma thickness by ≥ 5 mm; (2) increase in midline shift by ≥ 3 mm; or (3) increase in hematoma cavity volume by ≥ 25%.
The incidence will be reported as a percentage.
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Within 3 months after surgery
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Functional Outcome Measured by the Modified Rankin Scale (mRS)
Prazo: Within 3 months after surgery
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Functional Outcome Measured by the Modified Rankin Scale (mRS): Functional status will be measured using the Modified Rankin Scale (mRS), a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death).
Lower scores indicate better functional outcome.
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Within 3 months after surgery
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MMA identification rate
Prazo: Intra-operative
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Deviation between Planned and Actual Burr-hole Sites: MMA identification rate will be reported as a percentage.
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Intra-operative
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Number of participants experiencing one or more peri-operative surgical or medical complications
Prazo: Intra-operative through 30 days post-operatively
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Incidence of Peri-Operative Complications：Number of participants experiencing one or more peri-operative surgical or medical complications (e.g., wound infection, seizure, pneumonia, venous thromboembolism, acute subdural haematoma).
Reported as a count and percentage.
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Intra-operative through 30 days post-operatively
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Length of Hospital Stay
Prazo: up to 30 days
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Length of Hospital Stay: Length of hospital stay is defined as the number of days from admission to discharge.
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up to 30 days
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All-cause Mortality
Prazo: Within 3 months after surgery
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All-cause Mortality: Proportion of participants who die from any cause during follow-up; reported as percentage.
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Within 3 months after surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Ferimentos e Lesões
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Hemorragia
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Hemorragias Intracranianas
- Hemorragia Intracraniana Traumática
- Condições Patológicas, Sinais e Sintomas
- Hematoma Subdural
- Hematoma
- Hematoma Subdural Crônico
Outros números de identificação do estudo
- SAHAMU-CSDH-RCT-001
- 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)
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Descrição do plano IPD
We will share the individual participant data (IPD) underlying the results, including de-identified participant data:
Participant-level data: baseline characteristics and pre-specified outcome Outcome data: all measures used for the primary and secondary endpoints Study data files: datasets used for the statistical analyses (e.g., analysis-ready datasets and relevant derived variables)
Prazo de Compartilhamento de IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
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