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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: jie shen, MD
- Telefonnummer: +8613515515154
- E-post: efy126405@fy.ahmu.edu.cn
Studiesteder
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Anhui
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Hefei, Anhui, Kina, 230601
- The Second Affiliated Hospital of Anhui Medical University
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Ta kontakt med:
- jie shen, MD
- Telefonnummer: +8613515515154
- E-post: efy126405@fy.ahmu.edu.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of cSDH Recurrence (Hematoma Progression)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Sår og skader
- Patologiske prosesser
- Kronisk sykdom
- Sykdomsattributter
- Blødning
- Kraniocerebralt traume
- Traumer, nervesystemet
- Intrakranielle blødninger
- Intrakraniell blødning, traumatisk
- Patologiske tilstander, tegn og symptomer
- Hematom, subdural
- Hematom
- Hematom, Subdural, Kronisk
Andre studie-ID-numre
- SAHAMU-CSDH-RCT-001
- 202512022 (Annet stipend/finansieringsnummer: Anhui Provincial International Joint Research Center for Advanced Technology in Medical Imaging, Anhui University)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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)
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
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