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Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

25 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

440

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Anhui
      • Hefei, Anhui, Chine, 230601
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
          • Jie Shen, MD
          • Numéro de téléphone: +8613515515154
    • Jiangsu
      • Huai'an, Jiangsu, Chine, 223300
        • Huai'an first people's hospital
        • Contact:
      • Yangzhou, Jiangsu, Chine, 225009
        • Yangzhou University Affiliated Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: Frontal-region puncture drainage
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Comparateur actif: 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.
Procédure: Parietal Eminence region puncture drainage
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Residual hematoma maximum thickness
Délai: "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
Délai: "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
Délai: "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
Délai: "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
Délai: immediately after the procedure
Time from catheter placement to catheter removal, reported as hours/days per protocol.
immediately after the procedure
Postoperative complications
Délai: 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
Délai: "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
Délai: "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
Délai: From operation up to 3 months postoperatively
Death from any cause assessed at 3 months after surgery.
From operation up to 3 months postoperatively

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Second Hospital of Anhui Medical University

Collaborateurs

Yangzhou University
Huai'an First People's Hospital

Les enquêteurs

  • Directeur d'études: qi li, MD, The Second Hospital of Anhui Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 juin 2029

Dates d'inscription aux études

Première soumission

22 juillet 2026

Première soumission répondant aux critères de contrôle qualité

25 juillet 2026

Première publication (Réel)

28 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SAHAMU-CSDH-RCT-002
  • 202512022 (Autre subvention/numéro de financement: Anhui Provincial International Joint Research Center for Advanced Technology in Medical Imaging, Anhui University)

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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