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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：jie shen, MD
- 電話番号：+8613515515154
- メール：efy126405@fy.ahmu.edu.cn
研究場所
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Anhui
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Hefei、Anhui、中国、230601
- The Second Affiliated Hospital of Anhui Medical University
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コンタクト：
- jie shen, MD
- 電話番号：+8613515515154
- メール：efy126405@fy.ahmu.edu.cn
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of cSDH Recurrence (Hematoma Progression)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SAHAMU-CSDH-RCT-001
- 202512022 (その他の助成金/資金番号：Anhui Provincial International Joint Research Center for Advanced Technology in Medical Imaging, Anhui University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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