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| Name | Class |
|---|---|
| Shenzhen People's Hospital | OTHER |
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Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed effective and safe, some investigators have attempted to use endoscopic strategies to evacuate intracerebral hematomas. Some significant advances have also been reported in endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still crucial to implement a prospective and controlled study to evaluate the efficiency and safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the investigators will exclusively select some patients with intracerebral hemorrhage in the basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery versus stereotactic aspiration on neurologic outcomes for patients with intracerebral hemorrhage.
Although the incidence and mortality of spontaneous intracerebral hemorrhage (ICH) have been decreased with the improved management of high blood pressure, ICH may induce serious disability for the patients and continue to be a major socioeconomic problem. The evacuation of ICH using open craniotomy or computer tomography (CT)-guided stereotaxy may improve the survival rate of these patients but failed to prove efficacy in improving patients' functional outcome despite numerous efforts. Endoscopy-guided evacuation of ICH provides a less invasive and quicker surgical decompression, which may potentially improve the functional outcome for patients. In previous studies, endoscope-guided evacuation of ICH is often referred to as that an endoscope only provides an illuminating system while the operating channel is independent from the endoscope (endoscopy-controlled microneurosurgery or endoscopy-assisted microneurosurgery). In recent years, authors have been committed to explore the procedure of intra-endoscopy-guided evacuation of ICH, which means that the illuminating channel, the irrigation-aspiration channel and the working channel are all located in the endoscope. This kind of procedure can be called as real endoscopic neurosurgery (EN), which may potentially decrease the operative concomitant injuries at the most extent. However, the inherent drawbacks of intra-endoscopic procedures, including the limited visualization of the surgical field and the difficult maintenance of patency of the aspiration wand, can offset the advantages in some instances. The authors exclusively invented a special endoscopic transparent sheath for guiding hematoma puncture and an agitation-aspiration system (AAS) for keeping patency of the aspiration wand. Detailed procedures of their application will be implemented and verified in a series of patients with intracerebral hemorrhage. Meanwhile, the mortality rate, complications and other outcome parameters between this procedure and CT-guided procedures will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-endoscopy | Experimental | This intervention arm will receive intra-endoscopic evacuation surgery for ICH. |
|
| Stereotactic Aspiration | Placebo Comparator | This arm will receive stereotactic aspiration surgery for ICH evacuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-endoscopic surgery | Procedure | Intra-endoscopic surgery for evacuation of ICH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | all-cause motality rate within 90 days after the surgery | 90-day |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | the period from skin incision to wound suture | 24 h |
| days of ICU stay | the period between the end of the surgery to leaving the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Du, MD | Contact | 86-13823699011 | ftipa@163.com | |
| Yu-ping Peng, MD | Contact | 86-15914141979 | 83936462@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern University | Recruiting | Guangzhou | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32010057 | Derived | Du B, Xu J, Hu J, Zhong X, Liang J, Lei P, Wang H, Li W, Peng Y, Shan A, Zhang Y. A Clinical Study of the Intra-Neuroendoscopic Technique for the Treatment of Subacute-Chronic and Chronic Septal Subdural Hematoma. Front Neurol. 2020 Jan 17;10:1408. doi: 10.3389/fneur.2019.01408. eCollection 2019. | |
| 31080494 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 13, 2015 | |
| Reset | Jan 20, 2016 | |
| Release | Jan 23, 2016 | |
| Reset | Feb 19, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 13, 2015 | Jan 20, 2016 | |||
| Jan 23, 2016 |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo:stereotactic aspiration surgery |
| Procedure |
Placebo:stereotactic aspiration surgery for evacuation of ICH |
|
| 14 day |
| remnant blood in the hematoma after surgery | this parameter will be monitored by CT scan immediately after the surgery | 12 hour |
| Glasgow coma score | the GCS will be evaluated by a senior doctor 28 days after the surgery | 28 day |
| Glasgow outcome score | the GCS will be evaluated by a senior doctor 28 days after the surgery | 90-day |
| In-hospital cost | all medical cost during the in-hospital period | 28 day |
| rehemorrhage rate | Rehemorrhage almost occurs within 3 days after the surger. So cranial CT scan will be performed routinely 3 days later after surgery to evaluate the rehemorrhage rate | 3 day |
| intracranial infection | If the patient underwent a period of fever, cerebral fluid will be withdrawn by means of lumbar puncture and tested to verify whether the intracranial infection occurs | 14 day |
| Zhang Y, Shan AJ, Peng YP, Lei P, Xu J, Zhong X, Du B. The intra-neuroendoscopic technique (INET): a modified minimally invasive technique for evacuation of brain parenchyma hematomas. World J Emerg Surg. 2019 May 6;14:21. doi: 10.1186/s13017-019-0239-0. eCollection 2019. |
| 29926826 | Derived | Du B, Shan AJ, Zhang YJ, Wang J, Peng KW, Zhong XL, Peng YP. The intra-neuroendoscopic technique: A new method for rapid removal of acute severe intraventricular hematoma. Neural Regen Res. 2018 Jun;13(6):999-1006. doi: 10.4103/1673-5374.233442. |
| Feb 19, 2016 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |