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To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3~6 months after DC.
Objective:
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3~6 months after DC.
Design:
This study is a multi-center, prospective, randomized controlled, open-label trial.
Interventions:
Intervention measures were the time point of cranioplasty: within 6 weeks after decompressive craniectomy VS 3-6 months after decompressive craniectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | The autologous skull repair surgery will be completed within 6 weeks after the DC operation. |
|
| control group | Active Comparator | The surgery should be completed within 90 to 180 days after DC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| operation opportunity-within 6 weeks after the DC operation. | Procedure | The autologous skull repair surgery will be completed within 6 weeks after the DC operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) 0-2 | The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2 | at 180 (± 7) days |
| Measure | Description | Time Frame |
|---|---|---|
| mRS≤2 and mRS ≤3 | Proportion of mRS≤2 and proportion of mRS ≤3 | 90 (±7) days after CP |
| mRS ≤3 | Proportion of mRS≤2 and proportion of mRS ≤3 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality rate | All etiology of mortality | 180 (±7) days after CP surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaya Xu | Contact | 13984843194 | xkaya@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anshun People's Hospital (Ward One) | Anshun | Guizhou | 561000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28799868 | Background | Morton RP, Abecassis IJ, Hanson JF, Barber JK, Chen M, Kelly CM, Nerva JD, Emerson SN, Ene CI, Levitt MR, Chowdhary MM, Ko AL, Chesnut RM. Timing of cranioplasty: a 10.75-year single-center analysis of 754 patients. J Neurosurg. 2018 Jun;128(6):1648-1652. doi: 10.3171/2016.11.JNS161917. Epub 2017 Aug 11. | |
| 35061995 | Background |
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The study was open-label, endpoint-blinded, i.e. only the patients themselves and the treating physicians knew the randomization assignment results, baseline was evaluated by investigators who did not know the actual patient assignment, and primary endpoint visits were conducted by trained third parties who did not know what treatment the patients received.
| operation opportunity-within 90 to 180 days after the DC operation. | Procedure | The autologous skull repair surgery should be completed within 90 to 180 days after DC. |
|
| 180 (±7) days after CP |
| Mini-Mental State Examination (MMSE) score | Minimum score 0 and maximum score 30 with higher score being better outcome | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| Glasgow Outcome Score (GOS) | Minimum score 1 and maximum score 8 with higher number being better outcome | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| hydrocephalus or Cerebrospinal fluid shunt surgery rate | The incidence of hydrocephalus or CSF shunt surgery | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| Total medical expenses (excluding materials) | At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge |
| Complications related medical expenses | At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge |
| Incidence of infection, poor healing, and subcutaneous effusion | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| The incidence rate of intracranial hemorrhage | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| incidence of epilepsy | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| incidence of reoperation | 90 days (±7 days) and 180 days (±7 days) after CP surgery |
| Anshun People's Hospital (Ward Two) | Anshun | Guizhou | 561000 | China |
|
| The First People's Hospital of Bijie City | Bijie | Guizhou | China |
|
| Guizhou Provincial Workers' Hospital | Guiyang | Guizhou | China |
|
| Qianfengdong Prefecture People's Hospital | Kaili | Guizhou | China |
|
| Zunyi Medical University Affiliated Hospital | Zunyi | Guizhou | China |
|
| Neijiang First People's Hospital | Neijiang | Sichuan | China |
|
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| 28419358 | Background | Malcolm JG, Rindler RS, Chu JK, Chokshi F, Grossberg JA, Pradilla G, Ahmad FU. Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis. Neurosurgery. 2018 Mar 1;82(3):278-288. doi: 10.1093/neuros/nyx182. |
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| 16077318 | Background | Yamada A, Imai K, Nomachi T, Fujimoto T, Sakamoto H, Kitano S. Cranial distraction for plagiocephaly: quantitative morphologic analyses of cranium using three-dimensional computed tomography and a life-size model. J Craniofac Surg. 2005 Jul;16(4):688-93. doi: 10.1097/01.scs.0000168995.27882.66. |
| 16965895 | Background | Hokugo A, Sawada Y, Sugimoto K, Fukuda A, Mushimoto K, Morita S, Tabata Y. Preparation of prefabricated vascularized bone graft with neoangiogenesis by combination of autologous tissue and biodegradable materials. Int J Oral Maxillofac Surg. 2006 Nov;35(11):1034-40. doi: 10.1016/j.ijom.2006.06.003. Epub 2006 Sep 11. |
| 19427221 | Background | Martin MP, Olson S. Post-operative complications with titanium mesh. J Clin Neurosci. 2009 Aug;16(8):1080-1. doi: 10.1016/j.jocn.2008.07.087. Epub 2009 May 7. |
| 19485722 | Background | Gooch MR, Gin GE, Kenning TJ, German JW. Complications of cranioplasty following decompressive craniectomy: analysis of 62 cases. Neurosurg Focus. 2009 Jun;26(6):E9. doi: 10.3171/2009.3.FOCUS0962. |
| 12621197 | Background | Taub PJ, Rudkin GH, Clearihue WJ 3rd, Miller TA. Prefabricated alloplastic implants for cranial defects. Plast Reconstr Surg. 2003 Mar;111(3):1233-40. doi: 10.1097/01.PRS.0000046048.77472.23. No abstract available. |
| 30768137 | Background | Lilja-Cyron A, Andresen M, Kelsen J, Andreasen TH, Fugleholm K, Juhler M. Long-Term Effect of Decompressive Craniectomy on Intracranial Pressure and Possible Implications for Intracranial Fluid Movements. Neurosurgery. 2020 Feb 1;86(2):231-240. doi: 10.1093/neuros/nyz049. |
| 10883905 | Background | Winkler PA, Stummer W, Linke R, Krishnan KG, Tatsch K. Influence of cranioplasty on postural blood flow regulation, cerebrovascular reserve capacity, and cerebral glucose metabolism. J Neurosurg. 2000 Jul;93(1):53-61. doi: 10.3171/jns.2000.93.1.0053. |
| 15177389 | Background | Kuo JR, Wang CC, Chio CC, Cheng TJ. Neurological improvement after cranioplasty - analysis by transcranial doppler ultrasonography. J Clin Neurosci. 2004 Jun;11(5):486-9. doi: 10.1016/j.jocn.2003.06.005. |
| 74031 | Background | Yamaura A, Makino H. Neurological deficits in the presence of the sinking skin flap following decompressive craniectomy. Neurol Med Chir (Tokyo). 1977;17(1 Pt 1):43-53. doi: 10.2176/nmc.17pt1.43. No abstract available. |
| 27602507 | Background | Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J, Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ; RESCUEicp Trial Collaborators. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med. 2016 Sep 22;375(12):1119-30. doi: 10.1056/NEJMoa1605215. Epub 2016 Sep 7. |