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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
582
The autologous skull repair surgery will be completed within 6 weeks after the DC operation.
The autologous skull repair surgery should be completed within 90 to 180 days after DC.
Anshun People's Hospital (Ward One)
Anshun, Guizhou, China
Anshun People's Hospital (Ward Two)
Anshun, Guizhou, China
The First People's Hospital of Bijie City
Bijie, Guizhou, China
Guizhou Provincial Workers' Hospital
Guiyang, Guizhou, China
modified Rankin Scale (mRS) 0-2
The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2
Time frame: at 180 (± 7) days
mRS≤2 and mRS ≤3
Proportion of mRS≤2 and proportion of mRS ≤3
Time frame: 90 (±7) days after CP
mRS ≤3
Proportion of mRS≤2 and proportion of mRS ≤3
Time frame: 180 (±7) days after CP
Mini-Mental State Examination (MMSE) score
Minimum score 0 and maximum score 30 with higher score being better outcome
Time frame: 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
Time frame: 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
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
Total medical expenses (excluding materials)
Time frame: 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
Time frame: At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge
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Qianfengdong Prefecture People's Hospital
Kaili, Guizhou, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, China
Neijiang First People's Hospital
Neijiang, Sichuan, China
Incidence of infection, poor healing, and subcutaneous effusion
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
The incidence rate of intracranial hemorrhage
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
incidence of epilepsy
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
incidence of reoperation
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery