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Comparative Effectiveness of Different Surgical Timings on Neurological Outcomes for Cranioplasty: A Prospective Non-Randomized Controlled Trial

Comparative Effectiveness of Different Surgical Timings on Neurological Outcomes for Cranioplasty: A Prospective Non-Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094619
Enrollment
Unknown
Registered
2024-12-25
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cranial defect

Interventions

Group E:Early cranioplasty (within 3 months of decompressive craniectomy)
Group L:late cranioplasty (beyond 3 months)

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 65 years; (2) Have a skull defect size greater than 25 cm^2 (diameter greater than 5cm); (3) The skull defect must have resulted from one of the following conditions, which will be recorded for each patient: severe traumatic brain injury, malignant ischemic stroke, hemorrhagic stroke, or an infiltrative tumor; (4) Provide informed consent to participate in the study, either personally or through a legally authorized representative.

Exclusion criteria

Exclusion criteria: (1) Exhibit poor healing from the initial decompressive craniotomy surgeries; (2) Have uncontrolled intracerebral infections , defined as an infection that persists despite standard antibiotic treatment; (3) Have untreated intracranial hematoma; (4) Are deemed unsuitable for surgery due to poor general health conditions; (5) Present with hydrocephalus; (6) Are pregnant at the time of recruitment; (7) Have a clinical diagnosis of being in a minimally conscious state or a vegetative state.

Design outcomes

Primary

MeasureTime frame
Barthel Index;

Secondary

MeasureTime frame
EQ-5D scale;Glasgow Outcome Scale (GOS);Postoperative complications;

Countries

China

Contacts

Public ContactJunwen Guan

Department of Neurosurgery, West China Hospital of Sichuan University

guanjunwen_scu@163.com+86 136 6826 7639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026