NCT06740773 Risk Factors for Complications After Cranioplasty
| NCT ID | NCT06740773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Cranioplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-12-17 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cranial defects often result from brain injuries, hemorrhages, strokes, or brain tumors. These conditions can increase pressure inside the skull, and if left untreated, may lead to dangerous complications like brain herniation. To manage this, a common procedure called decompressive craniectomy is performed to reduce intracranial pressure. While this surgery often stabilizes the patient's condition, it leaves a cranial defect that exposes the brain to external risks, including pressure fluctuations and potential damage. In severe cases, patients with larger defects may develop complications such as sinking skin flap syndrome. Cranial reconstruction, also known as cranioplasty, is an important procedure to restore the skull's structure and protect the brain. This surgery can improve brain function, stabilize intracranial pressure, and enhance the patient's appearance. While cranioplasty is a standard neurosurgical procedure, it has a relatively high risk of complications compared to other brain surgeries. Common complications include infections, bleeding, hydrocephalus, and seizures. In severe cases, complications may lead to the failure of the reconstruction. Understanding the factors that contribute to complications after cranioplasty is crucial for neurosurgeons to improve outcomes and reduce risks. This study aims to identify these factors and develop predictive models for postoperative complications of cranioplasty.
Eligibility Criteria
Inclusion Criteria: * Patients who underwent cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Medical University, or Daping Hospital, Army Military Medical University between January 1, 2015, and July 31, 2023 * Diagnosed with cranial defects * Possessed complete and accessible electronic medical records * Patients had no prior history of cranioplasty Exclusion Criteria: * Patients with a prior history of cranioplasty * Severe comorbidities (such as serious cardiac, liver, kidney and immune system dysfunction) * Congenital cranial defects * Severe missing data
Contact & Investigator
Ning Yang, M.D., Ph.D
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06740773 clinical trial?
This trial is open to participants of all sexes, studying Cranioplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06740773 currently recruiting?
Yes, NCT06740773 is actively recruiting participants. Contact the research team at yangning@sdu.edu.cn for enrollment information.
Where is the NCT06740773 trial being conducted?
This trial is being conducted at Chongqing, China, Xi'an, China, Jinan, China.
Who is sponsoring the NCT06740773 clinical trial?
NCT06740773 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Ning Yang, M.D., Ph.D at Department of Neurosurgery, Qilu Hospital of Shandong University. The trial plans to enroll 1,000 participants.