Risk Factors for Complications After Cranioplasty
Recruiting now
Conditions studied: Cranioplasty, Postoperative Complications, Risk Assessment
In brief
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.
Key facts
- Study ID
- NCT06740773
- Run by
- Qilu Hospital of Shandong University
- People needed
- 1000
- Starts
- 2024-12-17
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-06-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department of Neurosurgery, Daping Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (enrolling)
- Department of Neurosurgery, Tang-Du Hospital — Xi'an, Shaanxi, China (enrolling)
- Department of Neurosurgery, Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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