Risk Factors for Complications After Cranioplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorQilu Hospital of Shandong University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with cranial defects who underwent their first cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University between January 1, 2015, and January 1, 2025, or at Tangdu Hospital of Air Force Medical University or Daping Hospital of the Army Medical University between January 1, 2015, and July 31, 2023.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Derivation Cohort
Group B: External Validation Cohort
Trial outcomes
Primary outcomes
1
Risk factors for postoperative complications of cranioplasty
The primary outcome is to identify factors associated with postoperative complications of cranioplasty. The analysis will focus on patient demographics, comorbidities, surgical details, and other clinical variables extracted from medical records
Time frame
From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.Secondary outcomes
1
Establishment predictive models for postoperative complications of cranioplasty
The secondary outcome is to develop and validate predictive models for postoperative complications of cranioplasty based on identified risk factors.
Time frame
From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Qilu Hospital of Shandong University
Lead sponsor
Daping Hospital of Army Medical University
Collaborator
Tang-Du Hospital
Collaborator
Source ClinicalTrials.gov