A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Neurosurgery, Daping Hospital of Army Medical University
RECRUITING
Chongqing
Department of Neurosurgery, Qilu Hospital of Shandong University
RECRUITING
Jinan
Department of Neurosurgery, Tang-Du Hospital
RECRUITING
Xi'an
Contact Information
Primary
Ning Yang, M.D., Ph.D
yangning@sdu.edu.cn
+86 13589040486
Backup
Bin Huang, Ph.D
hb@sdu.edu.cn
+86 18560085770
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Treatments
Derivation Cohort
Identification of risk factors, development and internal validation of predictive models
External Validation Cohort
External validation of the predictive models
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: Daping Hospital of Army Medical University, Tang-Du Hospital

This content was sourced from clinicaltrials.gov