Actively Recruiting

All Genders
NCT06740773

Risk Factors for Complications After Cranioplasty

Led by Qilu Hospital of Shandong University · Updated on 2025-06-05

1000

Participants Needed

3

Research Sites

54 weeks

Total Duration

On this page

Sponsors

Q

Qilu Hospital of Shandong University

Lead Sponsor

D

Daping Hospital of Army Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Risk Factors for Complications After Cranioplasty

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who underwent cranioplasty 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
  • Complete and accessible electronic medical records available
  • No prior history of cranioplasty
Not Eligible

You will not qualify if you...

  • Prior history of cranioplasty
  • Severe comorbidities such as serious cardiac, liver, kidney, or immune system dysfunction
  • Congenital cranial defects
  • Severe missing data

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Department of Neurosurgery, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

2

Department of Neurosurgery, Tang-Du Hospital

Xi'an, Shaanxi, China, 710038

Actively Recruiting

3

Department of Neurosurgery, Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

N

Ning Yang, M.D., Ph.D

CONTACT

B

Bin Huang, Ph.D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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