Risk Factors for Complications After Cranioplasty

June 2, 2025 updated by: Qilu Hospital of Shandong University

A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Cranial defects, often caused by conditions such as traumatic brain injuries, strokes, or brain tumors, present a significant clinical challenge. Decompressive craniectomy, frequently performed to manage increased intracranial pressure, leaves patients with cranial defects that require subsequent cranioplasty. Cranioplasty, while being a common neurosurgical procedure, has a higher complication rate compared to other cranial surgeries, warranting a deeper investigation into its risk factors.

In addition to identifying risk factors, this study aims to develop and validate predictive models for postoperative complications. Advanced statistical techniques, such as machine learning algorithms, will be used to assess the contribution of individual variables to complication risk.

By leveraging a large multi-center dataset, the study seeks to provide actionable insights into the prevention of postoperative complications. The results are expected to inform clinical decision-making, enhance patient outcomes, and improve the quality of perioperative care in neurosurgical practice.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bin Huang, Ph.D
  • Phone Number: +86 18560085770
  • Email: hb@sdu.edu.cn

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Department of Neurosurgery, Daping Hospital of Army Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Department of Neurosurgery, Tang-Du Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Neurosurgery, Qilu Hospital of Shandong University
        • Contact:
        • Contact:
          • Bin Huang, Ph.D
          • Phone Number: +86 18560085770
          • Email: hb@sdu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Derivation Cohort
Identification of risk factors, development and internal validation of predictive models
External Validation Cohort
External validation of the predictive models

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for postoperative complications of cranioplasty
Time Frame: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.
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
From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment predictive models for postoperative complications of cranioplasty
Time Frame: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.
The secondary outcome is to develop and validate predictive models for postoperative complications of cranioplasty based on identified risk factors.
From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Tang-Du Hospital
Daping Hospital of Army Medical University

Investigators

  • Principal Investigator: Ning Yang, M.D., Ph.D, Department of Neurosurgery, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

December 18, 2024

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202407-041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

Beginning 1 year after publication with no end date

IPD Sharing Access Criteria

The individual participant data (IPD) and supporting information are available from the corresponding author upon reasonable request via email. Access will be provided to researchers with a scientifically sound proposal and for non-commercial purposes, in compliance with ethical guidelines.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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