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NCT Number: NCT06740773

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.

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Key information

Conditions

Cranioplasty Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Risk Assessment

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, Daping Hospital of Army Medical University, Chongqing, Chongqing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Huang, Ph.D

CONTACT

[email protected]

+86 18560085770

Ning Yang, M.D., Ph.D

CONTACT

[email protected]

+86 13589040486

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

Daping Hospital of Army Medical University
Tang-Du Hospital

Registry information

Official study title

A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 18, 2024
Registry last updated: Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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