Risk Factors for Complications After Cranioplasty

Recruiting

• Conditions: Cranioplasty; Postoperative Complications; Risk Assessment

• Registration Number: NCT06740773
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-14
• Study Start: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors for postoperative complications of cranioplasty	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 Outcome Measures

Name	Time	Method
Establishment predictive models for postoperative complications of cranioplasty	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.

Trial Locations

Locations (3)

Department of Neurosurgery, Daping Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

Department of Neurosurgery, Tang-Du Hospital; 🇨🇳 Xi'an, Shaanxi, China

Department of Neurosurgery, Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China