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...

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...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-12-18
• Last Update Posted: 2024-12-20
• 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

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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

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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