Risk Factors for Complications After Cranioplasty

NCT06740773 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Observational

Started

2024-12-17

Last updated

2025-06-05

Condition(s) studied

CranioplastyPostoperative ComplicationsRisk Assessment

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (3)

Facility	City	Region	Status
Department of Neurosurgery, Daping Hospital of Army Medical University	Chongqing	Chongqing Municipality	Recruiting
Department of Neurosurgery, Tang-Du Hospital	Xi'an	Shaanxi	Recruiting
Department of Neurosurgery, Qilu Hospital of Shandong University	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06740773 on ClinicalTrials.gov ↗ ← All trials in China