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Clinical Trial NCT06740773 for Cranioplasty, Postoperative Complications, Risk Assessment is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Risk Factors for Complications After Cranioplasty 1,000

Recruiting
Clinical Trial NCT06740773 is an observational study for Cranioplasty, Postoperative Complications, Risk Assessment that is recruiting. It started on 17 December 2024 with plans to enroll 1,000 participants. Led by Qilu Hospital of Shandong University, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 5 June 2025.
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 crani...Show More
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...Show More
Official Title

A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty

Conditions
CranioplastyPostoperative ComplicationsRisk Assessment
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • KYLL-202407-041
NCT ID Number
NCT06740773
Start Date (Actual)
2024-12-17
Last Update Posted
2025-06-05
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
1,000
Study Type
Observational
Status
Recruiting
Keywords
Cranioplasty
Postoperative Complications
Risk factors
Retrospective Study
predictive model
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Derivation Cohort
Identification of risk factors, development and internal validation of predictive models
N/A
External Validation Cohort
External validation of the predictive models
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Risk factors for postoperative complications of cranioplasty
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 MeasureMeasure DescriptionTime Frame
Establishment predictive models for postoperative complications of cranioplasty
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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • 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

  • 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
Qilu Hospital of Shandong University logoQilu Hospital of Shandong University
  • Daping Hospital of Army Medical University logoDaping Hospital of Army Medical University
  • Tang-Du Hospital logoTang-Du Hospital
Study Central Contact
Contact: Ning Yang, M.D., Ph.D, +86 13589040486, [email protected]
Contact: Bin Huang, Ph.D, +86 18560085770, [email protected]
3 Study Locations in 1 Countries

Chongqing Municipality

Department of Neurosurgery, Daping Hospital of Army Medical University, Chongqing, Chongqing Municipality, 400042, China
Tianzun Li, MD, Contact, +86 15683213229, [email protected]
Recruiting

Shaanxi

Department of Neurosurgery, Tang-Du Hospital, Xi'an, Shaanxi, 710038, China
Bao Wang, M.D., Ph.D, Contact, +86 18092307582, [email protected]
Recruiting

Shandong

Department of Neurosurgery, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Ning Yang, M.D., Ph.D, Contact, +86 13589040486, [email protected]
Bin Huang, Ph.D, Contact, +86 18560085770, [email protected]
Recruiting