Identifying risk factors for complications after cranioplasty
A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty
This study looks at what factors might lead to complications after surgery to repair skull injuries, helping doctors make better decisions for their patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 3 sites (Chongqing, Chongqing Municipality and 2 other locations) |
| Trial ID | NCT06740773 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the risk factors associated with complications following cranioplasty, a procedure performed to repair cranial defects resulting from conditions like traumatic brain injuries and strokes. By utilizing a large multi-center dataset, the study aims to develop and validate predictive models using advanced statistical techniques, including machine learning algorithms. The goal is to identify individual variables that contribute to the risk of postoperative complications, thereby enhancing clinical decision-making and patient outcomes in neurosurgery.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone cranioplasty at specified hospitals and have complete electronic medical records.
Not a fit: Patients with a prior history of cranioplasty or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for postoperative complications in patients undergoing cranioplasty.
How similar studies have performed: While the approach of using predictive models in surgical outcomes is not entirely novel, the specific focus on cranioplasty complications represents a targeted investigation that has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chongqing, Chongqing Municipality and 2 other locations
- Department of Neurosurgery, Daping Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- Department of Neurosurgery, Tang-Du Hospital — Xi'an, Shaanxi, China (Recruiting)
- Department of Neurosurgery, Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Ning Yang, M.D., Ph.D — Department of Neurosurgery, Qilu Hospital of Shandong University
- Study coordinator: Ning Yang, M.D., Ph.D
- Email: yangning@sdu.edu.cn
- Phone: +86 13589040486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.