Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-12-17
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Derivation Cohort
Identification of risk factors, development and internal validation of predictive models
No interventions assigned to this group
External Validation Cohort
External validation of the predictive models
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with cranial defects
* Possessed complete and accessible electronic medical records
* Patients had no prior history of cranioplasty
Exclusion Criteria
* Severe comorbidities (such as serious cardiac, liver, kidney and immune system dysfunction)
* Congenital cranial defects
* Severe missing data
ALL
No
Sponsors
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Daping Hospital of Army Medical University
OTHER
Tang-Du Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Responsible Party
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Principal Investigators
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Ning Yang, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Qilu Hospital of Shandong University
Locations
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Department of Neurosurgery, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Department of Neurosurgery, Tang-Du Hospital
Xi'an, Shaanxi, China
Department of Neurosurgery, Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Bader ER, Kobets AJ, Ammar A, Goodrich JT. Factors predicting complications following cranioplasty. J Craniomaxillofac Surg. 2022 Feb;50(2):134-139. doi: 10.1016/j.jcms.2021.08.001. Epub 2021 Aug 25.
Chaturvedi J, Botta R, Prabhuraj AR, Shukla D, Bhat DI, Devi BI. Complications of cranioplasty after decompressive craniectomy for traumatic brain injury. Br J Neurosurg. 2016;30(2):264-8. doi: 10.3109/02688697.2015.1054356. Epub 2015 Jun 17.
Zanaty M, Chalouhi N, Starke RM, Clark SW, Bovenzi CD, Saigh M, Schwartz E, Kunkel ES, Efthimiadis-Budike AS, Jabbour P, Dalyai R, Rosenwasser RH, Tjoumakaris SI. Complications following cranioplasty: incidence and predictors in 348 cases. J Neurosurg. 2015 Jul;123(1):182-8. doi: 10.3171/2014.9.JNS14405. Epub 2015 Mar 13.
Belzberg M, Mitchell KA, Ben-Shalom N, Asemota AO, Wolff AY, Santiago GF, Shay T, Huang J, Manson PN, Brem H, Gordon CR. Cranioplasty Outcomes From 500 Consecutive Neuroplastic Surgery Patients. J Craniofac Surg. 2022 Sep 1;33(6):1648-1654. doi: 10.1097/SCS.0000000000008546. Epub 2022 Mar 4.
Malcolm JG, Rindler RS, Chu JK, Grossberg JA, Pradilla G, Ahmad FU. Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. J Clin Neurosci. 2016 Nov;33:39-51. doi: 10.1016/j.jocn.2016.04.017. Epub 2016 Aug 4.
Singh S, Singh R, Jain K, Walia B. Cranioplasty following decompressive craniectomy - Analysis of complication rates and neurological outcomes: A single center study. Surg Neurol Int. 2019 Jul 19;10:142. doi: 10.25259/SNI_29_2019. eCollection 2019.
Honeybul S, Ho KM. Long-term complications of decompressive craniectomy for head injury. J Neurotrauma. 2011 Jun;28(6):929-35. doi: 10.1089/neu.2010.1612. Epub 2011 Jun 1.
Henry J, Amoo M, Murphy A, O'Brien DP. Complications of cranioplasty following decompressive craniectomy for traumatic brain injury: systematic review and meta-analysis. Acta Neurochir (Wien). 2021 May;163(5):1423-1435. doi: 10.1007/s00701-021-04809-z. Epub 2021 Mar 23.
Other Identifiers
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KYLL-202407-041
Identifier Type: -
Identifier Source: org_study_id
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