Risk Factors for Complications After Cranioplasty

NCT06740773 | Recruiting

• 1 other identifier: KYLL-202407-041
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Cranioplasty; Postoperative Complications; Risk Assessment

Keywords

Cranioplasty; Postoperative Complications; Risk factors; Retrospective Study; predictive model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Derivation Cohort

Identification of risk factors, development and internal validation of predictive models

External Validation Cohort

External validation of the predictive models

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cranial defects who underwent their first cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University between January 1, 2015, and January 1, 2025, or at Tangdu Hospital of Air Force Medical University or Daping Hospital of the Army Medical University between January 1, 2015, and July 31, 2023.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Daping Hospital of Army Medical University: collaborator
• Tang-Du Hospital: collaborator

Study Sites (3)

Department of Neurosurgery, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Department of Neurosurgery, Tang-Du Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Department of Neurosurgery, Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 34580005 RESULT

• 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.

  PMID: 26083136 RESULT

• 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.

  PMID: 25768830 RESULT

• 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.

  PMID: 35245275 RESULT

• 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.

  PMID: 27499122 RESULT

• 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.

  PMID: 31528477 RESULT

• 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.

  PMID: 21091342 RESULT

• 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.

  PMID: 33759012 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ning Yang, M.D., Ph.D

  Department of Neurosurgery, Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Yang, M.D., Ph.D

CONTACT

+86 13589040486; yangning@sdu.edu.cn

Bin Huang, Ph.D

CONTACT

+86 18560085770; hb@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: December 17, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: The individual participant data (IPD) and supporting information are available from the corresponding author upon reasonable request via email. Access will be provided to researchers with a scientifically sound proposal and for non-commercial purposes, in compliance with ethical guidelines.

Locations

CN (3)