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Clinical Trials/NCT04791904
NCT04791904
Completed
Not Applicable

Predictive Factors for Cranioplasty Complications - A Decade Experience

Universidade do Porto1 site in 1 country168 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Decompressive Craniectomy and Cranioplasty
Sponsor
Universidade do Porto
Enrollment
168
Locations
1
Primary Endpoint
Surgical Complications
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies.

All patients submitted to cranioplasty since 2008 will be analyzed.

Detailed Description

Patients submitted to cranioplasty since 2008 to 2019 will be retrospectively analyzed. Will be considered for analysis all cases treated after decompressive craniectomy. Will be excluded patients with incomplete clinical or imaging records. Main factors determined as a possible influence on complications after cranioplasty will be recorded focusing on patients characteristics, craniectomy characteristics, surgical timing, and cranioplasty materials. Patients' records will be review by two investigators and data will be verified by a third investigator. records will be anonymously recorded.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ana Filipa Vaz Ferreira

Principal Investigator

Universidade do Porto

Eligibility Criteria

Inclusion Criteria

  • Cranioplasty surgery
  • Previous decompressive craniectomy

Exclusion Criteria

  • Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.
  • More than one decompressive craniectomy

Outcomes

Primary Outcomes

Surgical Complications

Time Frame: 6 months

Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention.

Study Sites (1)

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