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OpenTrials
Completed

NCT Number: NCT04791904

Predictive Factors for Cranioplasty Complications - A Decade Experience

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Universitário de São João

Porto, Portugal

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Surgical Complications

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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