Predictive Factors for Cranioplasty Complications - A Decade Experience

NCT ID: NCT04791904

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decompressive Craniectomy and Cranioplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ana Filipa Vaz Ferreira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pedro Silva, MD

Role: STUDY_DIRECTOR

University of Porto, Medicine Faculty

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Hospitalar Universitário de São João

Porto, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.