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CompletedNCT04791904Updated Aug 24, 2022

Predictive Factors for Cranioplasty Complications - A Decade Experience

An observational study in Decompressive Craniectomy and Cranioplasty, sponsored by Universidade do Porto. Completed at 1 site in Portugal. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by Universidade do Porto · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
168
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Decompressive Craniectomy and Cranioplasty

Keywords

  • Cranioplasty
  • Surgery Complications
  • Decompressive Craniectomy
03

In context

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients submitted to cranioplasty after decompressive craniectomy between 1 of January of 2008 and 21 of December of 2019.

Inclusion criteria

  • Cranioplasty surgery
  • Previous decompressive craniectomy

Exclusion criteria

Exclusion Criteria:

  • Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.
  • More than one decompressive craniectomy
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
168 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Surgical Complications

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

    Time frame: 6 months

07

Study locations

1 site
  • Centro Hospitalar Universitário de São João
    Porto, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04791904
Lead sponsor
Universidade do Porto
Responsible party
Ana Filipa Vaz Ferreira (Principal Investigator, Universidade do Porto) — Principal investigator
First posted
Mar 10, 2021
Start date
Sep 1, 2020
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022
Last update
Aug 24, 2022

Study contacts

Pedro Silva, MD
study director · University of Porto, Medicine Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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