Decompressive Craniectomy and CranioplastyNCT04791904
Predictive Factors for Cranioplasty Complications - A Decade Experience
An observational study of Decompressive Craniectomy and Cranioplasty, run by Universidade do Porto at 1 site in Portugal.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Decompressive Craniectomy and Cranioplasty
- How many people
- 168 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients submitted to cranioplasty after decompressive craniectomy between 1 of January of 2008 and 21 of December of 2019.
Who may be able to join
- Cranioplasty surgery
- Previous decompressive craniectomy
Who cannot join
- Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.
- More than one decompressive craniectomy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- Cranioplasty, Surgery Complications, Decompressive Craniectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complications
Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Sep 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompressive Craniectomy and CranioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Filipa Vaz Ferreira, Universidade do Porto
- Investigators
- Pedro Silva, MD, Study director, University of Porto, Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791904
- Sponsor's protocol ID
- 202101
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Cranioplasty Complications - A Decade Experience
- ClinicalTrials.gov ID
- NCT04791904
- Acronym / sponsor ID
- 202101
- Keywords
- Cranioplasty, Surgery Complications, Decompressive Craniectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients submitted to cranioplasty after decompressive craniectomy between 1 of January of 2008 and 21 of December of 2019.
Key inclusion criteria (2 listed)
- Cranioplasty surgery
- Previous decompressive craniectomy
Key exclusion criteria (2 listed)
- Incomplete records (Clinical and Imaging) since craniectomy to 6 months after cranioplasty.
- More than one decompressive craniectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical Complications
Time frame: 6 months
Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Silva, MD study director
University of Porto, Medicine Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompressive Craniectomy and Cranioplasty, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.