Predictive Factors for Cranioplasty Complications - A Dec... | NCT04791904

Studies
Predictive Factors for Cranioplasty Complications - A Decade Experience

NCT04791904

Sponsor

Universidade do Porto

Status

Completed

Last Update Posted

Aug 24, 2022Actual

Enrollment

168Actual

Phase

Not provided

Conditions

Decompressive Craniectomy and Cranioplasty

Interventions

Not provided

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Mar 6, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2022

Last Update Posted Date

Aug 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical Complications	Complications after cranioplasty - symptomatic hemorrhage, infection, re-intervention.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pedro Silva, MD	University of Porto, Medicine Faculty	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Hospitalar Universitário de São João		Porto			Portugal

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided