- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05579834
Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity
October 11, 2022 updated by: Cem KAYA, Gazi University
Perioperative Management in Terms of Hemothorax Caused by Posterior Correction
Owing to the development of instruments and surgical techniques, the number of spinal deformity correction surgeries has increased significantly.
The incidence of hemothorax due to posterior correction surgery for spinal deformity is reported to be as low as 0.1%, and the vast majority of these cases were treated through observation without additional intervention.
However, if hemothorax that occurs is missed, it can result in increased mortality and morbidity.
Furthermore, there is a paucity of data on management of hemothorax caused by posterior correction surgery.
The aim of this retrospective study is to evaluate our cases of hemothorax after posterior correction surgery for spinal deformity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
None Selected
-
Ankara, None Selected, Turkey, 06560
- Gazi Universitesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 14 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)
Description
Inclusion Criteria:
- Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hemothorax
Time Frame: 2016-2021
|
hemothorax caused by posterior correction surgery for spinal deformity
|
2016-2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2021
Primary Completion (Actual)
May 12, 2022
Study Completion (Actual)
July 3, 2022
Study Registration Dates
First Submitted
October 11, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 14, 2022
Last Update Submitted That Met QC Criteria
October 11, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GU-260121-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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