Spinal DeformityNCT05579834
Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity
An observational study of Spinal Deformity and Hemothorax Postoperative, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Spinal Deformity, Hemothorax Postoperative
- What is being tested?
- posterior correction surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2021to 3 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)
Who may be able to join
- Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi Üniversitesi
Ankara, None Selected, 06560
About this study
Official title: 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.
Read the detailed description
We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.
- Conditions
- Spinal Deformity, Hemothorax Postoperative
- Being tested
- posterior correction surgery
- Keywords
- spinal deformity, posterior correction surgery, hemothorax
- Medical subject headings
- Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior correction surgeryProcedure or surgery
Cases of hemothorax developing after posterior correction surgery for spinal deformities
What is being measured
The primary outcome is the main question the study is designed to answer.
hemothorax
hemothorax caused by posterior correction surgery for spinal deformity
Measured: 2016-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start18 Oct 2021
- Primary completion12 May 2022
- Study completion3 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cem KAYA, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579834
- Sponsor's protocol ID
- GU-260121-02
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Management in Terms of Hemothorax Caused by Posterior Correction
- ClinicalTrials.gov ID
- NCT05579834
- Acronym / sponsor ID
- GU-260121-02
- Conditions
- Spinal Deformity, Hemothorax Postoperative
- Keywords
- spinal deformity, posterior correction surgery, hemothorax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 14 Oct 2022 (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.
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.
Detailed description
We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)
Key inclusion criteria (1 listed)
- Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior correction surgeryCases of hemothorax developing after posterior correction surgery for spinal deformities | Procedure or surgery | – |
Primary outcome
hemothorax
Time frame: 2016-2021
hemothorax caused by posterior correction surgery for spinal deformity
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 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Spinal Deformity and Hemothorax Postoperative, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 Oct 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 Turkey (Türkiye). 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?
hemothorax (time frame: 2016-2021). 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 14 Oct 2022.