NCT05579834

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 11, 2022

Last Update Submit

October 11, 2022

Conditions

Spinal DeformityHemothorax Postoperative

Keywords

spinal deformityposterior correction surgeryhemothorax

Outcome Measures

Primary Outcomes (1)

  • hemothorax

    hemothorax caused by posterior correction surgery for spinal deformity

    2016-2021

Interventions

posterior correction surgeryPROCEDURE

Cases of hemothorax developing after posterior correction surgery for spinal deformities

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)

You may qualify if:

  • Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi Üniversitesi

Ankara, None Selected, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

October 18, 2021

Primary Completion

May 12, 2022

Study Completion

July 3, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

TU(1)