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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05803837
Other study ID # Thoracotomy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date November 20, 2022

Study information

Verified date April 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of the present study was to investigate the effect that corrective surgery for scoliosis would have on pulmonary function as well as the circumference of the chest. As a result, the current investigation was carried out on thirty individuals who had idiopathic scoliosis and had been admitted to the hospital. Before the surgery, after it had been completed (on the fifth day), and again three months later, the pulmonary function was tested.


Description:

The purpose of this study was to see how corrective scoliosis surgery affected pulmonary function and chest circumference. As a result, the current investigation was carried out on 30 individuals brought to the hospital with idiopathic scoliosis. The pulmonary function was assessed before surgery, on the fifth day following surgery, and three months thereafter.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 20, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: • Adolescent idiopathic scoliosis Exclusion Criteria: - smoking. - Associated comorbidity that affects PFT. - Any contraindication interfering with performing spirometry.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Cairo University Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Rao KE, Krodel D, Toaz EE, Fanelli J, Hajduk J, Kato K, Rychlik K, King E, Sarwark J, Grayhack J, Burjek NE. Introduction of an enhanced recovery pathway results in decreased length of stay in patients with adolescent idiopathic scoliosis undergoing posterior spinal fusion: A description of implementation strategies and retrospective before-and-after study of outcomes. J Clin Anesth. 2021 Dec;75:110493. doi: 10.1016/j.jclinane.2021.110493. Epub 2021 Sep 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary chest expansion chest circumference meaurement 10 months
Primary PFT PULMONARY FUNCTION TEST
Vital capacity (Liter).
Forced VITAL Capacity (Liter).
Maximal voluntary breathing (Liter).
10 months for each parameter
Secondary cobb angle In terms of measuring the major curve Cobb's angle, patient in a standing posterior-anterior (PA) radiograph, the angle is composed of two intersecting lines: the upper endplate of the main thoracic curve upper vertebra and the lower endplate of the main curve lower vertebra. These lines meet at the point where the upper endplate of the main thoracic curve upper vertebra and the lower endplate of the main curve lower vertebra meet. 10 months
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