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Thoracotomy Effects on Pulmonary Function Test and Chest Expansion

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05803837
Collaborator
(none)
30
Enrollment
1
Location
8.2
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Effects of Concave Thoracoplasty on Chest Circumference and Ventilatory Function in Adolescence With Idiopathic Scoliosis
    Actual Study Start Date :
    Mar 15, 2022
    Actual Primary Completion Date :
    Nov 15, 2022
    Actual Study Completion Date :
    Nov 20, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    intervention group

    one group

    Outcome Measures

    Primary Outcome Measures

    1. chest expansion [10 months]

      chest circumference meaurement

    2. PFT [10 months for each parameter]

      PULMONARY FUNCTION TEST Vital capacity (Liter). Forced VITAL Capacity (Liter). Maximal voluntary breathing (Liter).

    Secondary Outcome Measures

    1. cobb angle [10 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Adolescent idiopathic scoliosis

    Exclusion Criteria:

    • smoking.

    • Associated comorbidity that affects PFT.

    • Any contraindication interfering with performing spirometry.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Giza Egypt 215879

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: nisreen moh elnahass, Prof, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Khaled Takey Ahmed, Asssociate Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05803837
    Other Study ID Numbers:
    • Thoracotomy
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Khaled Takey Ahmed, Asssociate Professor, Cairo University
    lung functions and thoracotomy
    Additional relevant MeSH terms:
    Scoliosis

    Study Results

    No Results Posted as of Apr 7, 2023