Adolescent Idiopathic ScoliosisNCT05803837
Thoracotomy Effects on Pulmonary Function Test and Chest Expansion
An observational study of Adolescent Idiopathic Scoliosis, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 20 Nov 2022
- How long will I take part?
- 10 Days
- 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 12 to 18 years
- All sexes
- Child, Adult
Study population: thirty patients Participants have received a good explanation of the treatment and measurement device. aged between 12 and 18 years with AIS; the patients were admitted to hospital
Who may be able to join
- Adolescent idiopathic scoliosis
Who cannot join
- smoking.
- Associated comorbidity that affects PFT.
- Any contraindication interfering with performing spirometry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Concave Thoracoplasty on Chest Circumference and Ventilatory Function in Adolescence With Idiopathic Scoliosis
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- lung functions and thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | one group |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest expansion
chest circumference meaurement
Measured: 10 months
PFT
PULMONARY FUNCTION TEST
- Vital capacity (Liter).
- Forced VITAL Capacity (Liter).
- Maximal voluntary breathing (Liter).
Measured: 10 months for each parameter
Secondary outcomes (1)
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Mar 2022
- Primary completion15 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Takey Ahmed, Cairo University
- Investigators
- nisreen moh elnahass, Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803837
- Sponsor's protocol ID
- Thoracotomy
- Status last verified
- Apr 2023
- First submitted
- 7 Feb 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34482261
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concave Thoracoplasty on Chest Circumference and Ventilatory Function in Adolescence With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05803837
- Acronym / sponsor ID
- Thoracotomy
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- lung functions and thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 7 Apr 2023 (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.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | –one group |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- thirty patients Participants have received a good explanation of the treatment and measurement device. aged between 12 and 18 years with AIS; the patients were admitted to hospital
Key inclusion criteria (1 listed)
- Adolescent idiopathic scoliosis
Key exclusion criteria (3 listed)
- smoking.
- Associated comorbidity that affects PFT.
- Any contraindication interfering with performing spirometry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
chest expansion
Time frame: 10 months
chest circumference meaurement
PFT
Time frame: 10 months for each parameter
PULMONARY FUNCTION TEST * Vital capacity (Liter). * Forced VITAL Capacity (Liter). * Maximal voluntary breathing (Liter).
1 secondary outcome
cobb angle
Time frame: 10 months
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 7 Apr 2023.
- Background: PubMed 34482261Rao 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.
- 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.
nisreen moh elnahass, Prof study director
Cairo University
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 Adolescent Idiopathic Scoliosis, run by Cairo University at 1 site in Egypt.
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 3 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 7 Apr 2023. 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 Egypt. 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?
chest expansion (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803837, which also lists 1 linked publication.
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 7 Apr 2023.