Pectus ExcavatumNCT05844800
The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum
A study testing Nuss repair of Pectus Excavatum and Epidural anesthesia in people with Pectus Excavatum, run by Poznan University of Physical Education at 2 sites in Poland.
Trial summary
The goal of this study is to determine the effect of Nuss minimally-invasive repair technique of pectus excavatum (PE) on the postural stability in patients with PE. The main questions it aims to answer are: How surgical chest wall repair will affect postural stability of PE patients? What is the difference in… Read more about this study
- Who is it for?
- Ages 14 years and older, men only
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Nuss repair of Pectus Excavatum and Epidural anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesPoland
- Study dates
- Jan 2011to Sep 2022
- Phase
- Interventional
- 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 14 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pectus excavatum (experimental group)
- no posture defects (control group)
- no neurological disorders
- consent to the surgical intervention procedure (experimental group)
Who cannot join
- co-existence of defects in the anterior chest wall other than pectus excavatum
- presence of musculoskeletal anomalies
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
Poznan, 60-569
Poznan University of Physical Education
Poznan, 61-871
About this study
The goal of this study is to determine the effect of Nuss minimally-invasive repair technique of pectus excavatum (PE) on the postural stability in patients with PE.
The main questions it aims to answer are:
- How surgical chest wall repair will affect postural stability of PE patients?
- What is the difference in postural stability between patients with PE and healthy controls? Participants will undergo the Nuss repair surgery and will be tested before and afterwards for their postural stability with the use of the posturography method.
Researchers will compare PE male patients and healthy young men to see if PE posture defect affects postural stability.
Read the detailed description
The experiment was designed as a pretest-posttest control trial. The clinical examination and surgery intervention (minimally invasive repair of pectus excavatum - MIRPE) of pectus excavatum patients are done in Wielkopolska Centre of Pulmonology and Thoracosurgery in Poznań, Poland. Other postural stability assessment of both, experimental group and control group subjects are done in the Poznań University of Physical Education in Poland. The measurements are carried out twice, before and three months after the intervention for experimental group, and twice for control group as well. Before the experiment initial measurements connected to basic and somatic characteristics assessments are recorded. Participants are also familiarized with measurement methods.
All PE patients included in the study after preoperative examination undergo the Nuss surgery procedure (MIRPE): curved metal bars are inserted behind the sternum to correct the shape of the anterior chest wall. The bars are left in situ for three years and then removed. The operation is performed under general anesthesia in a hospital setting.
Postural stability as a dependent variable was examined with the use of the posturography method based on the measurement of centre of pressure (COP) displacements. The stabilometric platform CQStab2P in two-plates version (CQ Electronic System, Poland) is used for collecting COP data during trials. The platforms are equipped with strain gauges that facilitated the monitoring of the changes in ground reaction forces. It is connected to a computer equipped with software provided by the manufacturer of the platforms. Based on the data of ground reaction forces the position and displacements of COP are estimated in the software.
The sampling frequency of 200 Hz is used during data acquisition. According to producer declaration processing accurancy is equal to 0.1% (12-bit processing, effective 10-bit) during reproduction of statokinesiogram with accurancy of 1 mm with radius fluctuation of 10cm.
The force platforms are placed on a hard and flat floor surface. Before the start of the testing procedures, the participants rest in a sitting position for 5 min. During the measurement, only the researcher and the participant are present in the room. Participants need to perform trials in three conditions: 1) double stance with eyes open (EO); 2) double stance with eyes closed (EC); 3) one-leg standing with eyes open (OLS).
Each trial is run two times - summing 6 trials in each measurement with a 20-second break between the following trials. The order of trials is random to avoid potential learning effects. An average of two repetitions of specific trials is taken as the final result.
The primary outcomes of the study are:
- Average velocity of COP displacements and its components in anterior-posterior (AP) and medio-lateral (ML) directions (Vavg, VavgAP, VavgML, respectively). It's calculated as a ratio of the total path length covered by COP during the trial, and the time of the trial (mm/s).
- Indicators of the spatial distribution of COP displacements i.e.sway area (SA) and maximal COP displacementin AP and ML directions (MaxAP and MaxML, respectively). SA is calculated as the size of the area covered by the COP during the trial (mm2). MaxAP and MaxML are calculated as maximal swaydistance (mm) of the COP from the 0.0 point along Y and X axis in Cartesian coordinate system, respectively.
Study population is characterized also by age, body weight and height, and body mass index (BMI) - calculated as body weight/height2.
The main calculations related to the assessment of the variability of dependent variables are based on the ANOVA variance analysis method (test F). The analysis applied takes into account within-group factor of repeated measurements "time" with two levels (pre and post), and between-group factor "group" (experimental and control). For interaction effects ("group" × "time") the eta-squared effect size is calculated. The effect size indicates the percent of variance explained by particular effects of the dependent variable. To compare the average values of average velocities, area, and maximal COP displacement (both pre-post values within groups, and between groups in pre and post conditions) Bonferroni detailed post-hoc comparisons is used.
Between-groups comparison for secondary outcomes in pretest is done with the use of t-Student test. The minimum level of statistical significance was defined as p ≤ 0.05. The study is conducted using the Statistica v. 13.0 software program.
- Conditions
- Pectus Excavatum
- Being tested
- Nuss repair of Pectus Excavatum, Epidural anesthesia
- Keywords
- Pectus Excavatum, Postural Stability
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuss repair of Pectus ExcavatumProcedure or surgery
Also called minimally-invasive repair technique of Pectus Excavatum (MIRPE)
The Nuss procedure is a minimally-invasive repair technique of PE (MIRPE), whereby one to three curved metal bars are inserted behind the sternum to correct the shape of the anterior chest wall. The bars are left in situ for three years and then removed.
Epidural anesthesiaDrug
Also called Bupivacaine
The Nuss procedure of pectus excavatum repair surgery is performed under general anesthesia. Epidural anesthesia, with a constant infusion of 0.25% bupivacaine, was routinely used and was maintained in the early postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Pectus Excavatum | Experimental | Patients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE) Receives: Procedure: Nuss repair of Pectus Excavatum; Drug: Epidural anesthesia |
| Healthy Control | No intervention | Healthy control group with no posture defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability
Postural stability as a dependent variable examined with the use of the posturography method based on the measurement of Centre of Pressure displacements.
Measured: Three months
Secondary outcomes (1)
BMI
Body mass index (BMI) - calculated as body weight/height2
Measured: Single measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startJan 2011
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The experimental group of pectus excavatum patients (n=21) pre- and post intervention examination and control group of healthy subjects (n=22) examined twice.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
- Responsible party
- Sponsor
- Investigators
- Maria A Jarosz, M.Sc., Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844800
- Sponsor's protocol ID
- Maria Jarosz PhD Thesis
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data files will be made available as supplementary files in the scientific publication. Personal data will not be disclosed, only the raw results of posturographic analysis.
Publications
Pawlak K, Gasiorowski L, Gabryel P, Galecki B, Zielinski P, Dyszkiewicz W. Early and Late Results of the Nuss Procedure in Surgical Treatment of Pectus Excavatum in Different Age Groups. Ann Thorac Surg. 2016 Nov;102(5):1711-1716. doi: 10.1016/j.athoracsur.2016.04.098. Epub 2016 Jun 30.
PubMed 27373189de Loos ER, Daemen JHT, Pennings AJ, Heuts S, Maessen JG, Hulsewe KWE, Vissers YLJ. Minimally invasive repair of pectus excavatum by the Nuss procedure: The learning curve. J Thorac Cardiovasc Surg. 2022 Mar;163(3):828-837.e4. doi: 10.1016/j.jtcvs.2020.11.154. Epub 2020 Dec 10.
PubMed 33478832Blaszczyk JW, Beck M, Sadowska D. Assessment of postural stability in young healthy subjects based on directional features of posturographic data: vision and gender effects. Acta Neurobiol Exp (Wars). 2014;74(4):433-42. doi: 10.55782/ane-2014-2006.
PubMed 25576974
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum
- ClinicalTrials.gov ID
- NCT05844800
- Acronym / sponsor ID
- Maria Jarosz PhD Thesis
- Conditions
- Pectus Excavatum
- Keywords
- Pectus Excavatum, Postural Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
- Study start
- Jan 2011 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 6 May 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 goal of this study is to determine the effect of Nuss minimally-invasive repair technique of pectus excavatum (PE) on the postural stability in patients with PE.
The main questions it aims to answer are:
- How surgical chest wall repair will affect postural stability of PE patients?
- What is the difference in postural stability between patients with PE and healthy controls? Participants will undergo the Nuss repair surgery and will be tested before and afterwards for their postural stability with the use of the posturography method.
Researchers will compare PE male patients and healthy young men to see if PE posture defect affects postural stability.
Detailed description
The experiment was designed as a pretest-posttest control trial. The clinical examination and surgery intervention (minimally invasive repair of pectus excavatum - MIRPE) of pectus excavatum patients are done in Wielkopolska Centre of Pulmonology and Thoracosurgery in Poznań, Poland. Other postural stability assessment of both, experimental group and control group subjects are done in the Poznań University of Physical Education in Poland. The measurements are carried out twice, before and three months after the intervention for experimental group, and twice for control group as well. Before the experiment initial measurements connected to basic and somatic characteristics assessments are recorded. Participants are also familiarized with measurement methods.
All PE patients included in the study after preoperative examination undergo the Nuss surgery procedure (MIRPE): curved metal bars are inserted behind the sternum to correct the shape of the anterior chest wall. The bars are left in situ for three years and then removed. The operation is performed under general anesthesia in a hospital setting.
Postural stability as a dependent variable was examined with the use of the posturography method based on the measurement of centre of pressure (COP) displacements. The stabilometric platform CQStab2P in two-plates version (CQ Electronic System, Poland) is used for collecting COP data during trials. The platforms are equipped with strain gauges that facilitated the monitoring of the changes in ground reaction forces. It is connected to a computer equipped with software provided by the manufacturer of the platforms. Based on the data of ground reaction forces the position and displacements of COP are estimated in the software.
The sampling frequency of 200 Hz is used during data acquisition. According to producer declaration processing accurancy is equal to 0.1% (12-bit processing, effective 10-bit) during reproduction of statokinesiogram with accurancy of 1 mm with radius fluctuation of 10cm.
The force platforms are placed on a hard and flat floor surface. Before the start of the testing procedures, the participants rest in a sitting position for 5 min. During the measurement, only the researcher and the participant are present in the room. Participants need to perform trials in three conditions: 1) double stance with eyes open (EO); 2) double stance with eyes closed (EC); 3) one-leg standing with eyes open (OLS).
Each trial is run two times - summing 6 trials in each measurement with a 20-second break between the following trials. The order of trials is random to avoid potential learning effects. An average of two repetitions of specific trials is taken as the final result.
The primary outcomes of the study are:
- Average velocity of COP displacements and its components in anterior-posterior (AP) and medio-lateral (ML) directions (Vavg, VavgAP, VavgML, respectively). It's calculated as a ratio of the total path length covered by COP during the trial, and the time of the trial (mm/s).
- Indicators of the spatial distribution of COP displacements i.e.sway area (SA) and maximal COP displacementin AP and ML directions (MaxAP and MaxML, respectively). SA is calculated as the size of the area covered by the COP during the trial (mm2). MaxAP and MaxML are calculated as maximal swaydistance (mm) of the COP from the 0.0 point along Y and X axis in Cartesian coordinate system, respectively.
Study population is characterized also by age, body weight and height, and body mass index (BMI) - calculated as body weight/height2.
The main calculations related to the assessment of the variability of dependent variables are based on the ANOVA variance analysis method (test F). The analysis applied takes into account within-group factor of repeated measurements "time" with two levels (pre and post), and between-group factor "group" (experimental and control). For interaction effects ("group" × "time") the eta-squared effect size is calculated. The effect size indicates the percent of variance explained by particular effects of the dependent variable. To compare the average values of average velocities, area, and maximal COP displacement (both pre-post values within groups, and between groups in pre and post conditions) Bonferroni detailed post-hoc comparisons is used.
Between-groups comparison for secondary outcomes in pretest is done with the use of t-Student test. The minimum level of statistical significance was defined as p ≤ 0.05. The study is conducted using the Statistica v. 13.0 software program.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group of pectus excavatum patients (n=21) pre- and post intervention examination and control group of healthy subjects (n=22) examined twice.
| Arm | Type | Receives |
|---|---|---|
| Pectus Excavatum | Experimental | Procedure: Nuss repair of Pectus Excavatum, Drug: Epidural anesthesiaPatients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE) |
| Healthy Control | No intervention | –Healthy control group with no posture defects |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- pectus excavatum (experimental group)
- no posture defects (control group)
- no neurological disorders
- consent to the surgical intervention procedure (experimental group)
Key exclusion criteria (2 listed)
- co-existence of defects in the anterior chest wall other than pectus excavatum
- presence of musculoskeletal anomalies
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 |
|---|---|---|
| Nuss repair of Pectus ExcavatumAlso: minimally-invasive repair technique of Pectus Excavatum (MIRPE)The Nuss procedure is a minimally-invasive repair technique of PE (MIRPE), whereby one to three curved metal bars are inserted behind the sternum to correct the shape of the anterior chest wall. The bars are left in situ for three years and then removed. | Procedure or surgery | Pectus Excavatum |
| Epidural anesthesiaAlso: BupivacaineThe Nuss procedure of pectus excavatum repair surgery is performed under general anesthesia. Epidural anesthesia, with a constant infusion of 0.25% bupivacaine, was routinely used and was maintained in the early postoperative period. | Drug | Pectus Excavatum |
Primary outcome
Postural Stability
Time frame: Three months
Postural stability as a dependent variable examined with the use of the posturography method based on the measurement of Centre of Pressure displacements.
1 secondary outcome
BMI
Time frame: Single measurement
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 6 May 2023.
- Background: PubMed 27373189Pawlak K, Gasiorowski L, Gabryel P, Galecki B, Zielinski P, Dyszkiewicz W. Early and Late Results of the Nuss Procedure in Surgical Treatment of Pectus Excavatum in Different Age Groups. Ann Thorac Surg. 2016 Nov;102(5):1711-1716. doi: 10.1016/j.athoracsur.2016.04.098. Epub 2016 Jun 30.
- Background: PubMed 33478832de Loos ER, Daemen JHT, Pennings AJ, Heuts S, Maessen JG, Hulsewe KWE, Vissers YLJ. Minimally invasive repair of pectus excavatum by the Nuss procedure: The learning curve. J Thorac Cardiovasc Surg. 2022 Mar;163(3):828-837.e4. doi: 10.1016/j.jtcvs.2020.11.154. Epub 2020 Dec 10.
- Background: PubMed 25576974Blaszczyk JW, Beck M, Sadowska D. Assessment of postural stability in young healthy subjects based on directional features of posturographic data: vision and gender effects. Acta Neurobiol Exp (Wars). 2014;74(4):433-42. doi: 10.55782/ane-2014-2006.
- Individual participant dataSharing planned: Yes. Data files will be made available as supplementary files in the scientific publication. Personal data will not be disclosed, only the raw results of posturographic analysis.
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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.
Maria A Jarosz, M.Sc. principal investigator
Poznan University of Physical Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuss repair of Pectus Excavatum and Epidural anesthesia in people with Pectus Excavatum, run by Poznan University of Physical Education at 2 sites in Poland.
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 4 inclusion and 2 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Postural Stability (time frame: Three months). 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 NCT05844800, which also lists 3 linked publications.
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 6 May 2023.