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CompletedNCT05844800Updated May 6, 2023

The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum

An interventional study of Nuss repair of Pectus Excavatum and Epidural anesthesia in Pectus Excavatum, sponsored by Poznan University of Physical Education. Completed at 2 sites in Poland. Open to male participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 12 years 3 months after the study started (first participant enrolled Jan 2011, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
14 Years and older
Sex
Male
01

Study 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 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:

  1. 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).
  2. 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.

02

Conditions studied

  • Pectus Excavatum

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Keywords

  • Pectus Excavatum
  • Postural Stability
03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 43 is close to the median of 40 across 46 interventional studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pectus excavatum (experimental group)
  • no posture defects (control group)
  • no neurological disorders
  • consent to the surgical intervention procedure (experimental group)

Exclusion criteria

Exclusion Criteria:

  • co-existence of defects in the anterior chest wall other than pectus excavatum
  • presence of musculoskeletal anomalies
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Pectus Excavatum

    Patients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE)

    Procedure: Nuss repair of Pectus Excavatum · Drug: Epidural anesthesia

  • No intervention
    Healthy Control

    Healthy control group with no posture defects

Interventions

  • ProcedureNuss repair of Pectus Excavatum

    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.

    Also known as: minimally-invasive repair technique of Pectus Excavatum (MIRPE)

  • 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.

    Also known as: Bupivacaine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three months

Secondary outcomes

  1. BMI

    Body mass index (BMI) - calculated as body weight/height2

    Time frame: Single measurement

07

Study locations

2 sites
  • Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
    Poznań, 60-569, Poland
  • Poznan University of Physical Education
    Poznań, 61-871, Poland
08

References and documents

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 27373189 ↗
  • de 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 33478832 ↗
  • Blaszczyk 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will be available as soon as the scientific article will be published.

Access criteria: Access criteria will depend on the publisher of the scientific article.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05844800
Lead sponsor
Poznan University of Physical Education
Collaborators
Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
Responsible party
Sponsor
First posted
May 6, 2023
Start date
Jan 2011
Primary completion
Sep 2022
Completion
Sep 2022
Last update
May 6, 2023

Study contacts

Maria A Jarosz, M.Sc.
principal investigator · Poznan University of Physical Education

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bupivacaine

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