The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum
Primary Purpose
Pectus Excavatum
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Nuss repair of Pectus Excavatum
Epidural anesthesia
Sponsored by
About this trial
This is an interventional basic science trial for Pectus Excavatum focused on measuring Pectus Excavatum, Postural Stability
Eligibility Criteria
Inclusion Criteria: pectus excavatum (experimental group) no posture defects (control group) no neurological disorders consent to the surgical intervention procedure (experimental group) Exclusion Criteria: co-existence of defects in the anterior chest wall other than pectus excavatum presence of musculoskeletal anomalies
Sites / Locations
- Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
- Poznan University of Physical Education
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pectus Excavatum
Healthy Control
Arm Description
Patients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE)
Healthy control group with no posture defects
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
BMI
Body mass index (BMI) - calculated as body weight/height2
Full Information
NCT ID
NCT05844800
First Posted
April 6, 2023
Last Updated
April 25, 2023
Sponsor
Poznan University of Physical Education
Collaborators
Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
1. Study Identification
Unique Protocol Identification Number
NCT05844800
Brief Title
The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum
Official Title
The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
September 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Physical Education
Collaborators
Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
Pectus Excavatum, Postural Stability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pectus Excavatum
Arm Type
Experimental
Arm Description
Patients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE)
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Healthy control group with no posture defects
Intervention Type
Procedure
Intervention Name(s)
Nuss repair of Pectus Excavatum
Other Intervention Name(s)
minimally-invasive repair technique of Pectus Excavatum (MIRPE)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epidural anesthesia
Other Intervention Name(s)
Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural Stability
Description
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 Outcome Measure Information:
Title
BMI
Description
Body mass index (BMI) - calculated as body weight/height2
Time Frame
Single measurement
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pectus excavatum (experimental group)
no posture defects (control group)
no neurological disorders
consent to the surgical intervention procedure (experimental group)
Exclusion Criteria:
co-existence of defects in the anterior chest wall other than pectus excavatum
presence of musculoskeletal anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Jarosz, M.Sc.
Organizational Affiliation
Poznan University of Physical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Poznan University of Physical Education
City
Poznań
ZIP/Postal Code
61-871
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available as soon as the scientific article will be published.
IPD Sharing Access Criteria
Access criteria will depend on the publisher of the scientific article.
Citations:
PubMed Identifier
27373189
Citation
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.
Results Reference
background
PubMed Identifier
33478832
Citation
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.
Results Reference
background
PubMed Identifier
25576974
Citation
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.
Results Reference
background
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The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum
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