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
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:
Researchers will compare PE male patients and healthy young men to see if PE posture defect affects postural stability.
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:
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.
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 →Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
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
Healthy control group with no posture defects
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
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
BMI
Body mass index (BMI) - calculated as body weight/height2
Time frame: Single measurement
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.
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
Poznan University of Physical Education