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

NCT05844800 | Completed

• 1 other identifier: Maria Jarosz PhD Thesis
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Pectus Excavatum

Keywords

Pectus Excavatum; Postural Stability

Outcome Measures

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.

  Three months

Secondary Outcomes (1)

• BMI

  Single measurement

Study Arms (2)

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)

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

Healthy Control

NO INTERVENTION

Healthy control group with no posture defects

Interventions

Nuss repair of Pectus Excavatum PROCEDURE

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)

Pectus Excavatum

Epidural anesthesia DRUG

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

Pectus Excavatum

Eligibility Criteria

• Age: 14 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan: collaborator

Study Sites (2)

Wielkopolska Centre of Pulmonology and Thoracic Surgery in Poznan

Poznan, 60-569, Poland

Location

Poznan University of Physical Education

Poznan, 61-871, Poland

Location

Related Publications (3)

• 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.

  PMID: 27373189 BACKGROUND

• 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.

  PMID: 33478832 BACKGROUND

• 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.

  PMID: 25576974 BACKGROUND

MeSH Terms

Conditions

Funnel Chest

Interventions

Anesthesia, Epidural; Bupivacaine

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Maria A Jarosz, M.Sc.

  Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The experimental group of pectus excavatum patients (n=21) pre- and post intervention examination and control group of healthy subjects (n=22) examined twice.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 6, 2023
• Study Start: January 1, 2011
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

PL (2)