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Clinical trial

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

ID
Name
Maria Jarosz PhD Thesis
Description
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.
Trial arms
Trial start
2011-01-01
Estimated PCD
2022-09-01
Trial end
2022-09-01
Status
Completed
Treatment
Nuss 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.
Arms:
Pectus Excavatum
Other names:
minimally-invasive repair technique of Pectus Excavatum (MIRPE)
Epidural anesthesia
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.
Arms:
Pectus Excavatum
Other names:
Bupivacaine
Size
43
Primary endpoint
Postural Stability
Three months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The experimental group of pectus excavatum patients (n=21) pre- and post intervention examination and control group of healthy subjects (n=22) examined twice.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}
Updated at
2023-05-06

1 organization

1 product

1 indication

Organization
Poznan University of Physical Education
Product
Epidural anesthesia
Indication
Pectus Excavatum