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Funnel Chest clinical trials

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NCT ID: NCT05844800 Completed - Pectus Excavatum Clinical Trials

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

Start date: January 2011
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05570097 Completed - Funnel Chest Clinical Trials

Cryoanalgesia to Prevent Acute and Chronic Pain Following Nuss Procedure

Start date: September 28, 2022
Phase: N/A
Study type: Interventional

This Study study compared standard therapy (multimodal and regional analgesia) versus a novel approach (Cryoanalgesia combined with bilateral erector spine plane block and multimodal analgesia) in subjects undergoing minimal invasive modyfied Nuss procedure (thoracoscopy).

NCT ID: NCT05443113 Completed - Genetic Disease Clinical Trials

Young Pectus Excavatum Patients and Genetic Defects

Start date: September 1, 2019
Phase:
Study type: Observational

In most pectus excavatum (PE) patients an underlying genetic defect is not found with molecular analysis, as a direct genetic link with PE has yet to be found and because potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are identified in the first decade of life and thus of congenital origin making younger PE patients a unique patient group. Therefore, the research question is; is early-onset pectus excavatum (PE) more likely to be part of a genetic defect than PE which became apparent during puberty or adolescence?

NCT ID: NCT05201820 Completed - Pectus Excavatum Clinical Trials

Cryoanalgesia for Pain Management After Pectus Excavatum Repair

COPPER
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial. Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery. Randomized active controlled, parallel group, single-centre, trial (category IIb medical device). 88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia). PedsQLscale (23 items) two weeks after surgery. Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.

NCT ID: NCT05034601 Completed - Analgesia Clinical Trials

ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

Start date: September 25, 2021
Phase: N/A
Study type: Interventional

This is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral block (TPVB) in postoperative pain control after pectus excavatum repair.

NCT ID: NCT04751266 Completed - Clinical trials for Congenital Funnel Chest

Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)

Start date: March 2015
Phase:
Study type: Observational

The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.

NCT ID: NCT04448574 Completed - Funnel Chest Clinical Trials

Chest Wall Deformities in Children - Epidemiological Data

Start date: September 1, 2019
Phase:
Study type: Observational

Pectus excavatum (PE) or funnel breast is the most common congenital deformity of the chest wall, which occurs in about 1 in 400 births with a boy to girl ratio of 4: 1 to 3: 1. The etiology of PE is largely undefined, but there are numerous indications that genetic factors play a role in the development of PE. Up to 40% of patients report affected family members with similar congenital deformities. In many families, PE follows a pattern that would be compatible with an autosomal dominant or recessive pattern of inheritance. The data on the frequent occurrence of PE in family members fluctuate greatly and only a few genes associated with a PE have been identified so far.

NCT ID: NCT04362878 Completed - Pectus Excavatum Clinical Trials

Psychological Assessment of Patients With Chest Wall Deformities

Start date: October 8, 2019
Phase:
Study type: Observational

The study aims to investigate the most frequent psychological outcomes associated to chest wall deformities and patients' quality of life.

NCT ID: NCT04185870 Completed - Pectus Excavatum Clinical Trials

Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum

Start date: December 20, 2019
Phase: N/A
Study type: Interventional

Pectus excavatum is the most common congenital anterior chest wall deformity, known to occur in 1:400 of new-borns. Complaints may be of cosmetic nature or as a consequence of (cardio)pulmonary impairment. Part of the current work-up of pectus excavatum patients in Zuyderland Medical Centre (Heerlen, the Netherlands) is visual documentation of the deformity. Visual documentation is performed utilising a single-reflex camera and consists of 5 standard photographs (acquired from different angles) and two specialised recordings. These specialised recordings encompass a recording to measure the pectus excavatum's depth and a raster stereography recording to create a three-dimensional perspective. However, this form of visual documentation is not efficient, as it is time- and labor-intensive for the photographer and patient. Recently, another study started that aims to investigate whether three-dimensional (3D) optical surface scans can be used to determine pectus severity, as compared to chest radiographs and computed tomography scans (3DPECTUS study; METCZ20190048; NCT03926078). Building on this study it was determined whether 3D optical surface scans can be used as a tool to document the surface geometry of pectus excavatum. To determine whether the current standard photographs and specialised recordings can be replaced by a 3D scan, both methods are compared. To make this comparison, the pectus excavatum depth was chosen as an objective measure of agreement. If there is good agreement, it is assumed that the standard photos can be replaced by a 3D photo in the current work-up. This will subsequently result in a time saving as well as a reduced burden for the patient while acquisition of 3D scans takes only 10 seconds.

NCT ID: NCT03087734 Completed - Funnel Chest Clinical Trials

Evaluation of a New Model of Metallic Bar and Stabilizer for Use in MIRPE

Start date: October 3, 2017
Phase: N/A
Study type: Interventional

Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is consolidating as preferred technique for the treatment of this condition. In this technique a metal bar is inserted in retrosternal position, pushing the sternum without the necessity of resecting the condral cartilages. Despite the advantages obtained with this technique, it is not without complications and the displacement of the bar is one of the most important. In order to minimize this problem we developed a new model of stabilizers, as well as all necessary instruments for performing minimally invasive surgery. The aim of this study is to compare two surgical groups, one making use of the new oblique stabilizer compared to the conventional perpendicular stabilizer to determine which one has less displacement. Furthermore, this study also aims to assess the full range of instruments developed by a national company, to carry out this type of surgery, which has cost compatible with our economic reality, and that can be accessible to our Public Health patients.