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Pectus Excavatum clinical trials

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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: NCT04211935 Recruiting - Pain, Postoperative Clinical Trials

Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum

(MIRPE)
Start date: May 27, 2020
Phase: N/A
Study type: Interventional

Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).

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: NCT04167865 Recruiting - Pectus Excavatum Clinical Trials

Effects of Exercise Therapy on Pectus Excavatum

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

Pectus excavatum (PE); It is an anterior chest wall deformity, characterized by varying degrees of depression of the sternum and costal cartilage, usually occurring at birth or in the first year of life. In the treatment of non-severe PE; vacuum bell orthosis and physiotherapy (especially exercise) is recommended as an alternative to surgery. Although there is no literature or consensus about the role of physiotherapy, it is believed that it plays an important role in preventing or correcting deformities and creating a good cosmetic appearance. Therefore, in this study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to vacuum bell therapy.

NCT ID: NCT04081922 Recruiting - Pectus Excavatum Clinical Trials

Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children

Start date: February 10, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).

NCT ID: NCT04068324 Recruiting - Pectus Excavatum Clinical Trials

Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation

Start date: August 30, 2019
Phase: N/A
Study type: Interventional

Preoperative fasting is intended to lower the amount of gastric contents in order to decrease the incidence of aspiration associated with endotracheal intubation. However, recent studies show that longer fasting time does not reduce aspiration associated complications. Especially in pediatric patients, long fasting time increases patients' unpleasantness and therefore increases postoperative recovery quality. It also induces hypoglycemia. In many studies, ingesting clear liquids 2 hours up to general anesthesia decreases gastric contents and therefore the incidence of aspiration pneumonia, postoperative nausea and vomiting. Therefore anesthesiologist associations in the US and Europe recommend to drink small amount of clear liquid (water) up to 2 hours before the surgery. Nuss bar operation, or repair surgery of pectus excavatum is mostly done in pediatric patients. The procedure itself is very painful, requiring paramount amount of analgesics. Use of opioid analgesics increases postoperative nausea and vomiting. In this study, our aim is to evaluate preoperative fasting time and how preoperative supplement of clear liquid affects the quality of recovery postoperatively.

NCT ID: NCT04052321 Not yet recruiting - Pectus Excavatum Clinical Trials

Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans

CHEST
Start date: January 2021
Phase: N/A
Study type: Interventional

Pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. During this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. These bars remain in situ for two-to-three years before being removed. Despite the fact that the Nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. A recent study has investigated this phenomenon, utilizing three-dimensional (3D) optical surface scans acquired before and after Nuss bar removal. The authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after Nuss bar explantation, in comparison to the situation just prior to bar removal. They, moreover, found the time the bar was in situ to be predictive for retraction. However, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. Subsequently, a similar study with long-term assessments will be conducted.

NCT ID: NCT04046835 Not yet recruiting - Pectus Excavatum Clinical Trials

The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum

POSITION
Start date: January 2021
Phase:
Study type: Observational

Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.

NCT ID: NCT03926078 Recruiting - Pectus Excavatum Clinical Trials

Three-dimensional Optical Surface Imaging as a Diagnostic Tool in Pectus Excavatum

3D PECTUS
Start date: August 21, 2019
Phase: N/A
Study type: Interventional

Pectus excavatum (PE) is the most common anterior chest wall deformity. Currently, a chest radiography (CR) or Computed Tomography (CT) scan is acquired to determine and objectify pectus severity using the Haller Index. Alongside other determinants, the Haller Index value is used in the proces of clinical decision making and determine surgical candidacy. However, cross-sectional imaging based calculation of the Haller Index implies exposure to ionizing radiation that should be limited at all times to diminish the cumulative long-term risks of malignancy. Especially in pectus patients that often concerns children. Three-dimensional (3D) optical surface imaging offers a non-invasive, radiation-free alternative that may be used to obtain thoracic measures and determine pectus severity. However, for 3D images/scans to be used as a diagnostic tool in the proces of clinical decision making and determine surgical candidacy, its diagnostic accuracy should be evaluated. This will be investigated utilizing a pilot study design as no prior accuracy studies are available.

NCT ID: NCT03346876 Recruiting - Surgery Clinical Trials

Autonomic Dysfunction in Patients With Pectus Excavatum.

ADPE
Start date: August 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.