Clinical trial NCT04052321: Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
Official title: Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pectus Excavatum
Keywords: Three-dimensional optical surface imaging
Chest wall changes
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients that received 1 or more Nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment.

Exclusion Criteria:

* Patients in which the Nuss bar(s) or its stabilizers are or have been dislocated.
* Patients that received a second operation to treat any complications regarding the initial Nuss bar implantation.
* Patients with proven connective tissue diseases (e.g. Marfan's syndrome).
* Patients with a diagnosis of epilepsy (as the 3D scanner utilizes flashing light to acquire the torso topography)
* Patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.

Primary outcomes:
measure: Mean change in distance
timeFrame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
measure: Maximum change in distance
timeFrame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
measure: Volumetric changes
timeFrame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Secondary outcomes:
measure: Predictors of chest wall changes
timeFrame: Changes in volume, mean and maximum distance from baseline to 12 months
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
state: Limburg
Study officials:
References:
citation: Gomes-Fonseca J, Vilaca JL, Henriques-Coelho T, Direito-Santos B, Pinho ACM, Fonseca JC, Correia-Pinto J. A new methodology for assessment of pectus excavatum correction after bar removal in Nuss procedure: Preliminary study. J Pediatr Surg. 2017 Jul;52(7):1089-1097. doi: 10.1016/j.jpedsurg.2016.12.029. Epub 2017 Jan 7.