Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging

Not Applicable

• Conditions: Pectus Excavatum; Funnel Chest
• Interventions: Diagnostic Test: Three-dimensional imaging

• Registration Number: NCT04418583
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-13
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Three-dimensional imaging	Three-dimensional imaging	Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.

Primary Outcome Measures

Name	Time	Method
Mean change in chest wall dimensions	1 hour	difference between baseline (first image) and image after application of the Crane technique

Trial Locations

Locations (1)

Zuyderland Medical Centre; 🇳🇱 Heerlen, Limburg, Netherlands