A multicenter randomised study in which operative stabilization of rib fractures with a flail chest is compared with mechanical ventilation.

Withdrawn

• Conditions: multiple rib fractures; Unstable chest; 10005959; 10024970; 10005944

• Registration Number: NL-OMON37982
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

1. age > 17 jr.
2. Flail chest

Exclusion Criteria

1. non traumatic rib fractures
2. prior thoracotomy
3. Allergy for Titanium
4. Missing informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: Will ORIF of rib fractures with a flail chest in comparison<br /><br>to non-operative treatment lead to less pneumonia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary questions:<br /><br><br /><br>* Will surgical treatment of rib fractures with a flail in comparison to<br /><br>non-operative treatment result in a shorter duration of artificial respiration?<br /><br>* Will the surgical treatment of rib fractures with a flail in comparison to<br /><br>non-operative treatment result in a shorter IC stay?<br /><br>* Will the surgical treatment of rib fractures with a flail in comparison to<br /><br>non-operative treatment result in a shorter hospital stay?<br /><br>* Will the surgical treatment of rib fractures with a flail in comparison to<br /><br>non-operative treatment result in a faster or better reduction of pain.<br /><br>* Is surgical treatment of rib fractures with a flail in comparison to<br /><br>non-operative treatment more cost effective.</p><br>