Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos

Not Applicable

• Conditions: Polytraumatises With Rib Fractures

• Registration Number: NCT02635165
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-22
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08
• Primary Completion: 2019-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement
• The surgical procedure was performed in the first 48 hours after admission
• pathology with prognosis for survival 6-month-old inferior

Exclusion Criteria

• Paraplegia or Tetraplegia
• Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical
• Aorta hematoma or rupture
• ß-HCG positive in women
• titanium allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average cost hospitalization	4 weeks	Average cost hospitalization without the intensive care cost.The cost of the hospitalization will be calculated by adding the cost of the surgery and hospital stay- time of the surgery-The number of Stracos used by patient

Secondary Outcome Measures

Name	Time	Method
length of hospital stays of the intensive care department	4 weeks	From the first day to the last day in the intensive care department. Care department - monitoring patients with traumatic hemothorax - lung pulmonary infectious associated -
length of hospital stays	4 weeks	From the first day to the last day in the hospital
The vital capacity (VC)	visit 3 months, visit 6 months, visit 12 months after the surgery	Volume measurement (L)
The expiratory reserve volume (ERV)	visit 3 months, visit 6 months, visit 12 months after the surgery	Volume measurement (L)
Patient Global Assessment to measure quality of life	at visit 7 days, 28 days, 3 months, 6 months and 12 months
date of return to work	visit 3 months, 6 months and 12 months
occurence of pulmonary infection	12 months of follow up
The total lung capacity (TLC)	visit 3 months, visit 6 months, visit 12 months after the surgery	Volume measurement (L)
Residual volume (RV)	visit 3 months, visit 6 months, visit 12 months after the surgery	Volume measurement (L)
6 min walk test (6MWT)	visit 3 months, visit 6 months, visit 12 months after the surgery	Distance measurement (M)
Visual analog scorer for pain	at visit 7 days, 28 days, 3 months, 6 months and 12 months

Trial Locations

Locations (1)

Hospital University of Poitiers; 🇫🇷 Poitiers, France