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Nonoperative versus operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma. A multicenter prospective cohort study.


- candidate number28197
- NTR NumberNTR6833
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-nov-2017
- Secondary IDs17-544/C METC
- Public TitleNonoperative versus operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma. A multicenter prospective cohort study.
- Scientific TitleNonoperative versus operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma. A multicenter prospective cohort study.
- ACRONYMOPVENT2
- hypothesisThe aim of this large multicentre prospective cohort study is to compare rib fixation with nonoperative treatment of a flail chest and multiple rib fractures by evaluating treatment effects in ‘real-world’ patients treated in different level 1 trauma centers.
- Healt Condition(s) or Problem(s) studiedRib fracture fixation, Intensive care, Blunt thoracic trauma
- Inclusion criteriaAll adult (over 18 years) patients presenting at the Emergency Department (ED) of the participating hospitals with a CT scan confirmed flail chest or multiple rib fractures after blunt thoracic trauma will be enrolled in the cohort.
- Exclusion criteria- Mentally impaired patients who are unable to fill in the EQ5D-5L questionnaire
- Non-traumatic rib fractures
- Rib fractures as a result of cardiopulmonary resuscitation
- Allergy for titanium
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-jan-2021
- Target number of participants250
- InterventionsRib fracture fixation for patients with a flail chest or multiple rib fractures
- Primary outcome- Intensive care unit length of stay for patients with a flail chest

- Hospital length of stay for patients with multiple rib fractures
- Secondary outcome- Numerical rating scale (NRS) for pain on day 3, 5, 7 and 14
- Pneumonia during hospital stay; date of pneumonia
- In hospital mortality
- Days of epidural / IV / systematic analgesia (morphine)
- Number of days admitted to Intensive Care Unit (ICU)
- Number of days on mechanical ventilation`
- Number of days in need oxygen therapy
- Vital capacity
- Tracheostomy yes / no
- Number of complications during admission
- Total number of days admitted in the hospital
- Quality of life as measured with EQ5D-5L 1 year after trauma
- Lung function related problems as measured with the mMRC 1 year after trauma
- Implant related complaints and removal yes / no
- Cost-effectiveness of rib fixation
- Chest tube yes/no
- Timepoints- hospital admission
- 6 weeks after discharge
- 1 year after discharge
- Trial web sitewww.OPVENT2.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD R.M. Houwert
- CONTACT for SCIENTIFIC QUERIESMD PhD R.M. Houwert
- Sponsor/Initiator DePuy Synthes
- Funding
(Source(s) of Monetary or Material Support)
DePuy Synthes
- Publications
- Brief summaryPatients with thoracic injury and multiple rib fractures are at high risk of serious health outcomes. Nonoperative treatment for flail chest and multiple rib fractures has been the gold standard but there is an increasing popularity for rib fracture fixation in the last two decades, however, the literature remains scarce. The aim of this large multicentre prospective cohort study is to compare rib fixation with nonoperative treatment for flail chest or multiple rib fractures by evaluating treatment effects in ‘real-world’ patients treated in different level 1 trauma centers by means of a propensity score matched analysis.
- Main changes (audit trail)
- RECORD13-nov-2017 - 7-dec-2017


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