Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000356369
Ethics application status
Not yet submitted
Date submitted
22/06/2008
Date registered
24/07/2008
Date last updated
24/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The Surgical Treatment of Rib Fractures: a Randomised Controlled Trial
Scientific title
Management of Multiple Rib Fractures with Open Reduction and Internal Fixation: a Randomised Controlled Trial to Investigate Effect on Morbidity and Quality of Life.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib Fractures 3295 0
Condition category
Condition code
Injuries and Accidents 3457 3457 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open reduction and internal fixation of rib fractures.
Surgical approach: using thoracoscopy and muscle-sparing mini-thoracotomy incisions.
Surgical technique: fixation with an absorbable polylactide copolymer mesh and screw system and vicryl sutures.
Duration of surgery: 1.5 to 2.5 hours
Associated supportive treatment: intervention such as ventilation (other than for the duration of general anaesthesia), epidural or intravenous analgesia delivery and physiotherapy determined by the patient's associated injuries and respiratory function. Patients will only be ventilated prior to surgery if they have respiratory failure. Duration of ventilation and duration of need for analgesia (other than oral analgesia) are variables that shall be measured and compared between groups.
Period of overall intervention: patients will be reviewed in clinic for a minimum of 6 months. Duration of other specific treatments (other than surgery) such as analgesia shall be determined by patient need.
Intervention code [1] 3033 0
Treatment: Surgery
Comparator / control treatment
Treatment of patients with rib fractures using non-operative techniques including pain control, ventilatory support (invasive and non-invasive) and physiotherapy.
Duration: determined by patient need. Duration of ventilation and duration of need for analgesia (other than oral analgesia) are variables that shall be measured and compared between groups. Follow-up in clinic for a minimum of 6 months.
Control group
Active

Outcomes
Primary outcome [1] 4353 0
Assessment of Quality of Life (AQoL) instrument.
Timepoint [1] 4353 0
At 3 months and 6 months.
Primary outcome [2] 4354 0
Pain score: Numerical Rating Scale
Timepoint [2] 4354 0
At discharge, 3 months and 6 months.
Primary outcome [3] 4355 0
Respiratory complications: Pneumonia, empyema, and onset of ventilatory failure (requiring non-invasive or invasive respiratory support) after surgery or after cessation of initial ventilatory support.
Timepoint [3] 4355 0
At admission, 3 months and 6 months.
Secondary outcome [1] 7340 0
Duration of ventilation support
Timepoint [1] 7340 0
At admission (from time of admission for chest injury to time of discharge from acute inpatient hospital care)
Secondary outcome [2] 7341 0
Spirometry: Forced expiratory volume in 1 second (FEV1) and Vital Capacity (VC) expressed as a percentage of predicted.
Timepoint [2] 7341 0
At discharge, 3 months and 6 months.
Secondary outcome [3] 7562 0
Duration of need for epidural or intravenous analgesia
Timepoint [3] 7562 0
At admission (from time of admission for chest injury to time of discharge from acute inpatient hospital care)

Eligibility
Key inclusion criteria
Patients sustaining blunt chest trauma, with displaced fractures of two or more ribs
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with severe head injuries (GCS (Glasgow coma Score)<9 on admission), abdominal, spinal or pelvic injuries prohibiting appropriate positioning for surgery, patients not expected to survive at 48 hours, pregnancy, patient or family decline to consent, no consent available, any other contraindication to surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients admitted into the trauma unit at the Royal Melbourne Hospital with blunt chest trauma, are interviewed by a researcher. After consent is given by the patient or the patient's next-of-kin, a sealed envelope with treatment group allocation is opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table generated by a computer software programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
While the participant will not be blinded to the treatment allocation group, the follow-up with Quality of Life Questionnaires and Pain Scoring Systems will involve a blind assessor. The analysis of these outcomes shall then be assessed in a blind fashion.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 896 0
3052

Funding & Sponsors
Funding source category [1] 3503 0
Hospital
Name [1] 3503 0
Royal Melbourne Hospital
Country [1] 3503 0
Australia
Primary sponsor type
Individual
Name
Phillip Antippa
Address
Department of Cardiothoracic Surgery
Royal Melbourne Hospital
Gratten St, PARKVILLE. VIC 3052
Country
Australia
Secondary sponsor category [1] 3146 0
Individual
Name [1] 3146 0
Katherine Martin
Address [1] 3146 0
PO Box 305
FLEMINGTON
VIC 3031
Country [1] 3146 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5541 0
Ethics committee address [1] 5541 0
Ethics committee country [1] 5541 0
Date submitted for ethics approval [1] 5541 0
06/08/2008
Approval date [1] 5541 0
Ethics approval number [1] 5541 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28689 0
Address 28689 0
Country 28689 0
Phone 28689 0
Fax 28689 0
Email 28689 0
Contact person for public queries
Name 11846 0
Katherine Martin
Address 11846 0
PO Box 305
FLEMINGTON
VIC 3031
Country 11846 0
Australia
Phone 11846 0
+61 3 93427000
Fax 11846 0
+61 3 93764532
Email 11846 0
[email protected]
Contact person for scientific queries
Name 2774 0
Katherine Martin
Address 2774 0
PO Box 305
FLEMINGTON
VIC 3031
Country 2774 0
Australia
Phone 2774 0
+61 3 93427000
Fax 2774 0
+61 3 93764532
Email 2774 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.