Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000705088
Ethics application status
Approved
Date submitted
12/08/2010
Date registered
25/08/2010
Date last updated
25/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiopulmonary function before and after pectus excavatum surgical repair
Scientific title
Cardiopulmonary function before and after surgical repair in pectus excavatum patients
Secondary ID [1] 252521 0
none
Universal Trial Number (UTN)
U1111-1116-4756
Trial acronym
EFXPECTUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular function in patients with pectus excavatum 257940 0
aerobic capacity at exercise 257941 0
Condition category
Condition code
Human Genetics and Inherited Disorders 258109 258109 0 0
Other human genetics and inherited disorders
Surgery 258208 258208 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergo a simplified open repair using a limited transversal, or submammary incision in female patients. The mobilization of pectoralis muscles and rectus abdominis are just sufficient to expose the enlarged cartilages, which are resected subperichondrially (generally total bilateral cartilage resection from 3th to the 6th, limited to the extremities of the 7th cartilages). An optional transverse anterior osteotomy of the upper sternum, followed by elevation of the distal sternum is then performed. Approximative duration is 90 min. Sternal stabilization is achieved by using an easily removable metallic strut, which is removed under local anesthesia on an outpatient basis, 6 months after the initial procedure.
Intervention code [1] 256996 0
Treatment: Surgery
Comparator / control treatment
no control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258971 0
Maximal exercise performance is determined using an incremental exercise test performed on a calibrated electromagnetically braked cycle ergometer. Continuous measurement of inspired and expired oxygen and carbon dioxide output are done using in-line sensors together with spirometry. These parameters are then used to the calculation of VO2 (oxygen uptake)
Timepoint [1] 258971 0
before and one year after surgery
Secondary outcome [1] 265157 0
Oxygen pulse at maximal exercise is determined as the ratio of VO2 to heart rate
Timepoint [1] 265157 0
before and one year after surgery

Eligibility
Key inclusion criteria
pectus excavatum
Haller severity score up to 4
chest discomfort or chest pain
Minimum age
16 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are referred for evaluation to the surgical unit at Calmette Hospital, a tertiary care hospital affiliated with Lille University School of Medicine. Patients undergo evaluation which consisted of collection of data sets (repeated echocardiography, pulmonary function and exercise testing and chest computerized tomography (CT)-scan before and after surgery. After institutional review board approval and according to their consent, patients are then proposed to surgical repair.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2818 0
France
State/province [1] 2818 0
Nord

Funding & Sponsors
Funding source category [1] 257445 0
Self funded/Unfunded
Name [1] 257445 0
Country [1] 257445 0
France
Primary sponsor type
Hospital
Name
University Hospital (CHRU) of Lille France
Address
Calmette Hospital, 45 Bd Pr. LECLERCQ 59000 LILLE FRANCE
Country
France
Secondary sponsor category [1] 256733 0
None
Name [1] 256733 0
Address [1] 256733 0
Country [1] 256733 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259474 0
Local Ethics committee
Ethics committee address [1] 259474 0
Ethics committee country [1] 259474 0
France
Date submitted for ethics approval [1] 259474 0
01/01/2004
Approval date [1] 259474 0
01/01/2005
Ethics approval number [1] 259474 0

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

Contacts
Principal investigator
Name 31513 0
Address 31513 0
Country 31513 0
Phone 31513 0
Fax 31513 0
Email 31513 0
Contact person for public queries
Name 14760 0
Remi Neviere
Address 14760 0
Dpt of Physiology Faculty of Medicine
1 place de Verdun
59000 LILLE
FRANCE
Country 14760 0
France
Phone 14760 0
+33 320 62 69 68
Fax 14760 0
+33 320 62 69 93
Email 14760 0
[email protected]
Contact person for scientific queries
Name 5688 0
Remi Neviere
Address 5688 0
Dpt of Physiology Faculty of Medicine
1 place de Verdun
59000 LILLE
FRANCE
Country 5688 0
France
Phone 5688 0
+33 320 62 69 68
Fax 5688 0
+33 320 62 69 93
Email 5688 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.