Pectus ExcavatumPECTUSNCT02174796
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
A study testing surgical treatment and orthopedic treatment in people with Pectus Excavatum, run by Centre Jean Perrin at 5 sites in France.
Trial summary
this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- surgical treatment and orthopedic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesFrance
- Study dates
- 5 May 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients seeking treatment of a pectus excavatum
- Haller index > 3.2
- Desire for treatment
- age between 15 and 40 years old
Who cannot join
- Cognitive impairment
- Pregnancy
- Contraindication to exercise stress test or general anesthesia
- Coagulation disorders
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles
Clermont-Ferrand, 63000
Centre Jean Perrin
Clermont-Ferrand, 63011
CHU G Montpied, Service de Cardiologie et Maladies Vasculaires
Clermont-Ferrand, 63011
CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles
Saint-Etienne, 42100
CHU de St Etienne, Hôpital Nord, Chirurgie thoracique
Saint-Priest-en-Jarez, 42055
About this study
this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test
- Conditions
- Pectus Excavatum
- Being tested
- surgical treatment, orthopedic treatment
- Keywords
- Pectus excavatum, cardiac output, transthoracic impedancemetry
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentProcedure or surgery
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
orthopedic treatmentProcedure or surgery
orthopedic treatment by vacuum bell.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment group | Experimental | patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
intervention: surgical correction (Ravitch or Nuss type intervention). Receives: Procedure: surgical treatment |
| Orthopedic treatment group | Experimental | patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell. Receives: Procedure: orthopedic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output difference before and after intervention,during an exercise stress test
Cardiac output measured by transthoracic impedancemetry, during an exercise stress test
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Secondary outcomes (6)
Rest lung function tests
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Exercise functional capacity
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Exercise cardiac output
Exercise cardiac output (measured by transthoracic echocardiography)
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Quality of life
Quality of life SF36
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Mean energy expenditure
Mean energy expenditure will be evaluated by metabolic and physical activity monitor "armband" during 3 days (Kcal/min)
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Evaluation of postoperative neuropathic pain
Measured: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study start5 May 2014
- Primary completionFeb 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Filaire, Pr, Principal investigator, Centre Jean Perrin, Service de Chirurgie Thoracique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174796
- Sponsor's protocol ID
- 2013-A01811-44
- Acronym
- PECTUS
- Status last verified
- Jul 2017
- First submitted
- 23 Apr 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
- ClinicalTrials.gov ID
- NCT02174796
- Acronym / sponsor ID
- PECTUS / 2013-A01811-44
- Conditions
- Pectus Excavatum
- Keywords
- Pectus excavatum, cardiac output, transthoracic impedancemetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment group | Experimental | Procedure: surgical treatmentpatients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention). |
| Orthopedic treatment group | Experimental | Procedure: orthopedic treatmentpatients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients seeking treatment of a pectus excavatum
- Haller index > 3.2
- Desire for treatment
- age between 15 and 40 years old
Key exclusion criteria (4 listed)
- Cognitive impairment
- Pregnancy
- Contraindication to exercise stress test or general anesthesia
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatmentpatients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). | Procedure or surgery | Surgical treatment group |
| orthopedic treatmentorthopedic treatment by vacuum bell. | Procedure or surgery | Orthopedic treatment group |
Primary outcome
Cardiac output difference before and after intervention,during an exercise stress test
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Cardiac output measured by transthoracic impedancemetry, during an exercise stress test
6 secondary outcomes
Rest lung function tests
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Exercise functional capacity
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Exercise cardiac output
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Quality of life
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Mean energy expenditure
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Evaluation of postoperative neuropathic pain
Time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Filaire, Pr principal investigator
Centre Jean Perrin, Service de Chirurgie Thoracique
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical treatment and orthopedic treatment in people with Pectus Excavatum, run by Centre Jean Perrin at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output difference before and after intervention,during an exercise stress test (time frame: 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.