Pectus ExcavatumPEPNCT02337621
Pain, Exercise and Psychological Well-being in Pectus Excavatum
An observational study of Pectus Excavatum, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
Recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. Physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Pectus Excavatum
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2021
- Phase
- Observational
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss procedure)
Who may be able to join
- Children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum
Who cannot join
- History of chronic pain disorders
- History of major mental illness such as psychosis or bipolar disorder
- Cognitive impairment significantly below average age and/or grade level
- Non-English speaking parent or child
- Unable to obtain and keep access to a cellular phone
- Loss of wireless electronic activity monitor and refusal to replace to remain in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being
Recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. Physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term benefits of exercise and mobility on post-operative pain and return to normal functioning.
Read the detailed description
Major surgery has a drastic impact on the lives of patients and their families. Often, patients undergoing the Nuss procedure have lingering pain which can complicate recovery. Depending on the nature of the surgery and the severity of disease, this recovery period can be as short as a few days, or it can take several weeks and even months. Few studies have demonstrated the benefit of physical activity and exercise postoperatively on returning to normal function. Additionally, research has suggested that pain and recovery can be influenced by psychological factors.
The investigators will use wireless activity monitors to assess the activity levels of children who undergo major musculoskeletal surgery, specifically the Nuss procedure. The investigators will also evaluate this population for psychological well-being. In this pilot study, the investigators identify goals and objectives which will provide preliminary evidence for physical and psychological recommendations to reduce post-operative pain and improve recovery.
Families will be asked to complete questionnaires at different phases in the surgery (pre-surgery, post bar insertion, post bar removal). Children will be instructed to record any pain they are experiencing as a result of their condition or the surgery at various time points. The activity levels will also be followed over the course of the recovery period.
- Conditions
- Pectus Excavatum
- Being tested
- No intervention
- Keywords
- sunken chest, caved-in chest, chest deformity, sunken sternum
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| pectus excavatum surgical candidates | Any person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain scores
pain diary and self report via questionnaires
Measured: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Increase in activity level/exercise
wireless activity monitor and physical therapy notes
Measured: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Secondary outcomes (2)
mood
child self report and parental report via questionnaires
Measured: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
body image
child self report and parental report via modified Y-BOCS ; increased scores mean worse body image
Measured: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2020
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa McMahon, MD, Phoenix Children's Hospital
- Investigators
- Lisa McMahon, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337621
- Sponsor's protocol ID
- #14-124
- Acronym
- PEP
- Status last verified
- Apr 2022
- First submitted
- 10 Dec 2014
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fonkalsrud EW. Current management of pectus excavatum. World J Surg. 2003 May;27(5):502-8. doi: 10.1007/s00268-003-7025-5. Epub 2003 Apr 28.
PubMed 12715210Jaroszewski D, Notrica D, McMahon L, Steidley DE, Deschamps C. Current management of pectus excavatum: a review and update of therapy and treatment recommendations. J Am Board Fam Med. 2010 Mar-Apr;23(2):230-9. doi: 10.3122/jabfm.2010.02.090234.
PubMed 20207934Maagaard M, Tang M, Ringgaard S, Nielsen HH, Frokiaer J, Haubuf M, Pilegaard HK, Hjortdal VE. Normalized cardiopulmonary exercise function in patients with pectus excavatum three years after operation. Ann Thorac Surg. 2013 Jul;96(1):272-8. doi: 10.1016/j.athoracsur.2013.03.034. Epub 2013 May 14.
PubMed 23684487Tang M, Nielsen HH, Lesbo M, Frokiaer J, Maagaard M, Pilegaard HK, Hjortdal VE. Improved cardiopulmonary exercise function after modified Nuss operation for pectus excavatum. Eur J Cardiothorac Surg. 2012 May;41(5):1063-7. doi: 10.1093/ejcts/ezr170. Epub 2011 Dec 21.
PubMed 22219453Kelly RE Jr, Mellins RB, Shamberger RC, Mitchell KK, Lawson ML, Oldham KT, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Cooper D, Bagley T, Quinn A, Moskowitz AB, Paulson JF. Multicenter study of pectus excavatum, final report: complications, static/exercise pulmonary function, and anatomic outcomes. J Am Coll Surg. 2013 Dec;217(6):1080-9. doi: 10.1016/j.jamcollsurg.2013.06.019.
PubMed 24246622Nuss D, Kelly RE Jr, Croitoru DP, Katz ME. A 10-year review of a minimally invasive technique for the correction of pectus excavatum. J Pediatr Surg. 1998 Apr;33(4):545-52. doi: 10.1016/s0022-3468(98)90314-1.
PubMed 9574749Khan RS, Skapinakis P, Ahmed K, Stefanou DC, Ashrafian H, Darzi A, Athanasiou T. The association between preoperative pain catastrophizing and postoperative pain intensity in cardiac surgery patients. Pain Med. 2012 Jun;13(6):820-7. doi: 10.1111/j.1526-4637.2012.01386.x. Epub 2012 May 8.
PubMed 22568812Kelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723.
PubMed 19047237
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Outcomes for Pectus Excavatum: Pain, Exercise, and Psychological Well-being
- ClinicalTrials.gov ID
- NCT02337621
- Acronym / sponsor ID
- PEP / #14-124
- Conditions
- Pectus Excavatum
- Keywords
- sunken chest, caved-in chest, chest deformity, sunken sternum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 13 Jan 2015 (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.
Recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. Physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term benefits of exercise and mobility on post-operative pain and return to normal functioning.
Detailed description
Major surgery has a drastic impact on the lives of patients and their families. Often, patients undergoing the Nuss procedure have lingering pain which can complicate recovery. Depending on the nature of the surgery and the severity of disease, this recovery period can be as short as a few days, or it can take several weeks and even months. Few studies have demonstrated the benefit of physical activity and exercise postoperatively on returning to normal function. Additionally, research has suggested that pain and recovery can be influenced by psychological factors.
The investigators will use wireless activity monitors to assess the activity levels of children who undergo major musculoskeletal surgery, specifically the Nuss procedure. The investigators will also evaluate this population for psychological well-being. In this pilot study, the investigators identify goals and objectives which will provide preliminary evidence for physical and psychological recommendations to reduce post-operative pain and improve recovery.
Families will be asked to complete questionnaires at different phases in the surgery (pre-surgery, post bar insertion, post bar removal). Children will be instructed to record any pain they are experiencing as a result of their condition or the surgery at various time points. The activity levels will also be followed over the course of the recovery period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pectus excavatum surgical candidates | – | Other: No interventionAny person who is eligible to undergo the Nuss procedure for surgical correction of pectus excavatum |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who are scheduled to undergo surgical correction for pectus excavatum (Nuss procedure)
Key inclusion criteria (1 listed)
- Children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum
Key exclusion criteria (6 listed)
- History of chronic pain disorders
- History of major mental illness such as psychosis or bipolar disorder
- Cognitive impairment significantly below average age and/or grade level
- Non-English speaking parent or child
- Unable to obtain and keep access to a cellular phone
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 |
|---|---|---|
| No intervention | Other | pectus excavatum surgical candidates |
Primary outcome
Improvement in pain scores
Time frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
pain diary and self report via questionnaires
Increase in activity level/exercise
Time frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
wireless activity monitor and physical therapy notes
2 secondary outcomes
mood
Time frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
body image
Time frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)
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 25 Apr 2022.
- Background: PubMed 12715210Fonkalsrud EW. Current management of pectus excavatum. World J Surg. 2003 May;27(5):502-8. doi: 10.1007/s00268-003-7025-5. Epub 2003 Apr 28.
- Background: PubMed 20207934Jaroszewski D, Notrica D, McMahon L, Steidley DE, Deschamps C. Current management of pectus excavatum: a review and update of therapy and treatment recommendations. J Am Board Fam Med. 2010 Mar-Apr;23(2):230-9. doi: 10.3122/jabfm.2010.02.090234.
- Background: PubMed 23684487Maagaard M, Tang M, Ringgaard S, Nielsen HH, Frokiaer J, Haubuf M, Pilegaard HK, Hjortdal VE. Normalized cardiopulmonary exercise function in patients with pectus excavatum three years after operation. Ann Thorac Surg. 2013 Jul;96(1):272-8. doi: 10.1016/j.athoracsur.2013.03.034. Epub 2013 May 14.
- Background: PubMed 22219453Tang M, Nielsen HH, Lesbo M, Frokiaer J, Maagaard M, Pilegaard HK, Hjortdal VE. Improved cardiopulmonary exercise function after modified Nuss operation for pectus excavatum. Eur J Cardiothorac Surg. 2012 May;41(5):1063-7. doi: 10.1093/ejcts/ezr170. Epub 2011 Dec 21.
- Background: PubMed 24246622Kelly RE Jr, Mellins RB, Shamberger RC, Mitchell KK, Lawson ML, Oldham KT, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Cooper D, Bagley T, Quinn A, Moskowitz AB, Paulson JF. Multicenter study of pectus excavatum, final report: complications, static/exercise pulmonary function, and anatomic outcomes. J Am Coll Surg. 2013 Dec;217(6):1080-9. doi: 10.1016/j.jamcollsurg.2013.06.019.
- Background: PubMed 9574749Nuss D, Kelly RE Jr, Croitoru DP, Katz ME. A 10-year review of a minimally invasive technique for the correction of pectus excavatum. J Pediatr Surg. 1998 Apr;33(4):545-52. doi: 10.1016/s0022-3468(98)90314-1.
- Background: PubMed 22568812Khan RS, Skapinakis P, Ahmed K, Stefanou DC, Ashrafian H, Darzi A, Athanasiou T. The association between preoperative pain catastrophizing and postoperative pain intensity in cardiac surgery patients. Pain Med. 2012 Jun;13(6):820-7. doi: 10.1111/j.1526-4637.2012.01386.x. Epub 2012 May 8.
- Background: PubMed 19047237Kelly RE Jr, Cash TF, Shamberger RC, Mitchell KK, Mellins RB, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley T, Quinn A, Moskowitz AB. Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study. Pediatrics. 2008 Dec;122(6):1218-22. doi: 10.1542/peds.2007-2723.
- Pectus Excavatum Mobility and Stretching ExercisesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lisa McMahon, MD principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Excavatum, run by Phoenix Children's Hospital at 1 site in United States.
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 1 inclusion and 6 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Improvement in pain scores (time frame: change from baseline (2 weeks prior to bar insertion) to post bar removal surgery (3 years, 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337621, which also lists 8 linked publications.
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 25 Apr 2022.