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Occurrence of signs and symptoms of pectus excavatum (PE) in seniors


- candidate number4294
- NTR NumberNTR1507
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-okt-2008
- Secondary IDs07-4-035 METC
- Public TitleOccurrence of signs and symptoms of pectus excavatum (PE) in seniors
- Scientific TitleSymptomatic pectus excavatum in seniors; prevalence and recognition in daily practice.
- ACRONYMThe SPES project
- hypothesisPectus excavatum may not be as harmless as generally assumed and may lead to symptoms like dyspnea or fatigue after exercise
- Healt Condition(s) or Problem(s) studiedElderly patients, Pectus excavatum (PE)
- Inclusion criteria1. Age above 55
2. Chest X-ray within the last three years with PE visible
- Exclusion criteria1. Age under 55
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-mrt-2009
- Target number of participants100
- InterventionsObservational study, therefore no intervention
- Primary outcome- Occurrence and level of symptoms
- Level of detection of SPES
- Secondary outcome- Eventual treatment found
- Possible relevant comorbidity
- TimepointsChest X-ray results from the period 2005 until 2008 and relevant signs/symptoms in the same period
- Trial web sitehttp://www.spesweb.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. Ron A.G. Winkens
- CONTACT for SCIENTIFIC QUERIESDr. Ron A.G. Winkens
- Sponsor/Initiator University Hospital Maastricht (AZM), Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summaryPectus Excavatum (PE) is frequently seen during physical examination or noticed on chest X-rays. It is not considered to be clinically significant. It is, however, envisioned that PE can cause symptoms like dyspnoea, palpitations or fatigue in elderly patients. PE may therefore be not as harmless as it seems. Prevalence of PE is at least 1 in 1000 patients, but the prevalence of symptomatic PE in seniors (SPES) is unknown. This observational study tries to assess how often symptoms occur in patients in whom a PE was identified and to what extent the PE may be held responsible for these symptoms, in the presence or absence of another explanation or cause. In this observational study, we included all patients over 55 years in whom a PE was diagnosed in a chest X-ray in the three years before the start of the study. Except for an age under 55 there were no exclusion criteria. Of all included patients, medical records from the participating hospitals and from the general practitioners in the study regions were checked for evidence concerning symptoms related to SPES and the existence of (co)morbidity.
- Main changes (audit trail)
- RECORD27-okt-2008 - 10-nov-2008


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