- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01722279
The Long Term Impact of Bariatric Surgery on Quality of Life
Studieoversikt
Detaljert beskrivelse
Information from existing databases and medical records will be used to obtain a list of phone numbers for persons who had roux-en-y bariatric surgery at the SVBCE five or more years ago at the St. Vincent Bariatric Center of Excellence (SVBCE. The interview includes scripts that the caller will use to recruit subjects in either direct conversation, in voice mail or by leaving a message. Recruitment will cease after 400 complete post pilot interviews are obtained.
The interview covers topics related to physical and psychological health and quality of life. The number of questions asked will vary from subject to subject since some questions are asked only if a prior question is answered affirmatively. For example, if a subject responds "yes" when asked "have you had plastic surgery?" the subject is then asked what type of procedure they had. The topics covered are as follows: weight, current health, post surgery complications, relationships, work, cross addiction, mental health, diet, television viewing, exercise, and life satisfaction.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Indiana
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Carmel, Indiana, Forente stater, 46032
- St. Vincent Carmel Hospital Bariatric Center of Excellence
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had surgery at least 5 years before the survey was administered.
Exclusion Criteria:
- Patients having bariatric surgery at facilities other than St. Vincent Bariatric Center.
- Patients who had bariatric surgery less than 5 years before the survey period.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Bariatric surgery patients, at least 5 years post-surgery
Survey participants had bariatric surgery at the St. Vincent Bariatric Center of Excellence at least 5 years before completing survey.
|
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Flourishing Scale (Diener et al, 2009)
Tidsramme: 5 or more years after bariatric surgery
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5 or more years after bariatric surgery
|
|
Satisfaction with Life Scale (Diener et al, 1985)
Tidsramme: 5 or more years after bariatric surgery
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5 or more years after bariatric surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relationship satisfaction
Tidsramme: At least 5 years post-surgery
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At least 5 years post-surgery
|
|
|
Substance abuse and behavioral excesses
Tidsramme: At least 5 years post-surgery
|
Assesses presence of alcohol or other drug use problems, excessive spending, and problematic gambling
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At least 5 years post-surgery
|
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Physical Health Problems
Tidsramme: At least 5 years post-surgery
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Assesses presence of various obesity-related health problems including diabetes, hypertension, heart disease, stroke, hich cholesterol, sleep apnea, joint pain, etc.
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At least 5 years post-surgery
|
|
Weight history
Tidsramme: At least 5 years post-surgery
|
Assesses pre-surgery weight, current weight, and lowest post-surgical weight.
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At least 5 years post-surgery
|
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Satisfaction with surgery
Tidsramme: At least 5 years post-surgery
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At least 5 years post-surgery
|
|
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Contact with Bariatric Center caregivers
Tidsramme: At least 5 years post-surgery
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At least 5 years post-surgery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Leslie M Schuh, PhD, St. Vincent Carmel Bariatric Center of Excellence
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 10070 (Annen identifikator: CTEP)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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