- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01722279
The Long Term Impact of Bariatric Surgery on Quality of Life
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Indiana
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Carmel, Indiana, Förenta staterna, 46032
- St. Vincent Carmel Hospital Bariatric Center of Excellence
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Tvärsnitt
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Flourishing Scale (Diener et al, 2009)
Tidsram: 5 or more years after bariatric surgery
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5 or more years after bariatric surgery
|
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Satisfaction with Life Scale (Diener et al, 1985)
Tidsram: 5 or more years after bariatric surgery
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5 or more years after bariatric surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Relationship satisfaction
Tidsram: At least 5 years post-surgery
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At least 5 years post-surgery
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Substance abuse and behavioral excesses
Tidsram: At least 5 years post-surgery
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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
Tidsram: 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
|
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Weight history
Tidsram: At least 5 years post-surgery
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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
Tidsram: 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
Tidsram: At least 5 years post-surgery
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At least 5 years post-surgery
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Leslie M Schuh, PhD, St. Vincent Carmel Bariatric Center of Excellence
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 10070 (Annan identifierare: CTEP)
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