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- Register voor klinische proeven in de VS.
- Klinische proef NCT01998815
Role and Mechanisms of Obesity Surgery (RAMOSPHYSSURG)
Role and Mechanisms of Obesity Surgery - Physical Activity and Other Predictors of Hospital Stay, Recovery and Complications After Obesity Surgery
The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery.
The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure.
The investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea.
First aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of QoL and normal physical function.
The second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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-
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Gothenburg, Zweden, S41345
- Sahglrenska University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- >18 y of age
- BMI >35
Exclusion Criteria:
- non-knowledgeable in Swedish language
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Obese patients
Laparoscopic Roux-en-Y gastric bypass
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-operative recovery and complications
Tijdsspanne: 30 days
|
Length of hospital stay, post-operative sick-leave, rate of post-operative complications; bleeding, anastomotic leakage, re-admission, re-operation, thromboembolic complications (deep-venous thrombosis, pulmonary embolism).
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30 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-operative well-being and late complications
Tijdsspanne: 24 months
|
Post-operative well-being and late complications such as persistent gastrointestinal adverse symptoms abdominal discomfort, pain (measured using gastrointestinal symptom rating scale ;GSRS), dumping syndrome (measured by dumping syndrome rating scale), quality of life (SF-36 and EQ5d), physical activity level (Saltin Grimby), depression and anxiety rating (Hospital Depression and Anxiety rating scale), pain anxiety (Pain Catastrophizing scale).
|
24 months
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
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Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Dnr 310-13
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