Survey on GI and Nutritional Parameters Among OAGB Patients From Different Countries
24. november 2021 opdateret af: Shiri Sherf Dagan, Assuta Medical Center
Survey on Gastrointestinal and Nutritional Parameters Among One Anastomosis Gastric Bypass Patients From Different Countries
One Anastomosis Gastric Bypass (OAGB) surgery is a type of bariatric surgery (BS) which is gaining popularity worldwide and is considered to be a simple, safe and effective bariatric procedure in terms of weight loss and comorbidities resolution. However, only limited data exists on the nutritional and gastrointestinal (GI) consequences of this procedure.
This study aimed to gain information on GI and nutritional parameters from a large sample of OAGB patients living in 3 different countries.
Post-OAGB patients across Israel (n=277), Spain (n=105) and Portugal (n=111) were recruited to the study based on the time elapsed since surgery [1-6 months (1-6M), 6-12 months (6-12M) and 1-5 years (1-5Y) post-surgery]. Participants were asked to complete an anonymous survey delivered by SurveyMonkey®️ software which included data on demographics, comorbidities, anthropometrics, GI outcomes and satisfaction with the procedure.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
493
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Tel Aviv, Israel
- Assuta Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients aged 18 years or above who underwent primary OAGB in the last 5 years from Israel, Spain and Portugal
Beskrivelse
Inclusion Criteria:
- age ≥18 years old
- patients who underwent primary OAGB in the last 5 years
Exclusion Criteria:
- patients who had undergone other bariatric surgery
- current pregnancy
- lacked capacity to consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Israel
OAGB patients from Israel
|
Exposure to One Anastomosis Gastric Bypass
|
|
Spain
OAGB patients from Spain
|
Exposure to One Anastomosis Gastric Bypass
|
|
Portugal
OAGB patients from Portugal
|
Exposure to One Anastomosis Gastric Bypass
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported anthropometric outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by weight changes
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
A. Self-reported lifestyle outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by satisfaction and quality of life scales (scale of 0-100)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
B. Self-reported lifestyle outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by attendance to follow-up regime (no. of meetings)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
C.Self-reported lifestyle outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by adherence to the bariatric surgery health recommendations [physical activity (min/week), alcohol drinking (doses/day), smoking (current/past/never) and supplementation usage (non/monthly/weekly/daily)]
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
A. Self-reported nutritional outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by adherence to the bariatric surgery eating recommendations questionnaire (0=no, 1=partial, 2=yes)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
B. Self-reported nutritional outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by taste change, smell change and food aversion questionnaire (yes/no/open text for additional information)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
C. Self-reported nutritional outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by self-reported questionnaire for quick assessment of food tolerance after bariatric surgery (scored between 1-27, while higher scores represents better tolerance)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
A. Self-reported GI outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by no.
defecations per day and defecations texture
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
B. Self-reported GI outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by severity of dyspepsia symptoms scale (4-point graded scale -0 represents absence of symptoms and 3 represents severe symptoms which interfere to perform normal activities)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
|
C. Self-reported GI outcomes
Tidsramme: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Measured by Gastrointestinal Symptom Rating Scale (GSRS) (scored 15-105, while higher scores represents more severe symptoms)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. maj 2020
Primær færdiggørelse (Faktiske)
18. maj 2021
Studieafslutning (Faktiske)
1. november 2021
Datoer for studieregistrering
Først indsendt
13. november 2021
Først indsendt, der opfyldte QC-kriterier
13. november 2021
Først opslået (Faktiske)
26. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ASMC-0104-19
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