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Survey on GI and Nutritional Parameters Among OAGB Patients From Different Countries

24 november 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

493

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Israel
      • Tel Aviv, Israel
        • Assuta Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients aged 18 years or above who underwent primary OAGB in the last 5 years from Israel, Spain and Portugal

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Israel
OAGB patients from Israel
Procedur: One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass
Spain
OAGB patients from Spain
Procedur: One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass
Portugal
OAGB patients from Portugal
Procedur: One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Self-reported anthropometric outcomes
Tidsram: 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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
A. Self-reported lifestyle outcomes
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assuta Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 maj 2020

Primärt slutförande (Faktisk)

18 maj 2021

Avslutad studie (Faktisk)

1 november 2021

Studieregistreringsdatum

Först inskickad

13 november 2021

Först inskickad som uppfyllde QC-kriterierna

13 november 2021

Första postat (Faktisk)

26 november 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 november 2021

Senast verifierad

1 november 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • ASMC-0104-19

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