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

24. november 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

493

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Israel
      • Tel Aviv, Israel
        • Assuta Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Israel
OAGB patients from Israel
Fremgangsmåte: One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass
Spain
OAGB patients from Spain
Fremgangsmåte: One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass
Portugal
OAGB patients from Portugal
Fremgangsmåte: One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assuta Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. mai 2020

Primær fullføring (Faktiske)

18. mai 2021

Studiet fullført (Faktiske)

1. november 2021

Datoer for studieregistrering

Først innsendt

13. november 2021

Først innsendt som oppfylte QC-kriteriene

13. november 2021

Først lagt ut (Faktiske)

26. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • ASMC-0104-19

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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