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

Survey on Gastrointestinal and Nutritional Parameters Among One Anastomosis Gastric Bypass Patients From Different Countries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05134389
Enrollment
493
Registered
2021-11-26
Start date
2020-05-18
Completion date
2021-11-01
Last updated
2021-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

bariatric surgery, gastric bypass, weight outcomes, functional gastrointestinal disorders, nutrition

Brief summary

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.

Interventions

Exposure to One Anastomosis Gastric Bypass

Sponsors

Assuta Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported anthropometric outcomesOnly once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).Measured by weight changes

Secondary

MeasureTime frameDescription
B. Self-reported lifestyle outcomesOnly 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)
C.Self-reported lifestyle outcomesOnly 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 \[physical activity (min/week), alcohol drinking (doses/day), smoking (current/past/never) and supplementation usage (non/monthly/weekly/daily)\]
A. Self-reported nutritional outcomesOnly 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)
B. Self-reported nutritional outcomesOnly 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)
A. Self-reported lifestyle outcomesOnly 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)
A. Self-reported GI outcomesOnly 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
B. Self-reported GI outcomesOnly 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)
C. Self-reported GI outcomesOnly 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)
C. Self-reported nutritional outcomesOnly 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)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026