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NCT Number: NCT05134389

Survey on GI and Nutritional Parameters Among OAGB 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.

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assuta Medical Center

Tel Aviv, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One anastomosis gastric bypass

Procedure

Exposure to One Anastomosis Gastric Bypass

Primary outcomes

  1. Self-reported anthropometric outcomes

    Time frame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).

    Measured by weight changes

Secondary outcomes

  1. A. Self-reported lifestyle outcomes

    Time frame: 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)

  2. B. Self-reported lifestyle outcomes

    Time frame: 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)

  3. C.Self-reported lifestyle outcomes

    Time frame: 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)]

  4. A. Self-reported nutritional outcomes

    Time frame: 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)

  5. B. Self-reported nutritional outcomes

    Time frame: 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)

  6. C. Self-reported nutritional outcomes

    Time frame: 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)

  7. A. Self-reported GI outcomes

    Time frame: 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

  8. B. Self-reported GI outcomes

    Time frame: 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)

  9. C. Self-reported GI outcomes

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Assuta Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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