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CompletedNCT05134389Updated Nov 30, 2021

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

An observational study in Obesity, sponsored by Assuta Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.

Sponsored by Assuta Medical Center · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
493
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • bariatric surgery
  • gastric bypass
  • weight outcomes
  • functional gastrointestinal disorders
  • nutrition
03

In context

Lead sponsor

Assuta Medical Center is the lead sponsor of 41 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • age ≥18 years old
  • patients who underwent primary OAGB in the last 5 years

Exclusion criteria

Exclusion Criteria:

  • patients who had undergone other bariatric surgery
  • current pregnancy
  • lacked capacity to consent
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
493 participants (actual)
Patient registry
No

Groups and cohorts

  • Israel

    OAGB patients from Israel

    Procedure: One Anastomosis Gastric Bypass

  • Spain

    OAGB patients from Spain

    Procedure: One Anastomosis Gastric Bypass

  • Portugal

    OAGB patients from Portugal

    Procedure: One Anastomosis Gastric Bypass

Interventions

  • ProcedureOne Anastomosis Gastric Bypass

    Exposure to One Anastomosis Gastric Bypass

06

What researchers measure

Primary outcomes

  1. Self-reported anthropometric outcomes

    Measured by weight changes

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

Secondary outcomes

  1. A. Self-reported lifestyle outcomes

    Measured by satisfaction and quality of life scales (scale of 0-100)

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

  2. B. Self-reported lifestyle outcomes

    Measured by attendance to follow-up regime (no. of meetings)

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

  3. C.Self-reported lifestyle outcomes

    Measured by adherence to the bariatric surgery health recommendations \[physical activity (min/week), alcohol drinking (doses/day), smoking (current/past/never) and supplementation usage (non/monthly/weekly/daily)\]

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

  4. A. Self-reported nutritional outcomes

    Measured by adherence to the bariatric surgery eating recommendations questionnaire (0=no, 1=partial, 2=yes)

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

  5. B. Self-reported nutritional outcomes

    Measured by taste change, smell change and food aversion questionnaire (yes/no/open text for additional information)

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

  6. C. Self-reported nutritional outcomes

    Measured by self-reported questionnaire for quick assessment of food tolerance after bariatric surgery (scored between 1-27, while higher scores represents better tolerance)

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

  7. A. Self-reported GI outcomes

    Measured by no. defecations per day and defecations texture

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

  8. B. Self-reported GI outcomes

    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)

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

  9. C. Self-reported GI outcomes

    Measured by Gastrointestinal Symptom Rating Scale (GSRS) (scored 15-105, while higher scores represents more severe symptoms)

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

07

Study locations

1 site
  • Assuta Medical Center
    Tel Aviv, Israel
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05134389
Lead sponsor
Assuta Medical Center
Responsible party
Shiri Sherf Dagan (Dietitian and Epidemiologist, Principal Investigator, Assuta Medical Center) — Principal investigator
First posted
Nov 26, 2021
Start date
May 18, 2020
Primary completion
May 18, 2021
Completion
Nov 1, 2021
Last update
Nov 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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