Survey on GI and Nutritional Parameters Among OAGB Patients From Different Countries
November 24, 2021 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
493
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel Aviv, Israel
- Assuta Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Israel
OAGB patients from Israel
|
Exposure to One Anastomosis Gastric Bypass
|
|
Spain
OAGB patients from Spain
|
Exposure to One Anastomosis Gastric Bypass
|
|
Portugal
OAGB patients from Portugal
|
Exposure to One Anastomosis Gastric Bypass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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)
|
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
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)]
|
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
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)
|
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
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)
|
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
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)
|
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
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
|
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
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)
|
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
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)
|
Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2020
Primary Completion (Actual)
May 18, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
November 13, 2021
First Submitted That Met QC Criteria
November 13, 2021
First Posted (Actual)
November 26, 2021
Study Record Updates
Last Update Posted (Actual)
November 30, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ASMC-0104-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.