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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: One Anastomosis Gastric Bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Israel<br>OAGB patients from Israel | Procedure: One Anastomosis Gastric Bypass<br>* Exposure to One Anastomosis Gastric Bypass<br>|
| Spain<br>OAGB patients from Spain | Procedure: One Anastomosis Gastric Bypass<br>* Exposure to One Anastomosis Gastric Bypass<br>|
| Portugal<br>OAGB patients from Portugal | Procedure: One Anastomosis Gastric Bypass<br>* Exposure to One Anastomosis Gastric Bypass<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anthropometric outcomes | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, gastric bypass, weight outcomes, functional gastrointestinal disorders, nutrition