Survey on GI and Nutritional Parameters Among OAGB Patients From Different Countries
- Conditions
- Obesity
- Interventions
- Procedure: One Anastomosis Gastric Bypass
- Registration Number
- NCT05134389
- Lead Sponsor
- Assuta Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
- age ≥18 years old
- patients who underwent primary OAGB in the last 5 years
- patients who had undergone other bariatric surgery
- current pregnancy
- lacked capacity to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Portugal One Anastomosis Gastric Bypass OAGB patients from Portugal Spain One Anastomosis Gastric Bypass OAGB patients from Spain Israel One Anastomosis Gastric Bypass OAGB patients from Israel
- Primary Outcome Measures
Name Time Method Self-reported anthropometric outcomes 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 Outcome Measures
Name Time Method A. Self-reported lifestyle outcomes 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)
A. Self-reported nutritional outcomes 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)
B. Self-reported nutritional outcomes 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)
B. Self-reported lifestyle outcomes 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)
C.Self-reported lifestyle outcomes 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 \[physical activity (min/week), alcohol drinking (doses/day), smoking (current/past/never) and supplementation usage (non/monthly/weekly/daily)\]
C. Self-reported GI outcomes 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)
C. Self-reported nutritional outcomes 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)
A. Self-reported GI outcomes 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
B. Self-reported GI outcomes 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)
Trial Locations
- Locations (1)
Assuta Medical Center
🇮🇱Tel Aviv, Israel