Clinical trial NCT05134389: Survey on GI and Nutritional Parameters Among OAGB Patients From Different Countries
Official title: Survey on Gastrointestinal and Nutritional Parameters Among One Anastomosis Gastric Bypass Patients From Different Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: bariatric surgery
gastric bypass
weight outcomes
functional gastrointestinal disorders
nutrition
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 493
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.


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

Primary outcomes:
measure: Self-reported anthropometric outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
Secondary outcomes:
measure: A. Self-reported lifestyle outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: B. Self-reported lifestyle outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: C.Self-reported lifestyle outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: A. Self-reported nutritional outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: B. Self-reported nutritional outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: C. Self-reported nutritional outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: A. Self-reported GI outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: B. Self-reported GI outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
measure: C. Self-reported GI outcomes
timeFrame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References: