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

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: Obesity
• Intervention / Treatment: Procedure: One Anastomosis Gastric Bypass

• Study Type: Observational
• Enrollment (Actual): 493

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Assuta Medical Center

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Israel; OAGB patients from Israel	Procedure: One Anastomosis Gastric Bypass; Exposure to One Anastomosis Gastric Bypass
Spain; OAGB patients from Spain	Procedure: One Anastomosis Gastric Bypass; Exposure to One Anastomosis Gastric Bypass
Portugal; OAGB patients from Portugal	Procedure: One Anastomosis Gastric Bypass; Exposure to One Anastomosis Gastric Bypass

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).

Collaborators and Investigators

• Sponsor: Assuta Medical Center

Study record dates

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: nutrition; bariatric surgery; gastric bypass; functional gastrointestinal disorders; weight outcomes
• 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