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

NCT05134389 | Completed

• 1 other identifier: ASMC-0104-19
• Study Type: observational
• Target: 493
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (3)

Israel

OAGB patients from Israel

Procedure: One Anastomosis Gastric Bypass

Spain

OAGB patients from Spain

Procedure: One Anastomosis Gastric Bypass

Portugal

OAGB patients from Portugal

Procedure: One Anastomosis Gastric Bypass

Interventions

One Anastomosis Gastric Bypass PROCEDURE

Exposure to One Anastomosis Gastric Bypass

Israel; Portugal; Spain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age ≥18 years old
• patients who underwent primary OAGB in the last 5 years

You may not qualify if:

• patients who had undergone other bariatric surgery
• current pregnancy
• lacked capacity to consent

Sponsors & Collaborators

• Assuta Medical Center: lead

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Obesity; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian and Epidemiologist, Principal Investigator

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 26, 2021
• Study Start: May 18, 2020
• Primary Completion: May 18, 2021
• Study Completion: November 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

IL (1)