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

NCT ID: NCT05134389

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

493 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-18

Study Completion Date

2021-11-01

Brief Summary

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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

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Conditions

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Obesity

Keywords

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bariatric surgery gastric bypass weight outcomes functional gastrointestinal disorders nutrition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Israel

OAGB patients from Israel

One Anastomosis Gastric Bypass

Intervention Type PROCEDURE

Exposure to One Anastomosis Gastric Bypass

Spain

OAGB patients from Spain

One Anastomosis Gastric Bypass

Intervention Type PROCEDURE

Exposure to One Anastomosis Gastric Bypass

Portugal

OAGB patients from Portugal

One Anastomosis Gastric Bypass

Intervention Type PROCEDURE

Exposure to One Anastomosis Gastric Bypass

Interventions

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One Anastomosis Gastric Bypass

Exposure to One Anastomosis Gastric Bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assuta Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shiri Sherf Dagan

Dietitian and Epidemiologist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assuta Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ASMC-0104-19

Identifier Type: -

Identifier Source: org_study_id