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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05134389
Other study ID # ASMC-0104-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2020
Est. completion date November 1, 2021

Study information

Verified date November 2021
Source Assuta Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 493
Est. completion date November 1, 2021
Est. primary completion date May 18, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
One Anastomosis Gastric Bypass
Exposure to One Anastomosis Gastric Bypass

Locations

Country Name City State
Israel Assuta Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
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