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

Obesity Clinical Trial

Official title:

Survey on Gastrointestinal and Nutritional Parameters Among One Anastomosis Gastric Bypass Patients From Different Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134389
• Other study ID #: ASMC-0104-19
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Obesity

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).