ObesityNCT05134389
Survey on GI and Nutritional Parameters Among OAGB Patients From Different Countries
An observational study of Obesity, run by Assuta Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- One Anastomosis Gastric Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 493 participants
- Where
- 1 siteIsrael
- Study dates
- 18 May 2020to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients aged 18 years or above who underwent primary OAGB in the last 5 years from Israel, Spain and Portugal
Who may be able to join
- age ≥18 years old
- patients who underwent primary OAGB in the last 5 years
Who cannot join
- patients who had undergone other bariatric surgery
- current pregnancy
- lacked capacity to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- One Anastomosis Gastric Bypass
- Keywords
- bariatric surgery, gastric bypass, weight outcomes, functional gastrointestinal disorders, nutrition
- Medical subject headings
- Obesity, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Anastomosis Gastric BypassProcedure or surgery
Exposure to One Anastomosis Gastric Bypass
| Study group | Role | What they receive |
|---|---|---|
| Israel | OAGB patients from Israel Receives: Procedure: One Anastomosis Gastric Bypass | |
| Spain | OAGB patients from Spain Receives: Procedure: One Anastomosis Gastric Bypass | |
| Portugal | OAGB patients from Portugal Receives: Procedure: One Anastomosis Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported anthropometric outcomes
Measured by weight changes
Measured: 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
Measured by satisfaction and quality of life scales (scale of 0-100)
Measured: 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)
Measured: 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)]
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start18 May 2020
- Primary completion18 May 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiri Sherf Dagan, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134389
- Sponsor's protocol ID
- ASMC-0104-19
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Gastrointestinal and Nutritional Parameters Among One Anastomosis Gastric Bypass Patients From Different Countries
- ClinicalTrials.gov ID
- NCT05134389
- Acronym / sponsor ID
- ASMC-0104-19
- Conditions
- Obesity
- Keywords
- bariatric surgery, gastric bypass, weight outcomes, functional gastrointestinal disorders, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Israel | – | Procedure: One Anastomosis Gastric BypassOAGB patients from Israel |
| Spain | – | Procedure: One Anastomosis Gastric BypassOAGB patients from Spain |
| Portugal | – | Procedure: One Anastomosis Gastric BypassOAGB patients from Portugal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or above who underwent primary OAGB in the last 5 years from Israel, Spain and Portugal
Key inclusion criteria (2 listed)
- age ≥18 years old
- patients who underwent primary OAGB in the last 5 years
Key exclusion criteria (3 listed)
- patients who had undergone other bariatric surgery
- current pregnancy
- lacked capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Anastomosis Gastric BypassExposure to One Anastomosis Gastric Bypass | Procedure or surgery | Israel, Portugal, Spain |
Primary outcome
Self-reported anthropometric outcomes
Time frame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
Measured by weight changes
9 secondary outcomes
A. Self-reported lifestyle outcomes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Assuta Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported anthropometric outcomes (time frame: Only once in accordance to the time group (1-6 months, 6-12 months and 1-5 years post-surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.