Bariatric Surgery CandidateNCT04663425
Outcome of Bariatric Surgery in Patients With BMI Greater Than 60 .
An observational study of Bariatric Surgery Candidate, run by Assuta Medical Center.
Trial summary
Patients that underwent any type of bariatric surgery with BMI more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2008to 30 Sep 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients accepted to underwent bariatric surgery with BMI equal or above 60
Who may be able to join
- BMI above 60 Any bariatric surgery performed including revision
- Exclusion Crite ria: Tourist patients Patients under 18 years old
- -
Who cannot join
None listed.
About this study
Official title: Is Bariatric Surgery Effective in Super-super Morbid Obese Patients?
Patients that underwent any type of bariatric surgery with BMI more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction.
Read the detailed description
Patients that underwent bariatric surgery for BMI =60 or greater were considered for the study. The type of surgery were be analyze related to weight loss. Complication and operation difficulty will be assessed.
Co morbidities and treatment results post surgery will be considered as also, need for revisional surgery/
- Conditions
- Bariatric Surgery Candidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy operation | Outcome of patients that underwent sleeve gastrectomy with BMI greater than 60. | |
| Gastric bypass operation | Outcome of patients that underwent gastric bypass with BMI greater than 60. | |
| Gastric Band operation | Outcome of patients that underwent gastric banding with BMI greater than 60. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss after bariatric surgery
change in bodyweight following the surgery (kg)
Measured: from 1 to 12 years
co-morbidities rate following surgery
prevalence of diseases linked to obesity (hypertension, diabetes, sleep apnea)
Measured: from 1 to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start4 Apr 2008
- Primary completion19 Aug 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663425
- Sponsor's protocol ID
- AMC-05-20
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Bariatric Surgery Effective in Super-super Morbid Obese Patients?
- ClinicalTrials.gov ID
- NCT04663425
- Acronym / sponsor ID
- AMC-05-20
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2008 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 11 Dec 2020 (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.
Patients that underwent any type of bariatric surgery with BMI more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction.
Detailed description
Patients that underwent bariatric surgery for BMI =60 or greater were considered for the study. The type of surgery were be analyze related to weight loss. Complication and operation difficulty will be assessed.
Co morbidities and treatment results post surgery will be considered as also, need for revisional surgery/
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy operation | – | –Outcome of patients that underwent sleeve gastrectomy with BMI greater than 60. |
| Gastric bypass operation | – | –Outcome of patients that underwent gastric bypass with BMI greater than 60. |
| Gastric Band operation | – | –Outcome of patients that underwent gastric banding with BMI greater than 60. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients accepted to underwent bariatric surgery with BMI equal or above 60
Key inclusion criteria (3 listed)
- BMI above 60 Any bariatric surgery performed including revision
- Exclusion Crite ria: Tourist patients Patients under 18 years old
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight loss after bariatric surgery
Time frame: from 1 to 12 years
change in bodyweight following the surgery (kg)
co-morbidities rate following surgery
Time frame: from 1 to 12 years
prevalence of diseases linked to obesity (hypertension, diabetes, sleep apnea)
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 11 Dec 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by Assuta Medical Center.
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 3 inclusion and 0 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight loss after bariatric surgery (time frame: from 1 to 12 years). The study lists 2 primary outcomes in all. 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 11 Dec 2020.