Morbid ObesityNCT01583790
Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
An observational study of Morbid Obesity and Diabetes, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
The purpose of this study is to report data with patients after bariatric surgery. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Morbid Obesity, Diabetes, Hypertension
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Jan 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study includes about 1500 patients, 70% female and 30% male. All patients that had bariatric surgery and were in the follow-up group for longer than one month will take part in the study. A special emphasis will be given to special population groups such as adolescents, old patients, patients undergoing revision surgery, and patients that required a additional type of surgery in conjunction with the bariatric surgery (e.g., gallbladder removal).
Who may be able to join
- patients meeting established criteria set by the National Institutes of Health (NIH) for candidacy for bariatric surgery
- patients having a body mass index (BMI) of 35 with co-morbid conditions or BMI larger or equal 40 with or without co-morbid conditions,
- patients having a comorbidity that should be improved by the surgery
- Patients that are able to comprehend the risks and benefits and the surgical procedure
- patients having no glandular etiology for their obesity
- patients that have attempted to lose weight by conventional means
- patients that are willing to be observed over a long period of time
Who cannot join
- patients that can not obey one of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assuta Medical Center
Tel Aviv
Asnat Raziel, MD, 972-3-7645444, drraziel@zahav.net.il
Asnat Raziel, MD
About this study
Official title: A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
The purpose of this study is to report data with patients after bariatric surgery.
Read the detailed description
In the period 2006-2012 the ICBS-Israeli Center for Bariatric Surgery in Assuta Hospital has performed about 1500 bariatric surgeries including Laparoscopic Adjustable Gastric Banding, Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux en Y Gastric Bypass, and Duodenal switch. In addition, Pose and BPD procedures were performed.The ICBS team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. During that period patients data were collected as part of the medical practice in the Center and included BMI, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. During the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle.
The purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. Factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.
- Conditions
- Morbid Obesity, Diabetes, Hypertension
- Keywords
- Laparoscopic Sleeve Gastrectomy, Bariatric surgery, Morbid Obesity
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Hypertension
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 |
|---|---|---|
| no group | laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weightloss of patients
Measured: At least one year
Secondary outcomes (1)
Improvement of co-morbidities after surgery
Follow up visits were done at 1, 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery. They included physical examinations, blood analysis and assessment of comorbidities in collaboration with attending family physician.
Measured: At least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asnat Raziel, MD, Principal investigator, Medical Director, ICBS-Israeli Center for Bariatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583790
- Sponsor's protocol ID
- AR-001-12
- Status last verified
- Mar 2017
- First submitted
- 23 Apr 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
- ClinicalTrials.gov ID
- NCT01583790
- Acronym / sponsor ID
- AR-001-12
- Conditions
- Morbid Obesity, Diabetes, Hypertension
- Keywords
- Laparoscopic Sleeve Gastrectomy, Bariatric surgery, Morbid Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- 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.
The purpose of this study is to report data with patients after bariatric surgery.
Detailed description
In the period 2006-2012 the ICBS-Israeli Center for Bariatric Surgery in Assuta Hospital has performed about 1500 bariatric surgeries including Laparoscopic Adjustable Gastric Banding, Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux en Y Gastric Bypass, and Duodenal switch. In addition, Pose and BPD procedures were performed.The ICBS team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. During that period patients data were collected as part of the medical practice in the Center and included BMI, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. During the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle.
The purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. Factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no group | – | –laparoscopic sleeve gastrectomy |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study includes about 1500 patients, 70% female and 30% male. All patients that had bariatric surgery and were in the follow-up group for longer than one month will take part in the study. A special emphasis will be given to special population groups such as adolescents, old patients, patients undergoing revision surgery, and patients that required a additional type of surgery in conjunction with the bariatric surgery (e.g., gallbladder removal).
Key inclusion criteria (7 listed)
- patients meeting established criteria set by the National Institutes of Health (NIH) for candidacy for bariatric surgery
- patients having a body mass index (BMI) of 35 with co-morbid conditions or BMI larger or equal 40 with or without co-morbid conditions,
- patients having a comorbidity that should be improved by the surgery
- Patients that are able to comprehend the risks and benefits and the surgical procedure
- patients having no glandular etiology for their obesity
Key exclusion criteria (1 listed)
- patients that can not obey one of the inclusion criteria
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
Weightloss of patients
Time frame: At least one year
1 secondary outcome
Improvement of co-morbidities after surgery
Time frame: At least one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Asnat Raziel, MD principal investigator
Medical Director, ICBS-Israeli Center for Bariatric Surgery
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 Morbid Obesity and Diabetes, run by Assuta Hospital Systems 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asnat Raziel, MD (972-3-7645444, drraziel@zahav.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weightloss of patients (time frame: At least one year). 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 25 Jan 2018.