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Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583790
Recruitment Status : Unknown
Verified March 2017 by Assuta Hospital Systems.
Recruitment status was:  Recruiting
First Posted : April 24, 2012
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Assuta Hospital Systems

Brief Summary:
The purpose of this study is to report data with patients after bariatric surgery.

Condition or disease
Morbid Obesity Diabetes Hypertension

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
Study Start Date : January 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

no group
laparoscopic sleeve gastrectomy

Primary Outcome Measures :
  1. Weightloss of patients [ Time Frame: At least one year ]

Secondary Outcome Measures :
  1. Improvement of co-morbidities after surgery [ Time Frame: At least one year ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients that can not obey one of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583790

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Contact: Asnat Raziel, MD 972-3-7645444

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Assuta Medical Center Recruiting
Tel Aviv, Israel
Contact: Asnat Raziel, MD    972-3-7645444   
Principal Investigator: Asnat Raziel, MD         
Sponsors and Collaborators
Assuta Hospital Systems
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Principal Investigator: Asnat Raziel, MD Medical Director, ICBS-Israeli Center for Bariatric Surgery
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Responsible Party: Assuta Hospital Systems Identifier: NCT01583790    
Other Study ID Numbers: AR-001-12
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: March 2017
Keywords provided by Assuta Hospital Systems:
Laparoscopic Sleeve Gastrectomy
Bariatric surgery
Morbid Obesity
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms