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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Assuta Hospital Systems
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01583790
First received: April 23, 2012
Last updated: June 24, 2014
Last verified: March 2012
  Purpose

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


Condition
Morbid Obesity
Diabetes
Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Weightloss of patients [ Time Frame: At least one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of co-morbidities after surgery [ Time Frame: At least one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
no group
laparoscopic sleeve gastrectomy

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.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
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).

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583790

Contacts
Contact: Asnat Raziel, MD 972-3-7645444 drraziel@zahav.net.il

Locations
Israel
Assuta Medical Center Recruiting
Tel Aviv, Israel
Contact: Asnat Raziel, MD    972-3-7645444    drraziel@zahav.net.il   
Principal Investigator: Asnat Raziel, MD         
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Asnat Raziel, MD Medical Director, ICBS-Israeli Center for Bariatric Surgery
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01583790     History of Changes
Other Study ID Numbers: AR-001-12
Study First Received: April 23, 2012
Last Updated: June 24, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Assuta Hospital Systems:
Laparoscopic Sleeve Gastrectomy
Bariatric surgery
Morbid Obesity

Additional relevant MeSH terms:
Hypertension
Obesity
Obesity, Morbid
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014