Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
Recruitment status was: Recruiting
|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|
- Weightloss of patients [ Time Frame: At least one year ] [ Designated as safety issue: No ]
- 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.
|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)|
laparoscopic sleeve gastrectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583790
|Assuta Medical Center|
|Tel Aviv, Israel|
|Principal Investigator:||Asnat Raziel, MD||Medical Director, ICBS-Israeli Center for Bariatric Surgery|