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

• Conditions: Morbid Obesity; Diabetes; Hypertension

• Registration Number: NCT01583790
• Lead Sponsor: Assuta Hospital Systems

Brief Summary

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Status Verified: 2017-03
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weightloss of patients	At least one year

Secondary Outcome Measures

Name	Time	Method
Improvement of co-morbidities after surgery	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.

Trial Locations

Locations (1)

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel