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

Hypertension Clinical Trial

Official title:

A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01583790
• Other study ID #: AR-001-12
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2012
• Last updated: January 24, 2018
• Start date: January 2012
• Est. completion date: January 2020

Study information

• Verified date: March 2017
• Source: Assuta Hospital Systems
• Contact: Asnat Raziel, MD
• Phone: 972-3-7645444
• Email: drraziel[@]zahav.net.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weightloss of patients		At least one year
Secondary	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.	At least one year