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

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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Diabetes; Morbid Obesity

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Asnat Raziel, MD; Phone Number: 972-3-7645444; Email: drraziel@zahav.net.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Assuta Medical Center
    • Contact: Asnat Raziel, MD; Phone Number: 972-3-7645444; Email: drraziel@zahav.net.il
    • Principal Investigator: Asnat Raziel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
no group; laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weightloss of patients	At least one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems
• Investigators: Principal Investigator: Asnat Raziel, MD, Medical Director, ICBS-Israeli Center for Bariatric Surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Morbid Obesity; Bariatric surgery; Laparoscopic Sleeve Gastrectomy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: AR-001-12