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

NCT01583790 | Unknown

• 1 other identifier: AR-001-12
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Morbid Obesity; Diabetes; Hypertension

Keywords

Laparoscopic Sleeve Gastrectomy; Bariatric surgery; Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Weightloss of patients

  At least one year

Secondary Outcomes (1)

• Improvement of co-morbidities after surgery

  At least one year

Study Arms (1)

no group

laparoscopic sleeve gastrectomy

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Asnat Raziel, MD

  Medical Director, ICBS-Israeli Center for Bariatric Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asnat Raziel, MD

CONTACT

972-3-7645444; drraziel@zahav.net.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 24, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 25, 2018

Record last verified: 2017-03

Locations

IL (1)