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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01583790
Date of registration:	23/04/2012
Prospective Registration:	No
Primary sponsor:	Assuta Hospital Systems
Public title:	Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
Scientific title:	A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
Date of first enrolment:	January 2012
Target sample size:	2000
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT01583790
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Israel

Contacts

Name:	Asnat Raziel, MD
Address:
Telephone:	972-3-7645444
Email:	drraziel@zahav.net.il
Affiliation:

Name:	Asnat Raziel, MD
Address:
Telephone:
Email:
Affiliation:	Medical Director, ICBS-Israeli Center for Bariatric Surgery

Name:	Asnat Raziel, MD
Address:
Telephone:	972-3-7645444
Email:	drraziel@zahav.net.il
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum: 14 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Hypertension

Morbid Obesity

Intervention(s)

Primary Outcome(s)

Weightloss of patients [Time Frame: At least one year]

Secondary Outcome(s)

Improvement of co-morbidities after surgery [Time Frame: At least one year]

Secondary ID(s)

AR-001-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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