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Trial record 1 of 7 for:    bariatric surgery registry
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Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153308
First Posted: June 30, 2010
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Massachusetts, Worcester
  Purpose
The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.

Condition Intervention
Morbid Obesity Other: Observational Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Weight Loss after surgery [ Time Frame: Preop, Postop, Six Months, and Annually ]
    Baseline weight is recorded preoperatively. Time points after surgery when weight is recorded are two weeks, six weeks, 6 months, 1 year, 18 months, 2 years, then annually on the anniversary date of surgery.


Secondary Outcome Measures:
  • Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension [ Time Frame: Preop, Postop, Six Months, Annually ]
    Preoperatively co-morbidities of morbid obesity are recorded as well as treatment (ie: medications, CPAP machine). Resolution of co-morbidities postoperatively is measured/recorded for example by blood tests, sleep study, as well as changes or discontinuation of medications &/or interventions.


Enrollment: 4785
Study Start Date: April 2005
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bariatric Surgery Patients
Bariatric Surgery patients at UMass Memorial Medical Center
Other: Observational Study
This is an Observational study

Detailed Description:
See brief Summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UMMMC Bariatric Surgery Patients
Criteria

Inclusion Criteria:

  • Must be scheduled for Bariatric Surgery @ UMMMC

Exclusion Criteria:

  • Not scheduled for Bariatric Surgery @ UMMMC
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153308


Locations
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: John J Kelly, MD University of Massachusetts Medical School and UMass Memorial Medical Center
  More Information

Additional Information:
Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01153308     History of Changes
Other Study ID Numbers: H-11612
First Submitted: March 21, 2010
First Posted: June 30, 2010
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by University of Massachusetts, Worcester:
Morbid Obesity
Obesity
Weight Loss
Bariatric Surgery

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms