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Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

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ClinicalTrials.gov Identifier: NCT01153308
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Brief Summary:
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 or disease Intervention/treatment
Morbid Obesity Other: Observational Study

Detailed Description:
See brief Summary

Study Type : Observational
Actual Enrollment : 4785 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)
Study Start Date : April 2005
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Bariatric Surgery Patients
Bariatric Surgery patients at UMass Memorial Medical Center
Other: Observational Study
This is an Observational study



Primary Outcome Measures :
  1. 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 :
  1. 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.



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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

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

Additional Information:
Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01153308     History of Changes
Other Study ID Numbers: H-11612
First Posted: June 30, 2010    Key Record Dates
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