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Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01153308
First received: March 21, 2010
Last updated: August 13, 2013
Last verified: August 2013
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 5000
Study Start Date: April 2005
Estimated Primary Completion Date: December 2020 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01153308     History of Changes
Other Study ID Numbers: H-11612
Study First Received: March 21, 2010
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014