Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

August 17, 2015 updated by: University of Massachusetts, Worcester

Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See brief Summary

Study Type

Observational

Enrollment (Actual)

4785

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

UMMMC Bariatric Surgery Patients

Description

Inclusion Criteria:

  • Must be scheduled for Bariatric Surgery @ UMMMC

Exclusion Criteria:

  • Not scheduled for Bariatric Surgery @ UMMMC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preop, Postop, Six Months, and Annually

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preop, Postop, Six Months, Annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: John J Kelly, MD, University of Massachusetts Medical School and UMass Memorial Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 21, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-11612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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