Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

Morbid Obesity Clinical Trial

Official title:

Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153308
• Other study ID #: H-11612
• Status: Completed
• Phase: N/A
• First received: March 21, 2010
• Last updated: August 17, 2015
• Start date: April 2005
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

See brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4785
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Must be scheduled for Bariatric Surgery @ UMMMC

Exclusion Criteria:

• Not scheduled for Bariatric Surgery @ UMMMC

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Other:
• Observational Study
This is an Observational study

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss after surgery	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	No
Secondary	Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension	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	No

External Links

•   UMass Memorial Medical Center