- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05540314
Robotic Bariatric Database (RBD) Collaborative
With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss. In 1991, the National Institutes of Health Conference Statement on Gastrointestinal Surgery for Severe Obesity developed a consensus stating that bariatric surgery was the most effective treatment for obesity since it is associated with good long-term results in terms of weight loss, glycemic control and decreased mortality.
To collect and store clinical data related to the treatment outcomes of robotic bariatric surgery in order to develop an evidence base such that physicians can provide the best possible care to patients undergoing surgical weight loss interventions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75237
- Methodist Charlton Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 18 years of age
- Eligible for or have undergone robotic bariatric surgery per the treating physician
- Undergone robotic bariatric surgery between January 2018 and December 2019
Exclusion Criteria:
- Do not meet the Study Inclusion Criteria l
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Subjects that have undergone robotic bariatric surgery
Subjects that have undergone robotic bariatric surgery between January 2018 and December 2019
|
robotic bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Date of Birth
Time Frame: January 2018- December2019
|
mm/dd/yyyy
|
January 2018- December2019
|
|
Principal Operative Procedure is an Initial Primary Metabolic or Bariatric Procedure
Time Frame: January 2018- December 2019
|
Yes or No
|
January 2018- December 2019
|
|
Patient has a history of metabolic or bariatric surgery
Time Frame: January 2018- December 2019
|
Yes or No
|
January 2018- December 2019
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sachin S . Kukreja, MD, Methodist Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001.WMP.2022.D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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