Robotic Bariatric Database (RBD) Collaborative

Sponsor
Methodist Health System (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05540314
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: robotic bariatric surgery

Detailed Description

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. Cirocchi et al. stated that "Besides noninvasive conservative treatments (e.g., lifestyle modifications, medical treatment, and behavioral therapy), bariatric surgery is now playing an important role in the treatment for obesity. 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 (Cirocchi et al., 2013)."

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Robotic Bariatric Database (RBD) Collaborative
Actual Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Aug 10, 2023
Anticipated Study Completion Date :
Aug 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Subjects that have undergone robotic bariatric surgery

Subjects that have undergone robotic bariatric surgery between January 2018 and December 2019

Procedure: robotic bariatric surgery
robotic bariatric surgery

Outcome Measures

Primary Outcome Measures

  1. Date of Birth [January 2018- December2019]

    mm/dd/yyyy

  2. Principal Operative Procedure is an Initial Primary Metabolic or Bariatric Procedure [January 2018- December 2019]

    Yes or No

  3. Patient has a history of metabolic or bariatric surgery [January 2018- December 2019]

    Yes or No

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Charlton Medical Center Dallas Texas United States 75237

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Sachin S . Kukreja, MD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05540314
Other Study ID Numbers:
  • 001.WMP.2022.D
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022