ClinicalTrials.gov
ClinicalTrials.gov Menu

The Bariatric Surgery Registry (BSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03441451
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Commonwealth of Australia
The University of Auckland
Information provided by (Responsible Party):
Assoc/Prof Wendy Brown, Monash University

Brief Summary:
Persons with obesity are more likely to suffer from many other serious health conditions and are more likely to die young. Lifestyle interventions have not been found to be an effective long-term solution for treating obesity. When usual weight loss measures are not successful, bariatric, or 'weight loss,' surgery may be considered. Bariatric surgery is performed to help people with obesity achieve weight loss which they can maintain. Weight loss following bariatric surgery leads to improvement in health and well-being, and patients have been shown to live longer. It is invasive surgery which has surgical risks and potential side effects, including death. Since people are having this surgery to improve their health, it is important that the surgery is performed with a minimum of side effects, otherwise it cannot be justified. Information is collected about the surgery, any complications after the surgery, weight at various time points, and if the patient has diabetes and how it is is treated. Patient details are needed to be able to identify patients on the registry and track their progress through data linkages. Participants have information about their bariatric surgery provided to the registry by their surgeon or hospital. They may also be contacted directly by the registry staff to see if they had any complications and if the surgery had any effect on their health (if they have diabetes), weight, and well-being. The Registry will hold their identifiable information as it aims to follow each patient for ten years after their first bariatric operation. By systematically collecting information on every procedure performed in Australia and New Zealand, the registry will help to identify when surgeons, hospitals or procedures not performing to the expected standard. A Bariatric Surgery Registry should also be able to demonstrate how effectively bariatric surgery results in weight loss and improved health (using diabetes as a marker of health) across the two countries.

Condition or disease
Obesity

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 250000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Establishment of a Bariatric Surgery Clinical Quality Registry
Study Start Date : January 2012
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of defined adverse events following bariatric surgery [ Time Frame: Time of surgery to 90 days following surgery ]
    Information is collecting regarding the occurrence of one or more defined adverse events following bariatric surgery. Defined adverse events collected are: unplanned readmission to hospital, unplanned admission to the intensive care unit, unplanned return to the operating theatre, prolonged length of stay in hospital, and death. The reason for any of the events is also collected. If death occurs, the cause of death is collected to determine the likelihood of the death being caused by the bariatric surgery.


Secondary Outcome Measures :
  1. Mortality status following bariatric surgery [ Time Frame: Time of surgery up to 10 years after surgery ]
    Information is collected about each patient who has undergone bariatric surgery to ascertain mortality after the surgery and whether the cause of death was likely to be related to the patient having bariatric surgery.

  2. Effect of bariatric surgery on long term weight loss [ Time Frame: 12 months to 10 years after surgery ]
    Patient weight is collected on annual basis following a primary bariatric procedure to determine if weight loss is sustainable in the long term.

  3. Effectiveness of bariatric procedures [ Time Frame: 12 months to 10 years after surgery ]
    Information is collected as to whether a patient has subsequent bariatric procedures following the first surgery recorded by the registry.

  4. The effect of bariatric surgery on a patient's diabetes status [ Time Frame: 12 months to 10 years after surgery ]
    Information is collected at baseline as to whether or not a patient is identified as a diabetic and then on annual basis following surgery to see if the patient's diabetes status has changed.

  5. The effectiveness of bariatric surgery as treatment for diabetes [ Time Frame: 12 months to 10 years after surgery ]
    Information is collected at baseline as to how a patient identified as a diabetic is treated and then on annual basis following surgery to see if the patient still requires further treatment for diabetes and if treatment has changed from what was recorded at baseline.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
persons who undergo bariatric surgical procedures as treatment for obesity
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) >30 kg/m2

Exclusion Criteria:

  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441451


Contacts
Contact: Wendy Brown, MBBS +61 3 9903 0625 wendy.brown@monash.edu
Contact: Andrew MacCormick, MBBS +64 9 276 0000 andrew.maccormick@middlemore.co.nz

Locations
Australia, Victoria
Monash University Recruiting
Melbourne, Victoria, Australia
Sponsors and Collaborators
Monash University
Commonwealth of Australia
The University of Auckland
Investigators
Study Chair: Ian Caterson, MBBS Boden Institute
  Study Documents (Full-Text)

Documents provided by Assoc/Prof Wendy Brown, Monash University:
Study Protocol  [PDF] September 6, 2017


Additional Information:
Responsible Party: Assoc/Prof Wendy Brown, Professor Wendy Brown, Monash University
ClinicalTrials.gov Identifier: NCT03441451     History of Changes
Other Study ID Numbers: MonashU
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by Assoc/Prof Wendy Brown, Monash University:
Bariatric Surgery