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
|Condition or disease|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250000 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441451
|Contact: Wendy Brown, MBBS||+61 3 9903 email@example.com|
|Contact: Andrew MacCormick, MBBS||+64 9 276 firstname.lastname@example.org|
|Melbourne, Victoria, Australia|
|Study Chair:||Ian Caterson, MBBS||Boden Institute|