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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03441451
Registration number
NCT03441451
Ethics application status
Date submitted
22/01/2015
Date registered
22/02/2018
Date last updated
8/11/2022
Titles & IDs
Public title
The Bariatric Surgery Registry
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Scientific title
Establishment of a Bariatric Surgery Clinical Quality Registry
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Secondary ID [1]
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MonashU
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Universal Trial Number (UTN)
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Trial acronym
BSR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of defined adverse events following bariatric surgery
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Assessment method [1]
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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.
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Timepoint [1]
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Time of surgery to 90 days following surgery
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Secondary outcome [1]
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Mortality status following bariatric surgery
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Assessment method [1]
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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.
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Timepoint [1]
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Time of surgery up to 10 years after surgery
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Secondary outcome [2]
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Effect of bariatric surgery on long term weight loss
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Assessment method [2]
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Patient weight is collected on annual basis following a primary bariatric procedure to determine if weight loss is sustainable in the long term.
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Timepoint [2]
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12 months to 10 years after surgery
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Secondary outcome [3]
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Effectiveness of bariatric procedures
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Assessment method [3]
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Information is collected as to whether a patient has subsequent bariatric procedures following the first surgery recorded by the registry.
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Timepoint [3]
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12 months to 10 years after surgery
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Secondary outcome [4]
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The effect of bariatric surgery on a patient's diabetes status
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Assessment method [4]
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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.
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Timepoint [4]
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12 months to 10 years after surgery
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Secondary outcome [5]
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The effectiveness of bariatric surgery as treatment for diabetes
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Assessment method [5]
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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.
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Timepoint [5]
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12 months to 10 years after surgery
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Eligibility
Key inclusion criteria
* Body Mass Index (BMI) >30 kg/m2
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Minimum age
2
Years
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Maximum age
95
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Pregnant women
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
250000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Commonwealth of Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The University of Auckland
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03441451
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ian Caterson, MBBS
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Address
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Boden Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Wendy Brown, MBBS
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Address
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Country
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Phone
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+61 3 9903 0625
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/51/NCT03441451/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03441451
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