Trial Review

Please note the ANZCTR website will be unavailable from 1-2 pm (AEST) on Thursday, the 19th of June for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
12/12/2024

Titles & IDs
Public title
The Bariatric Surgery Registry
Scientific title
Establishment of a Bariatric Surgery Clinical Quality Registry
Secondary ID [1] 0 0
MonashU
Universal Trial Number (UTN)
Trial acronym
BSR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of defined adverse events following bariatric surgery
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Time of surgery to 90 days following surgery
Secondary outcome [1] 0 0
Mortality status following bariatric surgery
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Time of surgery up to 10 years after surgery
Secondary outcome [2] 0 0
Effect of bariatric surgery on long term weight loss
Assessment method [2] 0 0
Patient weight is collected on annual basis following a primary bariatric procedure to determine if weight loss is sustainable in the long term.
Timepoint [2] 0 0
12 months to 10 years after surgery
Secondary outcome [3] 0 0
Effectiveness of bariatric procedures
Assessment method [3] 0 0
Information is collected as to whether a patient has subsequent bariatric procedures following the first surgery recorded by the registry.
Timepoint [3] 0 0
12 months to 10 years after surgery
Secondary outcome [4] 0 0
The effect of bariatric surgery on a patient's diabetes status
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
12 months to 10 years after surgery
Secondary outcome [5] 0 0
The effectiveness of bariatric surgery as treatment for diabetes
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
12 months to 10 years after surgery

Eligibility
Key inclusion criteria
* Body Mass Index (BMI) >30 kg/m2
Minimum age
2 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant women

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
250000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Commonwealth of Australia
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Auckland, New Zealand
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Ian Caterson, MBBS
Address 0 0
Boden Institute
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wendy Brown, MBBS
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0625
Email 0 0
wendy.brown@monash.edu
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03441451