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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03441451




Registration number
NCT03441451
Ethics application status
Date submitted
22/01/2015
Date registered
20/02/2018
Date last updated
21/02/2018

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 - 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 - 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 - 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 - 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 - 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 - 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Commonwealth of Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Auckland
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03441451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Caterson, MBBS
Address 0 0
Boden Institute
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
wendy.brown@monash.edu
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable