ANZCTR - Registration

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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

12/12/2024

Titles & IDs

Public title

The Bariatric Surgery Registry

Scientific title

Establishment of a Bariatric Surgery Clinical Quality Registry

Secondary ID [1]

MonashU

Universal Trial Number (UTN)

Trial acronym

BSR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

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]

Incidence of defined adverse events following bariatric surgery

Timepoint [1]

Time of surgery to 90 days following surgery

Secondary outcome [1]

Mortality status following bariatric surgery

Timepoint [1]

Time of surgery up to 10 years after surgery

Secondary outcome [2]

Effect of bariatric surgery on long term weight loss

Timepoint [2]

12 months to 10 years after surgery

Secondary outcome [3]

Effectiveness of bariatric procedures

Timepoint [3]

12 months to 10 years after surgery

Secondary outcome [4]

The effect of bariatric surgery on a patient's diabetes status

Timepoint [4]

12 months to 10 years after surgery

Secondary outcome [5]

The effectiveness of bariatric surgery as treatment for diabetes

Timepoint [5]

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]

Monash University - Melbourne

Recruitment postcode(s) [1]

- Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

Monash University

Address

Country

Other collaborator category [1]

Other

Name [1]

Commonwealth of Australia

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

University of Auckland, New Zealand

Address [2]

Country [2]

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/study/NCT03441451

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ian Caterson, MBBS

Address

Boden Institute

Country

Phone

Fax

Contact person for public queries

Name

Wendy Brown, MBBS

Address

Country

Phone

+61 3 9903 0625

Fax

wendy.brown@monash.edu

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

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

Trial Review

Registering a new trial?

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