The Bariatric Surgery Registry

NCT03441451 | Recruiting DMC

• 1 other identifier: MonashU
• Study Type: observational
• Target: 250,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Time of surgery to 90 days following surgery

Secondary Outcomes (5)

• Mortality status following bariatric surgery

  Time of surgery up to 10 years after surgery

• Effect of bariatric surgery on long term weight loss

  12 months to 10 years after surgery

• Effectiveness of bariatric procedures

  12 months to 10 years after surgery

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

  12 months to 10 years after surgery

• The effectiveness of bariatric surgery as treatment for diabetes

  12 months to 10 years after surgery

Eligibility Criteria

• Age: 2 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persons who undergo bariatric surgical procedures as treatment for obesity

You may qualify if:

• Body Mass Index (BMI) \>30 kg/m2

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Monash University: lead
• Commonwealth of Australia: collaborator
• University of Auckland, New Zealand: collaborator

Study Sites (1)

Monash University

Melbourne, Victoria, Australia

RECRUITING

Related Publications (1)

• Brown WA, Brown DL, Holland JF, Campbell A, Cottrell J, Ahern S, Reilly J, Garduce P, Wetter J, Hamdorf JM, Talbot M, Baker S, MacCormick AD, Caterson ID. Metabolic bariatric surgery generates substantial, sustained weight loss and health improvement in a real-world setting. ANZ J Surg. 2025 May;95(5):895-903. doi: 10.1111/ans.19378. Epub 2025 Jan 9.

  PMID: 39785110 DERIVED

Related Links

• Australia and New Zealand Bariatric Surgery Registry

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian Caterson, MBBS

  Boden Institute

  STUDY CHAIR

Central Study Contacts

Wendy Brown, MBBS

CONTACT

+61 3 9903 0625; wendy.brown@monash.edu

Andrew MacCormick, MBBS

CONTACT

+64 9 276 0000; andrew.maccormick@middlemore.co.nz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Wendy Brown

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 22, 2018
• Study Start: January 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

AU (1)