The Bariatric Surgery Registry

ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-95
SponsorMonash University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body Mass Index (BMI) >30 kg/m2

Disqualifiers

Pregnant women

Trial population

persons who undergo bariatric surgical procedures as treatment for obesity

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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 frame
Time of surgery to 90 days following surgery

Secondary outcomes

1

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.

Time frame
Time of surgery up to 10 years after surgery
2

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.

Time frame
12 months to 10 years after surgery
3

Effectiveness of bariatric procedures

Information is collected as to whether a patient has subsequent bariatric procedures following the first surgery recorded by the registry.

Time frame
12 months to 10 years after surgery
4

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.

Time frame
12 months to 10 years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Monash University

Lead sponsor

Commonwealth of Australia

Collaborator

University of Auckland, New Zealand

Collaborator