BARIATRIC SURGERY REGISTRY - Monash University

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BARIATRIC SURGERY REGISTRY 2019/2020 ANNUAL REPORT

Statement This publication was produced by the Bariatric Surgery Registry Suggested Citation Backman B, Brown D, Cottrell J, Campbell A, Clancy W, Halim Shah Y J, Chadwick C, Budin A, MacCormick A, Caterson I and Brown W. The Bariatric Surgery Registry Annual Report, 2020. Monash University, Department of Epidemiology and Preventive Medicine. August 2020, Report No. 8 Data Analysis Ms. Dianne Brown (Team Lead) Mr. Angus Brian Campbell Mr. William Clancy Dr. Yazmin Johari Halim Shah (EWL and TWL calculations) Graphics Monash Print (Data Visualisation) Ms. Hayley Cottrell (Funders, Registry Timeline, Figure 2 Hospital Sites and Surgeons Represented in the Registry) Enquiries Any enquiries or comments regarding this publication should be directed to: Bariatric Surgery Registry Monash University Level 6, The Alfred Centre 99 Commercial Road, Melbourne 3004 Phone: 61 3 9903 0725 Fax: 61 3 9903 0717 med-bsr@monash.edu The contents of this report may not be published or used without permission. Data Period The data contained in this document was extracted from the Bariatric Surgery Registry as at 22 July 2020 but pertains to procedures that have occurred up to 30 June 2020. As the Registry does not capture data in real time, there may be a lag period between the occurrence of an event and its capture in the Registry’s database, BSR-i. Original release December 2020. Amended May 2021.

CONTENTS WHO WE ARE Purpose Benefits Funders Data Custodian Acknowledgement Of Country 4 4 4 4 5 5 PATIENT REPORTED OUTCOME MEASURES (PROMs) Progress to Date Future Directions 47 47 47 CONCLUSION 48 ACKNOWLEDGEMENTS 49 CHAIR’S REPORT 6 COMMITTEES AND STAFF 51 EXECUTIVE SUMMARY 7 GLOSSARY 52 ACKNOWLEDGEMENT 7 ABBREVIATIONS 53 INTRODUCTION 8 LIST OF TABLES 54 LIST OF FIGURES 55 APPENDIX 1: DATA ELEMENTS CAPTURED 56 APPENDIX 2: DATA COMPLETENESS 57 Registry Timeline Governance Ethical Review Data Reporting 8 9 10 10 DATA CAPTURE AND QUALITY 11 Eligibility Of Participants Data Capture Data Validation Missing Data 11 11 11 11 APPENDIX 3: LIST OF HOSPITAL SITES REPRESENTED IN THIS REPORT 58 12 APPENDIX 4: LIST OF HOSPITAL SITES WITH ETHICS APPROVAL 59 REGISTRY OVERVIEW Site And Surgeon Accrual Enrolment In The Registry AUSTRALIA ANALYSIS Enrolment In The Registry Demographics Procedures Captured By The Registry Safety Reporting Peri-Operative Defined Adverse Events And Complications Deaths Weight Outcomes Diabetes Outcomes Follow Up NEW ZEALAND ANALYSIS Enrolment In The Registry Demographics Procedures Captured By The Registry Safety Reporting Peri-Operative Defined Adverse Events And Complications Weight Outcomes Diabetes Outcomes Follow Up 12 14 15 16 16 18 26 26 28 29 33 36 37 38 38 39 42 42 43 45 46 Australia New Zealand Australia New Zealand 58 58 59 59 APPENDIX 5: REGISTRY’S PUBLICATIONS, PRESENTATIONS AND SEMINARS 60 Publications Presentations Posters Seminars APPENDIX 6: REFERENCES 60 60 60 60 61

WHO WE ARE Purpose Within the remit of a clinical quality registry, the Bariatric Surgery Registry seeks to answer the following: a. Is bariatric surgery safe? and b. Is bariatric surgery effective? To ensure that these questions can be addressed, the Registry has been designed with the underlying principle to provide data that is accurate, complete and valuable. Accuracy and completeness is controlled by the definition, collection, verification, storage, and analysis and reporting as outlined in the Registry’s Data Governance Framework. Benefits The Registry continues to encourage high-level stakeholder engagement and facilitates collaborations with governments, surgeons, private health groups, individual hospitals, medical technology and device industries, private health insurers and medical defence organisations to ensure that the data remains valuable. Most importantly, the Registry engages with participants to address how the Registry can aid in decision-making, assessment of risk and on-going journey of treatment. The involvement of the participants is paramount in regard to the data collection which the Registry strives to achieve, especially the annual follow up data. FUNDING PARTNERS The Bariatric Surgery Registry received funding in the last 12 months from the Commonwealth Government of Australia and the following supporters: The Registry would like to acknowledge and thank Medtronic for providing the start-up funding required for the New Zealand arm of the Registry. The Registry also looks forward to welcoming Johnson & Johnson in the 2020/2021 financial year as Platinum Sponsors. 4 Bariatric Surgery Registry Eighth Annual Report: 2019/20

DATA CUSTODIAN The Registry Custodian is the School of Public Health and Preventive Medicine (SPHPM) within the Faculty of Medicine, Nursing and Health Sciences at Monash University. ACKNOWLEDGEMENT OF COUNTRY The Bariatric Surgery Registry acknowledges the Traditional Land Custodians of Australia and we pay our respects to ancestors and Elders, past, present and future for the Aboriginal and Torres Strait Islander peoples of Australia. We welcome all Aboriginal and Torres Strait Islander peoples to our Registry. In recognition that we are a bi-national registry, the Bariatric Surgery Registry acknowledges Māori as Tangata Whenua of Aotearoa New Zealand and as Treaty partners with the Crown. The Registry collects, stores and uses health data of Indigenous participants with the upmost respect and integrity.

CHAIR’S REPORT PROFESSOR IAN CATERSON This is the eighth report of the Bariatric Surgery Registry (BSR). It continues to grow at a rapid pace and we now have surpassed 90,000 participants. For the reporting year, we present a total of 90,457 participants and 197 surgeons and 133 hospitals are represented in this report. We continue our success in data collection from New Zealand, with the inclusion of 1,519 participants since May 2018. Over the next 12 months, we need to continue our focus on strengthening this activity and ensure the continuing contribution to the Registry. We are really grateful for the ongoing work carried out daily by the staff in the Registry, by surgeons, by the staff in their rooms and in theatres, their hard work, expertise and continuing interest. The Registry can only be as good as the data it gets. We are committed to getting good long-term follow-up. Please, continue to help us to get this data. There continues to be interest in our Registry, its data and potential. This interest ranges from government to international collaborators and because we have made as sure as we can that the data is collected properly, that we do have involved surgeons and staff, we are seen as trustworthy and our data output useful. We look forward to the next 12 months with the focus on producing outputs on the effectiveness of bariatric surgery in our countries. We are happy to receive research proposals for use of de-identified data and we have established a process for dealing with these requests. Once again, we must thank the staff of the BSR – they continue to deal with problem issues calmly and efficiently, they are really involved and so helpful. Thank you all. Professor Ian D Caterson Director, Boden Institute, Charles Perkins Centre, University of Sydney Director, Charles Perkins Centre Royal Prince Alfred Clinic Past-President, World Obesity Federation 6 Bariatric Surgery Registry Eighth Annual Report: 2019/20

EXECUTIVE SUMMARY The Bariatric Surgery Registry (BSR) is proud to present the Eighth Annual Report as at 30 June 2020. Within the latter half of this reporting year, bariatric surgery was greatly affected by contingencies put in place in response to the COVID19 pandemic. This was true for both Australia and New Zealand and we observed a period of no bariatric procedures performed, unless in emergency cases. During this period, the Registry reached out to surgeons and their staff to help facilitate data entry, reviewing outstanding operations and follow up for resolution and entry and providing data for review and/or research where approved. During this period, the Registry also commenced additional data reviews and focused on validating participant reported data to ensure that information housed within the Registry was both accurate and clinically relevant. The first portion of this report presents the Registry overall, exploring the Registry’s hospital site and surgeon coverage binationally, as well as the overall total number of participants as at 30 June 2020. Following the overall presentation, the Registry has reported Australia and New Zealand analysis results individually, for the first time. In addition to the individual country presentation, the Registry also presents data specific to the common procedure types collected by the Registry: laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomies (LSG) and bypasses (one anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB)). Despite the presentation of country specific results, the Registry has observed similar trends to what it has reported in previous years: The new cohort of participants remains predominately female; Over 90% of primary procedures occur in private hospitals in Australia and over 70% of primary procedures in private hospitals in New Zealand; During the FY19/20 period in Australia, 2.1% of primary procedures and 7.6% of revision procedures had a defined adverse event. For New Zealand, 9.9% of primary procedures and 22.6% of revision procedures had a defined adverse event; and A significant shift in diabetes status from baseline to 1-year post-operative was observed for both Australia and New Zealand. There was also a large reduction in treatment rates at 12 months after surgery to that recorded at baseline. In addition to the noted trends above, the Registry has had a very successful reporting period, where milestones were actively achieved, namely: A total of 90,457 participants as at 30 June 2020 including the addition of 19,489 new participants in the past year; 197 surgeons from 134 hospitals are represented in this reporting period; 70% MBS capture achieved so far for the FY19/20 period; Commenced the Patient Reported Outcome Measures (PROMs) project; and Supported the continued growth in participation of hospital sites and surgeons from Australia and New Zealand. ACKNOWLEDGEMENT The Bariatric Surgery Registry recognises the commitment of its participating surgeons. Their involvement demonstrates the very essence of being a health professional with their commitment to integrity, a high standard of performance, and the public whom they serve. These surgeons and their dedicated support teams make time to regularly submit vital information to this study, willingly sharing their successes and the management of their patients’ complications. With their data, the Registry is able to offer the confidence necessary for making decisions about the provision of bariatric surgery in Australia and New Zealand to the benefit of all stakeholders, but most importantly for those afflicted with obesity who may be considering their treatment options. By taking part in the Bariatric Surgery Registry, participating surgeons are ensuring a high standard of care for bariatric patients. They are owed a debt of sincere gratitude. Bariatric Surgery Registry Eighth Annual Report: 2019/20 7

INTRODUCTION Registry Timeline 2009 With recommendations featured in the Georganas Report, OZZANZ (now ANZMOSS) identified the need for a Registry to track outcomes of bariatric surgery. 2010 Monash University was announced as the partner and Registry custodian for the Bariatric Surgery Registry in Australia and New Zealand. 2012 The Registry commenced as a pilot project within Victoria. Seed funding was provided by OZZANZ as well as industry partners Applied Medical, Allergan Health, Johnson & Johnson and GORE. A governing Steering Committee with an Independent Chair was formed with a wide range of representation. 2014 After the success of the pilot project, funding was secured from the Commonwealth’s Department of Health to roll out the Registry nationwide with 118 surgeons registering their interest to participate. At the end of 2014 there were 42 surgeons from 33 hospitals actively contributing to the Registry. 2016 The Registry successfully operates in VIC, NSW, QLD, SA, WA and TAS. The New Zealand arm of the Registry commences with the support of funding provided by industry. 2017 2018 With the ongoing, and valued funding support of the Registry’s industry partners, the first participant is successfully enrolled into the Registry in New Zealand and active data collection commences. The Registry celebrates surpassing 50,000 participants enrolled in the project. 2019 By mid-2020, the Registry successfully surpassed 90,000 participants while continuing to provide reporting and feedback on the safety, quality and efficacy of bariatric surgery in Australia and New Zealand. The ongoing and invaluable support continues from the Commonwealth's Department of Health, ANZMOSS and industry partners Applied Medical, Medtronic, GORE, Johnson & Johnson and AVANT. 8 The Registry successfully secured a 5 year funding agreement with the Commonwealth’s Department of Health to continue the success of the project in Australia. Bariatric Surgery Registry Eighth Annual Report: 2019/20 2020 The Registry successfully surpassed the enrollment of 80,000 participants by the end of 2019 with 216 surgeons having contributed from 134 hospitals across Australia and New Zealand. The project now covers all states and territories across Australia. A project focused on Patient Reported Outcome Measures (PROMs) commences within the Registry with intentions to standardise questions for future routine collection.

Governance The Registry aligns with the fundamentals detailed in the ‘Operating Principles and Technical Standards for Australian Clinical Quality Registries 2008’ and the ‘Framework for Australian Clinical Registries 2014’ as published by ACSQHC. This is to ensure that, as a Registry, it aligns and complies with the national standard and provides assurance to all stakeholders. The Registry is governed by the Steering Committee and this has convened since 2012, chaired by an independent obesity expert, Professor Ian Caterson. The Committee meets on a quarterly basis to advise the Registry on matters such as strategic direction, financial budget, data access, clinical quality and safety, quality development and operations. The BSR Programme Manager, in consultation with the Clinical Director for Australia, Professor Wendy Brown and the Clinical Lead for New Zealand, Associate Professor Andrew MacCormick, oversee the day-to-day operations of the Registry. Current membership includes representatives from the following organisations and/or societies: Monash University Australian and New Zealand Metabolic and Obesity Surgery Society (ANZMOSS) Royal Australasian College of Surgeons (RACS) Australia and New Zealand Gastro-Oesophageal Surgical Association (ANZGOSA) University of Auckland Medical Technology Association of Australia (MTAA) Australian Commonwealth Department of Health Community Representation One of the key achievements of the Steering Committee has been the establishment of the Data Governance Framework and the associated policies and processes that underpin the Registry including: Study Protocol Data Dictionary Outlier Policy (currently under development) BSR-i Business Rules Privacy Policy Data Element Variation Processes Grievance & Complaint Policy Data Capture Variation Processes Call Centre Protocol & Scripts BSR-i System Change Request Processes Data Access & Reporting Policy Reporting Templates MONASH PUBLIC HEALTH AND PREVENTIVE MEDICINE Bariatric Surgery Registry Eighth Annual Report: 2019/20 9

Ethical Review The Bariatric Surgery Registry was established for the purpose of improving the quality and safety of bariatric surgery and it is considered to be in the public’s interest. To function as a clinical quality registry, the Bariatric Surgery Registry collects, stores, and uses identifiable, personal and sensitive health information about bariatric patients for research into the quality, safety and effectiveness of bariatric surgery as treatment for obesity. To date, 40 Australian human research ethics committees (HRECs) have approved the study and certified that it meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). New Zealand’s Southern Health and Disability Ethics Committee approved the study in accordance with the requirements of the Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012). Amongst the 157 hospital sites across Australia and New Zealand which had been approved as at 30 June 2020 to participate in the Registry, 133 are represented in this report. Data Reporting The Registry follows a reporting cycle throughout the year to provide valuable data back to the key stakeholders. These reports include: Released to: Report Type Reporting Public Annual Report As at 30 June each year Public Semi-Annual Update As at 31 December each year Surgeon Individual Surgeon Reports As at 30 September each year Device Manufacturer (Funder) Individual Industry Reports As at 31 March each year Hospital Group (Participant) Hospital Group Reports As at 31 March each year The Registry also publishes a quarterly newsletter that is distributed to all internal and external stakeholders, hospitals and surgeons as well as potential new hospitals and surgeons that the Registry will seek to recruit. This newsletter is also published on the Registry’s website for participants to access. 10 Bariatric Surgery Registry Eighth Annual Report: 2019/20

DATA CAPTURE AND QUALITY Eligibility of Participants Anyone who undergoes bariatric surgery for the treatment for obesity in Australia or New Zealand is eligible for inclusion in the Bariatric Surgery Registry. Data Capture Surgeons or hospital data collectors provide data about the patients and their procedures using one of the following options: Web browser with secure authorised entry using the Registry Interface (BSR-i); or Paper based data forms (secure fax or posted) Upon receipt of this information, the Registry sends the bariatric patients a Participant Fact Sheet that details the Registry and what participation entails. The patient has a two-week period to opt-out of the Registry by calling a Free-call 1800- number. Patients have the option to completely opt-out, meaning that no data is held in the Registry other than that needed to identify them in the future should they have another procedure, or partial opt-out, meaning that they will allow their data to be held in the Registry but they do not wish to be called or contacted by the Registry. Participants have the right to opt-out at any stage during the follow-up period. To ensure that all bariatric procedures are captured, the Registry engages with the Hospital Information Services (HIS) at each hospital site to provide regular ICD-10 coding (ACHI codes) reports for bariatric procedures performed by surgeons who participate in the Registry. These reports are used to verify data submitted by surgeons/ hospital data collectors and are used as the primary source of data if the surgeon and/or hospital has not previously provided information. Surgeons or public hospital clinics provide follow-up data, either by return of a paper form or through submission on the BSR-i. If surgeons and/or public data collectors indicate they have not seen the participant, the Registry’s Call Centre will attempt to contact the participant. Data Validation Data validations and quality checks are performed on a monthly and quarterly basis to ensure the timely review and correction of data if required. These processes are to ensure information received is clinically correct and is recorded correctly in the BSR-i. Data validation processes include cross checking with hospitals, surgeons and/or participants to ensure that the Registry maintains the highest level of data integrity. Missing Data The need for near complete data capture is required to ensure the reliability of the Registry. The collected data provides information on the patient (to allow tracking and to identify risk factors), the patient’s weight and BMI, the patient’s health (diabetes status and treatment), the type of surgery undertaken, whether a concurrent liver or renal transplant took place, the device utilised, the need for revision or repeat surgery, unplanned admissions to ICU or readmissions to hospital as well as mortality. Missing data for most of the data elements collected is kept to a minimum. The Registry periodically validates and cleans the information submitted to ensure that data verification is complete and the data collated is accurate in nature. The minimum data set can be reviewed in Appendix 1. A data completeness report of the minimum data set is presented in Appendix 2 of this report. Bariatric Surgery Registry Eighth Annual Report: 2019/20 11

REGISTRY OVERVIEW Site and Surgeon Accrual The pilot registry commenced in 2012 at three sites in Victoria. Since that time, the Registry has grown to include 184 surgeons in Australia and 13 in New Zealand actively contributing. Figure 1 illustrates this growth across Australia and New Zealand since the commencement of the Registry. Over the past 12 months, there has been an 13.6% increase in hospital site representation across Australia and New Zealand to 133 alongside 197 surgeons represented. FIGURE 1 – SURGEONS AND HOSPITAL SITES REPRESENTED IN THE REGISTRY PER FINANCIAL YEAR 250 Hospitals Surgeons 206 197 200 150 147 142 133 130 116 98 100 95 98 2016/2017 2017/2018 73 55 50 22 9 0 12 Prior to 2014 2014/2015 2015/2016 Bariatric Surgery Registry Eighth Annual Report: 2019/20 2018/2019 2019/2020

FIGURE 2 – NUMBER OF HOSPITAL SITES AND NUMBER OF SURGEONS PER STATE CONTRIBUTING TO THE REGISTRY FOR FY 19/20 HOSPITALS SURGEONS PARTICIPANTS 26 8 25 2104 11 34 15 5428 955 39 51 4633 34 4 61 2 3710 11 176 13 608 * Please note there are 5 surgeons in Australia that contribute to the Registry in multiple states. ** South Australia and Northern Territory as well as New South Wales and the Australia Capital Territory are displayed as combined totals in Figure 2. Bariatric Surgery Registry Eighth Annual Report: 2019/20 13

Enrolment in the Registry Recruitment commenced as of February 2012 in Australia and May 2018 for New Zealand. For a patient to receive a Participant Fact Sheet, they must have had their procedure on or before 30 June 2020. As at 30 June 2020, the Registry confirmed the participation of 90,457 bariatric patients and their data and it is from this cohort the report is derived. A further 2,533 bariatric patients (2.72%) have chosen to opt out and are not represented in this report. Table 1 demonstrates the growth of the Registry from 1 February 2012 to 30 June 2020. In the past financial year, there was a 27.4% increase in the number of participants reported and the Registry continues to maintain an opt out rate of below 4%. TABLE 1 – CUMULATIVE PATIENT PARTICIPATION IN THE REGISTRY SINCE COMMENCEMENT IN FEBRUARY 2012 Participating Opt Out Opt Out Rate As at 30 June 2015 As at 30 June 2016 As at 30 June 2017 As at 30 June 2018 As at 30 June 2019 As at 30 June 2020 5,788 15,643 28,308 47,649 70,968 90,457* 213 554 1,146 1,898 2,340 2,533 3.5% 3.4% 3.8% 3.77% 3.16% 2.72% * includes 223 participants who only had an abandoned procedure includes Australia and New Zealand participants There have been some notable trends observed since the national roll out in 2014 including steep uptake of sleeve gastrectomy procedures that continues to increase as well as the emergence of bypass procedures. Figure 3 illustrates the accumulation rate of participants in the Registry by type during this period. FIGURE 3 – ACCUMULATION RATE OF PARTICIPANTS IN THE REGISTRY BY PATIENT TYPE FROM FEBRUARY 2012 TO 30 JUNE 2020 100000 90000 80000 70000 60000 LEGACY PARTICIPANT PRIMARY PARTICIPANT WITH 'OTHER' PROCEDURE 50000 PRIMARY PARTICIPANT WITH BYPASS PRIMARY PARTICIPANT WITH SLEEVE PRIMARY PARTICIPANT WITH BAND 40000 30000 20000 10000 0 2012 14 2013 2014 2015 2016 Bariatric Surgery Registry Eighth Annual Report: 2019/20 2017 2018 2019 2020

AUSTRALIA ANALYSIS Bariatric Surgery Registry Eighth Annual Report: 2019/20 15

Enrolment in the Registry Recruitment commenced in Australia as of February 2012 and has continued to increase each reporting period. As at 30 June 2020, the Registry confirmed the participation of 88,938 bariatric patients in Australia and it is from this cohort the report is derived. A further 2,518 bariatric patients (2.75%) have chosen to opt out and are not represented in this report. TABLE 2 – PATIENT PARTICIPATION FOR AUSTRALIA AS AT 30 JUNE 2020 As at 30 June 2020 Participating 88,938* Opt Out 2,518 Opt Out Rate 2.75% * includes 104 participants who only had an abandoned procedure Demographics As consistently reported by the Registry, bariatric procedures are performed predominantly on female participants in private hospitals in Australia. The distribution of sex in primary and revision procedures also shows a similar trend where females account for 78.0% of all primary procedures and 84.0% of revision procedures, males account for 22.0% of primary procedures and 16.0% of revision procedures. Table 3 demonstrates the key demographic indicators of participants enrolled in the Registry who have had a primary procedure in the last financial year (2019/20), with comparisons between primary procedures types as well as private and public hospital procedures. The mean age for primary procedures was 42.4 years old with females (41.8), on average, slightly younger than male (44.3) participants with primary procedures. TABLE 3 DEMOGRAPHICS OF PRIMARY PARTICIPANTS AT THEIR PRIMARY PROCEDURE IN AUSTRALIA (FY19/20) All Primary Procedures Public Private MALE FEMALE ALL Procedure Number 757 Band Primary Procedures All 12,962 13,719 Public Private Sleeve Primary Procedures All Public Private 44 227 271 544 10,677 11,221 Public Private All 166 2,001 2,167 Female Undergoing Procedure % 79.3% 77.9% 78.0% 84.1% 81.5% 81.9% 81.3% 77.8% 78.0% 72.3% 78.6% 78.1% Male Undergoing Procedure % 20.7% 22.0% 22.0% 15.9% 18.5% 18.1% 18.8% 22.2% 22.0% 27.7% 21.3% 21.8% Min Age at Op 16.7 14.4 14.4 22.2 16.4 16.4 16.7 14.4 14.4 19.2 15.5 15.5 Mean Age at Op 45.7 42.2 42.4 51.5 41.0 42.7 44.6 41.7 41.9 48.0 44.6 44.9 Max Age at Op 84.5 78.0 84.5 68.5 73.4 73.4 84.5 78.0 84.5 71.7 76.5 76.5 Min Age at Op 16.7 14.4 14.4 22.2 17.0 17.0 16.7 14.4 14.4 23.9 15.5 15.5 Mean Age at Op 44.7 41.7 41.8 52.6 40.6 42.6 43.4 41.2 41.3 47.2 44.2 44.4 Max Age at Op 84.5 78.0 84.5 68.5 73.4 73.4 84.5 78.0 84.5 71.7 76.5 76.5 Min Age at Op 19.2 14.8 14.8 35.3 16.4 16.4 27.1 14.8 14.8 19.2 18.2 18.2 Mean Age at Op 49.5 44.0 44.3 46.1 43.1 43.5 49.8 43.6 43.9 50.2 46.1 46.5 Max Age at Op 70.3 76.5 76.5 63.3 68.1 68.1 70.3 75.0 75.0 66.9 76.5 76.5 * p-value 0.001 (Two-sample t-test) statistically significant difference in mean age at operation between males and females ** Bypass includes both Roux-en-Y gastric bypass and one anastomosis gastric bypass procedures 16 All Bypass Primary Procedures** Bariatric Surgery Registry Eighth Annual Report: 2019/20

TABLE 4 – PERCENTAGE OF FEMALE VS. MALE PARTICIPANTS HAVING A REVISION PROCEDURE IN AUSTRALIA (FY19/20) All Revision Procedures Public Private All 345 3465 3810 Female Undergoing Procedure % 81.4% 84.3% 84.0% Male Undergoing Procedure % 18.6% 15.7% 16.0% Procedure Number Figure 4 and 5 illustrate the age range of both primary and revision participants at the time of procedure during the last financial year (2019/20) FIGURE 4 PARTICIPANTS’ AGE DISTRIBUTION AT TIME OF PRIMARY PROCEDURE IN AUSTRALIA (FY19/20) 25-29 6.8% 10.9% 14.3% 30-34 13.0% 14.5% 35-39 13.8% 14.6% 14.4% 11.1% 15.5% 40-44 15.3% 45-49 50-54 14.1% 7.9% 55-59 8.2% 4.1% 60-64 5.8% 1.8% 65-69 2.8% 0.3% 70-74 0.9% 0.1% Male 20-24 3.0% 5.1% Female Under20 0.6% 1.0% 75 0.1% FIGURE 5: PARTICIPANTS’ AGE DISTRIBUTION AT TIME OF REVISION PROCEDURE IN AUSTRALIA (FY19/20) 0.0% 0.9% 0.0% Under20 0.7% 20-24 30-34 6.2% 8.0% 35-39 8.0% 10.6% 40-44 10.0% 13.8% 14.0% 16.7% 15.3% 15.5% 18.7% 14.9% 11.2% 8.4% 9.4% 5.2% 3.8% 1.7% 0.6% 0.5% Male 25-29 2.3% 3.7% Female 45-49 50-54 55-59 60-64 65-69 70-74 75 Bariatric Surgery Registry Eighth Annual Report: 2019/20 17

Procedures Captured by the Registry Overview Figure 6 maps out the weight distribution of both primary and revision participants at the time of surgery. Whilst primary participants do make up the majority of the cohort captured by the Registry, they also typically have a higher weight at operation than those participants undergoing a revision procedure. FIGURE 6 PARTICIPANTS’ WEIGHT AT TIME OF PROCEDURE IN AUSTRALIA (FY19/20) Weight (Kgs) 0.0% 0.1% 0.6% 2.6% 13.5% 17.1% 90-99 17.4% 100-109 18.0% 110-119 13.9% 18.1% 120-129 9.9% 14.8% 130-139 7.0% 10.6% 140-149 5.0% 7.1% 150-159 2.8% 4.4% 2.8% 1.6% 1.0% Revision 80-89 12.3% 5.7% Primary 60-69 70-79 7.0% 1.0% 50-59 1.7% 160-169 1.3% 170-179 0.7% 180-189 0.2% 190-199 0.2% 0.1% 200-209 0.1% 0.2% 210-219 0.1% 0.0% 220-229 0.1% 0.0% 230-239 0.0% 0.0% 240-249 0.0% 0.0% 250-259 0.0% 0.0% 260 0.5% In total, the Registry has captured 97,007 procedures completed on 88,938 participants in Australia, however this excludes 104 participants who have only had an abandoned procedure. The Registry has captured a total of 222 abandoned procedures from 104 participants since February 2012. 32 of those abandoned procedures occurred in the last FY19/20. Table 5 demonstrates the total capture of procedures by the Regist

Bariatric Surgery Registry Eighth Annual Report: 2019/20 7 EXECUTIVE SUMMARY The Bariatric Surgery Registry (BSR) is proud to present the Eighth Annual Report as at 30 June 2020. Within the latter half of this reporting year, bariatric surgery was greatly affected by contingencies put in place in response to the COVID19 pandemic.

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