The 4th International Conference on NOTES Working Group 1 discussed the development of a registry to track natural orifice transluminal endoscopic surgery (NOTES) and hybrid cases. The registry currently includes 166 cases from a few US sites. Goals are to provide more safety and complication data to regulatory agencies and help adoption of new techniques. Milestones in the next 1-5 years include increasing US participation to 100% and helping to define best practices through data analysis. Ways to improve the registry include enhancing international cooperation and data sharing, and incentivizing participation.

1. 4th International Conference on NOTES ® Working Group 1 Registry Development

2. Inclusion Criteria (Taxonomy) What is a included in the registry? NOTES and hybrid cases Definitions: NOTES is any procedure that is transvisceral and through a natural orifice Assisted is NOTES in conjunction with an instrument placed directly through the abdominal wall

3. Issues- What are the key questions? Where is the Registry now? Goals of Registry Participation Milestones at 1 and 5 years

4. Where is registry now? 166 cases from only a few sites 162 are IRB-approved Most from US sites 10 registrants 8 from US 2 International

5. Challenges to the Registry Participation 100% of US cases Cooperation with existing international databases Double entry of cases into different registries

6. Goals of Registry Informative to FDA More information on complication/death Give background data to future instrumentation Ask FDA for input on needs/expectations 100% US participation Understanding of activity around the world Participants to benchmark selves against peers

7. Milestones set in 2008 1 year 5 year Get all human cases entered Yes in US Help adoption of new techniques ? √ Quality/safety Not yet Guide future research studies Not yet √ Cross-fertilization of techniques/ideas ? Define best practice/validation √ Address reimbursement issues √

8. How can registry be better? Improve participation Linking data from around the world Recognize limitations of registry Continue to redefine/reassess aims and “value added” by registry

9. Action Items Review current data for accuracy in reports Create reports for all fields Give a quarterly report to all registered participants Get input from the FDA Make data more useful for goals with FDA Appoint an FDA liaison

10. Action Items Work with international groups to enhance cooperation and enable data sharing Identify all international databases and create a common database or links ? Common website Obtain funding to increase robustness of database Get on agenda of all international NOTES meetings Add checkbox on abstract submissions to NOSCAR ® for registry participation

11. How to Encourage Participation Incentives Highlight entrants at NOSCAR meeting Allow participants to compare own data to others in the database Monthly report of cases entered to participants Requirement for presentation Cases have to be registered before entering abstracts/publications/ grants at NOSCAR, SAGES, DDW.

12. Join the NOSCAR Registry Go to www.NOSCAR.org to get a sign-on!