RESECT Overview

Transurethral REsection and Single instillation intra-vesical chemotherapy Evaluation in bladder Cancer Treatment (RESECT) Improving quality in TURBT surgery.

RESECT Prospective Phase Instructions

BURST will be ready for sites who have completed all of the steps to progress, to begin the prospective phase at the end of October 2021.

KEY POINT – there is still time to complete the retrospective phase even when the prospective phase has opened. So if the prospective phase has opened, have you missed the boat? The answer is absolutely not, the study is designed so that not all sites are in-sync, it creates some interesting study management challenges for us but this allows sites to progress through the study in a time frame that suits them.

Once we have opened the prospective phase of the study, sites will be invited to begin as they finish the minimum retrospective requirement. So we have said that sites can progress to the prospective phase once they have complete data about 25 retrospective cases, however the minimum for the number of collaborators at the site might be more, that’s ok, you can start the prospective phase and whilst you are waiting more prospective cases to be done, you can still go back and keep adding the rest of your retrospective cases. This is so that all sites can progress to the prospective phase as quickly as possible and have as long as possible to count prospective cases.

To start the prospective phase – you must have completed each of these steps to progress. When you have completed your approvals forms and completed at least 25 retrospective cases (with 80% new tumours) you will get an email from the RESECT team explaining what you need to do. This will be different depending on whether you have been randomised to early feedback, or standard feedback at the end of the prospective phase. You will then be invited, via email, to complete the study midpoint survey. Once this is completed, you will get your official invitation to begin the prospective phase. You can start counting potential cases FROM THE DATE YOU COMPLETE THE MID-POINT survey. But remember – you need to know the pathology so you will not be able to start entering prospective data until a few weeks later at the earliest.

So how will you know what cases you can count for your prospective phase? The answer is: after the date you receive the confirmation email from your midpoint survey.

The answer to how to do the prospective phase is very simple – it is essentially the same as the retrospective phase. The database will workout, based on the operative date, whether the case is in your retrospective series or your prospective series.

After the date you complete your mid-point survey you can start screening cases. Use the same case screening log, but since you need to know the pathology of the cases we recommend you do this with a month lag. So review all cases done in October at the end of November and so on.

It is important that you complete the data regularly since this will allow better audit of your practice The data that is required is exactly the same as the prospective phase so you may want to think of ways to improve data collection at your hospital to make things easier for you. However remember not all TURBTs will be eligible, and you still must assess the consecutive series of first and recurrent tumours separately

This question has been asked a few times – “How to we ensure the 80/20 split in new and recurrent cases when we do more recurrent cases than new cases at my hospital? “ Answer: You should assess the new and recurrent cases as TWO SEPARATE SERIES. Go through consecutive first tumour TURBTs and collect as many as you need, then go through consecutive recurrent tumour cases and collect as many as you need.

This is the overall timeline for the study. However remember different sites will progress at different stages. The important thing is that the sooner you complete the retrospective phase, the sooner you will be able to start counting cases for your prospective phase.

RESECT Prospective Phase Webinar

RESECT Study Sponsors

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