RESECT Overview


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

Registration FAQs


Can I still register my centre to take part in RESECT (as of Oct 2021)?

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You can still register and take part in RESECT if you can complete the study minimum requirements - we would encourage your team to work hard to complete the retrospective phase as quickly as possible as you cannot start the prospective phase until you have completed the retrospective phase. This means that the longer it takes for the retrospective phase to be completed, the less time there is to reach the minimum number of prospective cases.

Who should formally register my hospital site? How should site collaborators be registered?

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The “lead collaborator” should complete the formal hospital registration and add other site collaborators to the formal registration form. The other site collaborators will then receive emails asking them to confirm their involvement in RESECT.

What is the difference between collaborator registration and surgeon registration?

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The collaborator registration and the surgeon registration have different purposes and are done on different forms. For collaborator registration, collaborators should be added if: (1) they will require REDCap access for data entry, or, (2) they will be listed as authors. Everyone added to the collaborators page will be given redcap access and this information will be used to track the number of authors from each site. When collaborators receive their REDCap login details, there will be a separate area to log the details of the surgeons who do the TURBTs. The surgeons doing TURBTs may or may not overlap with some of the collaborators entering data, but all surgeons doing TURBTs need a record in the surgeon registration project.

Click here to view the video explaining how to navigate the surgeon registration.

How do I get access to my site registration form/ collaborator registration form or approvals upload form?

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When the lead collaborator completes the hospital registration form they were emailed links to all of the forms. If the lead collaborator cannot find the links, they should search their email inbox for emails from resect@bursturology.com or emails from an @ucl.ac.uk address. If they still can’t find the links then email us at resect@bursturology.com and we will resend them back to you.

What if I forget which surgeon is which code/I was not the person who registered the surgeon and so I don’t know the identifier?

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You should keep a key at your hospital linking the surgeon ID code to each surgeon. You can use the other weak identifiers in the database to confirm which surgeon is which (initials, years experience etc). If you still are not sure then please watch THIS video on our website which explains it in detail.

We have multiple hospitals in the same geographical area and the urologists in our area perform TURBTs at more than one site, does this affect our RESECT registration?

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Whether or not you register hospitals that are within the same area and have some sort of association with each other as one site or multiple sites depends on a few details - please see the flowchart below, but note, for each site the minimum requirement of cases is needed:

The only requirement is that the number of TURBTs at each site reaches the minimum requirement for authorship as per the RESECT protocol. The same urologists operating at more than one hospital is not an issue as long as the TURBT data itself is not duplicated.

When will I receive my REDCap login to enter data from our site for the RESECT study?

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The login details for REDCap will be sent out in due course. Please note this will not be sent out immediately after completion of the formal hospital registration form. Initially only the surgeon registration project will be available and then later the patient project.

How do we go about changing collaborators for the study?

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If you want to change a collaborator, you can do this by accessing the registration form. As the lead collaborator you can change this yourself. However, if you would like to change lead collaborator please email resect@bursturology.com If you are unable to find the registration link, we can send out new links for redcap to allow you to update the Registration form so that the previous collaborator can be removed and replaced

I have changed hospitals since registering as a lead collaborator at my initial hospital, can I remain as a lead collaborator?

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This is only possible if you can still perform the duties of the lead at the previous hospital. Alternatively, you can aim to join the study at your new hospital.

Previous lead collaborator has left RESECT, what constitutes substantial work on behalf of the project to be considered a co-lead?

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There is no set definition of this. We leave authorship / collaborator contribution decisions up to the sites to manage. If the lead collaborator registered, recruited other collaborators, gained approvals, identified cases and also put in place a handover to the new team before leaving, we would say this is likely to be sufficient.

Authorship Requirements FAQs


How many authors can we have for the minimum requirement? (25 retrospective/ 25 prospective).

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Please review the authorship requirement diagram:

More than 1 of our collaborators is a consultant/ attending, how do they fit into the authorship requirements?

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One consultant/ attending / permanent staff member will be required as the supervisor at every site. Any additional consultants will be treated the same as collaborators for the purposes of authorship requirement - the total number of authors is what matters.

Please click here to access calculator to determine minimimum number of cases needed

We have more recurrent tumour TURBTs than new tumour TURBTs at our hospital, how do we include enough new tumour TURBTs if we have to include consecutive cases?

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Consecutive cases apply separately to new tumour TURBTs and recurrent tumour TURBTs. You should split the TURBTs into these two groups and then count back consecutive cases separately within the groups. So you may find to get 20 consecutive new tumour TURBTs you have to go back 3 months, but to get 5 consecutive recurrent tumour TURBTs you only have to go back 2 weeks. You can submit all cases as new tumour TURBTs if you wish.

What happens if we ask to add more than one participating additional team member beyond the standard 3 (2 collaborators and 1 supervising consultant) but then do not quite meet the new recruitment target?

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In this case, unfortunately, you will be asked to remove the additional team members from the authorship recognition until the number of collaborators matches the recruitment expected.

Trainees initially involved in RESECT will be moving to new hospitals and new trainees will be joining our centre, is it possible to change/replace the study collaborators registered at our site during the study period?

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As long as the minimum requirement for the number of collaborators at your centre that is listed is met, this is not a problem. We will not check individual contributions unless there is a dispute. The individual contribution for each collaborator is approximately 20 cases per author, the calculator on our website (LINK HERE) can provide details with the exact numbers required for your centre. One possible solution is therefore for the collaborators currently at your hospital submit all of the data for the retrospective cases, then when the new people join they can do the prospective cases. In this scenario, you can add the new collaborators on the online forms whenever they join the team.

Protocol FAQs


Is the list of variables/data dictionary from the REDCap database design available?

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Currently (February 2021) the full data dictionary is not available. The types of data along with the limit of identifiability or the “smallest group to which a patient can be identified” is explained in the study protocol which is available on the website. This has been adequate for the majority of sites to gain approvals. If you need additional information we are happy to discuss if you email us.

For the retrospective phase, is there a date limit for how far back the TURBT procedures can go?

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As many retrospective cases as one wishes can be submitted (minimum 25) however there must be at least as many retrospective cases as prospective and 80% must be new/ first TURBTs in patients who have never had NMIBC before. Collaborators can go back as far as they want/ need to in order to fulfil this requirement but the cases must be consecutive.

Should patients undergoing re-resection be excluded?

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Planned re-resection cannot be the index procedure (i.e. the procedure for which the quality assessment is done). But you could go back and include the original TURBT as the index procedure for this patient. The index procedure must be the first TURBT for a new tumour. 80% of these must be in patients who have never had NMIBC before, 20% can be in people who have had it before. Details of both the index and re-TURBT will be recorded in the database under the same patient record.

Surgical residents/registrars often perform the TURBT rather than the consultant – how should these be reported?

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There will be a very clear section in the database where details of the grade/rank of the person doing the surgery is recorded along with level of supervision. Details (anonymous) of the responsible consultant and trainee will be recorded. All TURBTs meeting the eligibility criteria at a hospital must be included regardless of the person doing the procedure.

Please also make sure that any surgeons who do perform the TURBT have a surgeon record created for them in Redcap even if they didn’t have one created at the start of the project. Please see the explanatory video on surgeon registration for more information.

Our hospital performs TURBTs but patient’s do not receive follow up at our hospital, is my hospital eligible to participate in RESECT?

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We encourage you to obtain information about your patient’s first check cystoscopy even if it is not done at your hospital. This would be ethically appropriate since it is appropriate that a surgeon would seek to obtain this information about his own patients in order to audit their practice. If it is not possible for you to obtain this information you can still take part but please email us to discuss.

My centre has completed the minimum number of cases required for the retrospective phase, can we start the prospective phase now?

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We have not launched the prospective phase yet. This will launch when a minimum number of centres have completed the retrospective phase. The prospective phase will then last for 1 year from this date. In the meantime, we encourage collaborators to keep uploading retrospective cases. This will not only improve our analyses, but centres with higher recruitment will have higher chances of benefits like mainline authorship and being offered conference presentations.

Which TURBT cases should we use for the retrospective part of RESECT?

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The retrospective cases must count backwards from the date that your hospital completed the hospital registration. Sites cannot start prospective cases until we invite them to, this will be after they have submitted a minimum of 25 retrospective cases and when a sufficient number of sites have reached the minimum retrospective requirements.

My patient had a planned re-TURBT, should this be included in the original record or in a new record as a recurrence?

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Planned re-TURBTs are part of the original treatment episode and should be recorded in the same record as the original TURBT not as a new record.

My patient had a TURBT to treat a recurrence found a first check after the original TURBT, can I include this TURBT as a new record

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No. The original record for the patient should include the primary TURBT, a planned re-TURBT if there was one, any immediate adjuvant treatment after the primary TURBT (e.g. BCG), the first check, and the results of any procedure done to treat recurrence at the first check.

How do I know if a TURBT for recurrence can be included as a new record or if it should be in the original record for the first TURBT?

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Any recurrence happening after recurrence found at the first check can be included as a new record.

Primary TURBT - original record

Re-TURBT - original record

First check - original record

TURBT for recurrence found at first check - original record

TURBT for recurrence found after first check (e.g. second check) - new REDCap record for recurrent TURBT.

Which TURBT cases should we use for the retrospective part of RESECT?

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The retrospective cases must count backwards from the date that your hospital completed the hospital registration. Sites cannot start prospective cases until we invite them to, this will be after they have submitted a minimum of 25 retrospective cases and when a sufficient number of sites have reached the minimum retrospective requirements.

My patient had a planned re-TURBT, should this be included in the original record or in a new record as a recurrence?

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Planned re-TURBTs are part of the original treatment episode and should be recorded in the same record as the original TURBT not as a new record.

My patient had a TURBT to treat a recurrence found a first check after the original TURBT, can I include this TURBT as a new record

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No. The original record for the patient should include the primary TURBT, a planned re-TURBT if there was one, any immediate adjuvant treatment after the primary TURBT (e.g. BCG), the first check, and the results of any procedure done to treat recurrence at the first check.

How do I know if a TURBT for recurrence can be included as a new record or if it should be in the original record for the first TURBT?

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Any recurrence happening after recurrence found at the first check can be included as a new record.

Primary TURBT - original record

Re-TURBT - original record

First check - original record

TURBT for recurrence found at first check - original record

TURBT for recurrence found after first check (e.g. second check) - new REDCap record for recurrent TURBT.

Approvals FAQs


Is there a consent form for RESECT?

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RESECT is an observational audit of routine practice and as such does not constitute human subjects research therefore consent is not required.

Is there a deadline for receiving ethical approval from my hospital?

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There is no specific deadline for obtaining audit approval. We encourage that approval is obtained as soon as possible to allow for sufficient time to collect data for the study. You cannot upload any patient data until audit approval, waivers of approval or a confirmation statement from the lead collaborator along with a signature have been added to your site’s approvals page.

COVID Issues FAQs


My audit department has closed due to Covid, can I proceed with the study?

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In the absence of an audit department to provide approval, if you have reviewed the audit and data governance requirements at your hospital for this type of observational audit and are happy that all of the conditions are met, the clinical lead of the department should be able to provide authorization to undertake the audit. Other sites have simply uploaded an email trail to this effect.

COVID-19 has had a significant impact on the number of TURBT procedures performed at our hospital – can you advise what numbers we should give when asked about: 1) how many NEW/FIRST TURBTs are conducted each week? 2) how many TURBTs for RECURRENT bladder tumours are conducted in your hospital each week?

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The number of TURBTs performed should reflect the study period that you are collecting data for. For example, this might be June to December 2020 for the retrospective phase and February to December 2021 for the prospective phase. We accept case numbers are highly variable due to the COVID-19 pandemic - the reason we ask for this information is so that we can gauge a general impression of which centres are low/mid/high volume.

We have more retrospective cases than prospective cases as the number of TURBTs have greatly decreased in our center due to COVID-19 - is it ok to have more retrospective than prospective cases?

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Yes you can submit more retrospective than prospective cases however, you must still meet the minimum requirement for prospective cases We are happy to discuss if you think this will not be possible.

REDCap FAQs


How do you delete a patient’s record on REDCap? I started entering data for a patient then discovered they were ineligible for inclusion.

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On REDCap you cannot delete records that have already been created. We recommend that you clear this ineligible data in the record and replace it with data from a different, eligible patient. We also recommend to keep a log of all the screened patients/ those who were excluded at your site in the screening spreadsheet.

Other FAQs


We are unable to supply intravesical chemotherapy drugs, can we continue to work as a control group without chemotherapy in the prospective phase?.

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The study does not mandate a particular practice or method. You are able to continue with the prospective phase. However it would be helpful if you could supply information on reasons for why intravesical treatment was not available and if any other treatments are given as a replacement.


RESECT Study Sponsors


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