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Robot or scalpel? new study tests best bladder cancer surgery

NCT ID NCT03049410

Disease control Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two types of surgery to remove the bladder in people with bladder cancer: one done with a robot and one done as open surgery. About 339 patients took part across multiple hospitals. The main goal was to see which approach let patients spend more days at home and out of the hospital in the first 90 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
robot-assisted surgery
What this could lead to
If robot-assisted surgery proves better, patients may recover faster and spend more time at home after bladder removal.
What could go wrong
This is a completed trial comparing two surgical procedures, not a new drug. The benefit may be modest and depends on surgeon skill and patient factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

339 people

The number who actually took part.

Started

Mar 2017

Finished

Sep 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be over 18 years of age. * Male or female * Histopathological confirmation of bladder cancer (UCC, SCC, adenocarcinoma or rare variant) * CIS or stage pTa or pT1 or ≥pT2 or mobile bladder mass on bimanual examination under anaesthesia (see Section 22: Definitions for TNM definitions) * Node status ≤ N1 on imaging criteria or PET -ve outside pelvis * ECOG grade 0, 1, 2 or 3 * Able to give informed written consent to participate. Exclusion Criteria: * Unwilling to undergo cystectomy. * Previous abdominal surgery rendering them unsuitable for either iRARC or ORC. * Patients with upper urinary tract disease * Concomitant disease that would render the patient unsuitable for the trial * Pregnant or lactating females * Previous radiotherapy for bladder cancer

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer

Contacts and locations

Locations

  • Guy's Hospital

    London, United Kingdom

  • Lister Hospital

    Stevenage, United Kingdom

  • North Bristol NHS Trust

    Bristol, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, United Kingdom

  • Royal Berkshire Hospital

    Reading, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF, United Kingdom

  • St James' University Hospital

    Leeds, United Kingdom

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU, United Kingdom

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