Robotic Radical Cystectomy Outcomes

May 19, 2021 updated by: Simone Morselli, University of Florence

Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy

Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Careggi University Hospital
        • Sub-Investigator:
          • Mauro Gacci, MD
        • Sub-Investigator:
          • Riccardo Campi, MD
        • Contact:
        • Principal Investigator:
          • Simone Morselli, MD
        • Sub-Investigator:
          • Maria Rosaria Raspollini, MD
        • Principal Investigator:
          • Arcangelo Sebastianelli, MD
        • Sub-Investigator:
          • Donata Villari, MD
        • Sub-Investigator:
          • Graziano Vignolini, MD
        • Sub-Investigator:
          • Saverio Giancane, MD
        • Sub-Investigator:
          • Pietro Spatafora, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is made up of patients who underwent radical cystectomy at AOU Careggi, SOD Robotic Urological Surgery, Minimally Invasive and Renal Transplantation.

Description

Inclusion Criteria:

  • Age major or equal 18 years
  • Patients who will undergo radical cystectomy
  • Consent to participate

Exclusion Criteria:

  • Absence of willingness to participate
  • Further refusal to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Radical Cystectomy
Patients who underwent radical cystectomy for bladder cancer in our centre
Procedure: Radical Cystectomy
All the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc...

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants who will die from bladder cancer
Time Frame: From enrollment to late follow-up, up to 7 years
Bladder Cancer Specific Mortality after surgery
From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence
Time Frame: From enrollment to late follow-up, up to 7 years
Bladder Cancer Recurrence
From enrollment to late follow-up, up to 7 years
Number of participants who will die from all causes
Time Frame: From enrollment to late follow-up, up to 7 years
All cause mortality after surgery
From enrollment to late follow-up, up to 7 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants who will die from bladder cancer after Robotic Surgery
Time Frame: From enrollment to late follow-up, up to 7 years
Robotic surgery specific impact on survival
From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence after Robotic Surgery
Time Frame: From enrollment to late follow-up, up to 7 years
Robotic surgery specific impact on recurrence
From enrollment to late follow-up, up to 7 years
Number of participants who will experience surgical complications after Robotic Surgery
Time Frame: From enrollment to late follow-up, up to 7 years
Robotic surgery specific impact on surgical complications
From enrollment to late follow-up, up to 7 years
Variation in Quality of Life questionnaire after Robotic Surgery
Time Frame: From enrollment to late follow-up, up to 7 years
Robotic surgery specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
From enrollment to late follow-up, up to 7 years
Variation in Quality of Life questionnaire according to Urinary diversions
Time Frame: From enrollment to late follow-up, up to 7 years
Urinary diversion specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
From enrollment to late follow-up, up to 7 years
Number of participants who will experience surgical complications according to Urinary diversions
Time Frame: From enrollment to late follow-up, up to 7 years
Urinary diversion specific impact on surgical complications
From enrollment to late follow-up, up to 7 years
Number of participants who will experience bladder cancer recurrence according to Urinary diversions
Time Frame: From enrollment to late follow-up, up to 7 years
Urinary diversion specific impact on bladder cancer recurrence
From enrollment to late follow-up, up to 7 years
Number of participants who will die from bladder cancer according to Urinary diversions
Time Frame: From enrollment to late follow-up, up to 7 years
Urinary diversion specific impact on bladder cancer rmortality
From enrollment to late follow-up, up to 7 years
Number of participants who will die from all causes according to Urinary diversions
Time Frame: From enrollment to late follow-up, up to 7 years
Urinary diversion specific impact on all cause mortality after surgery
From enrollment to late follow-up, up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florence

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Ospedaliero-Universitaria Careggi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arcangelo Sebastianelli, MD, Careggi Hospital, University of Florence
  • Principal Investigator: Simone Morselli, MD, University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2031

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19303_oss

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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