NCT04900558

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
143mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Apr 2021Feb 2038

Study Start

First participant enrolled

April 29, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2038

Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

9.8 years

First QC Date

May 3, 2021

Last Update Submit

May 19, 2021

Conditions

Bladder CancerMuscle-Invasive Bladder CarcinomaOncologyRecurrenceSurgery

Keywords

CystectomyRadical CystectomyIleal ConduitNeobladderBladder CancerMuscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (3)

  • Number of participants who will die from bladder cancer

    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

    Bladder Cancer Recurrence

    From enrollment to late follow-up, up to 7 years

  • Number of participants who will die from all causes

    All cause mortality after surgery

    From enrollment to late follow-up, up to 7 years

Secondary Outcomes (9)

  • Number of participants who will die from bladder cancer after Robotic Surgery

    From enrollment to late follow-up, up to 7 years

  • Number of participants who will experience bladder cancer recurrence after Robotic Surgery

    From enrollment to late follow-up, up to 7 years

  • Number of participants who will experience surgical complications after Robotic Surgery

    From enrollment to late follow-up, up to 7 years

  • Variation in Quality of Life questionnaire after Robotic Surgery

    From enrollment to late follow-up, up to 7 years

  • Variation in Quality of Life questionnaire according to Urinary diversions

    From enrollment to late follow-up, up to 7 years

  • +4 more secondary outcomes

Study Arms (1)

Radical Cystectomy

Patients who underwent radical cystectomy for bladder cancer in our centre

Procedure: Radical Cystectomy

Interventions

Radical CystectomyPROCEDURE

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...

Radical Cystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi University Hospital

Florence, Tuscany, 50134, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNeoplasmsRecurrence

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Arcangelo Sebastianelli, MD

    Careggi Hospital, University of Florence

    PRINCIPAL INVESTIGATOR

  • Sergio Serni, Prof

    University of Florence

    PRINCIPAL INVESTIGATOR

  • Simone Morselli, MD

    University of Florence

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Morselli, MD

CONTACT

3473050852simone.morselli.89@gmail.com

Silvia Benemei, PhD

CONTACT

silvia.benemei@unifi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 25, 2021

Study Start

April 29, 2021

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2038

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

IT(1)