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Recruiting

NCT Number: NCT04900558

Robotic Radical Cystectomy Outcomes

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

Recruiting

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Key information

Conditions

Bladder Cancer Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Muscle-Invasive Bladder Carcinoma Neoplasms Neoplasms by Site Oncology Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Surgery Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Careggi University Hospital

Florence, Tuscany, 50134, Italy

Location status: Recruiting

Location contact

Andrea Liaci, MD

SUB_INVESTIGATOR

Arcangelo Sebastianelli, MD

CONTACT

[email protected]

Arcangelo Sebastianelli, MD

PRINCIPAL_INVESTIGATOR

Donata Villari, MD

SUB_INVESTIGATOR

Graziano Vignolini, MD

SUB_INVESTIGATOR

Luca Gemma, MD

SUB_INVESTIGATOR

Maria Rosaria Raspollini, MD

SUB_INVESTIGATOR

Mauro Gacci, MD

SUB_INVESTIGATOR

Pietro Spatafora, MD

SUB_INVESTIGATOR

Riccardo Campi, MD

SUB_INVESTIGATOR

Saverio Giancane, MD

SUB_INVESTIGATOR

Sergio Serni, Prof

PRINCIPAL_INVESTIGATOR

Simone Morselli, MD

CONTACT

[email protected]

3473050852

Simone Morselli, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radical Cystectomy

Procedure

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...

Primary outcomes

  1. 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

  2. Number of participants who will experience bladder cancer recurrence

    Time frame: From enrollment to late follow-up, up to 7 years

    Bladder Cancer Recurrence

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Benemei, PhD

CONTACT

[email protected]

Simone Morselli, MD

CONTACT

[email protected]

3473050852

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2031
Study completion
2038
First posted
May 25, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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