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Protocol of the Italian Radical Cystectomy Registry

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ClinicalTrials.gov Identifier: NCT04228198
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ettore De Berardinis, University of Roma La Sapienza

Brief Summary:

Background: Bladder cancer is the ninth most common type of cancer worldwide. In the past, Radical Cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy surgery. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy surgery comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence.

Methods: The study is an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing Radical Cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with recruitment phase between 1st January 2017-31st June 2020). Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy surgery). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerves sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc).

Discussion: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique.


Condition or disease Intervention/treatment
Bladder Cancer Procedure: Radical cystectomy

Detailed Description:

The aim of the project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy surgery comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence.

Twenty-eight participating centers across Italy will provide data for the study: Urology Clinic, University of Bologna; Department of Urology, AOU Careggi, Florence; European Institute of Oncology Milan; San Raffaele Hospital, Milan; University Hospital of Verona; Department of Urology, Policlinico Abano; Department of Urology, Spedali Civili, Brescia; Department of Urology and Kidney Transplantation, University of Foggia, Foggia; Galliera Hospital, Genova; ASST Niguarda Metropolitan Hospital, Niguarda; Policlinico Umberto I, Saproma; Department of Clinical Urology, University of Perugia; Department of Clinical Urology, AOUP Cisanello Hospital, Pisa; Department of Clinical Urology, Palermo University, Palermo; Department of Clinical Urology, Alessandria Hospital, Alessandria; Department of Clinical Urology, ASST Mantova, Mantova; Department of Clinical Urology, ASL Abruzzo; Department of Clinical Urology Ca Foncello Hospital, Treviso; Department of Clinical Urology II, Bari University, Bari; Department of Clinical Urology, Vittorio Emanuele Hospital, Catania; Department of Clinical Urology, Casa Sollievo della Sofferenza, Sgrotondo; Hospital Bassiano, Bassano; Department of Clinical Urology, Hospital San Francesco ASL 3, Nuoro; Department of Clinical Urology, Portogruaro; Department of Clinical Urology, Biella Hospital, Biella; Department of Clinical Urology Chioggia Hospital; Ausl Modena; Department of Urology and Kidney Transplantation, Bianchi-Melacrino-Morelli Grand Metropolitan Hospital.

The inclusion criteria are: 1) male and female consecutively recruited patients; 2) age ≥18 years; 3) histologically confirmed diagnosis of bladder cancer eligible for radical cystectomy surgery at date of enrollment; 4) providing written, informed consent.

At baseline and after 3, 6, 12, and 24 months post-surgery, data will be taken directly from the patients at their follow-up medical visits and entered into the online database. The physician identifying and recruiting patients is in charge of completing the data collection forms during follow-up, even if the patient is subsequently treated in another center.

Variables of interest include demographic variables (age, sex, etc), surgical factors (technique use, length of surgery, blood loss, type of urinary diversion, node burden, histological exams, surgical margins etc), mortality, morbidity (pre-, during- and post-surgery), oncological results, and functioning (continence and sexual performance) over follow-up.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol of the Italian Radical Cystectomy Registry: a Non-randomized, 24-month, Multicenter Study Comparing Robotic-assisted, Laparoscopic, and Open Surgery for Radical Cystectomy in Bladder Cancer
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort Intervention/treatment
Radical cystectomy
Patients with histologically confirmed diagnosis of bladder cancer undergoing radical cystectomy surgery at 28 Urology departments in Italy
Procedure: Radical cystectomy
Procedure/Surgery: Radical cystectomy. Removal of urinary bladder with three different approaches: i) Robotic-assisted, ii) Laparoscopic, and iii) Open Surgery




Primary Outcome Measures :
  1. Surgery time [ Time Frame: Baseline ]
    Total surgery time, in minutes during surgery at baseline

  2. Type of urinary diversion [ Time Frame: Baseline ]
    Type of urinary diversion performed during the cystectomy surgery at baseline

  3. Eventual conversion to open surgery [ Time Frame: Baseline ]
    If the surgery technique changes from laproscopic surgery to open surgery during the intervention at baseline

  4. Amount of surgical blood loss [ Time Frame: Baseline ]
    Amount of blood lost during the surgical procedure at baseline in milliliters

  5. Number of participants who underwent nerve-sparing [ Time Frame: Baseline ]
    Nerve sparing during baseline surgery (no/unilateral/bilateral)

  6. Number of participants who underwent lymphadenectomy [ Time Frame: Baseline ]
    lymphadenectomy (not performed/ bilateral external iliac nodes /bilateral presacral iliac) during baseline surgery


Secondary Outcome Measures :
  1. Histological evaluation of all patients [ Time Frame: Immediately after surgery ]
    Tumor histology, (transitional cell carcinoma, adenocarcinoma, or other)

  2. Rate of Mortality [ Time Frame: Up to 24 months ]
    All-cause mortality after surgery

  3. Rate of Hospitalization [ Time Frame: Up to 24 months ]
    Any in-patient hospitalization in teh 24 months following surgical discharge.

  4. Sexual potency rates [ Time Frame: Up to 24 months ]
    Sexual potency in the patient following surgery. Self-reported.

  5. Continence rates [ Time Frame: Up to 24 months ]
    Daytime and nighttime continence following surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population is composed of subjects affected by bladder cancer that will undergo radical cystectomy. Surgery has been than divided in three different approaches: laparoscopic, robot-assisted and open.
Criteria

Inclusion Criteria:

  • Male and female consecutively recruited patients
  • Age ≥18 years
  • Histologically confirmed diagnosis of bladder cancer eligible for radical cystectomy surgery (according to EAU guidelines) at date of enrollment
  • Providing written, informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228198


Locations
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Italy
policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences Recruiting
Roma, Italy, 00161
Contact: Ettore De Berardinis, Professor    +393355374223    ettore.deberardinis@uniroma1.it   
Principal Investigator: Ettore De Berardinis, Professor         
Sponsors and Collaborators
University of Roma La Sapienza
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ettore De Berardinis, Researcher, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04228198    
Other Study ID Numbers: R.I.C.
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases