Robotic and laparoscopic procedures in the urological field

ISRCTN	ISRCTN14196575
DOI	https://doi.org/10.1186/ISRCTN14196575
Sponsor	Regione Lombardia
Funders	Regione Lombardia, Foundazione ROUTE

Submission date: 04/07/2026
Registration date: 06/07/2026
Last edited: 06/07/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Giorgio Bozzini
Principal investigator, Scientific, Public

St. Anne's Hospital (l'Ospedale Sant'Anna), via Ravona san fermo della Battaglia
Como
22100
Italy

Phone	+393477945956
Email	segreteria@fondazioneroute.it

Study information

Primary study design	Observational
Observational study design	Case-control study
Scientific title	Comparison between robotic and laparoscopic approach to treat urological diseases
Study objectives	To assess the best options to treat urological conditions.
Ethics approval(s)	Approved 24/11/2019, UNIBUC EC (9 Panduri st., Bucarest, 54367, Romania; +40 0752011828; office@g.unibuc.ro), ref: RO st 3345/2020
Health condition(s) or problem(s) studied	Benign and neoplastic urological condition
Methodology	This observational study enrols patients before undergoing a surgical procedure and follows them prospectively for 5 years after surgery. As the final disease classification and risk stratification depend on the postoperative histopathology report, which is not available at enrolment, no randomization is performed. Patients are monitored according to standard clinical practice and European Association of Urology (EAU) follow-up guidelines, with surveillance schedules tailored to the histopathological findings. Clinical, pathological, and outcome data are collected and analysed using appropriate statistical methods to evaluate long-term patient outcomes and associations with disease characteristics. The results will provide evidence on prognosis and management in routine clinical practice. The follow-up approach and the fact that histopathology results are unknown at enrolment are clearly explained in the consent documentation.
Intervention type	Other
Primary outcome measure(s)	Disease-free survival (DFS) measured using data collected from patient medical records at baseline and 5 years follow up Duration of the procedure measured using data collected from patient medical records at baseline and 5 years follow up Neoplastic-related relapse measured using data collected from patient medical records at baseline and 5 years follow up Bleeding during the procedure measured using data collected from patient medical records at baseline and 5 years follow up Cost of the procedure measured using data collected from patient medical records at baseline and 5 years follow up
Key secondary outcome measure(s)
Completion date	31/12/2030

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	500
Total final enrolment	500
Key inclusion criteria	Patients who underwent robotic and laparoscopic procedures for urological conditions
Key exclusion criteria	1. Locally advanced or metastatic disease 2. Benign lesion at histopathology 3. Multiple renal masses 4. Coagulopathy or anticoagulants that could not be stopped 5. End-stage renal disease 6. Pregnancy
Date of first enrolment	01/07/2026
Date of final enrolment	31/12/2030

Locations

Countries of recruitment

France
Greece
Italy
Romania
Russian Federation
Spain

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

06/07/2026: Study’s existence confirmed by the Fondazione ROUTE, Italy.