Bladder Cancer Clinical Trial
Official title:
Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.
Verified date | January 2023 |
Source | Regina Elena Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective randomized study is designed to provide high level of evidence supporting superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially linked to a reduced invasiveness are considered as secondary endpoints. Investigators hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and to faster return to daily activities. These data will be taken into account in a matched cost analysis between arms. Secondary aims include a between arm matched comparison of perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and nighttime continence).
Status | Completed |
Enrollment | 116 |
Est. completion date | September 30, 2022 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients with muscle invasive high grade urothelial carcinoma (and variant histologies) of the bladder or high grade non muscle invasive BCG recurrent/refractory disease. Exclusion Criteria: - Cystectomy without curative intent (palliative, salvage). - Patients unfit for robotic cystectomy. |
Country | Name | City | State |
---|---|---|---|
Italy | Regina Elena NCI | Rome | Lazio |
Lead Sponsor | Collaborator |
---|---|
Regina Elena Cancer Institute | Ministero della Salute, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire | Comparison between open and robotic arms. | 6 months | |
Other | Assessment of quality of life at 6-mo follow-up with self-administered EORTC QLQ-C30 questionnaire | Comparison between open and robotic arms. | 6 months | |
Other | Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire | Comparison between open and robotic arms. | 12 months | |
Other | Assessment of quality of life at 12-mo follow-up with self-administered EORTC QLQ-C30 questionnaire | Comparison between open and robotic arms. | 12 months | |
Other | Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-BLM30 questionnaire | Comparison between open and robotic arms. | 24 months | |
Other | Assessment of quality of life at 24-mo follow-up with self-administered EORTC QLQ-C30 questionnaire | Comparison between open and robotic arms. | 24 months | |
Other | Disease free survival | Comparison between open and robitic arms | 24 months | |
Other | Cancer specific survival | Comparison between open and robitic arms | 24 months | |
Other | Overall survival | Comparison between open and robitic arms | 24 months | |
Other | Assessment of urinary continence with pad test. | Comparison between open and robotic arms | 12 months | |
Other | Assessment of urinary continence with pad test. | Comparison between open and robotic arms | 24 months | |
Primary | Number of participants requiring perioperative transfusions. | 50% reduction of perioperative transfusion rates in robotic arm. | 30 days | |
Secondary | Number of participants requiring insertion of nasogastric tube | Comparison between open and robotic arms. | 30 days | |
Secondary | Incidence of Clavien grade 1-2 perioperative complications at 30-d evaluation. | Comparison between open and robotic arms. | 30 days | |
Secondary | Incidence of Clavien grade 1-2 perioperative complications at 90-d evaluation. | Comparison between open and robotic arms. | 90 days | |
Secondary | Incidence of Clavien grade 1-2 perioperative complications at 180-d evaluation. | Comparison between open and robotic arms. | 180 days | |
Secondary | Incidence of patients requiring readmission. | Comparison between open and robotic arms. | 90 days | |
Secondary | Cost analysis. | Comparison between open and robotic arms. | 30 days |
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