RAdicale Cystectomy Evaluation. Comparative Effectiveness Study of Open versus Robot Assisted Laparoscopic Surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24266

Enrollment

338

Registered

2015-08-14

Start date

2015-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1.bladder cancer 2. (cost)-effectiveness 3. cystectomy 4. robot 5. surgery 6. complication 7. quality of life

Interventions

Robot assisted radical cystectomy (RARC) will be compared with open radical cystectomy (ORC)

Eligibility

Inclusion criteria

Inclusion criteria: • Patients with non-metastatic muscle-invasive (cT2-T4a) and uncontrolled or highrisk non Muscle-invasive bladder cancer (pTa-pT1) • Age >=18 • Able to fill in questionnaires • Signed informed consent

Exclusion criteria

Exclusion criteria: • Extensive previous abdominal surgery • Abdominal irradiation

Design outcomes

Primary

Measure	Time frame
Complications, i.e. the 90 days overall complication rate according to the Clavien-Dindo classification.	—

Secondary

Measure	Time frame
HRQOL, time to return to normal activity, operating time, hospital and intensive care stay, blood loss, transfusion parameters, costs, pathology results	—

Contacts

Public ContactC.J. Wijburg

wagnerlaan 55

cwijburg@rijnstate.nltel +31(0)88-005 6082

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)