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Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction (iRARC-KSW)

K

Kantonsspital Winterthur KSW

Status

Unknown

Conditions

Neobladder
Urinary Diversion
Complication of Surgical Procedure
Cystectomy
Urothelial Carcinoma
Robotic Surgical Procedures
Ileal Conduit
Complication, Postoperative

Treatments

Procedure: robot-assisted cystectomy

Study type

Observational

Funder types

Other

Identifiers

NCT03280459
2017-01260

Details and patient eligibility

About

Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.

Full description

The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 18 years
  • informed consent for operation and data use
  • Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy

Exclusion criteria

  • age <18 years
  • declined informed consent / data use
  • pregnancy

Trial design

200 participants in 2 patient groups

Ileal Conduit
Description:
Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
Treatment:
Procedure: robot-assisted cystectomy
Neobladder
Description:
Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
Treatment:
Procedure: robot-assisted cystectomy

Trial contacts and locations

1

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Central trial contact

Christoph Schregel, MD; Orlando Burkhardt, MD

Data sourced from clinicaltrials.gov

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