Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction
iRARC-KSW
Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedSeptember 12, 2017
September 1, 2017
8.4 years
August 29, 2017
September 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative complications
deviations from normal postoperative course \["Clavien-Dindo" Grade\]
1 year
Secondary Outcomes (16)
Treatment of tumor recurrence
through study completion, an average of 5 years
Quality of Life urology specific
1 year
Quality of Life overall
1 year
Operation Time
expected 4-8 hours
Postoperative Death by any cause
through study completion, an average of 5 years
- +11 more secondary outcomes
Study Arms (2)
Ileal Conduit
Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
Neobladder
Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
Interventions
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
Eligibility Criteria
Onkologic 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
You may qualify if:
- 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
You may not qualify if:
- age \<18 years
- declined informed consent / data use
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistenzarzt Urologie / resident Departement of Urology
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 12, 2017
Study Start
January 1, 2015
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
September 12, 2017
Record last verified: 2017-09