Clinical trial NCT03280459: Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction
Official title: Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urothelial Carcinoma
Cystectomy
Urinary Diversion
Complication of Surgical Procedure
Complication, Postoperative
Neobladder
Ileal Conduit
Robotic Surgical Procedures
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: postoperative complications
timeFrame: 1 year
Secondary outcomes:
measure: Treatment of tumor recurrence
timeFrame: through study completion, an average of 5 years
measure: Quality of Life urology specific
timeFrame: 1 year
measure: Quality of Life overall
timeFrame: 1 year
measure: Operation Time
timeFrame: expected 4-8 hours
measure: Postoperative Death by any cause
timeFrame: through study completion, an average of 5 years
measure: Pouch capacity
timeFrame: 1 year
measure: Type of tumor-recurrence
timeFrame: through study completion, an average of 5 years
measure: Blood loss
timeFrame: expected 4-8 hours
measure: Time to recurrence
timeFrame: through study completion, an average of 5 years
measure: Tumor specific death
timeFrame: through study completion, an average of 5 years
measure: Preoperative Tumor staging
timeFrame: 90 days
measure: Postoperative Tumor staging
timeFrame: 90 days
measure: Pouch-pressure
timeFrame: 1 year
measure: Postvoid residual urine
timeFrame: 1 year
measure: Functional length of urethral sphincter
timeFrame: 1 year
measure: Functional pressure of urethral sphincter
timeFrame: 1 year
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
References: