An observational study in Urothelial Carcinoma, Cystectomy and Urinary Diversion, sponsored by Kantonsspital Winterthur KSW. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by Kantonsspital Winterthur KSW · Observational
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.
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).
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
Exclusion Criteria:
Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
Procedure: robot-assisted cystectomy
Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
Procedure: robot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
postoperative complications
deviations from normal postoperative course \["Clavien-Dindo" Grade\]
Time frame: 1 year
Treatment of tumor recurrence
Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)
Time frame: through study completion, an average of 5 years
Quality of Life urology specific
EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer
Time frame: 1 year
Quality of Life overall
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients
Time frame: 1 year
Operation Time
duration of operation \[min\]
Time frame: expected 4-8 hours
Postoperative Death by any cause
Death by any cause \[n/months\]
Time frame: through study completion, an average of 5 years
Pouch capacity
interventional measurement of pouch capacity with pressure recording catheter \[ml\]
Time frame: 1 year
Type of tumor-recurrence
Location of tumor recurrence (local, metastasis)
Time frame: through study completion, an average of 5 years
Blood loss
blood loss during operation \[ml\]
Time frame: expected 4-8 hours
Time to recurrence
time until recurrence of tumor \[months\]
Time frame: through study completion, an average of 5 years
Tumor specific death
Time to tumor specific death \[months\]
Time frame: through study completion, an average of 5 years
Preoperative Tumor staging
Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
Time frame: 90 days
Postoperative Tumor staging
Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
Time frame: 90 days
Pouch-pressure
interventional measurement of pouch-pressure \[cmH2O\]with pressure recording catheter
Time frame: 1 year
Postvoid residual urine
Residual urin after voiding \[ml\]
Time frame: 1 year
Functional length of urethral sphincter
interventional measurement of Functional length of urethral sphincter \[mm\] with pressure recording catheter
Time frame: 1 year
Functional pressure of urethral sphincter
interventional measurement of functional pressure of urethral sphincter \[cmH2O\] with pressure recording catheter
Time frame: 1 year
Plan to share: Undecided — depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Kantonsspital Winterthur KSW