Complication of Surgical Procedure, Complication, Postoperative, Cystectomy, Ileal Conduit, Neobladder, Robotic Surgical Procedures, Urinary Diversion, Urothelial Carcinoma
Conditions
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).
Interventions
PROCEDURErobot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
Sponsors
Kantonsspital Winterthur KSW
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | 1 year | deviations from normal postoperative course \[Clavien-Dindo Grade\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life urology specific | 1 year | 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 |
| Quality of Life overall | 1 year | 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 |
| Operation Time | expected 4-8 hours | duration of operation \[min\] |
| Postoperative Death by any cause | through study completion, an average of 5 years | Death by any cause \[n/months\] |
| Pouch capacity | 1 year | interventional measurement of pouch capacity with pressure recording catheter \[ml\] |
| Type of tumor-recurrence | through study completion, an average of 5 years | Location of tumor recurrence (local, metastasis) |
| Blood loss | expected 4-8 hours | blood loss during operation \[ml\] |
| Treatment of tumor recurrence | through study completion, an average of 5 years | Treatment of tumor recurrence (radiotherapy, chemotherapy, operation) |
| Tumor specific death | through study completion, an average of 5 years | Time to tumor specific death \[months\] |
| Preoperative Tumor staging | 90 days | Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System) |
| Postoperative Tumor staging | 90 days | Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System) |
| Pouch-pressure | 1 year | interventional measurement of pouch-pressure \[cmH2O\]with pressure recording catheter |
| Postvoid residual urine | 1 year | Residual urin after voiding \[ml\] |
| Functional length of urethral sphincter | 1 year | interventional measurement of Functional length of urethral sphincter \[mm\] with pressure recording catheter |
| Functional pressure of urethral sphincter | 1 year | interventional measurement of functional pressure of urethral sphincter \[cmH2O\] with pressure recording catheter |
| Time to recurrence | through study completion, an average of 5 years | time until recurrence of tumor \[months\] |
Countries
Switzerland
Contacts
Primary ContactChristoph Schregel, MD
Backup ContactOrlando Burkhardt, MD
Outcome results
None listed