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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robot-assisted cystectomy | Procedure | Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | deviations from normal postoperative course ["Clavien-Dindo" Grade] | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of tumor recurrence | Treatment of tumor recurrence (radiotherapy, chemotherapy, operation) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Schregel, MD | Contact | christophschregel@gmx.de | ||
| Orlando Burkhardt, MD | Contact | +41792912821 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Winterthur | Recruiting | Winterthur | 8401 | Switzerland |
depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 | 1 year |
| Operation Time | duration of operation [min] | expected 4-8 hours |
| Postoperative Death by any cause | Death by any cause [n/months] | through study completion, an average of 5 years |
| Pouch capacity | interventional measurement of pouch capacity with pressure recording catheter [ml] | 1 year |
| Type of tumor-recurrence | Location of tumor recurrence (local, metastasis) | through study completion, an average of 5 years |
| Blood loss | blood loss during operation [ml] | expected 4-8 hours |
| Time to recurrence | time until recurrence of tumor [months] | through study completion, an average of 5 years |
| Tumor specific death | Time to tumor specific death [months] | 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) | 90 days |
| Postoperative Tumor staging | Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System) | 90 days |
| Pouch-pressure | interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter | 1 year |
| Postvoid residual urine | Residual urin after voiding [ml] | 1 year |
| Functional length of urethral sphincter | interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter | 1 year |
| Functional pressure of urethral sphincter | interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter | 1 year |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |