Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion

Conditions
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Cystectomy, Urothelial Carcinoma, Urinary Diversion, Complication of Surgical Procedure, Complication, Postoperative, Neobladder, Ileal Conduit, Robotic Surgical Procedures

Intervention / Treatment
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* Procedure: robot-assisted cystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ileal Conduit<br>Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy | Procedure: robot-assisted cystectomy<br>* Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy<br>|
| Neobladder<br>Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy | Procedure: robot-assisted cystectomy<br>* Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | deviations from normal postoperative course [Clavien-Dindo Grade] | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |