Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction

• Conditions: Urothelial Carcinoma; Cystectomy; Ileal Conduit; Neobladder; Robotic Surgical Procedures; Complication, Postoperative; Urinary Diversion; Complication of Surgical Procedure
• Interventions: Procedure: robot-assisted cystectomy

• Registration Number: NCT03280459
• Lead Sponsor: Kantonsspital Winterthur KSW

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-08-29
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-11
• Last Update Submitted: 2017-09-11
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• age <18 years
• declined informed consent / data use
• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ileal Conduit	robot-assisted cystectomy	Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
Neobladder	robot-assisted cystectomy	Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy

Primary Outcome Measures

Name	Time	Method
postoperative complications	1 year	deviations from normal postoperative course \["Clavien-Dindo" Grade\]

Secondary Outcome Measures

Name	Time	Method
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)
Preoperative Tumor staging	90 days	Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
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 \[n/months\]
Treatment of tumor recurrence	through study completion, an average of 5 years	Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)
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
Blood loss	expected 4-8 hours	blood loss during operation \[ml\]
Functional length of urethral sphincter	1 year	interventional measurement of Functional length of urethral sphincter \[mm\] with pressure recording catheter
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
Tumor specific death	through study completion, an average of 5 years	Time to tumor specific death \[months\]
Postoperative Tumor staging	90 days	Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
Time to recurrence	through study completion, an average of 5 years	time until recurrence of tumor \[months\]
Postvoid residual urine	1 year	Residual urin after voiding \[ml\]
Pouch-pressure	1 year	interventional measurement of pouch-pressure \[cmH2O\]with pressure recording catheter
Functional pressure of urethral sphincter	1 year	interventional measurement of functional pressure of urethral sphincter \[cmH2O\] with pressure recording catheter

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland