Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction

Urothelial Carcinoma Clinical Trial

— iRARC-KSW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03280459
• Other study ID #: 2017-01260
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2017
• Last updated: September 11, 2017
• Start date: January 1, 2015
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2017
• Source: Kantonsspital Winterthur KSW
• Contact: Christoph Schregel, MD
• Email: christophschregel[@]gmx.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Complication of Surgical Procedure
• Complication, Postoperative
• Cystectomy
• Ileal Conduit
• Neobladder
• Postoperative Complications
• Robotic Surgical Procedures
• Urinary Diversion
• Urothelial Carcinoma

Intervention

Procedure:
• robot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications	deviations from normal postoperative course ["Clavien-Dindo" Grade]	1 year
Secondary	Treatment of tumor recurrence	Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)	through study completion, an average of 5 years
Secondary	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
Secondary	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
Secondary	Operation Time	duration of operation [min]	expected 4-8 hours
Secondary	Postoperative Death by any cause	Death by any cause [n/months]	through study completion, an average of 5 years
Secondary	Pouch capacity	interventional measurement of pouch capacity with pressure recording catheter [ml]	1 year
Secondary	Type of tumor-recurrence	Location of tumor recurrence (local, metastasis)	through study completion, an average of 5 years
Secondary	Blood loss	blood loss during operation [ml]	expected 4-8 hours
Secondary	Time to recurrence	time until recurrence of tumor [months]	through study completion, an average of 5 years
Secondary	Tumor specific death	Time to tumor specific death [months]	through study completion, an average of 5 years
Secondary	Preoperative Tumor staging	Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)	90 days
Secondary	Postoperative Tumor staging	Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)	90 days
Secondary	Pouch-pressure	interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter	1 year
Secondary	Postvoid residual urine	Residual urin after voiding [ml]	1 year
Secondary	Functional length of urethral sphincter	interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter	1 year
Secondary	Functional pressure of urethral sphincter	interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter	1 year