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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03280459
Other study ID # 2017-01260
Secondary ID
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
Health authority
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

Study Design


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
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