Urothelial CarcinomaiRARC-KSWNCT03280459
Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction
An observational study of Urothelial Carcinoma and Cystectomy, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Cystectomy, Urinary Diversion
- What is being tested?
- robot-assisted cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2015to 1 Jun 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- age <18 years
- declined informed consent / data use
- pregnancy
Trial locations and contacts
1 site in 1 country.
Christoph Schregel, MD contact
Orlando Burkhardt, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Winterthur
Winterthur, 8401
Christoph Schregel, M.D., +4152264331 ext. +14766737873, christophschregel@gmx.de
Hubert John, M.D., +41522662982, hubert.john@ksw.ch
About this study
Official title: Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
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.
Read the 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).
- Conditions
- Urothelial Carcinoma, Cystectomy, Urinary Diversion, Complication of Surgical Procedure, Complication, Postoperative, Neobladder
- Being tested
- robot-assisted cystectomy
- Medical subject headings
- Carcinoma, Transitional Cell, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted cystectomyProcedure or surgery
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Ileal Conduit | Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy Receives: Procedure: robot-assisted cystectomy | |
| Neobladder | Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy Receives: Procedure: robot-assisted cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
deviations from normal postoperative course ["Clavien-Dindo" Grade]
Measured: 1 year
Secondary outcomes (16)
Treatment of tumor recurrence
Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)
Measured: 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
Measured: 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
Measured: 1 year
Operation Time
duration of operation [min]
Measured: expected 4-8 hours
Postoperative Death by any cause
Death by any cause [n/months]
Measured: through study completion, an average of 5 years
Pouch capacity
interventional measurement of pouch capacity with pressure recording catheter [ml]
Measured: 1 year
Type of tumor-recurrence
Location of tumor recurrence (local, metastasis)
Measured: through study completion, an average of 5 years
Blood loss
blood loss during operation [ml]
Measured: expected 4-8 hours
Time to recurrence
time until recurrence of tumor [months]
Measured: through study completion, an average of 5 years
Tumor specific death
Time to tumor specific death [months]
Measured: 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)
Measured: 90 days
Postoperative Tumor staging
Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
Measured: 90 days
Pouch-pressure
interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter
Measured: 1 year
Postvoid residual urine
Residual urin after voiding [ml]
Measured: 1 year
Functional length of urethral sphincter
interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter
Measured: 1 year
Functional pressure of urethral sphincter
interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jan 2015
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Schregel, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280459
- Sponsor's protocol ID
- 2017-01260
- Other IDs
- 2017
- Acronym
- iRARC-KSW
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
- ClinicalTrials.gov ID
- NCT03280459
- Acronym / sponsor ID
- iRARC-KSW / 2017-01260
- Conditions
- Urothelial Carcinoma, Cystectomy, Urinary Diversion, Complication of Surgical Procedure, Complication, Postoperative, Neobladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ileal Conduit | – | Procedure: robot-assisted cystectomyPatient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy |
| Neobladder | – | Procedure: robot-assisted cystectomyPatient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- age <18 years
- declined informed consent / data use
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot-assisted cystectomyRemoval of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy | Procedure or surgery | Ileal Conduit, Neobladder |
Primary outcome
postoperative complications
Time frame: 1 year
deviations from normal postoperative course ["Clavien-Dindo" Grade]
16 secondary outcomes
Treatment of tumor recurrence
Time frame: through study completion, an average of 5 years
Quality of Life urology specific
Time frame: 1 year
Quality of Life overall
Time frame: 1 year
Operation Time
Time frame: expected 4-8 hours
Postoperative Death by any cause
Time frame: through study completion, an average of 5 years
Pouch capacity
Time frame: 1 year
Type of tumor-recurrence
Time frame: through study completion, an average of 5 years
Blood loss
Time frame: expected 4-8 hours
Time to recurrence
Time frame: through study completion, an average of 5 years
Tumor specific death
Time frame: through study completion, an average of 5 years
Preoperative Tumor staging
Time frame: 90 days
Postoperative Tumor staging
Time frame: 90 days
Pouch-pressure
Time frame: 1 year
Postvoid residual urine
Time frame: 1 year
Functional length of urethral sphincter
Time frame: 1 year
Functional pressure of urethral sphincter
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Schregel, MD contact
Orlando Burkhardt, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Cystectomy, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Schregel, MD (christophschregel@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.