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Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction (iRARC-KSW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280459
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Christoph Schregel, 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.

Condition or disease Intervention/treatment
Urothelial Carcinoma Cystectomy Urinary Diversion Complication of Surgical Procedure Complication, Postoperative Neobladder Ileal Conduit Robotic Surgical Procedures Procedure: robot-assisted cystectomy

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ileal Conduit
Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
Procedure: robot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy

Neobladder
Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
Procedure: robot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy




Primary Outcome Measures :
  1. postoperative complications [ Time Frame: 1 year ]
    deviations from normal postoperative course ["Clavien-Dindo" Grade]


Secondary Outcome Measures :
  1. Treatment of tumor recurrence [ Time Frame: through study completion, an average of 5 years ]
    Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)

  2. Quality of Life urology specific [ Time Frame: 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

  3. Quality of Life overall [ Time Frame: 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

  4. Operation Time [ Time Frame: expected 4-8 hours ]
    duration of operation [min]

  5. Postoperative Death by any cause [ Time Frame: through study completion, an average of 5 years ]
    Death by any cause [n/months]

  6. Pouch capacity [ Time Frame: 1 year ]
    interventional measurement of pouch capacity with pressure recording catheter [ml]

  7. Type of tumor-recurrence [ Time Frame: through study completion, an average of 5 years ]
    Location of tumor recurrence (local, metastasis)

  8. Blood loss [ Time Frame: expected 4-8 hours ]
    blood loss during operation [ml]

  9. Time to recurrence [ Time Frame: through study completion, an average of 5 years ]
    time until recurrence of tumor [months]

  10. Tumor specific death [ Time Frame: through study completion, an average of 5 years ]
    Time to tumor specific death [months]

  11. Preoperative Tumor staging [ Time Frame: 90 days ]
    Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)

  12. Postoperative Tumor staging [ Time Frame: 90 days ]
    Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)

  13. Pouch-pressure [ Time Frame: 1 year ]
    interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter

  14. Postvoid residual urine [ Time Frame: 1 year ]
    Residual urin after voiding [ml]

  15. Functional length of urethral sphincter [ Time Frame: 1 year ]
    interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter

  16. Functional pressure of urethral sphincter [ Time Frame: 1 year ]
    interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280459


Contacts
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Contact: Christoph Schregel, MD christophschregel@gmx.de
Contact: Orlando Burkhardt, MD +41792912821

Locations
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Switzerland
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Christoph Schregel, M.D.    +4152264331 ext +14766737873    christophschregel@gmx.de   
Contact: Hubert John, M.D.    +41522662982    hubert.john@ksw.ch   
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Additional Information:

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Responsible Party: Christoph Schregel, Assistenzarzt Urologie / resident Departement of Urology, Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT03280459    
Other Study ID Numbers: 2017-01260
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Postoperative Complications
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes