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

Robotic Assisted Urologic Laparoscopy

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

Condition: Urothelial Carcinoma, Cystectomy, Urinary Diversion, Complication of Surgical Procedure, Complication, Postoperative, Neobladder, Ileal Conduit, Robotic Surgical Procedures

Intervention:

  • Procedure: robot-assisted cystectomy

Purpose:
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.

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03280459

Sponsor: Kantonsspital Winterthur KSW

Primary Outcome Measures:

  • Measure: postoperative complications
  • Time Frame: 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Treatment of tumor recurrence
  • Time Frame: through study completion, an average of 5 years
  • Safety Issue:
  • Measure: Quality of Life urology specific
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Quality of Life overall
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Operation Time
  • Time Frame: expected 4-8 hours
  • Safety Issue:
  • Measure: Postoperative Death by any cause
  • Time Frame: through study completion, an average of 5 years
  • Safety Issue:
  • Measure: Pouch capacity
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Type of tumor-recurrence
  • Time Frame: through study completion, an average of 5 years
  • Safety Issue:
  • Measure: Blood loss
  • Time Frame: expected 4-8 hours
  • Safety Issue:
  • Measure: Time to recurrence
  • Time Frame: through study completion, an average of 5 years
  • Safety Issue:
  • Measure: Tumor specific death
  • Time Frame: through study completion, an average of 5 years
  • Safety Issue:
  • Measure: Preoperative Tumor staging
  • Time Frame: 90 days
  • Safety Issue:
  • Measure: Postoperative Tumor staging
  • Time Frame: 90 days
  • Safety Issue:
  • Measure: Pouch-pressure
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Postvoid residual urine
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Functional length of urethral sphincter
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Functional pressure of urethral sphincter
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: January 1, 2015

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Phase:
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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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
  • declined informed consent / data use
  • pregnancy

Contact:

  • Christoph Schregel, MD
  • christophschregel@gmx.de

Location:

  • Kantonsspital Winterthur
  • Winterthur

    8401
    Switzerland

View trial on ClinicalTrials.gov

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