Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Overview

Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2011

Interventions

  • Device: Stapling device during radical cystectomy
    • Hemostasis
  • Device: Ligasure tissue sealing device
    • Efficacy of tissue sealing device during hemostasis

Arms, Groups and Cohorts

  • Active Comparator: Stapling device
    • Efficacy of stapling device during radical cystectomy
  • Active Comparator: Ligasure Device
    • Efficacy of ligasure tissue sealing device during radical cystectomy

Clinical Trial Outcome Measures

Primary Measures

  • Estimated Blood Loss
    • Time Frame: Perioperative

Secondary Measures

  • Operating Room Time in Minutes
    • Time Frame: Intraoperative time

Participating in This Clinical Trial

Inclusion Criteria

  • Muscle invasive bladder cancer – Male/Female gender Exclusion Criteria:

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: SChang, MD – Vanderbilt University
  • Overall Official(s)
    • Sam S Chang, MD, Principal Investigator, Vanderbilt University Medical Center

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