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

This study has been terminated.
(Enrollment was stopped after eighty patients were enrolled.)
Sponsor:
Information provided by (Responsible Party):
SChang, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00802633
First received: December 3, 2008
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Bladder Cancer
Hemostasis
 Device: Stapling device during radical cystectomy
Device: Ligasure tissue sealing device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Blood loss [ Time Frame: Perioperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Operative Time [ Time Frame: Intraoperative time ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Stapling device
 Device: Stapling device during radical cystectomy
Hemostasis
Other Name: Ethicon articulating stapler
Experimental: 2
Efficacy of ligasure tissue sealing device during radical cystectomy
 Device: Ligasure tissue sealing device
Efficacy of tissue sealing device during hemostasis
Other Name: Tissue sealing device

  Eligibility

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Muscle invasive bladder cancer
  • Male/Female gender

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802633

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sam S Chang, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: SChang, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00802633     History of Changes
Other Study ID Numbers: 081018
Study First Received: December 3, 2008
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Tissue sealing device
Articulating stapling device
Radical cystectomy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013