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

This study is ongoing, but not recruiting participants.

First Received: December 3, 2008 Last Updated: December 4, 2008 History of Changes

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00802633

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

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Surgery

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Secondary Outcome Measures:

Operative Time [ Time Frame: Intraoperative time ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stapling device	Device: Stapling device during radical cystectomy Hemostasis
2: Experimental Efficacy of ligasure tissue sealing device during radical cystectomy	Device: Ligasure tissue sealing device Efficacy of tissue sealing device during hemostasis

Eligibility

Criteria

Inclusion Criteria:

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

More Information

No publications provided

Responsible Party:	Vanderbilt University Medical Center ( Carl Bischoff, MD )
Study ID Numbers:	081018
Study First Received:	December 3, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802633 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Tissue sealing device
Articulating stapling device
Radical cystectomy

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms

Urogenital Neoplasms
Bladder Neoplasm
Urologic Neoplasms
Hemostatics

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Urologic Diseases
Urinary Bladder Diseases

Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009