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

Not Applicable

Terminated

• Conditions: Bladder Cancer; Hemostasis
• Interventions: Device: Stapling device during radical cystectomy; Device: Ligasure tissue sealing device

• Registration Number: NCT00802633
• Lead Sponsor: Vanderbilt University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Status Verified: 2013-12
• Results First Submitted: 2013-12-21
• Results First Submitted QC: 2013-12-21
• Last Update Submitted: 2013-12-21
• Results First Posted: 2014-02-11
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Muscle invasive bladder cancer
• Male/Female gender

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapling device	Stapling device during radical cystectomy	Efficacy of stapling device during radical cystectomy
Ligasure Device	Ligasure tissue sealing device	Efficacy of ligasure tissue sealing device during radical cystectomy

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss	Perioperative

Secondary Outcome Measures

Name	Time	Method
Operating Room Time in Minutes	Intraoperative time

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States