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TerminatedNCT00802633Updated Feb 11, 2014Results posted

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

An interventional study of Stapling device during radical cystectomy and Ligasure tissue sealing device in Bladder Cancer and Hemostasis, sponsored by Vanderbilt University. Terminated at 1 site in United States. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-02-11.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

Why this study was terminated
Enrollment was stopped after eighty patients were enrolled.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Bladder Cancer
  • Hemostasis

Keywords

  • Tissue sealing device
  • Articulating stapling device
  • Radical cystectomy
03

In context

Urinary Bladder Neoplasms

1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 1,183 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 520 studies on the registry; 18 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.

Browse Vanderbilt University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Muscle invasive bladder cancer
  • Male/Female gender

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Stapling device

    Efficacy of stapling device during radical cystectomy

    Device: Stapling device during radical cystectomy

  • Active comparator
    Ligasure Device

    Efficacy of ligasure tissue sealing device during radical cystectomy

    Device: Ligasure tissue sealing device

Interventions

  • DeviceStapling device during radical cystectomy

    Hemostasis

    Also known as: Ethicon articulating stapler

  • DeviceLigasure tissue sealing device

    Efficacy of tissue sealing device during hemostasis

    Also known as: Tissue sealing device

06

What researchers measure

Primary outcomes

  1. Estimated Blood Loss

    Time frame: Perioperative

Secondary outcomes

  1. Operating Room Time in Minutes

    Time frame: Intraoperative time

07

Results

Posted Feb 11, 2014
Limitations and caveats
Study terminated after 80 subjects

Participant flow

Participant flow — Overall Study
MilestoneStapling DeviceLigasure Device
Started4040
Completed4040
Not completed00

Outcome measures

PrimaryEstimated Blood Loss
Time frame:
Perioperative
Reported as:
Mean · milliliters
Estimated Blood Loss
millilitersStapling DeviceLigasure Device
Estimated Blood Loss686.5 ± 406.1707.5 ± 570.8
SecondaryOperating Room Time in Minutes
Time frame:
Intraoperative time
Reported as:
Mean · minutes
Operating Room Time in Minutes
minutesStapling DeviceLigasure Device
Operating Room Time in Minutes262.1 ± 74.9272.9 ± 73.3

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stapling Device—0/40 (0%)0/40 (0%)
Ligasure Device—0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Stapling DeviceLigasure DeviceTotal
Mean65.8 ± 9.668.5 ± 7.967.15 ± 8.75
Sex: Female, Male
Sex: Female, Male(Participants)Stapling DeviceLigasure DeviceTotal
Female3710
Male373370
Region of Enrollment
Region of Enrollment(participants)Stapling DeviceLigasure DeviceTotal
United States404080
08

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008, a primary completion of Dec 2011 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2014, 2 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2008
First posted
Dec 5, 2008
Start
Nov 2008
Primary completionActual
Dec 2011
CompletionActual
Jun 2012
Results first posted
Feb 11, 2014
Last update
Feb 11, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00802633
Lead sponsor
Vanderbilt University
Responsible party
SChang (MD, Vanderbilt University) — Principal investigator
First posted
Dec 5, 2008
Start date
Nov 2008
Primary completion
Dec 2011
Completion
Jun 2012
Results posted
Feb 11, 2014
Last update
Feb 11, 2014

Study contacts

Sam S Chang, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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