Trial Outcomes & Findings for Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device? (NCT NCT00802633)
NCT ID: NCT00802633
Last Updated: 2014-02-11
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Perioperative
Results posted on
2014-02-11
Participant Flow
Participant milestones
| Measure |
Stapling Device
Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis
|
Ligasure Device
Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Baseline characteristics by cohort
| Measure |
Stapling Device
n=40 Participants
Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis
|
Ligasure Device
n=40 Participants
Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 9.6 • n=39 Participants
|
68.5 years
STANDARD_DEVIATION 7.9 • n=41 Participants
|
67.15 years
STANDARD_DEVIATION 8.75 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
70 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
40 participants
n=41 Participants
|
80 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: PerioperativeOutcome measures
| Measure |
Stapling Device
n=40 Participants
Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis
|
Ligasure Device
n=40 Participants
Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis
|
|---|---|---|
|
Estimated Blood Loss
|
686.5 milliliters
Standard Deviation 406.1
|
707.5 milliliters
Standard Deviation 570.8
|
SECONDARY outcome
Timeframe: Intraoperative timeOutcome measures
| Measure |
Stapling Device
n=40 Participants
Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis
|
Ligasure Device
n=40 Participants
Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis
|
|---|---|---|
|
Operating Room Time in Minutes
|
262.1 minutes
Standard Deviation 74.9
|
272.9 minutes
Standard Deviation 73.3
|
Adverse Events
Stapling Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ligasure Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place