Bladder Cancer, Hemostasis
Conditions
Keywords
Tissue sealing device, Articulating stapling device, Radical cystectomy
Brief summary
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
Interventions
DEVICEStapling device during radical cystectomy
Hemostasis
DEVICELigasure tissue sealing device
Efficacy of tissue sealing device during hemostasis
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Muscle invasive bladder cancer * Male/Female gender
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated Blood Loss | Perioperative |
Secondary
| Measure | Time frame |
|---|---|
| Operating Room Time in Minutes | Intraoperative time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stapling Device Efficacy of stapling device during radical cystectomy
Stapling device during radical cystectomy: Hemostasis | 40 |
| Ligasure Device Efficacy of ligasure tissue sealing device during radical cystectomy
Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Stapling Device | Ligasure Device | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 9.6 | 68.5 years STANDARD_DEVIATION 7.9 | 67.15 years STANDARD_DEVIATION 8.75 |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 37 Participants | 33 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Estimated Blood Loss
Time frame: Perioperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapling Device | Estimated Blood Loss | 686.5 milliliters | Standard Deviation 406.1 |
| Ligasure Device | Estimated Blood Loss | 707.5 milliliters | Standard Deviation 570.8 |
Secondary
Operating Room Time in Minutes
Time frame: Intraoperative time
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stapling Device | Operating Room Time in Minutes | 262.1 minutes | Standard Deviation 74.9 |
| Ligasure Device | Operating Room Time in Minutes | 272.9 minutes | Standard Deviation 73.3 |