Excision of Kidney
Conditions
Brief summary
This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for renal artery and renal vein transection) and powered vascular stapler
Interventions
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC); * Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable; * American Society of Anesthesiologists (ASA) score \< 3; * No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed); * Willing to give consent and comply with study-related evaluation and treatment schedule; and * At least 18 years of age
Exclusion criteria
* Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment); * Pregnancy; * Physical or psychological condition which would impair study participation; or * The subject is judged unsuitable for study participation by the Investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions | Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours | Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding | Post-Op through 4 Week Follow-up | Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of SOC or PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to Renal Artery and Renal Vein transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). |
Countries
United States
Participant flow
Recruitment details
Recruitment was from July 2016 to July 2017 across 11 hospitals.
Pre-assignment details
In total, 302 subjects were screened, 270 subjects were randomized, and those 32 subjects who were not randomized did not satisfy inclusion or exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Facility's Current Instrumentation | 139 |
| Powered Vascular Stapler Use of the ECHELON FLEX™ Powered Vascular Stapler | 131 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Intra-operative exclusion criteria | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Powered Vascular Stapler | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 13.8 | 63.8 Years STANDARD_DEVIATION 13.9 | 64.1 Years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 7 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 77 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 92 Participants | 186 Participants | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 24 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) White | 116 Participants | 235 Participants | 119 Participants |
| Sex: Female, Male Female | 60 Participants | 128 Participants | 68 Participants |
| Sex: Female, Male Male | 71 Participants | 142 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 131 |
| other Total, other adverse events | 26 / 139 | 33 / 131 |
| serious Total, serious adverse events | 21 / 139 | 14 / 131 |
Outcome results
Primary
Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).
Time frame: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours
Population: All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions | 0.1359 proportion of transected vessels |
| Powered Vascular Stapler | Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions | 0.1836 proportion of transected vessels |
Secondary
Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding
Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of SOC or PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to Renal Artery and Renal Vein transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Time frame: Post-Op through 4 Week Follow-up
Population: All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding | 0.0144 proportion of participants |
| Powered Vascular Stapler | Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding | 0.0076 proportion of participants |