A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Excision of Kidney
- Sponsor
- Ethicon Endo-Surgery
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
Time Frame: 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 Outcomes
- Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding(Post-Op through 4 Week Follow-up)