An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

Ethicon Endo-Surgery270 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Excision of Kidney

Interventions

Surgeon's 'standard of care' staplerDEVICE

Ethicon Powered Vascular StaplerDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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