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

A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

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 Overview

• Status: Completed
• Conditions: Excision of Kidney
• Intervention / Treatment: Device: Surgeon's 'standard of care' stapler; Device: Ethicon Powered Vascular Stapler

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgeon's 'standard of care' stapler; Surgeon's standard of care stapler	Device: Surgeon's 'standard of care' stapler
Experimental: Ethicon Powered Vascular Stapler	Device: Ethicon Powered Vascular Stapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Post-Op through 4 Week Follow-up

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2016
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 23, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 15-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED