A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Phase: NA
Conditions: Excision of Kidney
Sponsor: Ethicon Endo-Surgery

 
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A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular 
Stapler in Laparoscopic Nephrectomies and Nephroureterectomies 
 
Protocol #:   ESC-15-002 
 
 
  
Document 
 
 
 
 
Effective Date 
 
 
 
Original                                                         November 17, 2015 
 
 
 
 
 
 
 
 
 
Sponsor:   
 
Ethicon Endo-Surgery, Inc. 
4545 Creek Road 
Cincinnati, OH 45242 
 
 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
The information in this document contains trade secrets and commercial information that are privileged or confidential 
and may not be disclosed unless such disclosure is required by federal or state law or regulations.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a need to know, but all 
such persons must be instructed not to further disseminate this information to others.  These restrictions on disclosure 
will apply equally to all future information supplied to you which is indicated as privileged or confidential. 
 
 
 
 

 
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INVESTIGATOR SIGNATURE 
 
I have read, understood, and agree to: 
 
Ensure that the requirements for obtaining informed consent are met; 
 
Conduct the study in accordance with this protocol, including applicable local laws and 
regulations; 
 
Maintain the confidentiality of all information received or developed in connection with 
this protocol; 
 
Report all serious adverse events as soon as possible, but no later than 24 hours after 
becoming aware of the event; 
 
Adhere to the publication policy , as stated in the Clinical Study Agreement, for data 
collected during this study; and 
 
Ensure that all associates, colleagues, and employees assisting in the conduct of the 
study are informed of their obligations in meeting the above commitments. 
 
I will ensure that the Institutional Review Board (IRB) / Ethics Committee (EC) review complies 
with governmental requirements and will be responsible for the initial and continuing review and 
approval of the clinical investigation.  I also agree to promptly report to the IRB/EC all changes 
in the research activity and all unanticipated problems involving risks to human subjects or 
others.  Additionally, I will not make any changes in the research without sponsor and IRB/EC 
approval of an amended protocol, except where necessary to eliminate apparent immediate 
hazards to human subjects. 
I agree to comply with all other requirements regarding the obligation of clinical investigators 
and all other pertinent requirements of the sponsor and government agencies. 
 
 
 
 
 
 
 
 
 Investigator Signature 
 
Date 
 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 

 
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SYNOPSIS 
 
Regulatory 
Classification:   
Class II Staple Implantable; Stapler, Surgical 21CFR 
878.4750. Cleared 11/24/2014, 510(k) # K141952 
CE Mark granted 02/27/2015, Certificate, G7 15 02 57666 
049 
Indication:   
The ECHELON FLEXTM Powered Vascular Stapler (PVS) 
with Advanced Placement Tip and its reloads are intended 
for transection and resection of tissue and vasculature.  
The instruments have application in multiple open or 
minimally invasive general, gynecologic, urologic, thoracic, 
and pediatric surgical procedures. The device will be 
utilized as described in the instruction for use (IFU). 

 
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Objective/Primary 
Endpoints:   
The primary objective of the trial is to demonstrate that the 
frequency of hemostatic interventions/procedures required 
intra-operatively or post-operatively related to the 
transection of the renal artery (RA) and renal vein (RV) 
during laparoscopic nephrectomies and 
nephroureterectomies with powered vascular stapler (PVS) 
is not increased when compared to standard of care (SOC). 
 
The primary performance endpoint will be: 
Incidence of hemostatic interventions/procedures 
completed for intra-operative bleeding related to the 
transection of the RA and RV during laparoscopic 
nephrectomies and nephroureterectomies with the use of 
standard of care stapler (SOC) or powered vascular stapler 
(PVS) defined as: 
 
Hemostasis intervention:  bleeding 
detected and controlled intra-operatively 
(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). 
 
No hemostasis intervention is defined as no bleeding at the 
staple line or bleeding that stops after initial blotting of 
staple line. 
 
The primary safety endpoint will be: 
Incidence of hemostatic interventions /procedures 
completed for post-operative bleeding related to the 
transection of the RA and RV during during laparoscopic 
nephrectomies and nephroureterectomies 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 
RA and RV transection). 
 
No hemostasis intervention is defined as no interventions 
needed for post-operative bleeding (related to RA and RV 
transection). 

 
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Study Design: 
This prospective, randomized, controlled, multi-center study 
will collect and compare data  from the surgeon’s current 
SOC stapler (for RA/RV transection) and powered vascular 
stapler.   
Number of 
Subjects 
(Planned): 
Approximately 250  subjects will be randomized 
Diagnosis/Criteria 
for Inclusion:   
Subjects satisfying the following criteria will be eligible for 
participation in this study: 
 
1.  Scheduled for a simple or radical  laparoscopic 
nephrectomy or a laparoscopic 
nephroureterectomy in accordance with the 
institution’s standard of care (SOC); 
2. Performance status 0-1 (Eastern     
Cooperative Oncology Group classification), if 
applicable; 
3. ASA score < 3;    
4. No prior history of partial or wedge 
nephrectomy (on the kidney in which the 
procedure will be performed); 
5. Willing to give consent and comply with study-
related evaluation and treatment schedule; 
and 
6. At least 18 years of age.  
 
Diagnosis/Criteria 
for Exclusion:   
Subjects will be excluded from the study for any of the 
following: 
1. Prior chemotherapy or radiation (within 30 
days prior to the procedure or the duration of 
the subject’s enrollment); 
2. Pregnancy; 
3. Physical or psychological condition which 
would impair study participation; or 
4. The subject is judged unsuitable for study 
participation by the Investigator for any other 
reason. 
 
Finished Product:   
ECHELON FLEXTM Powered Vascular Stapler with 
Advanced Placement Tip 

 
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Statistical 
Methods:   
Summary statistics and 95% confidence intervals will be 
provided for the number and frequency of interventions for 
the set of SOC and PVS subjects separately. This will be 
performed based on the total number of firings. An 
intervention is defined as any firing which is classified as 
hemostasis intervention.   Given that it is expected to have 
at least 300 firings in each group, the sample size of 
approximately 250 subjects is considered adequate for 
descriptive summarization of the number and frequency of 
surgical interventions. Assuming an approximate 
background intervention rate of 6%, the given sample size 
will provide reasonable precision in the estimation of the 
intervention rate to an expected margin of error for a 95% 
confidence interval of at most 2.9% for each group.  To 
establish that the intervention rate is not increased 
compared to SOC, a 95% confidence interval for the 
difference in proportion of firings requiring interventions for 
PVS minus SOC will be calculated and powered vascular 
stapler will be considered to have acceptable performance 
if the upper bound of the 95% confidence interval does not 
exceed 3%. 
The number and percentage of subjects requiring 
hemostasis interventions post-operatively that are classified 
as related to SOC or PVS for RA/RV transection (e.g. need 
for blood product transfusion or additional surgical 
procedure) will be summarized for each group as a primary 
safety endpoint.  
Additional endpoints will be summarized with descriptive 
statistics and 95% confidence intervals as appropriate for 
continuous or categorical measurements 
Safety will be assessed through the incidence of AEs and 
serious adverse events (SAEs), which will be coded using 
the Medical Dictionary for Regulatory Activities (MedDRA). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
 
Page 
INVESTIGATOR SIGNATURE ............................................................................................... 3 
SYNOPSIS .............................................................................................................................. 4 
SCHEDULE OF EVENTS .................................................................................................... 8 
ETHICS ................................................................................................................................. 11 
ADMINISTRATIVE REQUIREMENTS .................................................................................. 12 
1.0 
INTRODUCTION AND BACKGROUND ...................................................................... 13 
2.0 
STUDY OBJECTIVES ................................................................................................. 14 
2.1 
PRIMARY OBJECTIVE ............................................................................................... 14 
3.0 
INVESTIGATIONAL PLAN .......................................................................................... 14 
3.1 
GENERAL DESIGN ..................................................................................................... 14 
3.2 
PRIMARY ENDPOINTS .............................................................................................. 14 
3.3 
ADDITIONAL MEASUREMENTS / DATA COLLECTED ............................................. 15 
4.0 
INVESTIGATIONAL PLAN .......................................................................................... 15 
4.1 
OVERALL STUDY DESIGN ........................................................................................ 15 
4.2 
RANDOMIZATION ....................................................................................................... 16 
4.2.1 
INCLUSION CRITERIA............................................................................................ 16 
4.2.2 
EXCLUSION CRITERIA .......................................................................................... 16 
4.3 
PRIOR AND CONCOMITANT THERAPY ................................................................... 16 
4.3.1 
CONCOMITANT MEDICATIONS ............................................................................ 17 
4.4 
REMOVAL OF SUBJECTS FROM STUDY ................................................................. 17 
4.5 
IDENTITY OF STUDY PRODUCT(S) .......................................................................... 18 
4.6 
PRODUCT ACCOUNTABILITY ................................................................................... 18 
4.7 
STUDY PROCEDURES .............................................................................................. 19 
4.7.1 
PROCEDURE DESCRIPTION ................................................................................ 19 
4.7.2 
VISIT 1 – SCREENING (CAN OCCUR OVER SEVERAL DATES WITHIN 1-2 WEEKS 
OF VISIT 2- PROCEDURE) .................................................................................................. 19 
4.7.3 
VISIT 2 –PROCEDURE ........................................................................................... 19 
4.7.3.1 
PRE-PROCEDURE ............................................................................................. 19 
4.7.3.2 
INTRAOPERATIVE ............................................................................................. 19 
4.7.4 
VISIT 3 – POSTOPERATIVE THROUGH DISCHARGE ......................................... 20 
4.7.5 
VISIT 4-FINAL VISIT  (4 WEEK FOLLOW UP, POST PROCEDURE) .................... 21 
5.0 
DATA MANAGEMENT AND INTEGRITY .................................................................... 21 
5.1 
DATA COMPLETION AND RECORD KEEPING ........................................................ 21 
5.1.1  Source Documents ...................................................................................................... 21 
5.1.2  Electronic Data Capture ............................................................................................... 22 
5.1.3  Data Collection ............................................................................................................ 22 
5.1.4  Data Correction............................................................................................................ 22 
5.1.5  Data Privacy ................................................................................................................ 22 
5.1.6  Record Retention, Inspection, and Custody ................................................................ 23 

 
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5.2 
MEDICAL DICTIONARY CODING .............................................................................. 23 
6.0 
DATA QUALITY ASSURANCE ................................................................................... 23 
6.1 
INVESTIGATOR TRAINING ........................................................................................ 23 
6.2 
MONITORING ............................................................................................................. 23 
6.3 
PROTOCOL DEVIATIONS .......................................................................................... 24 
7.0 
STATISTICAL METHODS PLANNED IN THE PROTOCOL AND DETERMINATION OF 
SAMPLE SIZE ....................................................................................................................... 24 
7.1 
STATISTICAL AND ANALYTICAL PLANS .................................................................. 24 
7.2 
DETERMINATION OF SAMPLE SIZE ........................................................................ 24 
7.3 
ANALYSIS SETS ......................................................................................................... 24 
7.4 
ANALYSIS OF EFFECTIVENESS ............................................................................... 25 
7.5 
STATISTICAL/ANALYTICAL ISSUES ......................................................................... 25 
7.5.1 
HANDLING OF DROPOUTS OR MISSING DATA .................................................. 25 
7.5.2 
INTERIM ANALYSES AND DATA MONITORING ................................................... 25 
7.5.3 
MULTICENTER STUDIES ....................................................................................... 25 
7.5.4 
MULTIPLE COMPARISONS/MULTIPLICITY .......................................................... 25 
7.6 
ANALYSIS OF SAFETY .............................................................................................. 25 
8.0 
RISKS AND BENEFITS OF THE STUDY DEVICE AND CLINICAL INVESTIGATION26 
9.0 
ADVERSE EVENTS AND PRODUCT COMPLAINTS ................................................ 26 
9.1 
DEFINITIONS .............................................................................................................. 26 
9.1.1 
ADVERSE EVENT ................................................................................................... 26 
9.1.2 
ANTICIPATED ADVERSE EVENTS ........................................................................ 26 
9.1.3 
SERIOUS ADVERSE EVENT .................................................................................. 26 
9.1.4 
SEVERITY OF ADVERSE EVENTS ........................................................................ 27 
9.1.5 
RELATIONSHIP OF ADVERSE EVENTS ............................................................... 27 
9.1.6 
PRODUCT COMPLAINTS ....................................................................................... 28 
9.2 
REPORTING PROCEDURES FOR ADVERSE EVENTS/PRODUCT COMPLAINTS 28 
8 
28 
9.2.1 
REPORTING ADVERSE EVENTS .......................................................................... 28 
9.2.2 
REPORTING SERIOUS ADVERSE EVENTS ......................................................... 28 
9.2.3 
REPORTING PRODUCT COMPLAINTS ................................................................ 29 
10.0 
REFERENCE LIST .................................................................................................. 29 
APPENDIX I:  ANTICIPATED ADVERSE EVENTS .............................................................. 30 
 
 
 

 
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ETHICS 
Institutional Review Board/Ethics Committee 
Participating investigators will ensure that this protocol, Informed Consent Document (ICD), ICD 
or protocol amendments, and if applicable, any other written information provided to the 
subjects that assist in the decision to participate are reviewed by an Institutional Review Board 
(IRB) or Ethics Committee (EC) that complies with governmental requirements. The approving 
IRB/EC will be responsible for the initial and continuing review and approval of this clinical 
investigation.  Participating investigators will be required to promptly report to the IRB/EC as 
required by the IRB/EC’s policies.  Additionally, investigators will be required to refrain from 
making any changes in the clinical investigation plan without Sponsor and IRB/EC approval of 
an amended protocol, except where necessary to eliminate apparent immediate hazards to 
study subjects or others. 
Applicable Regulations  
This study will be conducted in compliance with Good Clinical Practice and in accordance with 
the Declaration of Helsinki, ISO 14155:2011, as well as any other applicable local and country 
regulatory requirements. 
Subject Information and Consent 
Regulations concerning the protection of subjects require that informed consent be obtained 
before a subject may participate in any clinical investigation.   
An IRB/EC approved informed consent must be sought from each subject and must be 
appropriately documented in the subject’s medical record prior to initiating the study. It is the 
Investigator’s responsibility to obtain written informed consent from the subject.  The 
Investigator may delegate this responsibility if appropriately documented. 
The informed consent process involves the following: giving a subject adequate information 
concerning the study, providing adequate time for the subject to consider all available options, 
responding to the subject’s questions, ensuring that the subject has comprehended this 
information and finally, obtaining the subject’s written consent to participate in this study.  All 
subjects in this study should be completely informed about the purpose, risks, benefits, and 
other pertinent details of this study.  The informed consent process is careful to avoid the 
perception of any coercion or undue influence on, or inducement of, the subject to participate, 
and does not waive or appear to waive the subject's legal rights.  The ICD is presented in 
native, non-technical language that is understandable to the subject. 
Prior to a subject’s participation in this study, an ICD will be signed and dated by the subject and 
person who conducted the consent discussion. The subject will be provided a copy of the 
signed ICD.  The ICD and any other written materials provided to the subject to assist in the 
decision to participate must be revised whenever new information becomes available that may 
be relevant to their willingness to participate or continue participation in this study.  Revision to 
the ICD and other written materials will receive IRB/EC approval before implementation.  Each 
subject will be required to sign any amended ICD (as required by the IRB/EC) and will receive a 
copy of the signed ICD.   
 
 
 
 
 

 
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ADMINISTRATIVE REQUIREMENTS 
This study is sponsored by Ethicon Endo-Surgery, Inc. (EES, Cincinnati, OH, USA) and will be 
conducted in approximately eight surgery centers in the United States and/or European Union 
under a single protocol approved by each participating site’s IRB/EC prior to implementation.   
The principal investigator at each study site is a surgeon qualified by education, experience, and 
training to perform the study procedure and to assume responsibility for the conduct of this 
study.  
 
The Data Management and Biostatistics groups of Ethicon Endo-Surgery, Inc.’s Global Surgery 
Clinical Development will be responsible for the analysis of data from this protocol.  An 
Electronic Data Capture (EDC) system will be utilized by study site personnel to transfer study 
data from source records (the first point of clinical data capture) onto common electronic case 
report forms (eCRFs). This system is a web-based, secure electronic software application 
(Medidata® Rave, 350 Hudson Street, 9th Floor, New York, New York, 10014).  This system 
was designed and is developed and maintained by Medidata in a manner that is compliant with 
national and international Good Clinical Practice (GCP) data protection/data privacy and 
electronic record/electronic signature (e.g. 21 CFR Part 11) regulatory requirements. 
 
Protocol Modifications 
All protocol amendments must be issued by the Sponsor, signed and dated by the Investigator, 
and should not be implemented without prior IRB/EC only logistical or administrative aspects of 
the study (e.g., change in Sponsor personnel, change of telephone number(s)). The Investigator 
will submit the protocol amendments to the IRB approval, except where necessary to eliminate 
immediate hazards to the subjects or when the change(s) involves /EC as per their local 
requirements. 
 

 
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1.0 
INTRODUCTION AND BACKGROUND 
Nephrectomy has many indications, for both simple and radical approaches. A simple 
nephrectomy is indicated in patients with irreversible kidney damage due to symptomatic 
chronic infection, obstruction, calculus disease, or severe traumatic injury. Simple nephrectomy 
is also indicated to treat renovascular hypertension due to noncorrectable renal artery disease 
or severe unilateral parenchymal damage caused by nephrosclerosis, pyelonephritis, reflux 
dysplasia, or congenital dysplasia of the kidney. 1 
Surgery (traditional or laparoscopic) is the primary treatment for most renal cancers2 while 
laparoscopic donor nephrectomy has remained a safe, less invasive, and effective technique for 
renal allograft procurement.3 
The most common reason for a nephroureterectomy (removal of the kidney and ureter) is 
transitional cell carcinoma.  Transitional cell carcinoma is a cancer that occurs within the 
transitional epithelium of the kidney, ureter, and/or bladder.  
The surgical procedures performed under this protocol are simple or radical laparoscopic 
nephrectomies or nephroureterectomies.  The laparoscopic approach typically utilizes several 
small incisions in the abdominal and/or flank area. Through these incisions, a surgeon uses a 
camera and specialized surgical instruments to conduct the operation and remove the entire 
affected kidney (and some of the surrounding tissues if indicated).   Laparoscopic nephrectomy 
is associated with less postoperative pain and a faster return to normal activities than open 
nephrectomy.4        
The ECHELON FLEXTM Powered Vascular Stapler with Advanced Placement Tip can transect 
vessels in restricted narrow spaces near delicate vascular anatomy.    With its narrow anvil and 
curved dissection tip, this stapler enhances visibility and provides precise placement.  
 
 

 
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2.0 
STUDY OBJECTIVES 
2.1 PRIMARY OBJECTIVE 
The primary objective of the study is to demonstrate that the frequency of hemostatic 
interventions/procedures required intra-operatively or post-operatively related to the 
transection of the renal artery (RA) and renal vein (RV) during simple, radical laparoscopic 
nephrectomies or laparoscopic nephroureterectomies with PVS is not increased when 
compared to standard of care (SOC).  
 
3.0 
INVESTIGATIONAL PLAN 
3.1 GENERAL DESIGN 
This prospective, randomized, controlled, multi-center study will collect and compare data 
from the surgeon’s current SOC stapler (for RA/RV transection) and PVS. Approximately 250 
individuals undergoing simple or radical laparoscopic nephrectomies or laparoscopic 
nephroureterectomies, and who meet study entry criteria, will be randomized in a 1:1 ratio to 
either the surgeon’s current SOC stapler or PVS.  Prospective subjects will be informed about 
the nature of the research, given the ICD to read, and if the subject understands the consent, 
will be asked to provide written consent (the ICD).   
 
3.2 PRIMARY ENDPOINTS 
The primary performance endpoint will be: 
 
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding 
related to the transection of the RA and RV during laparoscopic nephrectomies and 
nephroureterectomies with the use of standard of care stapler (SOC) or powered vascular 
stapler (PVS) defined as: 
 
Hemostasis intervention:  bleeding detected and controlled intra-operatively 
(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). 
 
No hemostasis intervention is defined as no bleeding at the staple line or bleeding that stops 
after initial blotting of staple line. 
 
The primary safety endpoint will be: 
 
Incidence of hemostatic interventions /procedures completed for post-operative bleeding 
related to the transection of the RA and RV during laparoscopic nephrectomies and 
nephroureterectomies 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 RA and RV transection). 
 

 
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No hemostasis intervention is defined as no interventions needed for post-operative 
bleeding (related to RA and RV transection). 
 
3.3 ADDITIONAL MEASUREMENTS / DATA COLLECTED 
a. Subject demographics;  
b. All adverse events; 
c. Anticoagulants taken preoperatively (up to 30 days prior to Visit 2) and concomitant 
medications associated with AEs; 
d. Relevant medical/surgical history (including hypertension, if applicable); 
e. Procedure details; 
f. 
Number of ports; 
g. Overall operating room and procedure duration; 
h. Intraoperative and postoperative surgical interventions (not associated with 
transection of the RA/RV), if applicable; 
i. 
Volume of estimated intra-operative blood loss; 
j. 
Date(s) of drain removal; 
k. Daily volume and characteristics of drainage; 
l. 
Transfusion of blood or blood  products;  
m. Device usability /articulation questions;   
n. Surgeon assessment of visualization; 
o. Surgeon Questionnaires; 
p. Concomitant procedures/interventions, if applicable; and 
q. Length of stay (LOS) from admission through discharge. 
 
The data collected for this study may be used for future research or enhancement of 
similar surgical tools. 
 
4.0 
INVESTIGATIONAL PLAN 
4.1 OVERALL STUDY DESIGN  
This is a prospective, randomized, controlled, multi-center study that is intended to 
demonstrate that the frequency of hemostatic interventions/procedures required intra-
operatively or post-operatively related to the transection of the renal artery (RA) and renal vein 
(RV) during simple, radical laparoscopic nephrectomies or laparoscopic nephroureterectomies 
with PVS is not increased when compared to standard of care (SOC).  
Eligible subjects will be randomized pre procedure in a 1:1 ratio to either the surgeon’s current 
SOC stapler or PVS. Subjects will be followed post-operatively through discharge and at 4 
weeks post surgery (final visit can be conducted either by phone or office visit). 
If the study surgeons have not completed previous ECHELON FLEXTM Powered Vascular 
Stapler with Advanced Placement Tip training, each surgeon must complete two procedures 
with ECHELON FLEXTM Powered Vascular Stapler with Advanced Placement Tip prior to their 
first randomized subject.  These subjects will be considered part of a learning curve and will be 
analyzed separately from the randomized subjects.   

 
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4.2 RANDOMIZATION 
In this non blinded study, randomization will be used to avoid bias in the assignment of the 
stapling device to be utilized for RA/RV transection for each subject, to increase the likelihood 
that attributes of the subject are evenly balanced between groups, and to enhance the validity 
of statistical comparisons between groups.  
The Sponsor will assign the stapling device randomly to each subject on a 1:1 basis to either 
the surgeon’s current SOC or PVS.  
In the event that a potential subject fails inclusion/exclusion criteria prior to randomization, this 
subject will be considered a screen failure. 
4.2.1 Inclusion Criteria 
Subjects satisfying the following criteria will be eligible for participation in this study: 
1. Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic 
nephroureterectomy  in accordance with the institution’s standard of care (SOC);  
2. Performance status 0-1 (Eastern Cooperative Oncology Group classification), if 
applicable; 
3.  ASA score < 3; 
4.  No prior history of partial or wedge nephrectomy (on the kidney in which the 
procedure will be performed); 
5.  Willing to give consent and comply with study-related evaluation and treatment 
schedule; and 
6.  At least 18 years of age.  
 
4.2.2 Exclusion Criteria 
Subjects will be excluded from the study for any of the following: 
1.  Prior chemotherapy or radiation (within 30 days prior to the procedure or the 
duration of the subject’s enrollment); 
2. Pregnancy; 
3. Physical or psychological condition which would impair study participation; or 
4. The subject is judged unsuitable for study participation by the Investigator for any 
other reason 
 
All subjects signing consent who do not meet the inclusion/exclusion criteria and therefore 
do not proceed to Visit 2/Procedure, and are not randomized, will be recorded as screen 
failures. The relevant electronic Case Report Form (eCRF) pages will be completed for all 
screen failure subjects and the data will therefore be included in the study database. 
 
4.3 
PRIOR AND CONCOMITANT THERAPY 
Study subjects may continue with their current medical care while in the study, including 
medications.   
 

 
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4.3.1 Concomitant Medications  
Anticoagulants taken preoperatively (up to 30 days prior to Visit 2) and medications 
prescribed due to an adverse event will be collected for this study.  No other concomitant 
medications will be collected. 
 
4.4  REMOVAL OF SUBJECTS FROM STUDY 
A subject has the right to withdraw from the study at any time for any reason without 
prejudice to his/her future medical care by the physician or the institution.  Should a subject 
(or subject’s legally authorized guardian/representative) decide to withdraw; all efforts will be 
made to collect and report the final visit observations as thoroughly and timely as possible.   
Subjects who withdraw from the study prior to randomization will be considered screen 
failures and will be replaced. Subjects who withdraw from the study post-randomization, will 
not be replaced. Subject participation may be terminated prior to completing the study for any 
of the reasons listed below.  When a subject’s participation is terminated prior to completing 
the study, the reason for withdrawal is to be documented on the Study Completion eCRF as 
well as in the source documentation:   
 
Withdrawal of Consent: 
The subject withdraws consent for participation in the study.  Any method of contact with the 
subject in which they state they no longer want to participate in the study specific activities 
constitutes withdrawal of consent.  When possible the reason for withdrawal of consent will 
be documented. 
 
Surgical: 
The Investigator must withdraw a subject intraoperative for the following reasons: 
 A simple or radical laparoscopic nephrectomy or laparoscopic nephroureterectomy 
not completed; 
 Conversion to an open procedure, unless directly related to transection of the 
RA/RV (subject will be followed for safety up to 30 days postop); or 
 Use of robotic assistance during surgery. 
 
Adverse Event: 
 
When the subject experiences an adverse event and the Principal Investigator or 
Medical Director believes it is in their best interest to discontinue participation in 
the study, they will be withdrawn.  
 
Death: 
When possible, the cause of death will be documented. 
 
Lost to follow-up: 
When contact with the subject has been lost without completing a final visit assessment, and 
every attempt to contact has failed, the subject will be considered lost to follow-up.  Final 

 
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The powered vascular staplers must be kept in a secure area.  Devices will only be used 
for treating subjects participating in the study, in accordance with the protocol.  The 
study device inventory must be available for periodic inspection/verification. 
 
4.7 STUDY PROCEDURES 
4.7.1 Procedure Description 
A simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy will be 
performed according to the institution’s SOC.    
 
4.7.2 Visit 1 – Screening (can occur over several dates within 1-2 weeks of Visit 
2- Procedure) 
Subjects will be evaluated according to the local investigator’s preferred practice. Subjects 
will be selected for a surgical procedure based on the preoperative investigations and the 
local investigator’s interpretation of the clinical picture.  
Eligible subjects will be provided with the study information including the ICD.  
The following screening activities will occur prior to the study procedure: 
 
The subject must be given ample time to review and sign the ICD; 
 
Collection of demographic information (year of birth, gender, ethnicity); 
 
Review and collection of relevant medical/surgical history, history of hypertension 
if applicable; 
 
Review/collection of inclusion/exclusion criteria and determination as to whether 
the subject is eligible for participation (retrospective data, per site SOC, is 
permitted to determine eligibility); and  
 
Anticoagulants taken preoperatively (up to 30 days prior to Visit 2), including stop 
date 
 
4.7.3 Visit 2 –Procedure  
4.7.3.1 Pre-procedure  
The following must be obtained prior to the surgical procedure: 
 
Date of hospital admission; 
 
Update to medical / surgical history, if applicable; 
 
Confirm inclusion and exclusion criteria; 
 
ASA score; and 
 
Randomization 
 
4.7.3.2 Intraoperative  
Data collected during procedure: 
 
Overall Operating Room (OR) time ; 

 
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 
Duration of procedure (first incision to skin closure); 
- 
Includes time to completion of resection (capturing the time 
laparoscopic camera is inserted until the specimen is received) 
 
Procedure data: 
- 
Type of surgery; 
- 
Number of renal arteries (1, 2, or 3+); 
- 
Location of affected kidney; 
- 
Confirm visualization of the cut line indicator field prior to transection; 
- 
Number of ports; 
- 
Intraoperative surgical interventions (not associated with transection 
of the RA/RV), if applicable; 
- 
Number and type of drain tubes placed, if applicable; 
- 
Reason for conversion to open surgery, if applicable; 
- 
Volume of estimated intra-operative blood loss; 
- 
Transfusion products (and rationale for use), if applicable; 
- 
Concomitant procedures/interventions performed, if applicable; 
- 
Tumor size and TNM staging, if available or applicable 
 
Intra-operative interventions/procedures on RA/RV to stop bleeding, if 
applicable; 
- 
Hemostasis intervention:  bleeding detected and controlled intra-
operatively (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). 
 
Device usage data: 
- 
Usability and articulation questions; 
 
Surgeon Device Questionnaire (PVS procedures only);  
 
Surgeon Satisfaction Questionnaire (SOC and PVS procedures);  
 
SURG-TLX (SOC and PVS procedures); 
 
Adverse Events; and 
 
Concomitant medication (associated with AEs) 
 
4.7.4 Visit 3 – Postoperative through Discharge 
Post procedure assessments will be completed from OR discharge until hospital 
discharge.  Data to be collected includes: 
 
Post-operative  interventions/procedures related to RA/RV bleeding, if 
applicable: 

 
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- 
Hemostasis intervention:  bleeding that occurs post-operatively 
requiring blood or blood product transfusion or an additional 
surgical procedure (and the relationship to SOC/PVS for RA/RV 
transection); 
 
Date of drain removal, if applicable 
 
Daily volume and characteristics of drainage (drain); 
 
Concomitant procedures/ interventions performed, if applicable; 
 
Adverse Events;  
 
Concomitant medication (associated with AEs); and  
 
Discharge date 
 
4.7.5 Visit 4-Final Visit  (4 week follow up, post procedure) 
This visit can be either an office visit or a telephone followup visit.  Data to be collected 
includes: 
 
Post-operative  interventions/procedures related to RA/RV bleeding, if 
applicable: 
- 
Hemostasis intervention:  Bleeding that occurs post-operatively 
requiring blood or blood product transfusion or an additional surgical 
procedure (and the relationship to SOC/PVS for RA/RV transection); 
 
Concomitant procedures/interventions performed, if applicable; 
 
Date of drain removal, if applicable 
    Daily volume and characteristics of drainage (drain), if applicable; 
 
Adverse Events;  
 
Concomitant medication (associated with AEs); and 
 
Subject exited from the study 
 
5.0 
DATA MANAGEMENT AND INTEGRITY 
5.1 DATA COMPLETION AND RECORD KEEPING 
5.1.1 
Source Documents 
Source documents are documents on which information regarding subjects is 
first recorded, including printed, hand written, or electronic documents.  
Investigator subject files or hospital records generally are the basis of source 
document information.  This includes but is not limited to, original subject files; 
hospital/clinic records; original recordings /tracing; digital images from automated 
instruments (e.g., cameras); radiographs; device accountability records; 
photographic negatives; and records kept at the investigation site, at the 
laboratories and at other departments involved in the clinical investigation. 
Source documents must be retained by the Investigator as part of the subject’s 
permanent medical record. The information in the source documents is used to 
complete the eCRFs. All information captured on the eCRFs should be 
completely and accurately supported in source documentation. Any additional 

 
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information relevant to the study should be included in the source documents. 
The Investigator will retain originals of all source documents, subject consent 
forms, and study data.  
5.1.2 
Electronic Data Capture 
An electronic data capture (EDC) system will be utilized by study site personnel 
to transfer study data from source records (medical records and/or source 
document worksheets) onto common eCRFs. This system is a web-based, 
secure electronic software application (Medidata® Rave, Medidata® Rave, 350 
Hudson Street, 9th Floor, New York, New York, 10014). This system was 
designed and is developed and maintained by Medidata in a manner that is 
compliant with national and international GCP data protection/data privacy and 
electronic record/electronic signature (e.g., 21 CFR Part 11) regulatory 
requirements. The EDC system will be used to facilitate the collection of all study 
data at the site. Designated site personnel will be responsible for entering subject 
data into the EDC system. All external and Sponsor internal users will be trained 
on the EDC application at a level dependent on their planned function. An EDC 
digital User Manual will be available under the help menu within the Medidata® 
Rave website to assist in the collection and entry of source data into the 
electronic casebook.   
 
There is a 24/7/365 Help Desk Support line 
 
staffed by the outsourced vendor that will be available to respond to questions. 
 
5.1.3 
Data Collection 
Each EDC eCRF will be completed by the PI or PI’s designee. Every effort 
should be made to respond to all monitoring and/or data management questions 
on each eCRF as completion of the data is required by the protocol. A unique ID 
number will identify each subject.  The subject’s unique ID number will be visible 
on each eCRF. At no time should the subject name appear on the eCRFs.  
All data should be recorded accurately and completely. The Investigator is 
responsible for reviewing and approving each completed eCRF. Assurance of 
overall review and approval will be documented by the Investigator electronically 
signing each subject’s electronic casebook. 
5.1.4 
 Data Correction 
Required data corrections to eCRFs will be prompted via automated electronic 
edit checks and/or queries manually created by Sponsor reviewers. The 
change(s), individual making the change(s), and time the change(s) were made 
to the eCRFs will be automatically captured in the audit trail within Medidata® 
Rave. 
5.1.5 
Data Privacy 
The collection, use, and disclosure of all personal data, including subject health 
and medical information, are to be maintained in compliance with applicable 
personal data protection and security laws and regulations that govern protected 
health information and the informed consent given by each study subject. When 
collecting and processing such personal data, appropriate measures are to be 
taken to maintain the confidentiality of subject health and medical information and 

 
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to prevent access by unauthorized persons. 
5.1.6 
Record Retention, Inspection, and Custody 
The PI must maintain all documentation related to the study until they receive 
Sponsor notification.  The PI will allow representatives of the Sponsor, the FDA, 
or other applicable government regulatory agencies to inspect all study records, 
eCRFs, and corresponding portions of the subject’s office and/or hospital medical 
records at regular intervals during the study. These inspections are to verify 
adherence to the protocol, integrity of the data being captured on the eCRFs, and 
compliance with applicable regulations. 
Subject medical records will be maintained in a confidential manner. Study 
reports will not identify subjects by name. These reports may be submitted to the 
FDA and/or applicable regulatory authorities.  
If custody of the records is transferred, notice of such a transfer should be given 
to the Sponsor no later than 10 working days after the transfer occurs. 
5.2 MEDICAL DICTIONARY CODING 
Medical dictionary coding of verbatim AE, and SAE captured on eCRFs will be performed 
using a coding thesaurus algorithm. The Medical Dictionary for Regulatory Activities and 
World Health Organization Drug Dictionary will be used after data entry and query 
resolution, via auto-encoding and interactive coding processes. 
 
6.0 
DATA QUALITY ASSURANCE 
Steps to be taken to assure the accuracy and reliability of data include the selection of 
qualified investigators and appropriate study centers, review of protocol procedures with 
the Investigator and associated personnel prior to the study, and periodic monitoring visits 
by the Sponsor.  The Sponsor will review eCRFs for accuracy and completeness during 
on-site monitoring visits or periodic reviews of the EDC system; any discrepancies will be 
resolved with the Investigator or designees, as appropriate.  The data entered into the 
clinical study database will be verified for accuracy. 
 
6.1 INVESTIGATOR TRAINING 
Prior to screening subjects for this study, the PI, sub-investigators, study coordinators, 
and other designated staff (as applicable) will be provided information on study 
execution, data collection, and procedures specific to this clinical protocol. 
6.2 MONITORING 
This study will be monitored by the Sponsor to ensure: 
 
The rights and well-being of the subjects are protected; 
 
Reported study data is accurate, complete, and verifiable from source 
documents; and 
 
The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), applicable GCPs, and with applicable local/regional 
regulatory requirements. 
The extent and nature of monitoring will be predetermined and based on considerations 

 
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such as the objective, design, complexity, and endpoints of the study and mutually 
agreed to by the Sponsor and investigators. Monitors will comply with established written 
standard operating procedures as well as procedures (i.e., monitoring plan) specified by 
the Sponsor for monitoring this study.  These monitoring procedures are characterized in 
the monitoring plan for this study. 
 
6.3 PROTOCOL DEVIATIONS 
A deviation (any activity conducted outside the parameters established by the study 
protocol) can be identified from a number of sources.  Potential sources include, but are 
not limited to: a member of the Investigator’s staff, a Sponsor representative during 
monitoring visits, or a member of the data management or statistical groups when entering 
or analyzing data.  Regardless of the source, it is crucial to document the deviation.  The 
PI will report protocol deviations to the IRB/EC as required by the IRB/EC procedures.  All 
deviations will be captured in the source as well as the eCRF. 
 
7.0 
STATISTICAL METHODS PLANNED IN THE PROTOCOL AND 
DETERMINATION OF SAMPLE SIZE 
7.1 STATISTICAL AND ANALYTICAL PLANS 
The Sponsor’s Data Management and Biostatistics groups will be responsible for the 
analysis of data from this protocol. A comprehensive and detailed Statistical Analysis Plan 
(SAP) will be finalized prior to database lock and will supplement the statistical design and 
analysis described in this section. 
Categorical variables will be summarized descriptively by frequencies and associated 
percentages. Continuous variables will be summarized descriptively by number of 
subjects, mean, standard deviation, median, minimum, and maximum. 
7.2 DETERMINATION OF SAMPLE SIZE 
Approximately 250 subjects will be randomized in the study in a 1:1 ratio to standard of 
care or powered vascular stapler.  Historical clinical study data on a similar powered 
surgical stapler demonstrated a need for staple line interventions in approximately 6% of 
firings on the pulmonary artery or pulmonary vein. This data also showed an average of 
2.6 to 2.9 firings per subject, and it is expected, given differences in device design and 
procedure, that each subject will require 2 to 3 firings on the renal vein or renal artery in 
the current study with powered vascular stapler.  
Given that it is expected to have a minimum of 300 firings in each group, the sample size 
of approximately 250 subjects is considered adequate for descriptive summarization of the 
primary performance endpoint, i.e. number and frequency of intra-operative surgical 
interventions. Assuming an approximate background intervention rate of 6%, the given 
sample size will provide reasonable precision in the estimation of the intervention rate to 
an expected margin of error for a 95% confidence interval of at most 2.9% for each group. 
7.3 ANALYSIS SETS 
There will be three analysis sets defined: 
 
The Full Analysis Set (FAS) will consist of all randomized subjects who had the 

 
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procedure performed and provide data on number of surgical interventions; 
 
The Per Protocol (PP) Analysis Set will consist of all subjects in the FAS who had 
no major protocol violations; 
 
The Safety Set consists of all randomized subjects on whom the procedure is 
started. 
The primary performance endpoint analysis will be performed on the Full Analysis Set and 
subjects will be classified according to their randomized treatment group.  The primary 
endpoint analysis will also be performed on the PP set as a sensitivity analysis to the 
results on the FAS. The summary of additional endpoints will also be performed on the 
Full Analysis Set.   Analysis of the primary safety endpoint and adverse event summaries 
will be performed on the Safety Set.   
7.4 ANALYSIS OF EFFECTIVENESS 
Summary statistics and 95% confidence intervals will be provided for the number and 
frequency of interventions for the set of SOC subjects and PVS subjects separately. This 
will be performed based on the total number of firings. An intervention is defined as any 
firing which is classified as hemostasis intervention.  To establish that the intervention rate 
is not increased compared to SOC, a 95% confidence interval for the difference in 
proportion of firings requiring interventions for PVS minus SOC will be calculated and 
powered vascular stapler will be considered to have acceptable performance if the upper 
bound of the 95% confidence interval does not exceed 3%.  
Additional endpoints will be summarized with descriptive statistics and 95% confidence 
intervals as appropriate for continuous or categorical measurements.   
7.5 STATISTICAL/ANALYTICAL ISSUES 
7.5.1 
Handling of Dropouts or Missing Data 
All summaries will be performed only on subjects undergoing the surgical procedure 
and only observed data will be summarized. There will be no imputation of data for 
early terminated subjects or for missing data within the database. 
7.5.2 
Interim Analyses and Data Monitoring 
No interim analysis is planned for this study. 
7.5.3 
Multicenter Studies 
No adjustment for center is planned in the statistical analysis. Center specific 
analyses may be conducted pending within-center sample size to understand the 
effect that surgeon techniques and site standard of care may have on the overall 
results.  
7.5.4 
Multiple Comparisons/Multiplicity 
No adjustment for multiplicity is necessary since multiple hypotheses are not being 
tested. 
7.6 ANALYSIS OF SAFETY 
The number and percentage of subjects requiring hemostasis interventions post-
operatively that are classified as related to SOC/PVS for RA/RV transection (e.g. need for 
blood product transfusion or additional surgical procedure) will be summarized for each 

 
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group as a primary safety endpoint.  
Safety will be assessed through the incidence of AEs and serious adverse events (SAEs), 
which will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). The 
incidence of AEs will be summarized at the MedDRA system organ class and preferred 
term level. Incidence of AEs will also be summarized by maximum severity. All reported 
adverse events will be listed.  
8.0 
RISKS AND BENEFITS OF THE STUDY DEVICE AND CLINICAL 
INVESTIGATION 
The procedure being performed with powered vascular stapler is identical to the 
procedure subjects would receive as part of their standard of care procedure. To date, 
no risks have been reported beyond standard risks associated with simple laparoscopic 
nephrectomies and laparoscopic nephroureterectomies.   This study may or may not 
provide any benefits to the subject.  
9.0 
ADVERSE EVENTS AND PRODUCT COMPLAINTS 
9.1 DEFINITIONS 
9.1.1 
Adverse Event 
An adverse event is defined as any undesirable clinical occurrence in a subject that 
may or may not be attributable to the device or procedure. All AEs, regardless of 
their relationship to the procedure or device, are to be recorded in the eCRF and 
reported to the Sponsor.   
In addition, the Investigator is required to provide: 
 
The onset and resolution dates of the event; 
 
The severity of the event; 
 
The outcome of the event; 
 
The relationship of the event to procedure and/or device (ECHELON 
FLEX™ Powered Vascular Stapler with Advanced Placement Tip or 
standard of care stapler); and 
 
The action taken for the medical management of the event. 
Postoperative pain is expected and will not be documented as an adverse event 
unless the Investigator considers the pain to exceed what is typically anticipated 
following a laparoscopic nephrectomy or laparoscopic nephroureterectomy. (This 
data is separate from incisional and/or trocar pain).  
9.1.2 
Anticipated Adverse Events 
An expected morbidity/procedural complication is defined as an AE that is known to 
be common or usual in nature, severity, or incidence during laparoscopic 
nephrectomies/ nephroureterectomies. 
A list of anticipated AEs that may occur during this study are listed in Appendix I. 
9.1.3 
Serious Adverse Event  
It is the Investigator’s responsibility to determine if an AE is an SAE. 

 
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SAEs are AEs that: 
 
Led to death, 
 
Led to serious deterioration in the health of the subject, that either resulted 
in 
- 
a life-threatening illness or injury, or 
- 
a permanent impairment of a body structure or a body function, or 
- 
in-patient or prolonged hospitalization, or 
- 
medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function, 
- 
Led to fetal distress, fetal death or a congenital abnormality or birth 
defect 
 
Note:  “Death” should not be reported as an adverse event.  The cause of death 
should be reported as an adverse event.  The only exception is “Sudden Death” 
when the cause is unknown. 
9.1.4 
Severity of Adverse Events 
It is the Investigator’s responsibility to assess the severity of an AE.  A change in 
severity may constitute a new reportable AE. 
The following guideline should be used to determine the severity of each adverse 
event: 
 
MILD:  Awareness of experience, but easily tolerated. No medical intervention 
required. 
 
MODERATE: Enough discomfort to interfere with usual activities. Medical 
intervention required. 
 
SEVERE: Inability to carry out usual activities.  Medical intervention (including 
hospitalization or prolongation of hospitalization) required. 
 
9.1.5 
Relationship of Adverse Events 
It is the Investigator’s responsibility to assess the relationship of an AE to the study 
procedure (laparoscopic nephrectomies/ nephroureterectomies) and powered 
vascular stapler or SOC. 
The following guidelines should be used in determining the relationship of an 
adverse event to the study device, study procedure, or other causality: 
 
Not Related – A clinical event (including abnormal laboratory result) that results 
from causes extraneous to administration of device/procedure/other and is most 
likely due to alternative etiology, (i.e., pre-existing condition, underlying disease, 
intercurrent illness, concomitant medications); 
 
Possibly – A clinical event (including abnormal laboratory result) that presents 
an unlikely association between device/procedure/other, which cannot be ruled 
out with certainty, but could also be explained by alternative etiology; 
 
Related– A clinical event (including abnormal laboratory result) that presents a 

 
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strong temporal relationship between device/procedure/other, in which an 
alternative etiology is unlikely; or 
 
Unknown – A clinical event (including abnormal laboratory result) that cannot 
be determined to be related or unrelated to device/procedure/other given the 
information obtained. 
 
9.1.6 
 Product Complaints 
A product complaint is defined as any written, electronic or oral communication that 
alleges deficiencies related to the identity, labeling, quality, durability, reliability, 
safety, effectiveness, or performance of a device (i.e., stapler) after it is released for 
distribution (policy of Johnson and Johnson Medical Device Quality 
management).  A product complaint may or may not be associated with an 
AE/SAE.   
 
9.2 REPORTING PROCEDURES FOR ADVERSE EVENTS/PRODUCT 
COMPLAINTS 
8  
 
  
9.2.1 
Reporting Adverse Events 
Data related to AEs will be recorded in the source documentation from the time of 
study enrollment (first incision) until the subject completes the study or terminates 
early. All AEs that are unresolved at study completion (or early termination) will be 
recorded as ongoing at study end. 
Data related to SAEs will be collected until event resolution, or until the event is 
considered stable, or until all attempts to determine the resolution of the event are 
exhausted. 
9.2.2 
Reporting Serious Adverse Events 
The site must complete the SAE eCRF within 24 hours of becoming aware of the 
event.    
Supporting SAE documentation can be faxed to: 
 
 
 
The Investigator will also be required to assess if the SAE is considered anticipated 
(see Appendix I) and if the event involved a product complaint. The report of an SAE 
by a study site does not constitute an admission that study personnel or the user 
facility (hospital/clinic) caused or contributed to the event. 
The study site is also responsible for submitting to the reviewing IRB/EC according to 
their IRB/EC procedures. 

 
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9.2.3 
Reporting Product Complaints 
All product complaints related to powered vascular stapler shall be documented 
throughout the clinical investigation.   
Product complaints related to powered vascular stapler must be reported to the 
Sponsor in a timely manner and no later than 24 hours after becoming aware of the 
event.  The Product Complaint Form must be emailed to the EES Customer 
Complaint team at the following email address: 
 
One copy of the processed form should be kept on-site and the device should be 
retained. EES representatives will organize collection of the device for evaluation as 
needed. 
 
10.0 REFERENCE LIST 
1. Santucci, R., Al-Qudah, H., (2013) “Radical Nephrectomy” , Medscape, accessed March 5, 
2015, http://emedicine.medscape.com/article/448878-overview#showall  
2. “Cancer Facts & Figures 2014”, American Cancer Society, Inc., accessed March 5, 2015, 
http://www.cancer.org/acs/groups/content/%40research/documents/webcontent/acspc-
042151.pdf  
3. Su, L., Ratner, L., Montgomery, R., Jarrett, T., Trock, B., Sinkov, V., Bluebond-Langner, R., 
Kavoussi, L (2004, Aug).  Annals of Surgery, Volume 240(2): 358-363 
4. Burgess, N. A., Koo, B. C, Calvert, R. C., Hindmarsh, A, Donaldson, P.J., Rhodes, M. 
(2007). Journal of Endourology; Volume 21, Issue 6: 610-613 
 
 
 
 
 
 
 
 
 

 
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APPENDIX I:  ANTICIPATED ADVERSE EVENTS 
 
Associated with Surgery and  
General Anesthesia 
Simple/Radical Laparoscopic Nephrectomy or 
Laparoscopic Nephroureterectomy Surgery 
Specific 
Acute Lung Injury 
Air/Gas Embolism  
Acute Respiratory Distress Syndrome 
Chylothorax 
Adhesions 
Diaphragmatic Injury 
Altered Mental Status 
Emphysema 
Anaphylaxis 
Esophageal Injury 
Anemia 
Incisional hernia 
Angina 
Injury to other organs 
Atelectasis 
Intercostal nerve injury 
Bacteremia 
Internal Hernia 
Bleeding 
Pneumothorax 
Bradycardia 
Small bowel obstruction 
Cardiac Arrhythmia 
Splenic injury 
Central line infection 
Thromboembolic Event 
Cerebrovascular Accident / Stroke 
Wound infection 
Congestive Heart Failure 
 
Constipation 
 
Death 
 
Deep Venous Thrombosis 
 
Dehydration 
 
Dementia 
 
Diarrhea 
 
DIC, Coagulopathy 
 
Dizziness 
 
Dyspnea 
 
Electrolyte Imbalance 
 
Fever, Pyrexia 
 
Headache 
 
Hematoma 
 
Hematuria 
 
Hypertension 
 
Hypotension, shock 
 
Hypoxia 
 
Ileus 
 
Infection/SSI/Abscess 
 
Jaundice 
 
Lethargy 
 
Leukocytosis 
 

 
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Liver Failure 
 
Mesenteric Infarct  
 
Mesenteric Ischemia 
 
Myocardial Infarction 
 
Nausea 
 
Obtundation, Depressed Level of Consciousness 
 
Oliguria 
 
Pain (increased/severe/chronic) 
 
Pneumonia 
 
Port Site Hernia 
 
Pulmonary Edema 
 
Pulmonary Embolism 
 
Renal Failure 
 
Respiratory Failure 
 
Respiratory Insufficiency 
 
Sepsis 
 
Somnolence 
 
Systemic Inflammatory Response Syndrome 
 
Tachycardia 
 
Thrombocytopenia 
 
Thromboembolic Event 
 
Thrombosis 
 
TIA 
 
Tightness of the chest, Angina 
 
Tinnitus 
 
Urinary Retention 
 
Urinary Tract Infection (UTI) 
 
Volume Depletion,  Hypovolemia 
 
Vomiting 
 
Wheezing 
 
Wound Dehiscence