Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
Phase: NA
Conditions: Pancreatic Neoplasms, Bile Duct Carcinoma
Sponsor: Washington University School of Medicine

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THUNDERBEAT™ INTEGRATED BIPOLAR AND ULTRASONIC FORCEPS IN THE 
WHIPPLE PROCEDURE:  A PROSPECTIVE REGISTRY TRIAL 
 
 
 
Washington University School of Medicine 
Department of Surgery 
660 S. Euclid Ave., Campus Box 8109 
St. Louis, MO 63110 
 
Version date: 10/14/2015 
Version number:  06 
 
 
 
 
 
Principal Investigator:  
William Hawkins, M.D. 
Phone:  
 
 
(314) 362-7046 
Email:  
 
 
hawkinsw@wudosis.wustl.edu 
 
 
Sub-Investigators: 
 
 
Steven M. Strasberg, M.D. 
Ryan C. Fields, M.D. 
 

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THUNDERBEAT™ INTEGRATED BIPOLAR AND ULTRASONIC FORCEPS IN THE 
WHIPPLE PROCEDURE 
 
 
 
TREATMENT SCHEMA 
 
 
Eligible Patients 
Patients age 18 years or older 
Patients scheduled for a Whipple procedure 
Provided informed consent 
Enrollment 
Randomization 
Group 1: Thunderbeat™ device 
or 
Group 2: Conventional device  
Intervention 
Assigned device utilized to perform dissection and vessel sealing 
during routine surgical procedure 
Post-Intervention Monitoring 
Standard post-operative recovery 
Follow-up 
Routine clinic visit 30 days postop 

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TREATMENT SCHEMA .................................................................................... Error! Bookmark not defined. 
1.0 
BACKGROUND AND RATIONALE ....................................................................................................... 4 
2.0 
OBJECTIVES ....................................................................................................................................... 4 
3.0 
PATIENTSELECTION ........................................................................................................................... 5 
4.0 
REGISTRATION PROCEDURES ............................................................................................................ 5 
5.0 
TREATMENTPLAN .............................................................................................................................. 6 
6.0 
ADVERSE EVENTREPORTING ............................................................................................................. 7 
7.0 
DATA SUBMISSION SCHEDULE ........................................................................................................ 10 
8.0 
DATA AND SAFETY MONITORING .................................................................................................... 10 
9.0 
STATISTICAL CONSIDERATIONS ....................................................................................................... 11 
APPENDIX A:  Karnofsky Performance Scale ............................................................................................... 14 
APPENDIX B: STUDY VISIT SCHEDULE ......................................................................................................... 15 
 

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1.0 
BACKGROUND AND RATIONALE 
 
1.1 
Whipple Procedure 
 
The procedure was originally described by Allessandro Codivilla in 1898.  A.O. Whipple improved 
it in 1935.  The Whipple procedure is the standard method for therapy of cancerous tumors, 
inflammation and stenosis near the head of the pancreas.   
 
Approximately 100 patients undergo an elective Whipple procedure at Washington University 
Medical Center each year. 
 
1.2 
ThunderbeatTM 
 
As the pancreas is fed by many vessels, it is necessary to use lots of ligatures, clips and sutures 
for hemostasis after dissection.  This dissection technique is very time consuming and requires 
numerous changes of instruments. The devices we currently have available for use in the 
operating suite are EnSeal and LigaSure.  A new type of surgical scissors that delivers 
ultrasonically generated frictional heat energy and electrically generated bipolar energy 
simultaneously, known as the Thunderbeat™ (Olympus, Japan), is now an available alternative 
for dissection and hemostasis.  [1-2] 
 
Thunderbeat™ was provided FDA clearance in March 2012 for use in open, laparoscopic, and 
endoscopic surgery, or in any procedure in which cutting, vessel ligation (sealing and cutting), 
coagulation, grasping and dissection is performed.  
 
The Thunderbeat™ device provides the first integration of both bipolar and ultrasonic energies 
delivered simultaneously from a single multi-functional instrument.  This integration provides the 
surgeon the ability to rapidly cut tissue with ultrasonic energy and to create reliable vessel seals 
with bipolar energy without having to change devices.  The current is provided by a special 
generator and contains a very high capacity with a low voltage.  The body’s proteins, such as 
collagen and elastin, are converted so a permanently sealed zone results.  As the tissue between 
the branches is sealed, lateral thermic tissue damages can be limited to a minimum.  Several 
authors have described a tendency of reduced intraoperative blood loss with bipolar energy 
devices.  Other trials show reduced operating time when a bipolar device is utilized in several 
surgical procedures, such as thyroid, hepatic, urologic, hemorrhoidectomy and gynecology 
surgery. [3-7] 
 
Correct dissection in the operating field is very important to avert secondary bleeding or other 
complications, which might cause re-operation or elevate the patients’ morbidity and mortality.   
 
The main difference between the predicate devices and the ThunderbeatTM seal and cut mode is 
that ThunderbeatTM uses ultrasonic and high frequency bipolar energy simultaneously to seal and 
cut tissue. 
 
 
2.0 
OBJECTIVES 
 
2.1 
Primary Objective 
 
This is a prospective observational feasibility/QI registry trial to evaluate operative blood loss and 
post-operative morbidity following use of the ThunderbeatTM device during the Whipple 
procedure.  This will be compared to patients whose Whipple procedure will be performed using 
conventional dissection and hemostasis techniques. 

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2.2 
Secondary Objectives 
 
1. To determine the operative time of the Whipple procedure when performed using the 
ThunderbeatTM device. This will be compared to patients whose Whipple procedure will be 
performed using conventional dissection and hemostasis techniques.  Will this device reduce 
the amount of time spent in the operating room for both the patient and the surgeon? 
 
2. To determine the cost of using the ThunderbeatTM device during the Whipple procedure. This 
will be compared to patients whose Whipple procedure will be performed using conventional 
dissection and hemostasis techniques.  Will the use of this device be fiscally feasible? 
 
 
3.0 
PATIENTSELECTION 
 
3.1 
Inclusion Criteria 
 
1. Scheduled to undergo an elective open or laparoscopic Whipple procedure  
2. At least 18 years of age.  
3. Karnofsky performance status > 80% (see Appendix A). 
4. Able to understand and willing to sign a written informed consent document. 
 
3.2 
Exclusion Criteria 
 
1. Pregnant or breastfeeding. 
2. Surgeon’s opinion at the time of dissection that the subject’s well being (e.g. bleeding or other 
independent acute health problems) would be compromised.   
 
3.3 
Inclusion of Women and Minorities 
 
Both men and women and members of all races and ethnic groups are eligible for this trial. 
 
 
 
4.0 
REGISTRATION PROCEDURES 
 
Patients must not start any protocol intervention prior to registration through the Siteman Cancer 
Center. 
 
The following steps must be taken before registering patients to this study: 
 
1. Confirmation of patient eligibility 
2. Registration of patient in the Siteman Cancer Center database 
3. Assignment of unique patient number (UPN) 
 
Once the patient has been entered in the Siteman Cancer Center database, the WUSM coordinator will 
forward verification of enrollment and the UPN via email. 
 
4.1 
Confirmation of Patient Eligibility 
 
The following information is required to confirm patient eligibility prior to registering patient: 
 
1. Registering MD’s name 
2. Patient’s race, sex, and DOB 
3. Three letters (or two letters and a dash) for the patient’s initials 

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4. Copy of signed consent form 
5. Planned date of enrollment 
6. Completed eligibility checklist, signed and dated by a member of the study team 
7. Copy of appropriate source documentation confirming patient eligibility 
 
4.2 
Patient Registration in the Siteman Cancer Center Database 
 
All patients must be registered through the Siteman Cancer Center database. 
 
4.3 
Assignment of UPN 
 
Each patient will be identified with a unique patient number (UPN) for this study.  Patients will 
also be identified by first, middle, and last initials.  If the patient has no middle initial, a dash will 
be used on the case report forms (CRFs).  All data will be recorded with this identification number 
on the appropriate CRFs. 
 
 
5.0 
TREATMENTPLAN 
 
5.1 
Preoperative Evaluation 
 
Eligible patients will have standard evaluations, procedures, and laboratory testing as 
determined necessary by their surgeon preoperatively. 
 
5.2 
Randomization 
 
Sixty patients will be recruited according to the sample size calculation.  Randomization will 
be performed by a Research Patient Coordinator and the patient assigned to the 
Thunderbeat™ group or the conventional group in a 1:1 ratio.  Randomization will only occur 
after the patient has signed the informed consent and will be documented in the case report 
file as well as communicated to the treating surgeon.  
 
Thunderbeat™ group (n=30) 
In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the 
Thunderbeat™ device (Olympus, Japan).   
 
Control group (n=30) 
In the conventional group, scissors, ligatures, clips and sutures will be used for dissection and 
hemostasis as necessary.   
 
Minimizing treatment bias 
A standardized operation technique will be used in both groups.  The same Thunderbeat™ 
device will be used throughout the length of the study.  The participating surgeons will have had 
experience performing at least 100 Whipple procedures to guarantee comparable treatment of 
patients.   
 
Minimizing measurement bias 
The patients will be blinded to the assigned operating technique. Surgeon’s blinding will not be 
possible due to the different techniques used during the operation.   
 
5.3 
Operative Procedure 
 
The surgical procedure will be conducted as planned.  The surgeon will follow the subject’s 
assigned group assignment (Thunderbeat™ or conventional) unless determined to be potentially 

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detrimental to the optimal care of the patient.  At that point, all techniques for dissection and 
hemostasis may be utilized as the surgeon deems necessary. 
 
At least 5 of the procedures will be videotaped for future use to produce educational and training 
materials.  No identifying information will be contained in the video. 
 
The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia 
notes where (EBL) is recorded during each surgical procedure in Allscripts and Clindesk.  The 
estimate of operative blood loss is measured by volume in the suction canisters and pads and is 
historically documented by the operative nursing staff during the operation.  
 
 
5.4 
Postoperative Care 
 
The post operative management is standard of care for all patients who undergo the Whipple 
procedure and will not be altered by their participation in this study.  
 
5.5 
Duration of Follow-Up 
 
Patients will be followed for 90 days following their surgical procedure.  Postoperative 
complications and adverse events will be closely monitored. Patients will be followed until 
resolution or stabilization of the adverse event.  Please see Appendix B for Study Visit 
Schedule. 
 
5.6 
Criteria for Removal from Study 
 
If at any time the constraints of this protocol are considered to be detrimental to the patient’s 
health (e.g. bleeding or other acute health problem) and/or the patient no longer wishes to 
proceed with the protocol intervention, the patient should be removed from the study and the 
reason(s) for discontinuation documented in the case report forms. 
 
Otherwise, the patient will receive the intervention and be followed as described. 
 
 
 
6.0 
ADVERSE EVENT REPORTING 
 
6.1 
Adverse Events 
 
Definition: any unfavorable medical occurrence in a human subject including any abnormal sign, 
symptom, or disease. 
 
 
Attribution (relatedness), Expectedness, and Seriousness: the definitions for the terms listed 
that should be used are those provided by the Department of Health and Human Services’ Office 
for Human Research Protections (OHRP).  A copy of this guidance can be found on OHRP’s 
website:http://www.hhs.gov/ohrp/policy/advevntguid.html 
 
The surgeon will discuss the expected risks of the surgery with the participant and participant 
and a separate surgical consent for the surgery acknowledging the risks. Expected risks of the 
surgery are listed below. 
 
• 
Perioperative complications: 
Iatrogenic injury, convert from laparoscopic approach to open procedure, use of other 

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hemostatic devices or therapies, blood transfusion 
 
• 
Postoperative complications: 
Secondary bleeding/hematoma, delirium, failure to thrive, urinary retention, surgical 
site infection, urinary tract infection, C-diff, colitis, Ileus, delayed gastric emptying, 
fistula, anemia, pneumonia, intraabdominal abscess, atrial dysrhythmia, myocardial 
infarction, cellulitis, deep vein thrombosis/pulmonary embolism, anastomotic leakage, 
re-intervention (operational), blood transfusion, sepsis, death. 
 
The above are complications of the surgical procedure and may be experienced by all patients 
on whom a Whipple procedure is performed.  Surgical complications are routinely identified and 
documented during the data abstraction process for the American College of Surgeons National 
Surgical Quality Improvement Program® (NSQIP).   NSQIP has very detailed and specific 
definitions used to assess these postoperative morbidities.  For the purposes of this study, the 
NSQIP definitions for the surgical complications will be utilized.  
 
Surgical complications will not be considered adverse events associated with the study, unless 
unanticipated and possibly related to the use of the Thunderbeat device. If an adverse event is 
reported, details related to the event will be obtained from medical record review and direct 
communication with the PI for severity and relatedness assessment.  The adverse event will 
then be recorded as part of the research and reported as necessary. If it is determined by the PI 
that the event is anticipated from surgery and not related to the device, it will not be reported 
as an adverse event as part of this study. 
 
 
6.2 
Unanticipated Problems 
 
Definition: 
 
• 
unexpected (in terms of nature, severity, or frequency) given (a)  the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the characteristics 
of the subject population being studied; 
• 
related or possibly related to participation in the research (possibly related means there 
is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
• 
suggests that the research places subjects or others at a greater risk of harm(including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
 
Potential perioperative complications that could occur due to the use of the Thunderbeat device 
include but are not limited to: 
 
• 
Thunderbeat Device**: 
Cracking, breaking, or deformation of the components of the Thunderbeat™ probe tip or jaw, 
or the detaching of the fragment from the Thunderbeat probe tip or jaw during or after the 
surgical procedure, and burning of unintended tissue.  Probe damage detected during 
surgery will trigger audible and visual generator alarms. 
 
**Please note that these risks may not occur during surgery and that they are the same risks as 
using any other similar device for the same indication that is currently on the market. 

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6.3 
Noncompliance 
 
Definition: failure to follow any applicable regulation or institutional policies that govern human 
subject’s research or failure to follow the determinations of the IRB.  Noncompliance may occur 
due to lack of knowledge or due to deliberate choice to ignore regulations, institutional policies, or 
determinations of the IRB. 
 
6.4 
Serious Noncompliance 
 
Definition: noncompliance that materially increases risks that result in substantial harm to 
subjects or others, or that materially compromises the rights or welfare of participants. 
 
6.5 
Protocol Exceptions 
 
Definition:  A planned deviation from the approved protocol that is under the research team’s 
control. Exceptions apply only to a single participant or a singular situation. 
 
Pre-approval of all protocol exceptions must be obtained prior to the event. 
 
6.6 
Reporting to the Human Research Protection Office (HRPO) at Washington 
University: 
 
The PI is required to promptly notify the IRB and Olympus, the study sponsor, of the following 
events: 
 
• 
Any unanticipated problems involving risks to participants or others which occur at WU, 
any BJH or SLCH institution, or that impacts participants or the conduct of the study. 
• 
Noncompliance with federal regulations or the requirements or determinations of HRPO. 
• 
Receipt of new information that may impact the willingness of participants to participate 
or continue participation in the research study. 
 
These events must be reported to HRPO within 10 working days of the occurrence of the event 
or notification to the PI of the event.  The death of a research participant that qualifies as a 
reportable event should be reported within 1 working day of the occurrence of the event or 
notification to the PI of the event. 
 
6.7 
Time frame for Reporting Required Events 
 
Reportable adverse events that are determined to be unanticipated and related to the 
Thunderbeat device will be recorded and reported for 90 days following the Whipple procedure.  
Events considered to be possibly, probably, or definitely related to standard of care therapy will 
not be reported. 
 
 
 
Deaths 
Any reportable death while on study or within 90 days of 
study 
Immediately, within 24 
hours, to PI and the IRB 
Adverse Events/Unanticipated Problems 

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Any reportable adverse events that are related and 
unanticipated problems as described above in Section 6.2 
(other than death) 
Immediately, within 24 
hours, to PI and within 10 
working days to the IRB 
All adverse events that are related and unanticipated 
problems regardless of grade and attribution should be 
submitted cumulatively 
Include in DSM report 
Noncompliance and Serious Noncompliance 
All noncompliance and serious noncompliance as described 
in Sections 6.3 and 6.4 
Immediately, within 24 
hours, to PI and within 10 
working days to the IRB 
 
 
7.0 
DATA SUBMISSION SCHEDULE 
 
Case Report Form 
Submission Schedule 
Original Consent Form 
Prior to registration 
Eligibility Checklist 
Demographics 
Clinical Characteristics 
Medical/Surgical History 
Form 
Prior to starting treatment.  Data collection 
will be captured in RedCap. 
Intra-operative Findings 
Operative and Post-procedural Form 
Following receipt of operative report 
Following receipt of discharge summary 
Data collection will be captured in 
RedCap. 
Adverse Event Assessment 
At the time of any unanticipated and 
related event 
Follow-Up Form: First and Second postop 
visit 
Approximately 30 and 90 days following 
surgery following routine clinic visit for 
post-surgical evaluation 
Data collection will be captured in 
RedCap. 
 
 
8.0 
DATA AND SAFETY MONITORING 
 
In compliance with the Washington University Institutional Data and Safety Monitoring Plan, the Principal 
Investigator will provide a Data and Safety Monitoring (DSM) report to the Washington University Quality 
Assurance and Safety Monitoring Committee (QASMC) and to Olympus, the study sponsor, semi-
annually beginning six months after accrual has opened (if at least five patients have been enrolled) or 
one year after accrual has opened (if fewer than five patients have been enrolled at the six-month mark). 
 
The Principal Investigator will review all patient data at least monthly and provide an annual report to the 
Quality Assurance and Safety Monitoring (QASM) Committee. This report will include: 
 
• 
HRPO protocol number, protocol title, Principal Investigator name, data coordinator name, 
regulatory coordinator name, and statistician 

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• 
Date of initial HRPO approval, date of most recent consent HRPO approval/revision, date of 
HRPO expiration, date of most recent QA audit, study status, and phase of study 
• 
History of study including summary of substantive amendments; summary of accrual suspensions 
including start/stop dates and reason; and summary of protocol exceptions, error, or breach of 
confidentiality including start/stop dates and reason 
• 
Study-wide target accrual and study-wide actual accrual 
• 
Protocol activation date 
• 
Average rate of accrual observed in year 1, year 2, and subsequent years 
• 
Expected accrual end date 
• 
Objectives of protocol with supporting data and list the number of participants who have met each 
objective 
• 
Measures of efficacy 
• 
Early stopping rules with supporting data and list the number of participants who have met the 
early stopping rules 
• 
Summary of toxicities 
• 
Abstract submissions/publications 
• 
Summary of any recent literature that may affect the safety or ethics of the study  
 
The study principal investigator and Research Patient Coordinator will monitor for serious adverse events 
on an ongoing basis.  Once the principal investigator or Research Patient Coordinator becomes aware of 
a research related adverse event, the AE will be reported to the HRPO according to institutional 
guidelines and to Olympus, the study sponsor. 
 
 
9.0 
STATISTICAL CONSIDERATIONS 
 
9.1 
Study Objectives and Endpoints 
 
The primary objective of the study is to determine if the use of the Thunderbeat™ device provides 
a reduction in operative blood loss. The measurement of operative blood loss will come from the 
intraoperative anesthesia notes where estimated blood loss is recorded during each surgical 
procedure.  
 
The secondary objectives are intraoperative and postoperative morbidity, hospital length of stay 
and operative time.   
 
Primary endpoint 
The primary endpoint will be the estimated operative blood loss.  The estimated blood loss will be 
measured per the standard of care and will be documented in the operation log.   
 
Secondary endpoints 
• 
Operation time measured from the beginning of the surgical procedure (incision of the skin) to 
the end of the surgical procedure (closure of the skin).   
• 
Anesthesia time measured from the initiation of anesthesia induction to the time of extubation 
• 
Perioperative complications: 
o 
Iatrogenic injury 
o 
Need for conversion from laparoscopic approach to open procedure 
o 
Need for the use of other hemostatic devices or therapies 
o 
Intraoperative requirement of blood product transfusion 
• 
Postoperative complications through 90 days from day of surgery: 
o 
Secondary bleeding/hematoma 
o 
Wound infection 
o 
Gastroparesis 
o 
Postoperative pancreatic fistula 
o 
Intraabdominal abscess 

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o 
Anastomotic leakage 
o 
Re-intervention (operational) 
o 
Postop requirement for blood product transfusion 
o 
Hospital mortality 
• 
Overall cost of the operation, calculated by the indirect and direct costs during the hospital 
stay and the costs accumulated 90 days postoperatively 
 
9.2 
Study Design 
 
To achieve comparable groups for known and unknown risk factors randomization will be 
performed as unistratified block randomization with random block sizes in a 1:1 allocation ratio.  
Allocation to treatment will be carried out by means of a computer-generated random study 
numbers with group assignment.   
 
9.3 
Sample Size 
 
Appropriate sample size is calculated based on assumption of difference of 20 percent in blood 
loss in favor of the Thunderbeat™ device as compared with conventional techniques.  This 
difference is considered clinically relevant based on previous similar studies [9-11].  A sample 
size of 60 is considered sufficient to prove this difference, if present (alpha error set at 0.05, 
power>80 percent).   
 
Approximately 100 patients per year undergo a Whipple procedure at Washington University 
Medical Center.  The estimated time frame to enroll 60 patients is approximately 18 to 24 months.  
 
 
The total expected enrollment is 60 patients: 30 Thunderbeat and 30 conventional.   
 
9.4 
Data Analysis 
 
Data analysis for this study will be descriptive in nature. Demographic and clinical characteristics 
of the sample, as well as intraoperative findings and post-surgery complications will be 
summarized using descriptive statistics. The incidences of surgical complications and procedure-
related adverse events will be calculated, and the confidence intervals will also be provided.  
 
Patients assigned to the Thunderbeat™ group will be compared with those who had 
conventional techniques using х2 tests for categorical variables and Student’s t-tests for 
continuous variables. For the t-tests equal variances were not be assumed, unless significant by 
Levene’s test. Mann-Whitney U tests will be utilized for non-normally distributed variables.  Two-
tailed P values 0.05 will be considered statistically significant. 
 
Multivariate analyses for intraoperative blood loss (mL), operative time (minutes), postoperative 
morbidity (any grades 1–5 and major grades 3–5), and hospital length of stay (days) will be 
performed using binary logistic regression and linear regression models to examine the 
relationship between intervention groups and examined outcomes and to identify potential 
confounders. The results of multivariate analyses will be expressed as odds ratios with 
corresponding 95% confidence intervals. All analyses will be performed using SPSS 20.0 
statistical software (SPSS Inc.Chicago, IL). 

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REFERENCES 
 
 
1. Seehofer D, Mogl M, Boas-Knoop S, Unger J, Schirmeier A, Chopra S, Eurich D.  Safety and 
efficacy of new integrated bipolar and ultrasonic scissors compared to conventional laparoscopic 
5-mm sealing and cutting instruments.  SurgEndosc 2012.  
 
2. Milsom J, Trencheva K, Monette S, Pavoor R, Shukla P, Ma J, Sonoda T.  Evaluation of the 
safety, efficacy, and versatility of a new surgical energy device (THUNDERBEAT) in comparison 
with Harmonic ACE, LigaSure V, and EnSeal devices in a porcine model.  J 
LaparoendoscAdvSurg Tech 20112; 22:378-376.  
3. Youssef T, Mahdy T, Farid M, Latif AA: Thyroid surgery: Use of the LigaSure Vessel Sealing 
System versus conventional knot tying.  Int J Surg 2008; 6:323-327. 
 
4. Cheang T, Hanna S, Wright F, Law C.  Use of a collagen-sealing device in hepatic resection: a 
comparative analysis to standard resection technique.  HPB 2006; 8:194-199.  
 
5. Sengupta S, Webb D.  Use of a computer-controlled bipolar diathermy system in radical 
prostatectomies and other open urological surgery.  ANZ J Surg 2001; 71:538-540.   
 
6. Muzi M, Milito G, Nigro C, Cadeddu F, Andreoli F, Amabile D, Farinon AM.  Randomized clinical 
trial of Ligasure and conventional diathermy haemorrhoidectomy.  British Journal of Surgery 
2007; 94:937-942.  
 
7. Janssen P, Brolmann H, van Kesteren P, Bongers M, Turkow A, Heymans M, Huirne J.  
Perioperative outcomes using LigaSure compared with conventional bipolar instruments in 
laparoscopic hysterectomy: a randomized controlled trial.  BJOG 2011; 118:1568-1575/     
 
8. A.  Porembka MR. Hall BL. Hirbe M. Strasberg SM. Quantitative weighting of postoperative 
complications based on the accordion severity grading system: demonstration of potential impact 
using the american college of surgeon’s national surgical quality improvement program. Journal 
of the American College of Surgeon 2010; 210(3):286-298 
 
9. X.  Campagnacci R, De Sanctis A, Baldarelli M, Rimini M, Lezoche G, Guerrieri M.  
Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic 
colectomies: a comparative study.  SurgEndosc 2007; 21:1526-31.  
 
10. Y.  Rimonda R, Arezzo A,Garroe C, Allaix ME, Giraudo G, Morino M.  Electrothermal bipolar 
vessel sealing system vs harmonic scalpel in colorectoal laparoscopic surgery: a prospective 
randomized study.  Dis Colon Rectum 2009; 52:657-661.   
 
11. Z.  Takeda M, Ichilhara T, Kukoda Y.  Comparison study of electrothermal bipolar vessel sealer 
and ultrasonic coagulating shears in laparoscopic colectomy.  SurgEndosc 2005; 19:226-8.   
 

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APPENDIX A:  Karnofsky Performance Scale 
 
Description 
Percent(%) 
Normal; no complaints; no evidence of disease 
100 
Able to carry on normal activity; minor signs and symptoms of disease 
 
90 
Normal activity with effort; some signs and symptoms of disease 
 
80 
Cares for self; unable to carry on normal activity or do work 
 
70 
Requires occasional assistance, but is able to care for most personal needs 
 
60 
Requires considerable assistance and frequent medical care 
 
50 
Disabled; requires special care and assistance 
40 
Severely disabled; hospitalization indicated although death not imminent 
 
30 
Very sick; hospitalization necessary; requires active support treatment 
 
20 
Moribund; fatal processes progressing rapidly 
10 
Dead 
0 

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APPENDIX B: STUDY VISIT SCHEDULE 
 
 
Baseline 
Intervention 
Follow-Up 
 
Screening2 
Day of 
Surgery 
Hospital 
Discharge 
30 Day Post-
Op Visit3 
90 Day 
Status5 
Past medical history1 
X 
 
 
 
 
Informed consent 
X 
 
 
 
 
Physical exam4 
X 
 
 
 
 
Operating time from skin incision to closure (mins) 
 
X 
 
 
 
Anesthesia time (mins) 
 
X 
 
 
 
Intraoperative estimated blood loss (cc) 
 
X 
 
 
 
Administration of blood products 
 
X 
X 
 
 
Peri and postoperative complications 
 
X 
X 
X 
X 
Hospital length of stay 
 
 
X 
 
 
Mortality 
 
 
X 
X 
X 
1Study-relevant past medical and surgical history 
2Screening procedures to be completed within 60 days of surgery. 
3To be performed 30 days from day of surgery ±14 days.  
4Baseline height, weight, gender, karnofsky performance status, medications from pre-surgical physical examination 
5Medical records (inpatient and outpatient) will be reviewed by a study team member for additional postoperative complications.  No direct 
contact or clinic visit required.