A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
Phase: NA
Conditions: Colon Cancer
Sponsor: Weill Medical College of Cornell University

Cover letter 
IRB Approved Title: A Randomized Controlled Trial comparing THUNDERBEAT to the 
Ligasure energy device during Laparoscopic Colon Surgery   
WCMC IRB Protocol #: 1403014955 
IRB Initial Approval date: 06/25/2014 
ClinicalTrial.gov # NCT02628093 
Participating locations  
Weill Cornell Medical College, New York Presbyterian Hospital 
1300 York Avenue 
New York, NY 10065 
USA 
 
 
Subsequent IRB Protocol Approved Amendments and date of approval  
 Amendment 006         02/08/2019 
Amendment 005          11/08/2018  
Amendment 002          12/05/2015 
 
 
 
 
 
 
 
 
 
 
 

 
Objective 
The Primary objective of this study is to compare the clinical performance (efficacy) of the new 
laparoscopic energy device THUNDERBEAT in performing soft tissue dissection dividing and 
sealing blood vessels compared to Ligasure in  human subjects undergoing Laparoscopic colon 
and rectal surgery. 
Design 
Prospective randomized controlled study, with 2 groups based on the instrument used for tissue 
dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2 – Ligasure 
Methods 
60 subjects with colon neoplasm or diverticulitis were randomized into one of the groups in 
equal chances 
Inclusion 
Patients that will be undergoing a Left Laparoscopic Colon Resection 
Older than 18 years old 
ASA 1 to 3 
Elective surgeries 
Patients who willingly provide informed consent 
 
Exclusion 
Morbidly obese patients (BMI >35) 
Patients with acute diverticulitis 
Patients with multiple previous abdominal surgeries 
Patients on anticoagulants 
Patients who cannot, tolerate a major surgery 
Patients for whom electrosurgery is contraindicated 
Patients who are pregnant 
Patients who have IBD 
 
Study Protocol 
Informed consent is to be obtained prior to procedure. 
 
After informed consent was obtained, data was collected prospectively before, during and after 
the surgical procedure up to 30 days after the surgery from the data of the surgical procedure.  
 
Study Procedures: 
This project will consist only of prospective data collection. No interventions will be done for 
research purpose. Data will be collected prospectively on: 
-Patients (before, during and after surgery) 

-The THUNDERBEAT and LigaSure instruments  
 
Data will be collected on data collection sheets  and entered in a password protected database  
Primary Outcomes/Definitions  
Overall time for dissection of the soft tissues necessary for specimen removal during colon 
resection, measured in minutes, from the start of colon mobilization to specimen removal from 
the abdominal cavity    
 
Versatility between the two instruments  
Versatility in this study is defined as: quality performance of the surgical instrument under study 
based on the outcome evaluation of the following variables: 
 
Hemostasis,  
Sealing ability 
Cutting 
Dissection  
Tissues Manipulation  
 
all measured by a score system from 1-5 in which  1 is the worst and 5 is the best and adjusted/ 
weighted for their importance by Coefficient of Importance with following distribution of the 
importance:  
1. Hemostasis     27. 5 % = 0.275 
2. Sealing ability   7.5 % =0.275 
3. Cutting 20 % = 0.2 
4. Dissection 15%= 0.15 
5. Tissues Manipulation 10 % = 0.1 
 
The two (2) instruments will be compared in terms of versatility. An average score above 3 will 
be considered a high versatility and score 3 and below 3 as low versatility.  
Hemostasis, Sealing, Cutting, Dissection and Tissues Manipulation will be scored only by the 
surgeon. Hemostasis and Sealing ability will be measured on arterial vessels by surgeon and 
cutting, dissection and tissue manipulation will be measured on mesenteric tissue. 
 
Secondary Outcomes  
 
Evaluation of surgeons' experience for THUNDERBEAT or LigaSure will be measured with a 
survey 
 
The design of the instrument in terms of surgical maneuvering is being evaluated via the opinion 
of the surgeons using an 8-item questionnaire, grading  the 8 items on the scale from 1 to 10 
where a score of 1 is worst and 10 is the best.   
 
Drier surgical field -evaluation of the entire surgical field for oozing of blood or any other body 
fluids using a scoring system as well as video and photo documentation 
 
Difference in the patient's outcome after laparoscopic surgery using those two devices. 

Difference in operative procedure time measured in minutes from incision start time to end of 
surgery (placement of the last stitch during closure of abdominal incisions) 
 
Other relevant intra and post-operative data will be collected prospectively from patients and the 
hospital charts prior to, during and after surgery. 
This would include such outcome measures as postoperative bleeding, failure of the 
instrumentation to control bleeding intraoperatively or successfully dissect tissues, complications 
related to use of the instrument, etc. 
 
We will compare the postoperative complication using Clavien-Dindo classification.  5 
Patients will be assessed daily after surgery until discharge, at the first follow up visit within the 
first 30 days following surgery and at 30 days.   
 
 
Statistical Considerations 
 
Because this is a pilot randomized study, no formal sample size calculation is required. With 60 
patients total and 30 in each arm, we will estimate differences in dissection time between the two 
groups (THUNDERBEAT and LigaSure). These estimated differences will serve as preliminary 
data (i.e., hypothesis-generating) for future studies. 
A total of 60 patients undergoing Left Colectomy Resection will be accrued for this study. Extra 
10 patients will be recruited in anticipation of a 15% withdrawal. Patients will be randomized at 
equal ratio to: Group 1: Using THUNDERBEAT instrument for dissection or Group 2: Using 
Ligasure instrument.  
 
The primary endpoint of this study is overall time for dissection of the soft tissues necessary for 
specimen removal during colon resection, measured in minutes, from the start of the start of 
colon mobilization to specimen removal from the abdominal cavity.  
 
Demographic, preoperative, and postoperative variables will be compared between groups by the 
two-sample t-test/Wilcoxon rank-sum test for continuous variables and the chi-square 
test/Fisher's exact test for categorical variables, as appropriate.  All p-values will be two-sided 
with statistical significance evaluated at the 0.05 alpha level. Ninety-five percent confidence 
intervals will be calculated to assess the precision of the obtained estimates All analyses will be 
performed in JMP 10.0 (Cornell University, Ithaca, NY).  
 
Randomization 
 
Stratified randomization with blocking will be used in the trial.  Strata are formed by the two 
different Instruments used during the surgical procedures: TB and LIG for both arms. Random 
permuted blocks within strata will be used to ensure balance between instruments. The size of a 
block will not be revealed during the study, only known to the biostatistician. The biostatistician 
will generate randomization lists before the trial starts, using the method of random permuted 
blocks within strata   
 
Scientific Background 

With the growing use of laparoscopic techniques for intraabdominal surgery, different surgical 
energy devices have been developed to shorten operative time and to lessen the need for 
instrument exchange.  Dissection of the bowel mesentery and other soft tissues can take a 
significant amount of time, attributable to the need for safe and effective hemostasis. As a 
solution, energy-based devices are being developed that efficiently dissect the mesentery and 
occlude blood vessels, even larger ones up to 6-7 mm.  
Three energy based methods currently used during surgical procedures for vessel ligation and 
dissection include monopolar electrosurgery (ME), bipolar electrosurgery (BE) and 
ultrasonically-activated surgery (UAS).  ME results in greater amount of thermal tissue damage 
and intraperitoneal temperature variations when compared to UAS and BE, respectively. Bipolar 
electrosurgical technology has been considered as possibly a safer method for dissection and 
vessel ligation in laparoscopic colon and rectal surgery in particular, because electrical energy is 
used differently, preventing undesirable injuries.P1,2
P  Some studies evaluating vascular control 
during laparoscopic surgery between electrosurgical devices have reported that electro thermal 
bipolar vessel sealing has better results and effectiveness, less blood loss and a slight advantage 
in operating time.P3, 4
P UAS devices are multi-functional and are equipped for coagulation, cutting, 
dissection and grasping but are only approved for use on sealing vessels up to 4-5 mm in 
diameter .  A study comparing ultrasonic and bipolar devices in a porcine bowel mesentery 
model reported that UAS provides a reduced resection time with no difference in thermal bowel 
wall damage.P5
P    Amongst the current ultrasonic devices, laparoscopic dissection time in a 
porcine bowel mesentery model was shorter with AutoSonix and Sonosurg technology when 
compared to UltraCision technology.P6
P   Technical advances in electrosurgery and other energy 
sources are improving over time, becoming more powerful and efficient. A new unique 
laparoscopic energy device THUNDERBEAT (TB, Olympus, Japan) has been developed that 
delivers BOTH ultrasonically generated frictional heat energy and electrically generated bipolar 
energy simultaneously.  This tool is also multi-functional and the surgeon will be able to 
coagulate (even large blood vessels), cut, and dissect during surgery and potentially reduce the 
need for instrument exchange. A recent study in a porcine model conducted at WCMC and 
presented at ACS meeting 2011, compared the versatility, bursting pressure, thermal spread, and 
dissection time of the new TB device in comparison to commercially available ultrasonic and 
bipolar energy devices: Harmonic ACE (HA, Ethicon, USA) , LigaSure V (LIG, Covidien, USA) 
and En Seal (EnSeal, Ethicon, USA). The study demonstrated that TB has a higher versatility 
compared to other instruments with faster dissection speed, similar bursting pressure, and 
acceptable thermal spread.P7 
 
 
References 
 
1. 
Targarona EM, Balague C, Marin J, et al. Energy sources for laparoscopic colectomy: a 
prospective randomized comparison of conventional electrosurgery, bipolar computer-
controlled electrosurgery and ultrasonic dissection. Operative outcome and costs analysis. 
Surg Innov 2005; 12(4):339-44. 
2. 
Campbell PA, Cresswell AB, Frank TG, et al. Real-time thermography during energized 
vessel sealing and dissection. Surg Endosc 2003; 17(10):1640-5. 

3. 
Takada M, Ichihara T, Kuroda Y. Comparative study of electrothermal bipolar vessel 
sealer and ultrasonic coagulating shears in laparoscopic colectomy. Surg Endosc 2005; 
19(2):226-8. 
4. 
Campagnacci R, de Sanctis A, Baldarelli M, et al. Electrothermal bipolar vessel sealing 
device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative 
study. Surg Endosc 2007; 21(9):1526-31. 
5. 
Bergamaschi R, Yavuz Y, Marvik R. Laparoscopic bowel resection: a comparison of 
three ultrasonically activated devices. JSLS 2003; 7(1):19-22. 
6. 
Gossot D, Buess G, Cuschieri A, et al. Ultrasonic dissection for endoscopic surgery. The 
E.A.E.S. Technology Group. Surg Endosc 1999; 13(4):412-7. 
7.        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. Laparoendosc Adv Surg Tech A. 2012 May;22(4):378-86.