A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

Study Overview
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Brief Summary
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Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2 - Ligasure Population

Detailed Description
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Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2 - Ligasure Population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary 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.

Official Title
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A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

Conditions
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Colon Cancer

Intervention / Treatment
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* Device: THUNDERBEAT
* Device: LIGASURE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Morbidly obese patients (BMI >35) Patients with acute diverticulitis Patients with multiple previous abdominal surgeries Patients on anticoagulants Patients who can not, tolerate a major surgery Patients for whom electrosurgery is contraindicated Patients who are pregnant Patient with IBDs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: THUNDERBEAT<br>THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels | Device: THUNDERBEAT<br>* Tissue dissection and vessels ligation<br>|
| Other: LIGASURE<br>LIGASURE energy device will be used for dissection of tissue and ligation of vessels | Device: LIGASURE<br>* Tissue dissection and vessels ligation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Time for Dissection of the Soft Tissues | from the start of colon mobilization to specimen removal from the abdominal cavity | Day 0 Surgical procedure | 
| Versatility Score | Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average. | Day 0 Surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Post Surgical Stay in the Hospital | Length of post surgical stay in the hospital measured in days | from Surgery date to the discharge date from the hospital up to 30 days | 
| Dryness of the Surgical Field Average Score Mean/sd | Measured by score from 1 to 5 where 1 means Heavy bleeding , hemostasis achieved with the instrument with more than 2 attempts, and 5 means No oozing at vessel or tissue site in entire surgical field . | Day 0 Surgical Procedure | 
| Intraoperative Complication Related to the Energy Devices | Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable Yes or No | Day 0 Surgical procedure | 
| Delayed Thermal Injuries Related to Energy Devices | Delayed thermal injuries related to Energy devices that occur after surgery within 30 days of the surgical date, measured as categorical variables Yes or No. | DAY 1 to DAY 30 Postsurgery | 
| Operative Procedure Time | operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision | Day 0 Surgical Procedure |