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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
THUNDERBEAT	THUNDERBEAT	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels
LIGASURE	LIGASURE	LIGASURE energy device will be used for dissection of tissue and ligation of vessels

Primary Outcome Measures

Name	Time	Method
Overall Time for Dissection of the Soft Tissues	Day 0 Surgical procedure	from the start of colon mobilization to specimen removal from the abdominal cavity
Versatility Score	Day 0 Surgical procedure	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.

Secondary Outcome Measures

Name	Time	Method
Length of Post Surgical Stay in the Hospital	from Surgery date to the discharge date from the hospital up to 30 days	Length of post surgical stay in the hospital measured in days
Intraoperative Complication Related to the Energy Devices	Day 0 Surgical procedure	Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"
Delayed Thermal Injuries Related to Energy Devices	DAY 1 to DAY 30 Postsurgery	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".
Dryness of the Surgical Field Average Score Mean/sd	Day 0 Surgical Procedure	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 .
Operative Procedure Time	Day 0 Surgical Procedure	operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision

Locations (1): Weill Cornell Medical Center- NYPH
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New York, New York, United States