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

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

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

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

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.

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.

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 .

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 that occur after surgery within 30 days of the surgical date, measured as categorical variables "Yes" or "No".

operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision

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

Milsom JW, Trencheva K, Momose K, Peev MP, Christos P, Shukla PJ, Garrett K. A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery. Surg Endosc. 2022 Jun;36(6):4265-4274. doi: 10.1007/s00464-021-08765-8. Epub 2021 Nov 1.