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

Weill Medical College of Cornell University73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Colon Cancer

Interventions

THUNDERBEATDEVICE

Tissue dissection and vessels ligation

LIGASUREDEVICE

Tissue dissection and vessels ligation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medical Center- NYPH

New York, New York, United States

Outcomes

Primary Outcomes

Overall Time for Dissection of the Soft Tissues

from the start of colon mobilization to specimen removal from the abdominal cavity

Time frame: 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.

Time frame: Day 0 Surgical procedure

Secondary Outcomes

Length of Post Surgical Stay in the Hospital

Length of post surgical stay in the hospital measured in days

Time frame: 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 .

Time frame: 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"

Time frame: 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".

Data from ClinicalTrials.gov

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