A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Overall Time for Dissection of the Soft Tissues
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
THUNDERBEAT
THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels
Intervention: THUNDERBEAT (Device)
LIGASURE
LIGASURE energy device will be used for dissection of tissue and ligation of vessels
Intervention: LIGASURE (Device)
Outcomes
Primary Outcomes
Overall Time for Dissection of the Soft Tissues
Time Frame: Day 0 Surgical procedure
from the start of colon mobilization to specimen removal from the abdominal cavity
Versatility Score
Time Frame: 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 Outcomes
- Length of Post Surgical Stay in the Hospital(from Surgery date to the discharge date from the hospital up to 30 days)
- Intraoperative Complication Related to the Energy Devices(Day 0 Surgical procedure)
- Delayed Thermal Injuries Related to Energy Devices(DAY 1 to DAY 30 Postsurgery)
- Dryness of the Surgical Field Average Score Mean/sd(Day 0 Surgical Procedure)
- Operative Procedure Time(Day 0 Surgical Procedure)