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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:February 17, 2016
End Date:July 2019
Contact:Koiana Trencheva, M.S.
Email:kivanova@med.cornell.edu
Phone:646-962-2342

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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.

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
We found this trial at
1
site
New York, New York 10065
Principal Investigator: Jeffrey W Milsom, MD
?
mi
from
New York, NY
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