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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628093
• Other study ID #: 1403014955
• Status: Completed
• Phase: N/A
• Start date: February 17, 2016
• Est. completion date: May 2, 2019

Study information

• Verified date: March 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Device:
• THUNDERBEAT
Tissue dissection and vessels ligation
• LIGASURE
Tissue dissection and vessels ligation

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center- NYPH	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Olympus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Time for Dissection of the Soft Tissues	from the start of colon mobilization to specimen removal from the abdominal cavity	Day 0 Surgical procedure
Primary	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.	Day 0 Surgical procedure
Secondary	Length of Post Surgical Stay in the Hospital	Length of post surgical stay in the hospital measured in days	from Surgery date to the discharge date from the hospital up to 30 days
Secondary	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 .	Day 0 Surgical Procedure
Secondary	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"	Day 0 Surgical procedure
Secondary	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".	DAY 1 to DAY 30 Postsurgery
Secondary	Operative Procedure Time	operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision	Day 0 Surgical Procedure