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

March 4, 2020 updated by: Weill Medical College of Cornell University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical Center- NYPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: THUNDERBEAT
THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels
Device: THUNDERBEAT
Tissue dissection and vessels ligation
Other: LIGASURE
LIGASURE energy device will be used for dissection of tissue and ligation of vessels
Device: LIGASURE
Tissue dissection and vessels ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 Surgical procedure
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.
Day 0 Surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Post Surgical Stay in the Hospital
Time Frame: from Surgery date to the discharge date from the hospital up to 30 days
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
Dryness of the Surgical Field Average Score Mean/sd
Time Frame: Day 0 Surgical Procedure
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
Intraoperative Complication Related to the Energy Devices
Time Frame: Day 0 Surgical procedure
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
Delayed Thermal Injuries Related to Energy Devices
Time Frame: DAY 1 to DAY 30 Postsurgery
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
Operative Procedure Time
Time Frame: Day 0 Surgical Procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Olympus

Investigators

  • Principal Investigator: Jeffrey Milsom, MD, WCMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2016

Primary Completion (Actual)

May 2, 2019

Study Completion (Actual)

May 2, 2019

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1403014955

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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