Skip to main content
OpenTrials
Completed

NCT Number: NCT02628093

A ProspectiveTrial 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical Center- NYPH

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THUNDERBEAT

Device

Tissue dissection and vessels ligation

LIGASURE

Device

Tissue dissection and vessels ligation

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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 .

  3. 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"

  4. 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".

  5. 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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Olympus

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2015
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.