Clinical trial NCT02628093: A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
Official title: A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2015-12-11
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Time for Dissection of the Soft Tissues
timeFrame: Day 0 Surgical procedure
measure: Versatility Score
timeFrame: Day 0 Surgical procedure
Secondary outcomes:
measure: Length of Post Surgical Stay in the Hospital
timeFrame: from Surgery date to the discharge date from the hospital up to 30 days
measure: Dryness of the Surgical Field Average Score Mean/sd
timeFrame: Day 0 Surgical Procedure
measure: Intraoperative Complication Related to the Energy Devices
timeFrame: Day 0 Surgical procedure
measure: Delayed Thermal Injuries Related to Energy Devices
timeFrame: DAY 1 to DAY 30 Postsurgery
measure: Operative Procedure Time
timeFrame: Day 0 Surgical Procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center- NYPH
state: New York
Study officials:
affiliation: WCMC
name: Jeffrey Milsom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milsom JW, Trencheva K, Momose K, Peev MP, Christos P, Shukla PJ, Garrett K. A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery. Surg Endosc. 2022 Jun;36(6):4265-4274. doi: 10.1007/s00464-021-08765-8. Epub 2021 Nov 1.