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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Colon Cancer

Treatments: Device: LIGASURE; Device: THUNDERBEAT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02628093

1403014955

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

73 participants in 2 patient groups

THUNDERBEAT

Other group

Description:

THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels

Treatment:

Device: THUNDERBEAT

LIGASURE

Other group

Description:

LIGASURE energy device will be used for dissection of tissue and ligation of vessels

Treatment:

Device: LIGASURE