N/A N=60 Randomized Other

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

Colon Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02628093 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Overall Time for Dissection of the Soft Tissues — 91; 77 minutes — p=0.214

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: THUNDERBEAT (Device); LIGASURE (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Time for Dissection of the Soft Tissues	91; 77	0.214
PRIMARY Versatility Score	4.8; 4.7	0.007 sig
SECONDARY Length of Post Surgical Stay in the Hospital	4.5; 5.3	—
SECONDARY Dryness of the Surgical Field Average Score Mean/sd	4.5; 4.4	—
SECONDARY Intraoperative Complication Related to the Energy Devices	0; 0	—
SECONDARY Delayed Thermal Injuries Related to Energy Devices	0; 0	1.0
SECONDARY Operative Procedure Time	176; 170	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02628093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.