N/A
Completed N=60
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
Source: ClinicalTrials.gov NCT02628093 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Overall Time for Dissection of the Soft Tissues — 91; 77 minutes — p=0.214
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
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 | — |
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
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. Informational only — not medical advice.