Trials / Completed
CompletedNCT02628093
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | THUNDERBEAT | Tissue dissection and vessels ligation |
| DEVICE | LIGASURE | Tissue dissection and vessels ligation |
Timeline
- Start date
- 2016-02-17
- Primary completion
- 2019-05-02
- Completion
- 2019-05-02
- First posted
- 2015-12-11
- Last updated
- 2020-03-18
- Results posted
- 2020-02-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02628093. Inclusion in this directory is not an endorsement.