Colon Cancer Clinical Trial

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

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

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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.

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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

Study is for people with:

Colon Cancer

Estimated Enrollment:

73

Study ID:

NCT02628093

Recruitment Status:

Completed

Sponsor:

Weill Medical College of Cornell University

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There is 1 Location for this study

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Weill Cornell Medical Center- NYPH
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

73

Study ID:

NCT02628093

Recruitment Status:

Completed

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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