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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-17

Study Completion Date

2019-05-02

Brief Summary

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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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Detailed Description

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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

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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THUNDERBEAT

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

Group Type OTHER

THUNDERBEAT

Intervention Type DEVICE

Tissue dissection and vessels ligation

LIGASURE

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

Group Type OTHER

LIGASURE

Intervention Type DEVICE

Tissue dissection and vessels ligation

Interventions

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THUNDERBEAT

Tissue dissection and vessels ligation

Intervention Type DEVICE

LIGASURE

Tissue dissection and vessels ligation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No