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Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Harmonic scapel
Ligasure
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Morbid Obesity focused on measuring laparoscopy, obesity, harmonic scalpel, ligasure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • obesity
  • BMI over 40 kg/m^2

Exclusion Criteria:

  • Normal BMI cases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    harmonic scapel

    Ligasure sealing device

    Arm Description

    Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices

    Ligasure used in obesity surgery for the comparison of different surgical devices Randomly chosen cases where ligasure is used instead of hamonic scalpel in surgical procedures comparison of multiple dissectors

    Outcomes

    Primary Outcome Measures

    Safety and efficacy of sealing
    Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch.

    Secondary Outcome Measures

    Bleeding
    Amount of blood loss in the operation

    Full Information

    First Posted
    August 10, 2015
    Last Updated
    September 1, 2015
    Sponsor
    Inonu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02538328
    Brief Title
    Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
    Official Title
    Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inonu University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.
    Detailed Description
    The investigators' department performs 150 gastric bypass surgeries annually. Surgeons use both harmonic scalpel and ligasure sealing device in cases. Aim is to compare both of these devices over coming each other. Benefits ease of these devices are compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    laparoscopy, obesity, harmonic scalpel, ligasure

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    harmonic scapel
    Arm Type
    Active Comparator
    Arm Description
    Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices
    Arm Title
    Ligasure sealing device
    Arm Type
    Placebo Comparator
    Arm Description
    Ligasure used in obesity surgery for the comparison of different surgical devices Randomly chosen cases where ligasure is used instead of hamonic scalpel in surgical procedures comparison of multiple dissectors
    Intervention Type
    Device
    Intervention Name(s)
    Harmonic scapel
    Other Intervention Name(s)
    ultrasonic dissector
    Intervention Description
    different surgical devices used in the obesity surgery
    Intervention Type
    Device
    Intervention Name(s)
    Ligasure
    Other Intervention Name(s)
    Bipolar Vessel sealing device
    Intervention Description
    Bipolar vessel sealing system used in obesity surgery
    Primary Outcome Measure Information:
    Title
    Safety and efficacy of sealing
    Description
    Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Bleeding
    Description
    Amount of blood loss in the operation
    Time Frame
    During the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: obesity BMI over 40 kg/m^2 Exclusion Criteria: Normal BMI cases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    cüneyt kayaalp, prof
    Organizational Affiliation
    GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery

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