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

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT02538328
Collaborator
(none)
90
Enrollment
2
Arms
12
Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Harmonic scapel
  • Device: Ligasure
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: harmonic scapel

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

Device: Harmonic scapel
different surgical devices used in the obesity surgery
Other Names:
  • ultrasonic dissector

    • Device: Ligasure
    Bipolar vessel sealing system used in obesity surgery
    Other Names:
  • Bipolar Vessel sealing device

    		•
    Placebo Comparator: Ligasure sealing device

    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

    Device: Harmonic scapel
    different surgical devices used in the obesity surgery
    Other Names:
  • ultrasonic dissector

    • Device: Ligasure
    Bipolar vessel sealing system used in obesity surgery
    Other Names:
  • Bipolar Vessel sealing device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and efficacy of sealing [1 year]

      Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch.

    Secondary Outcome Measures

    1. Bleeding [During the operation]

      Amount of blood loss in the operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • obesity

    • BMI over 40 kg/m^2

    Exclusion Criteria:
    • Normal BMI cases

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Inonu University

    Investigators

    • Principal Investigator: cüneyt kayaalp, prof, GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Serdar Kırmızı, General Surgeon in Gastrointestinal Surgery, Inonu University
    ClinicalTrials.gov Identifier:
    NCT02538328
    Other Study ID Numbers:
    • 2014/105
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Sep 2, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Serdar Kırmızı, General Surgeon in Gastrointestinal Surgery, Inonu University
    laparoscopy
    obesity
    harmonic scalpel
    ligasure
    Additional relevant MeSH terms:
    Obesity
    Obesity, Morbid

    Study Results

    No Results Posted as of Sep 2, 2015