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

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ClinicalTrials.gov Identifier: NCT02538328
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Serdar Kırmızı, Inonu University

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
Morbid Obesity Device: Harmonic scapel Device: Ligasure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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 Name: ultrasonic dissector

Device: Ligasure
Bipolar vessel sealing system used in obesity surgery
Other Name: 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 Name: ultrasonic dissector

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




Primary Outcome Measures :
  1. Safety and efficacy of sealing [ Time Frame: 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 [ Time Frame: During the operation ]
    Amount of blood loss in the operation



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

Inclusion Criteria:

  • obesity
  • BMI over 40 kg/m^2

Exclusion Criteria:

  • Normal BMI cases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538328


Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: cüneyt kayaalp, prof GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY

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Responsible Party: Serdar Kırmızı, General Surgeon in Gastrointestinal Surgery, Inonu University
ClinicalTrials.gov Identifier: NCT02538328     History of Changes
Other Study ID Numbers: 2014/105
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Serdar Kırmızı, Inonu University:
laparoscopy
obesity
harmonic scalpel
ligasure
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms