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

September 1, 2015 updated by: Serdar Kırmızı, Inonu University
Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obesity
  • BMI over 40 kg/m^2

Exclusion Criteria:

  • Normal BMI cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: During the operation
Amount of blood loss in the operation
During the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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