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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Device: Harmonic scapel; Device: Ligasure

• Registration Number: NCT02538328
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-01
• Last Update Submitted: 2015-09-01
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• obesity
• BMI over 40 kg/m^2

Exclusion Criteria

• Normal BMI cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
harmonic scapel	Harmonic scapel	Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices
harmonic scapel	Ligasure	Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices
Ligasure sealing device	Harmonic scapel	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
Ligasure sealing device	Ligasure	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Bleeding	During the operation	Amount of blood loss in the operation