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NCT02538328 Clinical Trial

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

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02538328
Other study ID # 2014/105
Secondary ID
Status Completed
Phase N/A
First received August 10, 2015
Last updated September 1, 2015
Start date July 2014
Est. completion date July 2015

Study information
Verified date August 2015
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- obesity

- BMI over 40 kg/m^2

Exclusion Criteria:

- Normal BMI cases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Device:
• Harmonic scapel
different surgical devices used in the obesity surgery
• Ligasure
Bipolar vessel sealing system used in obesity surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Inonu University

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and efficacy of sealing Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch. 1 year Yes
Secondary Bleeding Amount of blood loss in the operation During the operation Yes
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