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临床试验/NCT02538328
NCT02538328已完成不适用

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

Inonu University0 个研究点目标入组 90 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Safety and efficacy of sealing

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •BMI over 40 kg/m^2

排除标准

  • •Normal BMI cases

研究组 & 干预措施

harmonic scapel

Active Comparator

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

干预措施: Harmonic scapel (Device)

harmonic scapel

Active Comparator

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

干预措施: Ligasure (Device)

Ligasure sealing device

Placebo Comparator

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

干预措施: Harmonic scapel (Device)

Ligasure sealing device

Placebo Comparator

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

干预措施: Ligasure (Device)

结局指标

主要结局

Safety and efficacy of sealing

时间窗: 1 year

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

次要结局

  • Bleeding(During the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serdar Kırmızı

General Surgeon in Gastrointestinal Surgery

Inonu University

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