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临床试验/NCT04931706
NCT04931706Unknown不适用

Double Magnetic-assisted Single-port Nissen Sleeve

Unidad Internacional de Cirugia Bariatrica y Metabolica1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Surgical Complications

研究概览

简要总结

New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

详细描述

A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Any patient with controlled comorbidities suffering from obesity and GERD.

排除标准

  • •Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

结局指标

主要结局

Surgical Complications

时间窗: 1 month

any adverse event during the surgery

Surgical time

时间窗: 30 minutes

how long does the surgery take

Weight loss follow up

时间窗: 1 month

Kg that the patient loss

次要结局

未报告次要终点

研究者

发起方
Unidad Internacional de Cirugia Bariatrica y Metabolica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Borjas

Director

Unidad Internacional de Cirugia Bariatrica y Metabolica

研究点 (1)

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