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[由国家预防和健康促进秘书处(SENPE)、国家药品和卫生用品管理局(SEEDO)、国家卫生服务局(SEN)和国家卫生监督局(SECO)支持的胃内气球置入术中的知情同意:法律方面]

[Informed consent in the intragastric balloon supported by SENPE, SEEDO, SEN and SECO: legal aspects].

作者信息

Abilés V, Martínez Olmos M A, Escartí M A, Bretón I, Cáncer E, Pelaez N, Álvarez V, Culebras J M, Mazure R A

机构信息

Hospital Costa del Sol, Marbella, España.

出版信息

Nutr Hosp. 2012 Mar-Apr;27(2):419-24. doi: 10.1590/S0212-16112012000200011.

Abstract

INTRODUCTION

Intra-gastric balloon (IGB) is an invasive, temporary, non-surgical technique for the treatment of obesity. Its outcomes mainly depend on the patient's collaboration.

OBJECTIVE

The aim was to adapt the informed consent used for bariatric surgery to a method that has especial characteristics.

MATERIALS AND METHODS

We used the informed consent proposed by ASAC for bariatric surgery and 8 statements related to IGB included in the WESTLAW ES database.

RESULTS

The review of the statements defines the IGB treatment as a curative-intended and non-satisfactive therapy with an obligation of the means used, but not the outcomes, by the treating physician. Moreover, the obligations of providing a correct and complete information -which includes the dietary regime- should be observed, as well as the possible therapeutic alternatives and finally, the proceeding used should be in written.

CONCLUSIONS

The informed consent is a medico-legal document which content should consider the latest jurisprudence on the minimally invasive techniques for the treatment of obesity.

摘要

引言

胃内气球(IGB)是一种用于治疗肥胖症的侵入性、临时性、非手术技术。其治疗效果主要取决于患者的配合。

目的

旨在将用于减肥手术的知情同意书调整为具有特殊特征的方法。

材料与方法

我们采用了ASAC提出的用于减肥手术的知情同意书以及WESTLAW ES数据库中包含的与IGB相关的8条声明。

结果

对这些声明的审查将IGB治疗定义为一种旨在治愈但不尽人意的治疗方法,治疗医生对所使用的手段(而非结果)负有责任。此外,应遵守提供正确和完整信息(包括饮食方案)的义务,以及可能的治疗替代方案,最后,所采用的程序应以书面形式进行。

结论

知情同意书是一份医疗法律文件,其内容应考虑肥胖症微创治疗的最新判例法。

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