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临床试验/NCT04129879
NCT04129879已完成不适用

ABC Technique as a Novel Approach for Endometriosis Surgery

Acibadem University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2014年1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
发起方
入组人数
115
试验地点
1
主要终点
number of samples taken from each region

研究概览

简要总结

Endometriosis is a chronic disease defined as the existence of endometrium like lesions outside of the uterine cavity. The diagnosis is based on examination of lesions under the microscope and capturing endometrial gland and stroma. The mostly used surgical technique to diagnose and treat endometriosis is laparoscopic surgery. In our novel technique for endometriosis surgery, we used methylene blue for its natural blue color to make endometriotic lesions more visible and to filter red, yellow and white colors reflecting from the peritoneal surface.

详细描述

Endometriosis is a chronic disease defined as existence of endometrium like lesions outside of the uterine cavity. The diagnosis is based on examination of lesions under microscope and capturing endometrial gland and stroma. The prevalence of endometriosis upon women on their reproductive ages, all over the world is at least 10%. This prevalence depends on surgically proven lesions that are excised, according to the this the real prevalence is still unknown because of underdiagnosis and being unable to capture endometriotic lesions.

Endometriosis is usually described as having three subtypes, which are peritoneal, ovarian endometriomas and deep infiltrative endometriosis (DIE). Peritoneal endometriosis is the most undiagnosed type according to lack of diagnostic tests and being unrecognizable on imaging modalities while ovarian endometriomas and deep infiltrative endometriosis lesions can be realized by ultrasound or MRI imaging. Also, these three subtypes are mostly existing together and even with uterine endometriosis which is named as adenomyosis. Considering the difficulties of capturing an endometriotic lesion most of the surgeries done for deep endometriosis or ovarian endometriomas usually fail upon insufficient excision of the disease.

The main presentations of endometriosis are pain and infertility. Whether it can be thought the most devastating anatomical lesion may cause more pain, the pain of endometriosis is usually unrelated with the characteristics of pathology or severity of the disease. Therefore, a small lesion even not visible to the naked eye may cause more pain than a large DIE nodule. This knowledge arises the importance of threating all lesions on a symptomatic patient with pain.

The mostly used surgical technique to diagnose and treat endometriosis is laparoscopic surgery. Under laparoscopic scope endometriotic lesions can bee seen in black, red, white colors and as flat or polypoid. Human eye can see wave lengths between 400-700 nm. And it is not always easy to visualize all pathologies even with the 4 to 40 times magnification of usual laparoscopic scopes. Human vision under white-light reflection cannot easily discriminate different tissue types. Making color contrasts make objects easy to be catch by human eye.

In our novel technique for endometriosis surgery we used methylene blue for its natural blue color to make endometriotic lesions more visible and to filter red, yellow and white colors reflecting from peritoneal surface.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •patients who have endometriosis
  • •patients who approved their data to be used for research manner
  • •operations with only peritoneal endometriosis

排除标准

  • •operations without the diagnosis of endometriosis
  • •patients who have not approved their data to be used for research manner
  • •operations which also include endometriomas and/or deep infiltrative endometriosis

研究组 & 干预措施

1

Experimental

all patients treated by conventional bare eye technique and then the use of methylene blue contrast technique to visualize endometriotic lesions perioperatively

干预措施: ABC technique (Procedure)

结局指标

主要结局

number of samples taken from each region

时间窗: retrospective 1 year period

次要结局

  • number of endometriosis positivity came out of each excision(retrospective 1 year period)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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