A Multicentre Study to Examine the Short and Long Term Outcomes of the Conservative Management of Benign-looking Adnexal Masses and the Pre-operative Characterisation of Ovarian Tumours
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses
研究概览
简要总结
The purpose of this study is to learn more about the appearance and behavior of benign-looking adnexal masses.
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Benign-looking means that when viewed here by ultrasound it has the appearance of looking not harmful or not malignant.
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Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa includes, but is not limited to, the ovaries and the fallopian tubes.
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Masses refers to a variety of structures, including but not limited to:
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ovarian cysts that are fluid filled sacs within or attached to an ovary
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ovarian tumors that can be solid tissue or a combination of cysts and solid tissue
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hydrosalpinges that are fluid collections in the fallopian tube
Many women have what appear to be benign adnexal masses. Many times, removal of the masses with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these masses could be cancer. There is not much information available for doctors to know how and when to follow these masses, or which ones will become cancer.
This study will combine information from centers all around the world regarding the behavior of all types of benign adnexal masses. The aim of this study is to develop decision tools for doctors to know the best way to treat these masses in order to improve the detection of ovarian cancer while at the same time reduce the number of unnecessary operations.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman at least 18 years old with an adnexal mass.
- •Any mass with benign ultrasound morphology may be suitable for conservative management.
- •Pregnant patients can be included, but their data will be analysed separately.
排除标准
- •Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.
- •Any cyst with features of malignancy is excluded from the conservative management
- •The denial or withdrawal of oral informed consent
结局指标
主要结局
Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses
时间窗: Up to five years
次要结局
- Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign(Up to five years)