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临床试验/NCT05624567
NCT05624567尚未招募不适用

Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study

Medical University of Vienna0 个研究点目标入组 800 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
主要终点
Symptom correlation with #ENZIAN

研究概览

简要总结

All patients undergoing surgery due to suspected endometriosis in a previously selected 3-month period within the study period (between 12/2022 and 12/24) (each participating center will define the particular 3 months in question) will be asked to participate in this study. Upon inclusion, patients will be asked to fill out questionnaires regarding endometriosis-associated symptoms as well as a detailed patient history. Furthermore, patients will be asked to fill out 2 standardized questionnaires, one regarding quality of life (Endometriosis-Health Profile-30) and one regarding sexual function (Female Sexual Function Index). Six and 12 months after surgery, patients will again be asked to fill out these two standardized questionnaires as well as a questionnaire regarding postsurgical therapy and endometriosis-associated symptoms. The surgeon will be asked to fill out a form regarding the surgical procedure and possible surgical complications.

The primary endpoints of this multicenter observational study are to prospectively examine:

  1. if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification
  2. if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Planned surgery for suspected endometriosis
  • Age between 18 and 50
  • signed informed consent

排除标准

  • menopause
  • current malignant disease

结局指标

主要结局

Symptom correlation with #ENZIAN

时间窗: 12/2022-12/2024

Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification

Endometriosis surgery and #ENZIAN - Correlation with quality of life?

时间窗: 12/2022-12/2024

Does the surgical intervention have an effect on the quality of life in relation to the individual #ENZIAN compartments.

次要结局

未报告次要终点

研究者

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

René Wenzl

Ao. Univ. Prof. Dr.

Medical University of Vienna

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