EUCTR2015-000644-42-NL进行中(未招募)不适用
aparoscopic advanced Imaging Techniques in Endometriosis therapy: LITE-study. A pilot trial. - LITE study
VU University medical center (VUmc)0 个研究点开始时间: 2016年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Oral and written informed consent
- •Age 18 years and older
- •Premenopausal women
- •Elective laparoscopic treatment of endometriosis lesions by CO 2 laser/ bipolar diathermy or surgical excision.
- •Presence of endometriosis (ASRM III-IV) confirmed by previous laparoscopy or likely to be present based on TVUS or MRI, including uni- or bilateral ovarian endometrioma.
- •Regular preoperative work-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Women who are legally or mentally incapable or unable to give informed consent
- •Age younger than 18 years
- •ASA (American Society of Anaesthesiologists) score higher than 3
- •Woman who have had major open abdominal surgery
- •Pregnancy
- •Malignancy
- •Iodine allergy
- •Hypersensitivity reaction to prior usage of indocyanin green injection
- •Hyperthyroidism or autonomous thyroid adenoma
- •Chronic kidney failure (eGFR<55)
- •Chronic liver failure (ASAT, ALAT, AF and yGT > two times the max normal value)
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