Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Cervical volume removed
研究概览
简要总结
Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis and therapy of lesions of the female genital tract as a substitution or a complementary method to colposcopy with the development of new standards for a tissue sparing therapy Use of existing laparoscopic instruments, which allow a better quality level in the diagnosis and therapy than the current routine.
Development of new optics and instruments, which allow a tissue sparing approach Pre and postoperative measurement of the cervical volume, to be sure that the tissue removal is kept to a minimum level Development of qualitaty parameters for the most tissue respecting operations of the uterine cervix Prospective evaluation of the influence of tissue sparing surgery on future pregnancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Karnowsky-Index > 80,
- •18-80 years,
排除标准
- •Pregnancy,
- •Previous or current cancer,
- •Radio therapy of the pelvis,
- •Serious internistic accompanying diseases,
- •Psychiatric diseases,
- •HIV infection,
- •Drug addiction.
结局指标
主要结局
Cervical volume removed
时间窗: İmmediately after surgery
Cervical volume removed during the operation is recorded
İntraoperative Complications
时间窗: During the intraoperative
Complications encountered during the prodecure
Short term complications
时间窗: Within 48 hours after operation
Complications within 48 hours after operation
Late complications
时间窗: After 48 hours
Complications occuring after 48 hours
次要结局
未报告次要终点
研究者
Giuseppe Vercellino
MD
Charite University, Berlin, Germany