NCT04406597招募中不适用
Safety, Effectiveness and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Ovarian Cystectomy
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年5月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The exposure rate
研究概览
简要总结
The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal woman patient age 18-45 years
- •Women with regular period
- •Women with ovarian neoplasm (size: 3-10cm)
- •Laparoscopic surgery required
- •Body mass index 18.5-27.9kg/m2
- •Subject able to comprehend and give informed consent for participation in this study
- •Signed informed consent form
排除标准
- •Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure
- •The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free
- •Women with Polycystic ovary syndrome
- •Baseline AMH less than 0.5ng / mL
- •Known to have participated in any other clinical trials or hormone therapy within 3 months
- •Women during pregnancy and lactation
- •Women in acute stage infection of reproductive system or other parts
- •Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery
- •Women with known or suspected poor compliance who cannot complete the trial
- •Those who can not sign the informed consent
研究组 & 干预措施
the New Tissue Containment System group
Experimental
Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
干预措施: the New Tissue Containment System (Device)
Open group
No Intervention
Without any protection system during Laparoscopic Ovarian Cystectomy
结局指标
主要结局
The exposure rate
时间窗: End of study - approximately two years
• Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
次要结局
- The patients' life quality postoperative: questionaire(Three months after the surgery)
- Mean procedure time(Within one week after the surgery)
- The ovarian reserve function(Three months after the surgery)
- The rate of failure during in-bag cystectomy procedure(End of study - approximately two years)
- Estimated blood loss during operation(Within one week after the surgery)
- The Surgery Task Load Index(Within one week after the surgery)
- Rate of Intra- or post-operative complications(Three months after the surgery)
研究者
Jing Liang
Vice Director of Obstetrics and Gynecology
China-Japan Friendship Hospital
研究点 (1)
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