NCT04392674招募中不适用
Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation
Jing Liang1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年5月20日最近更新:
适应症
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 safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
研究概览
简要总结
The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Pre- and Peri-menopausal woman patient age 18-45 years
- •Women with fibroids and indication for laparoscopic myomectomy.
- •Normal Pap smear result within one year
- •MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
- •The body mass index of the patients is 18.5-27.9kg/m2
- •Signed informed consent form
排除标准
- •• Women with Known or suspected malignancy
- •patients with severe pelvic adhesion found during the operation
- •The body mass index of the patient ≥ 28kg/m2
- •Diameter of a single uterine fibroid>10cm
- •patients during pregnancy and lactation
- •Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
- •Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
- •Patients who are known to have participated in any other clinical trial within 3 months
- •Patients who cannot sign informed consent
- •Patients with acute stage infection of the reproductive system or other sites
结局指标
主要结局
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
时间窗: approximately two years
The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.
次要结局
- The probability of failure during in-bag morcellation procedure(approximately two years)
- The Patients' life quality postoperative(approximately two years)
- Mean procedure time(approximately two years)
- The Surgeon Task Load Index(approximately two years)
- Post-operative pain(approximately two years)
- Intra- or post-operative complications(approximately two years)
- Estimated blood loss during operation(approximately two years)
研究者
Jing Liang
professor
China-Japan Friendship Hospital
研究点 (1)
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