NCT04423172Unknown不适用
Safety, Efficacy and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laprascopic Hysterectomy
Jing Liang0 个研究点目标入组 120 人开始时间: 2020年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- The exposure rate
研究概览
简要总结
The study is designed to evaluate the safety, operability and efficacy of performing the new tissue containment system during laparoscopic hysterectomy. Pre- and perimenopausal women undergoing laparoscopic hysterectomy.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre- and Peri-menopausal woman patient age 18-65 years
- •Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for laparoscopic hysterectomy.
- •Normal Pap smear result within one year
- •The uterus is larger than 12 weeks of gestation
- •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 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 exposure rate
时间窗: 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
- Mean procedure time(Within one day after the surgery)
- The probability of failure during in-bag morcellation procedure(approximately two years)
- Estimated blood loss during operation(Within one day after the surgery)
- Post-operative pain(Within one month after the surgery)
- Rate of intra- or post-operative complications(Three months after the surgery)
- The Surgeon Task Load Index(Within one week after the surgery)
- The Patients' life quality postoperative(One months after the surgery)
研究者
Jing Liang
professor
China-Japan Friendship Hospital
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