Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
2022年10月25日 更新者：Jing Liang
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
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
研究概览
研究类型
介入性
注册 (预期的)
400
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fang Zhao, MD
- 电话号码：861084206115
- 邮箱：fangzhaow@163.com
研究联系人备份
- 姓名：Yao Wang, PHD
- 电话号码：861084205983
学习地点
-
-
-
Beijing、中国
- 招聘中
- China-Japan Friendship Hospital
-
接触：
- Fang Zhao
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
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
Exclusion Criteria:
• 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：using the new tissue containment system
using the new tissue containment system during Laparoscopic myomectomy morcellation
|
using the new tissue containment system during Laparoscopic myomectomy morcellation
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
大体时间：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. |
approximately two years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The probability of failure during in-bag morcellation procedure
大体时间：approximately two years
|
Failure is defined as the operator's inability to successfully insert and extract the device.
|
approximately two years
|
|
Mean procedure time
大体时间：approximately two years
|
Mean procedure time will be measured by hour/minutes.
|
approximately two years
|
|
Estimated blood loss during operation
大体时间：approximately two years
|
Blood loss during operation will be measured by volume (mL)
|
approximately two years
|
|
Post-operative pain
大体时间：approximately two years
|
Post-operative pain will be measured by Visual Analog Score - VAS
|
approximately two years
|
|
Intra- or post-operative complications
大体时间：approximately two years
|
Intra or post complications rate (e.g.
urinary, intestinal or nerve injury)
|
approximately two years
|
|
The Surgeon Task Load Index
大体时间：approximately two years
|
The Surgeon Task Load Index be measured by designated Questionnaire.
|
approximately two years
|
|
The Patients' life quality postoperative
大体时间：approximately two years
|
The Patients' life quality postoperative be measured by Questionnaire.
|
approximately two years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年5月20日
初级完成 (预期的)
2022年12月1日
研究完成 (预期的)
2022年12月20日
研究注册日期
首次提交
2020年5月14日
首先提交符合 QC 标准的
2020年5月14日
首次发布 (实际的)
2020年5月19日
研究记录更新
最后更新发布 (实际的)
2022年10月26日
上次提交的符合 QC 标准的更新
2022年10月25日
最后验证
2022年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.