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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| using the new tissue containment system | Experimental | using the new tissue containment system during Laparoscopic myomectomy morcellation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the new tissue containment system | Device | using the new tissue containment system during Laparoscopic myomectomy morcellation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The probability of failure during in-bag morcellation procedure | Failure is defined as the operator's inability to successfully insert and extract the device. | approximately two years |
| Mean procedure time |
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Inclusion Criteria:
Pre- and Peri-menopausal woman patient age 18-45 years
Exclusion Criteria:
• Women with Known or suspected malignancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Zhao, MD | Contact | 861084206115 | fangzhaow@163.com | |
| Yao Wang, PHD | Contact | 861084205983 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
IPD will to be shared with other researchers after four years
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Mean procedure time will be measured by hour/minutes.
| approximately two years |
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | approximately two years |
| Post-operative pain | Post-operative pain will be measured by Visual Analog Score - VAS | approximately two years |
| Intra- or post-operative complications | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) | approximately two years |
| The Surgeon Task Load Index | The Surgeon Task Load Index be measured by designated Questionnaire. | approximately two years |
| The Patients' life quality postoperative | The Patients' life quality postoperative be measured by Questionnaire. | approximately two years |