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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Using the New Tissue Containment System group | Experimental | using the new tissue containment system during Laparoscopic Hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system. |
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| Open group | No Intervention | Without using any procteciton system during Laprascopic Hysterectomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the new tissue containment system | Device | Using the new tissue containment system during Laparoscopic hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system. |
| Measure | Description | Time Frame |
|---|---|---|
| The exposure rate | Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination". | approximately two years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean procedure time | Mean procedure time will be measured by hour/minutes. | Within one day after the surgery |
| The probability of failure during in-bag morcellation procedure | Failure is defined as the operator's inability to successfully insert and extract the device. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Yang, MD | Contact | 8684206115 | kong-yj@163.com |
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IPD will to be shared with other researchers after four years
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| approximately two years |
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | Within one day after the surgery |
| Post-operative pain | The patients' post-operative pain will be measured by The Visual Analog Score (VAS).The maximum value is 10 and the minimum is 0. The lower score means a better outcome. | Within one month after the surgery |
| Rate of intra- or post-operative complications | Intra or post complications rate (e.g. urinary, intestinal or nerve injury) | Three months after the surgery |
| The Surgeon Task Load Index | The Surgery Task Load Index will be measured by questionaire. The maximum value is 120 and the minimum is 0. The higher score means a worse outcome. | Within one week after the surgery |
| The Patients' life quality postoperative | The patients' life quality will be measured by The World Health Organization's Quality of Life Questionnaire-Brief Version(WHOQOL-BREF).The maximum value is 120 and the minimum is 0. The higher score means a better outcome. | One months after the surgery |