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The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the New Tissue Containment System group | Experimental | Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy |
|
| Open group | No Intervention | Without any protection system during Laparoscopic Ovarian Cystectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the New Tissue Containment System | Device | Laparoscopic Ovarian Cystectomy using 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". | End of study - approximately two years |
| Measure | Description | Time Frame |
|---|---|---|
| The ovarian reserve function | The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH) | Three months after the surgery |
| Mean procedure time | Mean procedure time will be measured by hour/minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Wang, MD | Contact | 8684206115 | wangyaopumc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 086010 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Within one week after the surgery |
| Estimated blood loss during operation | Blood loss during operation will be measured by volume (mL) | Within one week 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 patients' life quality postoperative: questionaire | 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. | Three months after the surgery |
| The Surgery 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 rate of failure during in-bag cystectomy procedure | Failure is defined as the operator's inability to successfully insert and extract the device. | End of study - approximately two years |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |