Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy

Study Overview
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Brief Summary
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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.

Official Title
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Safety, Effectiveness and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Ovarian Cystectomy

Conditions
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Ovary Neoplasm, Surgery

Intervention / Treatment
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* Device: the New Tissue Containment System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal woman patient age 18-45 years Women with regular period Women with ovarian neoplasm (size: 3-10cm) Laparoscopic surgery required Body mass index 18.5-27.9kg/m2 Subject able to comprehend and give informed consent for participation in this study Signed informed consent form Exclusion Criteria: Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free Women with Polycystic ovary syndrome Baseline AMH less than 0.5ng / mL Known to have participated in any other clinical trials or hormone therapy within 3 months Women during pregnancy and lactation Women in acute stage infection of reproductive system or other parts Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery Women with known or suspected poor compliance who cannot complete the trial Those who can not sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the New Tissue Containment System group<br>Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy | Device: the New Tissue Containment System<br>* Laparoscopic Ovarian Cystectomy using the New Tissue Containment System<br>|
| No Intervention: Open group<br>Without any protection system during Laparoscopic Ovarian Cystectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |