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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe exposure rate
• Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
Time frame: End of study - approximately two years
The ovarian reserve function
The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
Time frame: Three months after the surgery
Mean procedure time
Mean procedure time will be measured by hour/minutes.
Time frame: Within one week after the surgery
Estimated blood loss during operation
Blood loss during operation will be measured by volume (mL)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Within one week after the surgery
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The rate of failure during in-bag cystectomy procedure
Failure is defined as the operator's inability to successfully insert and extract the device.
Time frame: End of study - approximately two years