Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
- Conditions
- SurgeryOvary Neoplasm
- Interventions
- Device: the New Tissue Containment System
- Registration Number
- NCT04406597
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the New Tissue Containment System group the New Tissue Containment System Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
- Primary Outcome Measures
Name Time Method The exposure rate End of study - approximately two years • Exposure is defined as "disruption of the device (using dye leak testing or water testing) or visible tissue dissemination".
- Secondary Outcome Measures
Name Time Method Mean procedure time Within one week after the surgery Mean procedure time will be measured by hour/minutes.
The ovarian reserve function Three months after the surgery The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH)
The rate of failure during in-bag cystectomy procedure End of study - approximately two years Failure is defined as the operator's inability to successfully insert and extract the device.
Estimated blood loss during operation Within one week after the surgery Blood loss during operation will be measured by volume (mL)
The Surgery Task Load Index Within one week after the surgery 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.
Rate of Intra- or post-operative complications Three months after the surgery Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
The patients' life quality postoperative: questionaire Three months after the surgery 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.
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China