Ovary Neoplasm, Surgery
Conditions
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.
Interventions
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean procedure time | Within one week after the surgery | Mean procedure time will be measured by hour/minutes. |
| Estimated blood loss during operation | Within one week after the surgery | Blood loss during operation will be measured by volume (mL) |
| 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 ovarian reserve function | Three months after the surgery | The ovarian reserve function is reflected by the concentration of anti-mullerian hormone(AMH) |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYao Wang, MD
Outcome results
None listed