Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
NCT ID: NCT04406597
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2022-05-20
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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the New Tissue Containment System group
Using the New Tissue Containment System during Laparoscopic Ovarian Cystectomy
the New Tissue Containment System
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
Open group
Without any protection system during Laparoscopic Ovarian Cystectomy
No interventions assigned to this group
Interventions
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the New Tissue Containment System
Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Jing Liang
Vice Director of Obstetrics and Gynecology
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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fang zhao
Role: primary
Other Identifiers
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NTCS-LOC
Identifier Type: -
Identifier Source: org_study_id
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