PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Lapar… (NCT03374397) | Clinical Trial Compass
CompletedPhase 3
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
South Korea52 participantsStarted 2017-12-06
Plain-language summary
The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female, 18 years ≤ Ages \<45 years
* laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography
* women with regular menstruation
* women with regular menstruation cycle from 21 days to 45 days
* Proper state for laparoscopic operation (American society of Anesthesiologists Physical Status classification 1 or 2)
* Patients who signed and approved informed consent
Exclusion Criteria:
* Patients without ovarian cyst
* Patients with malignant female genital disease
* Patients with bilateral ovarian cysts
* Age ≥ 45
* Pregnancy or lactating women
* Serum AMH\<0.05 ng/ml
* Patients with endocrine disease such as thyroid abnormality, hyperprolactinemia, cushing disease, etc
* Patients with hormone replacement therapy during 3 months
* Patients who is considered to be difficult to perform the clinical trial when researchers judge
What they're measuring
1
Hemostasis
Timeframe: post operative 48 hours later,1 week later, and 12 weeks later