Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
Recruiting · NCT04643106 · Interventional (participants receive a specific treatment) · Lead sponsor: Seoul National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomysuturing with barbed sutures during laparoscopic ovarian cystectomy
What this trial is about
This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.
Who can take part
Age range
19 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Informed consent.
- Age: 19-45 year-old women
- American Society of Anesthesiologists Physical Status classification 1 or 2
- Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
- Regular menstruation every 21-45 days
Exclusion criteria
- No 'ovarian' endometriosis
- Suspicious disease of ovarian malignancy
- Age: 18 and younger, 46 and older
- Pregnancy or breastfeeding.
- Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
- Hormonal therapy within recent 3 months
- Considered as inappropriate by the researcher's judgment.
Where it is running
2 locations listed.
- Seoul National University Hospital - Seoul, South Korea
- Dongguk University Ilsan Hospital - Goyang-si, Gyeonggi-do, South Korea