PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

Ovarian Cyst Benign Clinical Trial

— PRAHA  

Official title:

A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374397
• Other study ID #: 2017-1707
• Status: Completed
• Phase: Phase 3
• Start date: December 6, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cyst Benign
• Ovarian Cysts

Intervention

Drug:
• Surgiguard
Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis	Change of serum hemoglobin from baseline	post operative 48 hours later,1 week later, and 12 weeks later
Secondary	Ovarian function preservation	Change of serum AMH from baseline	post operative 48 hours later,1 week later, and 12 weeks later
Secondary	Volume of ovary	ovarian volume measured by ultrasonography	post operative 48 hours later,1 week later, and 12 weeks later