Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

Benign Ovarian Cyst Clinical Trial

— PRAHA-2  

Official title:

A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643106
• Other study ID #: 2008-059-1147
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: Hyunji Lim, MD
• Phone: 82-2-2072-2821
• Email: hyunji3292[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.

Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Ovarian Cyst
• Ovarian Cysts

Intervention

Procedure:
• Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
• suturing with barbed sutures during laparoscopic ovarian cystectomy
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si	Gyeonggi
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	Ovarian function preservation 12 weeks after surgery	Reduction rate of AMH level in serum 12 weeks after surgery	12 weeks after surgery
Secondary	Ovarian function preservation 48 weeks after surgery	Reduction rate of AMH level in serum 48 weeks after surgery	48 weeks after surgery
Secondary	The time required to finish hemostasis	Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control	during operation
Secondary	the success rate of hemostasis within 10 minutes	Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes	during operation
Secondary	Blood loss during operation	The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle	during operation
Secondary	Hemoglobin	Change of serum hemoglobin from baseline	post-op 2 days, 12 weeks and 48 weeks
Secondary	Transfusion during admission	whether patients are transfused during admission period	post-op 2 days
Secondary	Adverse events associated with operation, bleeding or transfusion	any adverse events during admission period	post-op 2 days
Secondary	Hospitalization period	days from admission day to discharge day	within post-op 2 weeks
Secondary	Operation running time	time from anesthesia start to delivery of patient to recovery room	during operation