Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function (PRAHA-2)

Seoul National University

Status: Enrolling

Conditions: Benign Ovarian Cyst

Treatments: Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy; Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04643106

2008-059-1147

Details and patient eligibility

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Hemostatic agent group

Experimental group

Description:

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding.

Treatment:

Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

Suturing group

Active Comparator group

Description:

During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted.

Treatment:

Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy