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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Benign Ovarian Cyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hemostatic agent group

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.

Group Type EXPERIMENTAL

Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

Intervention Type PROCEDURE

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)

Suturing group

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.

Group Type ACTIVE_COMPARATOR

suturing with barbed sutures during laparoscopic ovarian cystectomy

Intervention Type PROCEDURE

During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

Interventions

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Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)

Intervention Type PROCEDURE

suturing with barbed sutures during laparoscopic ovarian cystectomy

During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No