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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-45
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No 'ovarian' endometriosis

Suspicious disease of ovarian malignancy

Age: 18 and younger, 46 and older

Pregnancy or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy

    Procedure/Surgery

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

  • suturing with barbed sutures during laparoscopic ovarian cystectomy

    Procedure/Surgery

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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Hemostatic agent groupExperimental treatment 1 intervention
Group B: Suturing groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ovarian function preservation 12 weeks after surgery

Reduction rate of AMH level in serum 12 weeks after surgery

Time frame
12 weeks after surgery

Secondary outcomes

1

Ovarian function preservation 48 weeks after surgery

Reduction rate of AMH level in serum 48 weeks after surgery

Time frame
48 weeks after surgery
2

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

Time frame
during operation
3

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

Time frame
during operation
4

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

Time frame
during operation

Other outcomes

Sponsors and contacts

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