Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
- Conditions
- Benign Ovarian Cyst
- Interventions
- Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomyProcedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
- Registration Number
- NCT04643106
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suturing group suturing with barbed sutures during laparoscopic ovarian cystectomy 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. Hemostatic agent group Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy 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.
- Primary Outcome Measures
Name Time Method Ovarian function preservation 12 weeks after surgery 12 weeks after surgery Reduction rate of AMH level in serum 12 weeks after surgery
- Secondary Outcome Measures
Name Time Method Transfusion during admission post-op 2 days whether patients are transfused during admission period
the success rate of hemostasis within 10 minutes during operation Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes
Ovarian function preservation 48 weeks after surgery 48 weeks after surgery Reduction rate of AMH level in serum 48 weeks after surgery
Blood loss during operation during operation The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle
Hemoglobin post-op 2 days, 12 weeks and 48 weeks Change of serum hemoglobin from baseline
Adverse events associated with operation, bleeding or transfusion post-op 2 days any adverse events during admission period
Hospitalization period within post-op 2 weeks days from admission day to discharge day
The time required to finish hemostasis during operation Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control
Operation running time during operation time from anesthesia start to delivery of patient to recovery room
Trial Locations
- Locations (2)
Dongguk University Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of