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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Ovarian function preservation 12 weeks after surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy (Procedure)
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.
Intervention: suturing with barbed sutures during laparoscopic ovarian cystectomy (Procedure)
Outcomes
Primary Outcomes
Ovarian function preservation 12 weeks after surgery
Time Frame: 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
Secondary Outcomes
- Transfusion during admission(post-op 2 days)
- the success rate of hemostasis within 10 minutes(during operation)
- Blood loss during operation(during operation)
- Hemoglobin(post-op 2 days, 12 weeks and 48 weeks)
- Adverse events associated with operation, bleeding or transfusion(post-op 2 days)
- Hospitalization period(within post-op 2 weeks)
- Ovarian function preservation 48 weeks after surgery(48 weeks after surgery)
- The time required to finish hemostasis(during operation)
- Operation running time(during operation)
Investigators
Hee Seung Kim
associate professor
Seoul National University Hospital