Benign Ovarian Cyst
Conditions
Keywords
endometriosis, endometrioma, ovarian cystectomy, ovarian function, ovarian reserve, hemostatic agent, suture
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.
Interventions
PROCEDUREHemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
PROCEDUREsuturing with barbed sutures during laparoscopic ovarian cystectomy
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian function preservation 12 weeks after surgery | 12 weeks after surgery | Reduction rate of AMH level in serum 12 weeks after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Ovarian function preservation 48 weeks after surgery | 48 weeks after surgery | Reduction rate of AMH level in serum 48 weeks after surgery |
| 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 |
| Operation running time | during operation | time from anesthesia start to delivery of patient to recovery room |
| Transfusion during admission | post-op 2 days | whether patients are transfused during admission period |
Countries
South Korea
Contacts
Primary ContactHyunji Lim, MD
Backup ContactHee seung Kim, MD/PhD
Outcome results
None listed