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The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy
In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurgiGuard | Active Comparator | Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery |
|
| Bipolar electrocauterization | No Intervention | Bipolar electrocauterization during surgery Drug(-) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgiguard | Drug | Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis | Change of serum hemoglobin from baseline | post operative 48 hours later,1 week later, and 12 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian function preservation | Change of serum AMH from baseline | post operative 48 hours later,1 week later, and 12 weeks later |
| Volume of ovary | ovarian volume measured by ultrasonography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Seung Kim, MD/PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33875738 | Derived | Park SJ, Seol A, Lee N, Lee S, Kim HS; PRAHA Study Group. A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy. Sci Rep. 2021 Apr 19;11(1):8495. doi: 10.1038/s41598-021-87965-7. |
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| post operative 48 hours later,1 week later, and 12 weeks later |