Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FloSeal group | Experimental | After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) |
|
| Electrocautery group | Active Comparator | After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloSeal application | Procedure | After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis time | Immediately after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian function after surgery | within 6 months after surgery | |
| Operative time | 1 day (Immediately after surgery) | |
| Intraoperative blood loss |
Not provided
Inclusion Criteria:
WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Seoul | 138-736 | South Korea |
Not provided
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Electrocautery | Procedure | After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery |
|
| During surgery |
| Postoperative drainage duration | within 1 week after surgery |
| Length of postoperative stay | within 1 month after surgery |
| Postoperative complications | Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0. | within 1 months after surgery |