Clinical trial · Interventional
Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY
NCT01683877CI-TRIAL-00070104completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Ovarian Tumor | Benign Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrocautery | Procedure | — | UNRESOLVED |
| FloSeal application | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FloSeal group
- description
- After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
- interventionNames
- Procedure: FloSeal application
- type
- ACTIVE_COMPARATOR
- label
- Electrocautery group
- description
- After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
- interventionNames
- Procedure: Electrocautery
Primary outcomes (1)
- measure
- Hemostasis time
- timeFrame
- Immediately after operation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women * Patients who is planned to undergo laparoscopic ovarian cystectomy * American Society of Anesthesiologists Physical Status classification (ASA PS) 1-2 * Patients with adequate bone marrow, renal and hepatic function: 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 * Patient must be suitable candidates for surgery * Patients who have signed an approved Informed Consent Exclusion Criteria: * Patients with a history of pelvic or abdominal radiotherapy; * Patients who are pregnant or nursing * Patients who is receiving or requires hormone replacement therapy after surgery * Patients who is undergoing hysterectomy at this time * Patients who is undergoing unilateral or bilateral oophorectomy * Previous history of ovarian cystectomy or oophorectomy * Patients with contraindications to surgery * Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Patient compliance and geographic proximity that do not allow adequate follow-up. * Hormone therapy within 3 months before surgery
References
Publications (0)
Data not yet available
No reference posted for this study.