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PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY


N/A
20 Years
N/A
Open (Enrolling)
Female
Benign Ovarian Tumor

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Trial Information

PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Hemostasis time

Outcome Time Frame:

Immediately after operation

Safety Issue:

No

Principal Investigator

Joo-Hyun Nam, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Asan Medical Center Institutional Review Board

Study ID:

FloSeal-OC

NCT ID:

NCT01683877

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Benign Ovarian Tumor
  • Ovarian Neoplasms

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