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OpenTrials
Completed

NCT Number: NCT01683877

Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy

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Key information

Conditions

Benign Ovarian Tumor

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FloSeal application

Procedure

After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)

Electrocautery

Procedure

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Primary outcomes

  1. Hemostasis time

    Time frame: Immediately after operation

Secondary outcomes

  1. Ovarian function after surgery

    Time frame: within 6 months after surgery

  2. Operative time

    Time frame: 1 day (Immediately after surgery)

  3. Intraoperative blood loss

    Time frame: During surgery

  4. Postoperative drainage duration

    Time frame: within 1 week after surgery

  5. Length of postoperative stay

    Time frame: within 1 month after surgery

  6. Postoperative complications

    Time frame: within 1 months after surgery

    Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 12, 2012
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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