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OpenTrials
Completed

NCT Number: NCT01679483

Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube
  • FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB
  • Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection
  • 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

  • American Society of Anesthesiology Physical Status 0-1
  • Performance status of ECOG 0-2
  • 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
  • Patients with contraindications to surgery;
  • Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
  • Patient's compliance and geographic proximity that do not allow adequate follow-up.
  • Patients who undergo only lymph node sampling

Treatment and study plan

FloSeal application

Drug

At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

Primary outcomes

  1. Incidence of lymphocele an lymphatic ascites

    Time frame: within 1 year after surgery

Secondary outcomes

  1. Time interval from surgery to removal of closed drain system

    Time frame: with 2 weeks after surgery

  2. Postoperative drain amount

    Time frame: with 2 weeks after surgery

  3. Postoperative hospital stay

    Time frame: within 2 weeks after surgery

  4. Postoperative bleeding incidence

    Time frame: within 2 weeks after surgery

  5. Postoperative complication incidence

    Time frame: within 1 month after surgery

  6. Quality of life

    Time frame: within 1 year after surgery

  7. 2-year disease free survival and overall survival

    Time frame: 2 years after surgery

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2012
Registry last updated
May 31, 2017

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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