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


N/A
20 Years
N/A
Open (Enrolling)
Female
Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tubal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Incidence of lymphocele an lymphatic ascites

Outcome Time Frame:

within 1 year after surgery

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-LND

NCT ID:

NCT01679483

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Gynecologic Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Fallopian Tubal Cancer
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Lymphocele
  • Ovarian Neoplasms
  • Adenoma

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