THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
FloSeal application
Urogenital Diseases+17
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, South KoreaOpen Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center in Google Maps