Clinical trial · Interventional
Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer
THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL
NCT01679483CI-TRIAL-00027885completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tubal Cancer | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FloSeal application | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FloSeal group
- description
- This group will undergo appropriate cancer surgery for each patient with pelvic lymph node dissection +/- para-aortic lymph node dissection. At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
- interventionNames
- Drug: FloSeal application
- type
- NO_INTERVENTION
- label
- No FloSeal group
- description
- All surgical procedures of control group is the same with study group except that Floseal is not applicated in control group.
Primary outcomes (1)
- measure
- Incidence of lymphocele an lymphatic ascites
- timeFrame
- within 1 year after surgery
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.