Clinical trial · Interventional
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
- 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)
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies. Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment. A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND. The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND. The investigators designed prospective randomized controlled study as a pilot study. The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Floseal | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Floseal
- description
- application of floseal to one side of pelvis after pelvic lymphadenectomy
- interventionNames
- Drug: Floseal
- type
- NO_INTERVENTION
- label
- Control
- description
- counter-site of pelvis; no intervention after pelvic lymphadenectomy
Primary outcomes (1)
- measure
- Frequency of pelvic lymphocele
- timeFrame
- 6 month
- description
- Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Gynecologic cancer patients who need laparotomic bilateral PLND Exclusion Criteria: * Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)
References
Publications (0)
Data not yet available