Abstract | BACKGROUND: METHODS/DESIGN: We will perform a multicentre, blinded, randomized, controlled trial comprising 140 women with gynecologic malignancies undergoing pelvic lymphadenectomy. Women will be randomly allocated to Tachosil® application or no application. Primary outcome is efficacy, defined as lymphocele CTCAE 4.03 grade ≥2 within four weeks after surgery. Secondary outcomes are asymptomatic lymphocele verified by ultrasound, medical or surgical intervention. Assuming a two-sided 5% significance level, a power of 80%, and a drop out rate of 10%, a sample size of 68 patients per group was calculated to detect a 66% absolute decrease in symptomatic lymphoceles. DISCUSSION: TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT01470677, protocol ID: TACHO-1). This study is registered at the EudraCT database (EudraCT number: 2011-003115-34).
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Authors | Christoph Grimm, Stephan Polterauer, Samir Helmy, David Cibula, Michal Zikan, Alexander Reinthaller, Clemens Tempfer |
Journal | BMC cancer
(BMC Cancer)
Vol. 14
Pg. 635
(Aug 30 2014)
ISSN: 1471-2407 [Electronic] England |
PMID | 25175029
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Drug Combinations
- TachoSil
- Fibrin
- Fibrinogen
- Thrombin
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Topics |
- Adolescent
- Adult
- Aged
- Drug Combinations
- Female
- Fibrin
(therapeutic use)
- Fibrinogen
(administration & dosage)
- Humans
- Intraoperative Care
- Lymph Node Excision
(adverse effects)
- Lymphocele
(pathology, prevention & control)
- Middle Aged
- Pelvis
(pathology, surgery)
- Postoperative Complications
(drug therapy, prevention & control)
- Thrombin
(administration & dosage)
- Treatment Outcome
- Uterine Neoplasms
(surgery)
- Young Adult
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