title: A collagen-fibrin patch (Tachosil®) for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: a randomized clinical trial.
abstract: BACKGROUND
  Lymphoceles are a common complication after pelvic lymphadenectomy in women with gynecologic malignancies. Although typically asymptomatic, lymphoceles can superinfect requiring medical or surgical intervention. A single center randomized controlled trial provided first evidence, that a collagen-fibrin patch (Tachosil®) is effective in the prevention of symptomatic lymphoceles after pelvic lymphadenectomy.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  We aim to provide further evidence for the efficacy of a collagen-fibrin patch in the prevention of symptomatic lymphoceles in women with gynecological malignancies undergoing pelvic lymphadenectomy.
  
  
  BACKGROUND
  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).
authors.affiliation: Department of General Gynecology and Gynecologic Oncology, Comprehensive Cancer Center - Gynecologic Cancer Unit, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. christoph.grimm@meduniwien.ac.at.
authors.forename: Christoph
authors.initials: C
authors.lastname: Grimm
authors.forename: Stephan
authors.initials: S
authors.lastname: Polterauer
authors.forename: Samir
authors.initials: S
authors.lastname: Helmy
authors.forename: David
authors.initials: D
authors.lastname: Cibula
authors.forename: Michal
authors.initials: M
authors.lastname: Zikan
authors.forename: Alexander
authors.initials: A
authors.lastname: Reinthaller
authors.forename: Clemens
authors.initials: C
authors.lastname: Tempfer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004338:Drug Combinations; D005260:Female; D005337:Fibrin / Q000627:therapeutic use*; D005340:Fibrinogen / Q000008:administration & dosage*; D006801:Humans; D007430:Intraoperative Care; D008197:Lymph Node Excision / Q000009:adverse effects*; D008210:Lymphocele / Q000473:pathology / Q000517:prevention & control*; D008875:Middle Aged; D010388:Pelvis / Q000473:pathology / Q000601:surgery*; D011183:Postoperative Complications / Q000188:drug therapy / Q000517:prevention & control*; D013917:Thrombin / Q000008:administration & dosage*; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000601:surgery*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C518955:TachoSil; D005337:Fibrin; D005340:Fibrinogen; D013917:Thrombin