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/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:

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.

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).

• 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)

Chemical References

• Drug Combinations
• TachoSil
• Fibrin
• Fibrinogen
• Thrombin

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