A collagen-fibrin patch for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies: A randomized clinical trial.

Abstract

OBJECTIVE:

To evaluate the efficacy of a collagen-fibrin patch for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies.

METHODS:

In a multicenter, randomized, clinical trial, 164 women with pelvic lymphadenectomy were allocated either to bilateral pelvic application of two collagen-fibrin patches or no intervention. Main outcome was efficacy, defined as reduction of symptomatic lymphocele rate diagnosed within four weeks after surgery. Secondary outcomes were asymptomatic lymphoceles and subsequent interventions. Sample size was based on the assumption that application of a collagen-fibrin patch reduces the prevalence of symptomatic lymphoceles by at least 66%. The study was single-blinded, i.e., patients and primary outcome assessors, but not surgeons, were blinded to the treatment allocation.

RESULTS:

A total of 75 women were randomized to the intervention and 89 to the control group. All women received the allocated intervention. In total, 42 (27.4%) lymphoceles and 8 (5.2%) symptomatic lymphoceles were observed. Symptomatic lymphoceles were observed in 5/68 (7.4%) women in the intervention group and 3/85 (3.5%) women in the control group (p = 0.47). Asymptomatic lymphoceles were observed in 16 (23.5%) women in the intervention group compared to 18 (21.2%) in the control group (p = 0.85). In a multivariate logistic regression model, no independent risk factor for the development of a symptomatic lymphocele was ascertained.

DISCUSSION:

Intraoperative application of collagen-fibrin patches to the pelvic side walls does not reduce the incidence of symptomatic lymphoceles in women with gynecologic malignancies undergoing pelvic lymphadenectomy.

• Authors: Christoph Grimm, Stephan Polterauer, Samir Helmy-Bader, Michal Zikan, David Cibula, Florian Heitz, Philipp Harter, Arnd Giese, Alexander Reinthaller, Clemens Tempfer
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 149 Issue 1 Pg. 140-145 (04 2018) ISSN: 1095-6859 [Electronic] United States
• PMID: 29395308 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018. Published by Elsevier Inc.

Topics

• Female
• Genital Neoplasms, Female (surgery)
• Humans
• Lymph Node Excision (adverse effects, methods)
• Lymphocele (etiology, prevention & control)
• Middle Aged
• Postoperative Complications (etiology, prevention & control)
• Single-Blind Method