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

ABSTRACT: 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.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.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.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).

SUBMITTER: Grimm C

PROVIDER: S-EPMC4156659 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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

Grimm Christoph C Polterauer Stephan S Helmy Samir S Cibula David D Zikan Michal M Reinthaller Alexander A Tempfer Clemens C

BMC cancer 20140830

<h4>Background</h4>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.<h4>Methods/design</h4>We will perform a multicentre, blinded, randomize ...[more]

PMID: 25175029

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Project description:ObjectiveTo examine changes in performance and outcomes of pelvic exenteration for gynecologic malignancies.MethodsThis is a population-based retrospective study examining the Nationwide Inpatient Sample between 2001 and 2015. Women with cervical, uterine, vaginal, and vulvar malignancies who underwent pelvic exenteration were examined. Comorbidity, perioperative complications, total charges, length of stay, and mortality were assessed.ResultsThere were 2647 cases included. Cervical cancer was the most common malignancy (45.1%), followed by vaginal cancer (27.6%). 26.9% of women had a Charlson Comorbidity Index ≥3, which significantly increased from 23.3% in 2001-2005 to 33.3% in 2011-2015 (42.9% relative increase, P < 0.001). Obese women undergoing exenteration increased significantly from 4.5% in 2001-2005 to 19.4% in 2011-2015 (3.3-fold relative increase, P < 0.001). The perioperative complication rate was 68.1%, including 38.7% with multiple complications. The mortality rate was 1.9%. The number of women with multiple perioperative complications increased from 29.4% in 2001-2005 to 52.8% in 2011-2015 (78.6% relative increase, P < 0.001). More recent year of surgery, obesity, higher comorbidity, higher household income, surgery at large bedsize hospital, urinary diversion, vaginal reconstruction, and vulvar cancer were associated with an increased risk of multiple complications on multivariable analysis (all, P < 0.05). Median length of stay was 14 (IQR 9-21) days, and the number of women hospitalized ≥28 days significantly increased from 12.6% in 2001-2005 to 19.1% in 2011-2015 (51.6% relative increase, P < 0.001). The median corrected total charges increased from $121,854 to $185,100 between 2001 and 2015 (net difference +$63,246, 51.9% relative increase, P < 0.001).ConclusionWomen undergoing pelvic exenteration for gynecologic malignancies became more obese and comorbid during the study period. Pelvic exenteration for women with gynecologic malignancies is associated with high morbidity and mortality as well as substantial treatment-related costs.

Project description:BackgroundDespite that pelvic and para-aortic lymphadenectomy (PPaLND) is recommended as part of accurate surgical staging by International Federation of Gynecology and Obstetrics (FIGO) in endometrial cancer, the impact of para-aortic lymphadenectomy on survival remains controversial. The aim of this work is to evaluate the survival benefits or risks in endometrial cancer patients who underwent surgical staging with or without para-aortic lymphadenectomy using meta-analysis.MethodsLiterature search was undertaken using PubMed, Embase, and Cochrane Library databases for relevant articles published between January 1, 1990, and January 1, 2017, without language restriction. The primary outcome was overall survival (OS); progression-free survival (PFS)/recurrence-free survival (RFS)/disease-free survival (DFS)/disease-related survival (DRS) was also analyzed. Subgroup analysis and sensitivity analysis were conducted to investigate the source of heterogeneity. Quality assessments were performed by Newcastle-Ottawa Quality Assessment Scale (NOS). Publication bias was evaluated by using Begg and Egger tests. The hazard ratio (HR) was pooled with random-effects or fixed-effects model as appropriate.ResultsEight studies with a total of 2793 patients were included. OS was significantly longer in PPaLND group than in pelvic lymphadenectomy (PLND) group for patients with endometrial cancer [HR 0.68; 95% confidence interval (CI) 0.55-0.84, P < .001, I = 12.2%]. Subgroup analysis by recurrence risk explored the same association in patients at intermediate- or high-risk (HR 0.52; 95% CI 0.39-0.69, P < .001, I = 41.4%), but not for low-risk patients (HR 0.48; 95% CI 0.21-1.08, P = .077, I = 0). PPaLND with systematic resection of all para-aortic nodes up to renal vein also improved PFS/RFS/DFS/DRS, compared with PLND (HR 0.52, 95% CI 0.37-0.72, P < .001, I = 0). No publication bias was observed among included studies.ConclusionPPaLND is associated with favorable survival outcomes in endometrial cancer patients with intermediate- or high-risk of recurrence compared with PLND, particularly with regards to OS. PPaLND with systematic resection of all para-aortic nodes up to renal vein also improve PFS compared with PLND. Further large-scale randomized clinical trials are required to validate our findings.

Dataset Information

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

Publications

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

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