Search

Purpose: To evaluate the effect of a collagen-fibrin sealant patch (TachoSil®) in preventing postoperative complications after inguinofemoral lymphadenectomy for vulvar cancer., Methods: Double-blind randomized-controlled trial on consecutive patients undergoing bilateral inguinofemoral lymphadenectomy for vulvar cancer. Intraoperatively, inguinofemoral areas were randomized: one was treated with TachoSil®, while the contralateral had standard closure without collagen-fibrin sealant patch. Surgical outcomes, amount of drainage volume, duration of drain placement, and any postoperative complication (vulvar wound dehiscence, inguinal wound dehiscence, cellulitis, lymphangitis, lymphoceles, and hematoma) were recorded. Leg measurements were taken preoperatively and during postoperative follow-up until 6 months to evaluate lymphedema., Results: A total of 19 patients were enrolled and 38 inguinofemoral dissections were performed. There was no significant difference between the investigational and control arm in the amount of drainage volume (p = 0.976), and duration of drain placement (p = 0.793). The postoperative complications, excluding lymphedema, were 10/19 (53%) in investigational arm and 9/19 (47%) in control arm (p = 0.74). At the end of follow-up, the prevalence of grade 1 lymphedema was 44.4% and 50% in investigational and control arm, respectively (p = 0.744); grade 2 and 3 lymphedema had a prevalence of 33.3% in both arms (p = 1)., Conclusion: Application of TachoSil® does not seem to improve postoperative lymphorrhagia nor to reduce the incidence of postoperative complications in patients undergoing inguinofemoral lymphadenectomy for vulvar cancer. Considering this point, it would be useful to identify additional strategies in inguinofemoral dissection for the prevention of these complications.

Objective: To explore whether TachoSil, a hemostatic patch, can reduce the incidence of lymphocele formation. Development of a lymphocele is a frequent complication after pelvic lymph node dissection (PLND) for nodal staging in prostate cancer., Materials and Methods: From 2013 to 2017, 100 patients with prostate cancer who were set to undergo a staging PLND before external beam radiotherapy (n = 50) or PLND concomitant with radical prostatectomy (RP) (n = 50) were prospectively randomized 1:1 between bilateral TachoSil placement or nonplacement. Primary end points were radiographic lymphocele development, lymphocele volume (1 week and 1 month postoperatively), and the duration and volume of postoperative catheter drainage., Results: Patient, tumor, and surgical characteristics of the TachoSil and the control groups did not differ significantly. In total, 65 patients (65%) experienced a radiographic lymphocele up to 3 months after surgery: 29 (58%) in the TachoSil group and 36 (72%) in the control group (P = .34). Significantly less radiographic lymphoceles were observed 1 week postoperatively for patients who underwent sole PLND and 1 month postoperatively for patients who underwent PLND with RP in the TachoSil group compared with the control group (16% vs 48%, P = .024, and 24% vs 52%, P = .047, respectively). The other postoperative characteristics presented no significant differences between the 2 groups, neither for patients undergoing sole PLND nor for patients undergoing PLND with RP., Conclusion: Patients undergoing bilateral TachoSil placement after PLND seem less likely to develop a radiographic lymphocele early postoperatively. Nevertheless, the clinical relevance of the use of TachoSil remains highly debatable., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Postoperative morbidity associated with groin lymphadenectomy remain high and still represents a major concern for this patients. The aim of this study was to confirm the efficacy of TachoSil(®) in preventing postoperative complications after inguinofemoral lymphadenectomy for gynecological malignancy., Study Design: An observational study was conducted to evaluate the incidence of postoperative complications among 49 patients (TachoSil(®) group=24; control group=25) underwent groin dissection enrolled in two Italian Department of Gynecology Oncology from 2011 to 2014., Results: A total of 74 inguinal dissections were performed. Bilateral groin dissection was performed in 25 patients (Tachosil group=10; group 2=15). Patients in TachoSil(®) group showed a lower daily drainage volume with a mean volume of 84 ml (range 30-465) vs. 143 ml (range -72 to 413) in the control group (p=.004), and a lower total drainage volume with a mean of 540 ml (range 90-930) vs. 900 ml (range 200-3270) for Tachosil and control group, respectively. A lower incidence of lymphocyst required drainage, cellulitis, wound infection and late lymphedema was observed in TachoSil group even without reaching statistical significance., Conclusions: This observational study confirmed that the use of TachoSil(®) seems to be highly effective in reducing the rate of postoperative lymphorrea and postoperative complications after groin dissection in case of gynecological malignancies. Larger multicenter prospective study is advisable to validate our preliminary results., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objective: To describe the incidence of symptomatic lymphocele (SLC) after an aggressive tumor debulking surgery and lymphadenectomy in patients with ovarian cancer and peritoneal carcinomatosis with or without TachoSil®., Material and Methods: A pilot retrospective comparative observational study was performed between patients with advanced ovarian cancer International Federation of Gynecology and Obstetrics stages III-IV who underwent complete debulking surgery and radical retroperitoneal lymphadenectomy. In 18 patients, 4 TachoSil® patches were placed in the retroperitoneal area, since January 2014-October 2014. This group was compared with other 18 consecutive patients matched by age, International Federation of Gynecology and Obstetrics stage, surgical complexity, American Society of Anesthesiologists score, comorbidity, and BMI without the use of TachoSil®., Results: Baseline characteristics were similar between groups. There were no statistically significant differences in terms of surgical complexity, surgical time, estimated blood loss, node removed, length of hospital stay, and complications between groups. SLC was diagnosed in 7 patients (38.8%) without TachoSil®, and in 2 patients (11.1%) with TachoSil® (p = 0.121). The use of TachoSil® was associated with a statistically significant lower re-admission rate (p = 0.041) and with a significantly shorter time to adjuvant chemotherapy (p = 0.02)., Conclusions: Using TachoSil® in women with advanced stage ovarian cancer who underwent radical debulking with retroperitoneal lymph node dissection is associated with a non-statistically significant reduction in the incidence of SLC. A larger-scale randomized controlled study should be conducted to confirm our preliminary results., (© 2016 S. Karger AG, Basel.)

Background: This study evaluated the use of TachoSil as an adjunctive therapy for reducing axillary lymphocele formation., Methods: Eighty-six patients diagnosed with breast cancer N+ and treated with axillary lymphadenectomy received a TachoSil patch in the axillary wound. Using a database of patients without placing a hemostatic patch, we applied a matched case-control in a 1-to-2 fashion. Multiple and logistic regression analyses were used to evaluate postoperative results., Results: Patient group with TachoSil showed a significantly lower drainage volume (P < .001) and the length of stay was significantly shorter (P < .001). The number of patients with evacuative punctures was 24.5% in the group with patch versus 51.2% in the control group (P < .001). In multivariate analysis, the use of TachoSil was a significant predictor of reducing axillary drainage volume (P < .001), mean length of hospital stay (P = .001), and number of evacuative punctures of lymphocele (odds ratio .264, 95% confidence interval .144 to .484, P < .001)., Conclusion: The use of TachoSil in axillary lymphadenectomy may be a safe and useful treatment option for reducing axillary drainage volume, incidence of symptomatic lymphocele, and hospital stay., (Copyright © 2014 Elsevier Inc. All rights reserved.)

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).

Objective: Lymphoceles are among the most common postoperative complications of pelvic lymphadenectomy (PL), with a reported incidence of 1% to 50%. Symptoms are pelvic pain, leg edema, gastrointestinal obstruction, obstructive uropathy, and deep vein thrombosis, and severe complications such as sepsis and lymphatic fistula formation. After laparoscopic PL, we tested the prevention of lymphoceles using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland) on 55 patients with endometrial cancer stages IB to II who had undergone laparoscopy., Materials and Methods: The authors divided the patients into 2 laparoscopy groups: PL plus TachoSil (group 1: 26 patients) and PL without TachoSil in a control group (group 2: 29 patients), as historical cohort of patients who underwent PL between 2010 and 2012. We collected surgical parameters, and the patients underwent ultrasound examination on postoperative days 7, 14, and 28. The main outcome measures were the development of symptomatic or asymptomatic lymphoceles, the need for further surgical intervention, as adverse effect of surgery, and the drainage volume and duration., Results: The same number of lymph nodes in both groups was removed; group 1 showed a lower drainage volume. Lymphoceles developed in 5 patients in group 1 and in 15 patients in group 2; of these, only 2 patients were symptomatic in group 1 and 5 patients were symptomatic in group 2, without statistical difference and no percutaneous drainage request., Conclusions: In this preliminary investigation, the intraoperative laparoscopy application of TachoSil seems to reduce the rate of postoperative lymphoceles after PL, providing a useful additional treatment option for reducing drainage volume and preventing lymphocele development after PL.

The lymphocele is the most frequently encountered complication after axillary dissection performed for breast cancer (15-81%). This study compares the efficacy of a lympho-hemostatic combipatch TachoSil(®) versus conventional implementation of a suction drain on the incidence and severity of lymphoceles. This is a case (group TachoSil(®)n=20) control (drainage group) n=40 study. In our study, we demonstrated an increased rate of postoperative complications (<3weeks) in the group TachoSil(®) (P=0.0265) explained by a lymphocele rate significantly higher (P=0.0194). However, no significant difference was demonstrated on the severity of these lymphoceles. Beyond 3weeks postoperatively, the two groups were comparable in terms of postoperative complications. The TachoSil(®) does not prevent the formation of seroma but their severity is not increased. In addition, it reduces of more than 48hours the duration of hospitalization stay (P=0.002)., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Background and Objectives: The prevention of lymphoceles was tested using collagen patch coated with the human coagulation factors (TachoSil) on 58 consecutive patients with endometrial cancer who had undergone hysterectomy and pelvic lymphadenectomy (PL)., Methods: Patients were randomized in two groups: standard technique plus TachoSil (30 patients, group 1) and standard technique only (28, group 2). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 7, 14, and 28. The main outcome measures were: the development of symptomatic or asymptomatic lymphoceles, the need for further surgical intervention, as adverse effect of surgery and the drainage volume and duration., Results: Same number of lymph nodes in both groups was removed; group 1 showed a lower drainage volume. Lymphoceles developed in 7 patients in group 1 and 16 in group 2, but only 3 were symptomatic in group 1 and 9 symptomatic in group 2, with statistical difference. Percutaneous drainage proved necessary in five cases: only one was in group 1 and four in group 2., Conclusions: Intraoperative application of TachoSil reduced rate of postoperative lymphocysts after PL, and it seems to provide a useful additional treatment option for reducing drainage volume and preventing lymphocele development after PL., (Copyright © 2011 Wiley Periodicals, Inc.)

Objective: To evaluate the effect of TachoSil in preventing postoperative complications after groin dissection performed for primary or recurrent gynecologic malignancy., Methods: In a case-control analysis, the incidence of postoperative complications-including lymphocyst formation, wound breakdown and/or infection, and chronic lymphedema-was examined among 8 patients who received TachoSil and 16 controls (standard technique) treated for vulvar cancer or recurrent ovarian/breast cancer at San Gerardo Hospital, Monza, Italy, from 2008 to 2011., Results: Thirty-eight inguinal dissections were performed in the 24 patients. Bilateral groin dissection was performed in 14 patients (n=4 in the study group; n=10 in the control group). Patients in the study group had a lower mean daily drainage volume than those in the control group (133 mL [range, 50-356 mL] vs 320 mL [range, 67-472 mL]; P<0.001) and a lower incidence of lymphocyst requiring drainage (25.0% vs 62.5%), cellulitis (12.0% vs 25.0%), and wound infection (0.0% vs 25.0%)., Conclusion: The use of TachoSil seems to be effective in reducing the rate of postoperative complications after inguinofemoral lymphadenectomy in cases of gynecologic malignancy., (Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Purpose: Pelvic lymphadenectomy is frequently performed simultaneously with radical prostatectomy to determine lymph node status and the most frequently recorded postoperative complication is the development of a symptomatic lymphocele. This study evaluated TachoSil as an adjunct treatment in preventing lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer., Materials and Methods: A total of 60 consecutive patients who had undergone radical prostatectomy and pelvic lymphadenectomy were prospectively enrolled in this study. The patients were randomly assigned to a standard technique with the use of clips and electrocoagulation plus TachoSil, or to standard technique only. All patients underwent ultrasound examination on postoperative days 7, 14 and 28 to test for the development of symptomatic or asymptomatic lymphoceles. Drainage volume and duration were also recorded., Results: The baseline characteristics of the 2 randomized groups were well matched. Those patients in whom we used TachoSil showed a lower drainage volume with a mean total volume of 64 +/- 45 ml (range 0 to 110) vs 190 +/- 62.72 ml (range 70 to 270, p = 0.009), and had significantly fewer symptomatic and asymptomatic lymphoceles (5 vs 19, p = 0.001). Only 5 percutaneous surgical procedures to drain the lymphoceles proved necessary, 1 of which occurred in the group with TachoSil., Conclusions: TachoSil seems to provide a useful additional treatment option for reducing drainage volume and preventing lymphocele development after extraperitoneal radical retropubic prostatectomy with pelvic lymphadenectomy.