A total of 185 patients scheduled for NSS for small, superficial kidney tumours were included in an open, randomised, prospective, multicentre, parallel-group trial. Primary objectives were to test haemostatic efficacy and safety of TachoSil versus standard suturing. Efficacy was tested by comparing intraoperative time to haemostasis (primary end point). Secondary objectives included proportion of subjects with haemostasis after 10 min of trial treatment, occurrence of haematoma on day 2 after surgery, volume and haemoglobin concentration of postoperative drainage fluid, and surgeon’s rating of usefulness of trial treatments. Safety was evaluated by occurrence of adverse events.
Results
In the intent-to-treat population, time to haemostasis was significantly shorter with TachoSil versus standard suturing (mean: 5.3 vs. 9.5 min [p < 0.0001]). Haemostasis was obtained within 10 min in 92% of patients in the TachoSil group and in 67% in the standard treatment group (p < 0.0001). Differences in other secondary end points were not statistically significant. Both treatments were well tolerated. Surgeons rated TachoSil higher in terms of convenience to prepare and apply, and impression of efficacy.
Conclusion
TachoSil was superior to standard suturing in obtaining intraoperative control of haemorrhage and was as well tolerated as standard haemostatic treatment during NSS.
Introduction
Over recent years, nephron-sparing surgery (NSS) has become the standard treatment for small (<4 cm), peripherally located kidney tumours in patients with a normal contralateral kidney [1], [2], [3], [4]. The benefits of NSS include decreased risk of renal insufficiency [5] and positive impact on quality of life [6], [7]. It is likely that partial nephrectomy will become increasingly common [8]. In addition, recent publications recommend nephron-sparing surgery even in selected patients with localised RCC > 4 cm with an optimal long-term outcome [9], [10], [11], [12].
However, despite the move towards less extensive surgery and the availability of numerous treatment modalities, intra- and postoperative haemorrhage of the kidney resection surface remains a challenge. The current standard haemostatic method is suturing, although actual techniques may vary slightly between centres.
TachoSil is a sterile ready-to-use absorbable patch for intraoperative topical application. It consists of an equine collagen patch coated with the fibrin glue components, human fibrinogen and human thrombin. It thus combines the assets of a pliable patch material with the haemostatic and adhesive properties of the coagulation factors. The product is currently approved in Europe for supportive haemostatic treatment in surgery. The efficacy and safety of Tachosil have been demonstrated in liver resection [12], [14] and pulmonary lobectomy [15], [16] trials. The predecessors of TachoSil (TachoComb® and TachoComb® H) have proven to be efficacious haemostats and tissue sealants from several years of clinical use.
This study evaluated TachoSil as a haemostatic adjunct treatment in NSS and compared the haemostatic efficacy and safety of TachoSil with standard suturing.
Section snippets
Study design and objectives
This was an open, randomised, prospective, multicentre and multinational, parallel group phase 3 trial. Resection of small, superficial kidney tumours not extending into the collecting duct system were performed by open surgery by using standard techniques. However, use of laser scalpel, infrared coagulator, or argon beamer was not allowed for the resection, and the integrity of the pelvicalyceal system was to be maintained. Primary control of major haemorrhagic points was performed by using
Results
A total of 208 patients were screened, with 185 being included in the trial at 13 centres in Austria, Belgium, and Germany between September 2002 and October 2004. The ITT population consisted of patients randomly allocated to TachoSil (n = 92) and standard suturing (n = 93). A total of 3 patients discontinued from the trial (TachoSil: 1 patient because of nephrectomy and 1 because of patient noncompliance; standard suturing: 1 patient because of nephrectomy; Fig. 1). One TachoSil patch was used in
Discussion
The present trial demonstrates that TachoSil provides a useful adjunctive treatment option to primary haemostasis in NSS. Earlier studies have demonstrated that long-term cancer-free survival after NSS is comparable to that of radical nephrectomy, especially in low-stage renal carcinoma with localised, cortical tumours with a diameter ≤4 cm and with a normal contralateral kidney (elective indication) [1], [2], [3], [5], [17], [18], [19], [20] provided a sufficiently large margin of resection [18]
Conflicts of interest
The study was sponsored by Nycomed Denmark and the Department of Urology of the University of the Saarland was reimbursed financially for all expenses made.
Effective wound management is important, as millions of people suffer traumatic injuries and surgical operations annually. Proper wound closure is essential for the structural and functional restoration of damaged tissues. In addition to conventional sutures, various advanced surgical materials with multiple functions have been developed for more reliable and improved wound healing performance in the past few years. Here, polymeric surgical materials for soft tissue wound closure are comprehensively reviewed, including both commercially available materials and newly developed materials. These materials, based on natural, synthetic or composite polymers, are classified and discussed as invasive and non-invasive surgical materials. Their properties (antibacterial, hemostatic, stimuli-responsive, drug delivery, or a combination thereof) are critically analysed in the context of improving wound healing. Moreover, how to tune these properties (e.g., chemical grafting of antibacterial moieties, nano-enabled regulation of hemostasis, dual stimuli-responsive design, etc.) are clearly discussed. Finally, challenges in the field and potential solutions to tackle them are also proposed. This review should inspire more research efforts to develop the next generation of promising surgical polymeric materials for clinical applications.
Our specific aim was to introduce the TachoSil binding suturing technique for renal cell carcinoma (RCC) patients when closing the parenchymal defect after tumor excision during laparoscopic partial nephrectomy (LPN), which is a novel technique for reducing the risk of developing subsequent pseudoaneurysm (PA).
We identified 113 pT1aN0M0 RCC patients who underwent LPN at our institution. Eighty-one (72%) patients underwent the suturing procedure without binding TachoSil, whereas 32 (28%) patients underwent renorraphy with the renal defect closed together with TachoSil. The vascular complications were evaluated by computed tomography or magnetic resonance imaging with enhanced contrast material at the first visit after LPN. We conducted Fischer's exact test to determine risk factors for transcatheter arterial embolization (TAE).
The median age was 55 (36–86) years old and the median follow-up time was 65 (12–147) months. In the overall population, there were 11 (11%) patients who underwent TAE because they developed PA. All 11 patients exhibited the imaging findings of PA, and were all from the conventional suturing group. In contrast, no patients for whom the TachoSil binding method was used had any significant findings on imaging (14% vs. 0%). Based on the analysis to determine risk factors for TAE due to PA development, the TachoSil binding suturing technique was one of the significant indicators for reducing the risk of developing PA.
Our study demonstrated that the TachoSil binding suturing technique might reduce the development of PA after LPN. Prospective randomized study and comparison to the standard 2 or 3–layer renorrhaphy is needed to prove its actual value.
2019, Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
The aim of this study was to investigate whether the use of a thrombin-fibrinogen biosponge (TachoSil) has any advantage in tongue healing.
A retrospective study with 30 patients treated with partial glossectomy (below half a tongue) was designed. We compared the results from a group using the biosponge (n =15 patients) and a control group (n = 15). Variables taken into consideration were bolus clearance, frenulum flexibility, and oral transit time. With these parameters, we formulated a “tongue remaining functional” (TRF) scale to assess tongue functionality after the surgery. We also evaluated long-term quality of life by using the Functional Intraoral Glasgow Scale (FIGS).
In this study, TRF score, bolus clearance, oral transit time, and frenulum flexibility were significantly improved in the biosponge group. However, there were no differences between the 2 groups in the FIGS scores.
The use of the biosponge in this pilot study showed positive long-term effects in lingual healing and functionality after partial glossectomies.
Incidental durotomy (ID) during surgery for lumbar herniated disks or lumbar spinal stenosis is a serious complication that requires immediate recognition and repair. The incidence of ID during percutaneous endoscopic lumbar decompression has increased along with the demand for endoscopic spinal surgery. The management of ID during endoscopic surgery is more complicated and difficult than management during open surgery. A hemostatic agent, TachoSil (Nycomed, Linz, Austria), is used for control of local bleeding in several types of surgery, but its use in dural repair in endoscopic spinal surgery has not been described.
We present 3 cases in which the double-layer TachoSil packing technique was used in the management of ID during percutaneous stenoscopic lumbar decompression.
This case report reconfirms the efficacy and utility of TachoSil for IDs that occur during endoscopic spinal surgery and minimally invasive surgery. To our knowledge, this is the first report on the use and effectiveness of TachoSil for managing IDs during endoscopic spinal surgery. We hope that other surgeons will find this technique helpful in managing IDs.
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.
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.
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.
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.
Tachosil®, a fibrin-collagen coated patch, has been licensed in 2004 in Europe for the support of surgical hemostatic interventions. The efficacy and safety of this patch has been demonstrated in patients undergoing liver resection, pulmonary lobectomy, and kidney tumor resection [12–14]. A randomized controlled trial in men with prostate cancer undergoing pelvic lymphadenectomy observed significant reduction of sonographically detected lymphoceles as wells as reduced mean drainage volumes [4].
To evaluate the efficacy of a collagen-fibrin patch for the prevention of symptomatic lymphoceles after pelvic lymphadenectomy in women with gynecologic malignancies.
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.
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.
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.
