Use Of Hemostatic Agents Research Articles

Physician and Hospital-level Variation in Hemostatic Agent Use in Benign Gynecologic Procedures

To identify recent nationwide trends in hemostatic agent (HA) use and to explore factors associated with HA use in 3 benign gynecologic surgery contexts: isolated hysterectomy, pelvic organ prolapse repair, and anti-incontinence surgery. Retrospective cohort study. Vizient Clinical Database. Three cohorts of female patients of ≥18 years who underwent benign isolated hysterectomy, pelvic organ prolapse repair, or anti-incontinence procedures were identified between October 2015 and December 2019. HAs are topically applied procoagulant products used for surgical hemostasis and use during included encounters was determined by charge codes. Subject-, hospital-, and surgeon-level characteristics and costs were captured. Data were initially analyzed in the aggregate and based on procedure category using the chi-square test or independent samples t tests as appropriate. A bootstrap forest model was used to identify the factors most predictive of HA use. In the final cohort of 184 070 encounters, HAs were used most frequently in hysterectomy (20.7%) and least in anti-incontinence surgery (10.9%). The use of HAs increased from 15.6% in quarter 4 2015 to 19.2% in quarter 4 2019 (p <.001). Encounters using HAs cost more than encounters without HAs ($6271.10 vs $4572.00; p <.001). A bootstrap forest model inclusive of all variables found surgeon and hospital identity cumulatively predictive of 84.9% of HA use, 65.5% and 19.4%, respectively. There was significant variation in HA use among individual surgeons, with 59.9% never using HAs. Of those who did use HAs, 72.8% used HAs more frequently than the mean provider HA use rate (19.4%) and 9.2% used HAs in every case he/she performed. The significant variation in HA use is driven primarily by physician and hospital identity, suggesting that use of HA in these benign gynecologic surgical contexts may be determined more by physician- and hospital-level factors than patient-level factors.

Silk Fibroin-Based Biomaterials for Hemostatic Applications.

Hemostasis plays an essential role in all surgical procedures. Uncontrolled hemorrhage is the primary cause of death during surgeries, and effective blood loss control can significantly reduce mortality. For modern surgeons to select the right agent at the right time, they must understand the mechanisms of action, the effectiveness, and the possible adverse effects of each agent. Over the past decade, various hemostatic agents have grown intensely. These agents vary from absorbable topical hemostats, including collagen, gelatins, microfibrillar, and regenerated oxidized cellulose, to biologically active topical hemostats such as thrombin, biological adhesives, and other combined agents. Commercially available products have since expanded to include topical hemostats, surgical sealants, and adhesives. Silk is a natural protein consisting of fibroin and sericin. Silk fibroin (SF), derived from silkworm Bombyx mori, is a fibrous protein that has been used mostly in fashion textiles and surgical sutures. Additionally, SF has been widely applied as a potential biomaterial in several biomedical and biotechnological fields. Furthermore, SF has been employed as a hemostatic agent in several studies. In this review, we summarize the several morphologic forms of SF and the latest technological advances on the use of SF-based hemostatic agents.

Hemostats in Spine Surgery: Literature Review and Expert Panel Recommendations.

Bleeding in spine surgery is a common occurrence but when bleeding is uncontrolled the consequences can be severe due to the potential for spinal cord compression and damage to the central nervous system. There are many factors that influence bleeding during spine surgery including patient factors and those related to the type of surgery and the surgical approach to bleeding. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Hemostatic agents are available in a variety of forms and materials and with considerable variation in cost, but specific evidence to support their use in spine surgery is sparse. A literature review was conducted to identify the pre-, peri-, and postsurgical considerations around bleeding in spine surgery. The review generated a set of recommendations that were discussed and ratified by a wider expert group of spine surgeons. The results are intended to provide a practical guide to the selection of hemostats for specific bleeding situations that may be encountered in spine surgery.

Thromboembolic events from the intraoperative use of topical gelatin and albumin-glutaraldehyde haemostatic agents

BackgroundAn under-recognised complication of gelatin-based [GBA] and albumin-glutaraldehyde-based haemostat agents [AGA] is their potential to embolise. This review aims to collate and analyse cases reported in the literature of perioperative thromboembolic phenomena secondary to locally applied GBA and AGA agents. Methods An electronic search was performed on databases Embase, Ovid Medline, Proquest, Scopus and Pubmed. 8875 articles were reviewed from title and abstract. After exclusion criteria and duplicates were removed, 13 articles with 18 cases were included for analysis. Data extracted from each of the articles included patient demographics, surgery type, the haemostatic agent used, clinical features, radiology and pathological findings, and associated morbidity and mortality. ResultsThromboembolic events reported included fourteen secondaries to GBA and four from AGA. Cases included twelve pulmonary emboli, three peripheral emboli, two cerebral emboli and one coronary embolus. Embolic phenomena were most common following spinal orthopaedic surgery in GBA patients [43%], and Type A Aortic dissection repair in AGA patients [100%]. The application of 10ml or more of GBA was frequently reported in cases [64%]. Six cases were fatal. The time course of each event ranged from occurring intraoperatively to 45 days post-operation. ConclusionGBA and AGA agents are associated with venous and arterial embolisation and high overall mortality. GBA application over an unclear bleeding site poses a risk of arterial embolisation. Surgical fields should be dried before the application of AGA. Quantities of GBA &gt; 10mL were frequently reported. GBA and AGA embolisation can occur anywhere from immediate to 45 days postoperatively.

Analyzing Liver Tissue Responses To Local Hemostatic Agents

Objective – Our study aimed at evaluating changes in liver tissues after simulated injury and use of novel hemostatic agents (containing tranexamic acid) in the course of in vivo experiment. Material and Methods – The following hemostatic agents were studies: TachoComb collagen plate (Group 1); samples of novel local hemostatic agents based on sodium carboxymethyl cellulose (CMC), Na-CMC (Group 2); Na-CMC + tranexamic acid (Group 3). We performed the study on 30 rabbits with simulated liver laceration via laparoscopy, and were stopping bleeding by means of the above-mentioned methods. Then, on liver tissue micrographs, we were measuring capsule thickness (μm), sizes of hepatocytes and their nuclei (px), number of binuclear hepatocytes. We were also calculating nuclear-cytoplasmic ratio (NCR) of hepatocytes, as well as identifying qualitative and quantitative capsule composition in tested samples. Results – In the collagen plate group, the capsule width was 3.2-fold and 3.6-fold of this parameter in samples from Groups 2 and 3. Indirectly, this finding implied more severe inflammatory and regenerative processes aimed at limiting injury area, and was confirmed by statistically significant differences in the cellular composition of the capsule surrounding tested samples (fibroblastic cells predominated in Groups 2 and 3, and there were fewer of them in Group 1). The highest cell index (CI) value was detected in Group 3. Conclusion – A significant boundary zone separating tested materials from the liver parenchyma was also observed due to connective tissue growth as part of inflammatory response.

Effects of Preoperative Gabapentin on Clinical Outcomes After Outpatient Midurethral Sling Placement.

This study aimed to evaluate transient urinary retention in women undergoing outpatient midurethral sling placement who received preoperative gabapentin (treated) versus those who did not (untreated). Secondary outcomes included unexpected admission rates, analgesic usage, time to discharge, and pain. This was a retrospective cohort study including women who underwent outpatient midurethral sling placement from 2015 to 2019. Exclusion criteria included suprapubic catheter placement, planned overnight admission, abnormal preoperative postvoid residual volume, and prolonged postoperative catheterization. Logistic regression was performed to evaluate gabapentin usage and urinary retention after adjusting for patient characteristics. Three hundred two women met the inclusion criteria, with 19.5% experiencing urinary retention after midurethral sling placement. Women older than 65 years were more likely to have urinary retention than those aged 18-65 years (29.8% vs 17.6%, P = 0.054). Of treated participants, 26% had urinary retention versus 18% of untreated participants (P = 0.162). Adjusting for age, parity, pain, operative time, blood loss, sling type, analgesic, scopolamine patch, or hemostatic agent use, treated participants had 72% higher odds of urinary retention (adjusted odds ratio, 1.72; 95% confidence interval, 0.88-3.38; P = 0.113). There was no difference in unexpected admission, analgesic usage, time to discharge, or pain between groups. One of 5 women had urinary retention after outpatient midurethral sling placement. Although no statistically significant difference was found in urinary retention between groups, the odds of urinary retention in the treated group were increased. Because there was no difference in pain, analgesic usage, or time to discharge between groups, investigation regarding gabapentin use for outpatient urogynecologic surgery is needed.

Hemostatic Agents in Orthodontics: a review

Introduction and aims: Loss of the bracket‒tooth bond is one of the most common complaints of patients during orthodontic treatment. Various factors play a role in preventing the loss of such a strong bond between the bracket and tooth, one of which is the maintenance of proper isolation and prevention of contamination of tooth surface with blood during the surgical exposure of the impacted tooth. In case of bleeding during disimpaction treatment, the use of hemostatic agents might decrease the odds of tooth surface contamination with blood, resulting in a strong bond. This study aimed to evaluate the effect of different hemostatic agents on the bond between the bracket and tooth. Materials and methods: Science Direct, PubMed, and Google Scholar databases were searched for relevant previous studies published from 2010 to 2020. These studies’ titles and abstracts were evaluated for inclusion criteria. In vivo and in vitro studies evaluating the effect of hemostatic agents on the bracket‒tooth bond were included. Results: Eight studies were included in the study based on inclusion criteria; five studies were in vitro, and two were in vivo; one study had both designs. Of in vitro studies evaluating the bond strength, five studies reported a higher bond strength in the control group than the group in which the tooth surfaces were contaminated with a hemostatic agent; besides, the bond strength in the hemostatic agent group was higher than that in the group in which the tooth surfaces were contaminated with blood. Of in vivo studies, two studies evaluated bracket failure as a criterion to evaluate bonding quality. In one of these studies, bracket failure in the control groups was more than the hemostatic agent group, and in the other study, it was more prevalent in the hemostatic agent group than the control groups. Studies comparing different hemostatic agents did not report any significant differences in bonding quality. Conclusion: It appears that the use of hemostatic agents in disimpaction treatments can prevent contamination of tooth surface with blood, increasing the bond strength between the bracket and tooth; however, care should be exercised to prevent tooth surface contamination with hemostatic agents.

Comparison of modified rapid deployment hemostat dressing with standard haemostat as part of standardized perihepatic packing for major liver trauma in a level 1 trauma center

Introduction Uncontrolled hemorrhage is a major cause of mortality in surgery and trauma. Damage control surgery (DCS) is essential in the management of these cases. The use of topical hemostatic agents has increased over the last two decades with the evolution of DCS and trauma-induced coagulopathy. The aim of this study was to compare the performance of standard perihepatic packing with the addition of either a MRDH (modified rapid deployment hemostat) or a non-MRDH hemostatic dressing. Methods This was a retrospective, comparative analysis of prospectively collected data held in the registry of a level I trauma center in Bologna, Italy, between 2005 and 2019. 33 patients with grade IV/V liver injuries who underwent a standardized perihepatic packing with hemostatic dressings were enrolled in the study. The study group included 21 patients treated with standard packing plus MRDH. The control group included 12 patients treated with standard packing plus a combination of fibrillar absorbable hemostat and human fibrin sealant. Results The two groups were homogeneous in terms of age and American Association for the Surgery of Trauma (AAST) grade although the MRDH one seemed to have more severe injury: hemodynamic instability was present in 95% of MRDH patients vs. 83% in the control group. Also, Injury Severity Score (ISS) and New Injury Severity Score (NISS) were 41 vs 35.5 and 47 vs 39.1, respectively. The incidence of re-bleeding requiring repacking at the second-look laparotomy was 4.7% in MRDH patients vs. 16.7% in non-MRDH patients ( p = .5, OR = 4). The overall complication rate was of 23% after the introduction of MRDH vs. 81% in the control group. Conclusion Despite the potential effectiveness of MRDH, this study does not seem to confirm a significant superiority of this hemostat over the standard.

The Effect of Topical Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Posterior Lumbar Laminectomy and Discectomy: A Randomized, Double-Blind, Controlled Trial Study.

Randomized, double-blind, controlled trial study. This study aimed to evaluate the safety and efficacy of topical tranexamic acid (TXA) on intraoperative blood loss (IBL) in patients that have degenerative lumbar canal stenosis and undergo posterior lumbar laminectomy and discectomy. The volume of IBL is directly proportional to potential surgical complications. Recent reports have shown that the topical use of antifibrinolytic drugs, such as TXA, during surgery might decrease IBL and improve patient outcomes. A total of 104 patients with lumbar canal stenosis were enrolled in this randomized, double blinded clinical trial. Participants were randomized and divided into two groups: TXA (54 cases) and control (50 cases). In the TXA group, a TXA solution was used for washing and soaking, whereas, in the control group, irrigation of wound was with normal saline. IBL, pre- and postoperative coagulative studies, operation time, conventional hemostatic agent usage, systemic complications, and length of hospitalization were consecutively recorded. All participants were followed for an additional two months to gather data on their recovery status and time to return to work (RTW). At baseline, there was no difference in clinical or lab findings, between the groups. IBL and use of hemostatic agents were significantly decreased in TXA group, as compared to the control group (p=0.001 and p=0.011, respectively). Systemic complications, length of hospitalization, and RTW were not significantly different between groups (p=0.47, p=0.38, and p=0.08, respectively). This study showed that topical use of TXA during surgery may decrease IBL and minimize the use of hemostatic materials during posterior midline-approach laminectomy and discectomy, without increasing the potential for complications seen with intravenous TXA usage.

The role of Glubran 2 as biliostatic agent in liver resection

Background: Two of the most important sugical complications after liver resection are the development of biloma, an encapsulated collection of bile outside the biliary tree supported by a predominantly iatrogenic biliary fistula, and bile likeage. The development of biliary complications increases postoperative mortality, so the use of topical hemostatic agents have been recommended. Nonetheless, in Literature, only few study focused attention on the use of these agents to prevent complication related to liver resection

Effect of Topical Administration of Tranexamic Acid on Intraoperative and Postoperative Blood Loss during Posterior Cervical Laminectomy and Fusion Surgery: A Retrospective Study.

To assess the role of topical administration of tranexamic acid (TXA) on intraoperative and postoperative blood loss of patients undergoing posterior cervical laminectomy and lateral mass screw ?xation (PCLF) compared to a control group. The data of 88 patients that underwent PCLF surgery, including 41 females and 47 males, were included in this retrospective study. Data elements including intraoperative blood loss (IBL), postoperative blood loss (PBL), amount of blood transfusion, surgical time, use of hemostatic agents, length of hospital stay, and time to return to work were extracted from medical records and compared between those who received topical TXA during surgery (irrigation of the surgical field with a solution of 3 g TXA in 100 ml normal saline) and an age- and sex-matched control group. There were 48 patients in the TXA group and 40 patients in the control group. There were no significant differences in the baseline measurements and the level of operation between the two groups. The results showed that IBL and PBL were significantly lower in the TXA group compared to the control group (p=0.03 and p < 0.01, respectively). There were no significant differences in the need for blood transfusion, surgical time, and hospital stay between the two groups (p > 0.05). Moreover, the use of hemostatic materials during surgery and the time to return to work were significantly lower in the topical TXA group (p=0.04 and p < 0.01, respectively). Topical TXA efficiently reduces intraoperative and postoperative bleeding in patients undergoing posterior cervical laminectomy and PCLF surgery. These results need further investigation in future studies to draw a definite conclusion.

Effective prediction model for preventing postoperative deep vein thrombosis during bladder cancer treatment.

ObjectiveTo begin to understand how to prevent deep vein thrombosis (DVT) after an innovative operation termed intracorporeal laparoscopic reconstruction of detenial sigmoid neobladder, we explored the factors that influence DVT following surgery, with the aim of constructing a model for predicting DVT occurrence.MethodsThis retrospective study included 151 bladder cancer patients who underwent intracorporeal laparoscopic reconstruction of detenial sigmoid neobladder. Data describing general clinical characteristics and other common parameters were collected and analyzed. Thereafter, we generated model evaluation curves and finally cross-validated their extrapolations.ResultsAge and body mass index were risk factors for DVT, whereas postoperative use of hemostatic agents and postoperative passive muscle massage were significant protective factors. Model evaluation curves showed that the model had high accuracy and little bias. Cross-validation affirmed the accuracy of our model.ConclusionThe prediction model constructed herein was highly accurate and had little bias; thus, it can be used to predict the likelihood of developing DVT after surgery.

Use of liquid topical hemostatic agents in bleeding from the veins of the esophagus

Use of liquid topical hemostatic agents in bleeding from the veins of the esophagus

Effectiveness of use of local hemostatic agents for external bleeding by visiting ambulance teams

The alternative use of local hemostatic agents based on chitosan is the gentlest method of stopping bleeding, with minimal damaging effect on tissues, in comparison with the imposition of a hemostatic tourniquet or a pressure bandage.Goal. To evaluate the effectiveness of temporary stopping of external bleeding with the help of local hemostatic agents based on chitosan in powder and bandage forms and to determine the expediency of their use by visiting ambulance teams.Materials and methods. Specialists of the field teams of Ambulance and Medical Emergency Care Station n. a. A. S. Puchkov (Moscow, Russia) used local hemostatic agents based on chitosan in the form of a powder, a bandage in comparison with traditional hemostatic agents (a hemostatic tourniquet to stop arterial bleeding and a pressure bandage). The criteria for hemostasis were the absence of wetting of the pressure bandage and the absence of the need for a hemostatic tourniquet.Results. 103 patients were included in the main group, and 106 patients with arterial and venous bleeding from wounds of various localization were included in the control group. The age of patients in the compared groups ranged from 18 to 94 years. When using hemostatic powder and bandage, primary hemostasis was achieved in 99 patients in 96.1 % of cases, compared with the control group in 76 patients in 67.9 % of cases.Conclusions. Simplicity and ease of use, the speed of stopping bleeding and achieving results, as well as the absence of the need for special skills among specialists in the use of hemostatic agents, improved the quality of emergency medical care for patients with bleeding and allowed them to be recommended as a dressing for emergency medical care.

Post-cesarean ileus: An assessment of incidence, risk factors and outcomes

ObjectiveTo estimate the frequency of post cesarean paralytic ileus and to identify associated risk factors and outcomes. Study designA retrospective cohort study of woman who underwent cesarean delivery between 2005 and 2019. All parturients who had cesarean delivery were stratified and compared according to whether or not they were diagnosed with a paralytic ileus. Women were excluded if they had an intestinal injury or repair during the cesarean or if they suffered from a post cesarean mechanical bowel obstruction diagnosed during re-laparotomy. Basic demographics, obstetric history, current delivery characteristics, re-suturing indications and outcomes were obtained and analyzed. Univariate analyses were followed by a multivariate analysis (adjusted Odds Ratio (aORs) ; [95% Confidence Interval]). ResultsA total of 23,486 women met the inclusion and exclusion criteria of which 135 (0.6%) were diagnosed with paralytic ileus whilst 23,347 (99.4%) did not and served as the control group. Multivariate analysis revealed that an estimated intra-operative blood loss ≥ 1000 ml was the most significant risk factor for post cesarean paralytic ileus (aOR 2.27 (1.18–4.36)), followed by multifetal gestation (aOR 2.08 (1.24–3.51)), corporeal uterine incision (aOR 1.97 (1.07–3.63)), use of topical hemostatic agents (aOR 1.78 (1.19–2.66)) and increasing maternal age (aOR 1.78 (1.19–2.66)). Regarding maternal outcomes, post cesarean paralytic ileus was associated with higher rates of postpartum hemorrhage (44.4% vs. 13.4%, p < 0.01), transfusion of blood products (23.7% vs. 3.9%, p < 0.01), post-cesarean exploratory laparotomy (4.4% vs. 0.1%, p < 0.01) and prolonged hospital stay (32.6% vs. 5.2%, p < 0.01). ConclusionIn our population, whilst post cesarean paralytic ileus is infrequent, when it occurs it is associated with increased short-term maternal morbidity.

Topical hemostatic agents in neurosurgery, a comprehensive review: 15years update.

Hemostasis in neurosurgery is of utmost importance. Bleeding management is one of the crucial steps of each neurosurgical procedure. Several strategies, namely thermal, mechanical, electric, and chemical, have been advocated to face blood loss within the surgical field. Over time, countless hemostatic agents and devices have been proposed. Furthermore, the ever-growing recent technological innovation has made available several novel and interesting tools. Pursuant to their impact on surgical practice, we perceived the imperative to update our previous disclosure paper. Therefore, we reviewed the literature and analyzed technical data sheets of each product in order to provide an updated and comprehensive overview in regard to chemical properties, mechanisms of action, use, complications, tricks, and pitfalls of topical hemostatic agents.

Применение местных гемостатических препаратов для профилактики гематом ложа электрокардиостимулятора

BACKGROUND: Prevention of pacemaker pocket hematoma is an urgent problem of modern cardiovascular surgery. A method of prevention of hematomas may be application of local hemostatic agents. One of such means is incomplete silver salt of polyacrylic acid, registered in the Russian Federation as a medical product under the trade name “Hemoblock”. AIM: To evaluate the efficacy and safety of partial silver salt of polyacrylic acid (Hemoblock®) as a hemostatic drug for prophylaxis of pacemaker (PM) pocket hematoma. MATERIALS AND METHODS: The study included 29 patients (18 men) with average age of 72.8 ± 9.8 years and indications for PM implantation. The patients were divided into 2 groups, partial silver salt of polyacrylic acid was used during the PM implantation in group A, 0.9% NaCl solution was used in group B. Anticoagulant therapy was not cancelled. In the postoperative period, patients underwent a daily examination by a surgeon, on the 3th–5th day — an ultrasound of soft tissues in the area of the PM pocket to diagnose hemorrhagic complications. After 1 month, a control examination of the postoperative wound and an assessment of the PM function were performed. RESULTS: In 1 (6.3%) patient in group B, a PM pocket hematoma was found which required drainage in the dressing room and increased the period of hospitalization after surgery to 7 days. Soft tissue imbibition with blood was observed in 9 (56.3%) group B patients. No PM pocket hematomas and imbibition of soft tissues were observed in group A. PM implantation with uninterrupted anticoagulant therapy without the use of hemostatic agents increases the risk of soft tissue imbibition with blood by 2.3 times (p = 0.001, r = 0.605, RR 2.3, 95% CI 1.3–4). Age, gender, body mass index, body surface area, left ventricular ejection fraction, type of anticoagulation therapy, indication for PM implantation, type of PM, and the peculiarities of the operation did not influence the risk of development of PM pocket hematoma or soft tissue imbibition with blood (p &gt; 0.05). CONCLUSION: The use of a partial silver salt of polyacrylic acid (Hemoblock®) can reduce the risk of development of hematomas and soft tissue imbibition with blood in the area of the pacemaker pocket and does not lead to the development of infectious complications and allergic reactions.

Transfusion management of trauma from the 2019 El Paso mass shooting incident.

Mortality rates, transfusion ratios, trauma management logistics, and assault characteristics from the El Paso mass shooting incident (MSI) are evaluated in comparison to other MSIs. In 2019, El Paso, TX experienced the eighth-deadliest MSIs in modern US history. In this 21st mass killing in the United States of 2019, 19 people died immediately, and four of 27 injured, later died from ballistic injuries. We examined the victims' injuries, pre-hospital treatments, transfusions, rotational thromboelastometry (ROTEM) interpretation, tranexamic acid (TXA) use, and compared El Paso's outcomes with other MSIs. Fifteen casualties were treated for bullet injuries at University Medical Center (UMC). Three were in critical condition; one died during surgery. Of the remaining victims, two were guarded, and the remaining ten in stable condition. Anatomic trauma locations included chest, abdomen, hip, breast, thigh and arm. Haemostatic agents and TXA were administered to arriving patients. Seven casualties receiving blood products were administered 95 units at UMC (45 red blood cells [RBC], 38 fresh frozen plasma [FFP], 8 platelets and 4 cryoprecipitate). ROTEM guided mass transfusion decisions in three patients. Out of seven MSIs reviewed, El Paso had the highest mortality rate (50.0%) and lowest RBC:FFP:admission ratio (1.18 at UMC). We report the greatest proportion of transfusions per admission for an MSI and are first to discuss ROTEM roles to guide transfusion and manage coagulopathy during an MSI. This case highlights the severity and impact of MSIs on victims and requirements to follow established transfusion protocols with adjunct use of ROTEM, TXA and haemostatic agents.

PD12-05 PER-PROTOCOL ANALYSIS FROM THE CLOCK II RANDOMIZED CLINICAL TRIAL COMPARING OFF-CLAMP VERSUS ON-CLAMP PURE LAPAROSCOPIC PARTIAL NEPHRECTOMY

You have accessJournal of UrologyKidney Cancer: Localized: Surgical Therapy I (PD12)1 Sep 2021PD12-05 PER-PROTOCOL ANALYSIS FROM THE CLOCK II RANDOMIZED CLINICAL TRIAL COMPARING OFF-CLAMP VERSUS ON-CLAMP PURE LAPAROSCOPIC PARTIAL NEPHRECTOMY Riccardo Bertolo, Pierluigi Bove, Marco Sandri, Chiara Cipriani, Luca Cindolo, Costantino Leonardo, Paolo Parma, Mario Falsaperla, Domenico Veneziano, Antonio Celia, Andrea Minervini, and Alessandro Antonelli Riccardo BertoloRiccardo Bertolo More articles by this author , Pierluigi BovePierluigi Bove More articles by this author , Marco SandriMarco Sandri More articles by this author , Chiara CiprianiChiara Cipriani More articles by this author , Luca CindoloLuca Cindolo More articles by this author , Costantino LeonardoCostantino Leonardo More articles by this author , Paolo ParmaPaolo Parma More articles by this author , Mario FalsaperlaMario Falsaperla More articles by this author , Domenico VenezianoDomenico Veneziano More articles by this author , Antonio CeliaAntonio Celia More articles by this author , Andrea MinerviniAndrea Minervini More articles by this author , and Alessandro AntonelliAlessandro Antonelli More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001987.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Comprehensive systematic literature reviews including pure laparoscopic partial nephrectomy (LPN) showed no impact on either surgical or oncological outcomes by the off-clamp technique. This finding is debatable and based on the pooled analysis of mostly small sample size studies, affected by several bias. We aimed to report a comparative analysis of perioperative outcomes of on-clamp vs off-clamp LPN in the setting of a randomized controlled trial. METHODS: 217 patients with RENAL masses ≤10 were randomized to on-clamp (106) vs off-clamp (111) LPN (The CLOCK II trial - ClinicalTrials.gov NCT 02287987). Data were collected at 5 participating institutions. One experienced surgeon per institution performed all the surgeries. Baseline and perioperative outcomes were collected and analyzed. The per-protocol analysis (patients who actually received an on-clamp or an off-clamp approach) is herein reported. RESULTS: After randomization, treatment groups were comparable at baseline in age, body mass index, comorbidities, clinical tumor size, RENAL score, serum creatinine, hemoglobin. A total of 189 patients actually underwent surgery as assigned (82 vs 107 on-clamp vs off-clamp, respectively). Tumors treated by an on-clamp approach were significantly bigger (4.0, IQR 3.0-5.0, vs 3.0, IQR 2.2-4.0 cm) but no difference was found in the baseline RENAL score. Regarding the perioperative outcomes, significant differences were found in the resection technique, the renorrhaphy technique, the use of hemostatic agents, the complications’ and transfusions’ rates, the operative time and the hospital stay, favoring the off-clamp approach. Groups were comparable in the blood loss. No significant differences were found in the positive surgical margins rate. CONCLUSIONS: When analyzing the patients who actually received an on-clamp or an off-clamp approach in the setting of a randomized trial, off-clamp LPN resulted in at least non inferior perioperative outcomes. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e204-e204 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Riccardo Bertolo More articles by this author Pierluigi Bove More articles by this author Marco Sandri More articles by this author Chiara Cipriani More articles by this author Luca Cindolo More articles by this author Costantino Leonardo More articles by this author Paolo Parma More articles by this author Mario Falsaperla More articles by this author Domenico Veneziano More articles by this author Antonio Celia More articles by this author Andrea Minervini More articles by this author Alessandro Antonelli More articles by this author Expand All Advertisement Loading ...

The Use of Hemostatic Agents to Decrease Bleeding Complications in General Plastic Surgery Procedures.

Background:Within plastic surgery, hematomas and seromas are frequently reported complications that can negatively impact wound healing and result in significant morbidity in patients. As a result, there has been considerable interest in hemostatic agents to complement traditional methods of hemostasis. The purpose of this study was to evaluate postoperative bleeding complications and duration of Jackson-Pratt (JP) drain use in general plastic surgery procedures with and without hemostatic agents.Methods:After obtaining institutional review board approval, a retrospective chart review was performed. Patients who underwent bilateral breast reduction, panniculectomy, or abdominoplasty were included. Data collected included indication for surgery, type of operation, use of hemostatic agent, specifically fibrin sealant (FS, EVICEL, Ethicon, USA) or combination powder (CP, HEMOBLAST Bellows, Biom’up, France), length of follow-up, time to JP drain removal, postoperative complications, and specimen weight. This was a consecutive experience where initially no hemostatic agent was used, followed by use of FS, and then CP.Results:The use of a hemostatic agent resulted in reduced time duration for JP drain use and overall fewer recorded complications in the hemostatic agent groups. Although not significant, the hemostatic agent group (FS and CP) experienced fewer hematomas and seromas compared with the nonhemostatic agent group. JP drain duration was significantly less among breast reduction (3.46 versus 6.92 days, P < 0.01) for CP when compared with FS.Conclusion:The use of hemostatic agents in general plastic surgery procedures may result in decreased postoperative complications and significantly reduce time to JP drain removal.