Need for Grass Root Innovation in Developing Countries: Case for Stationary Binder Clips in Scalp Hemostasis.

OBJECTIVE: The primary training in any surgical practice starts with tissue handling and effective hemostasis. Neurosurgical procedures start with an incision in the scalp and require summative use of mechanical hemostats and bipolar coagulation to achieve hemostasis. Though Raney clips are the most popular and effective in maintaining hemostasis, their high cost and nonreusability become deterrents for routine use in resource-stricken environments. METHODS: We have compared stationery binder clips of different sizes with Raney clips on the parameters of effectiveness, availability, and cost. Binder clips were also used in intraoperative settings for scalp hemostasis. The comparative efficacy, additional usage of cautery, and need for sterilization are also discussed. RESULTS: We describe our experience with simple stationery metal binder clips in maintaining effective hemostasis in a cost-effective manner. The 25-mm size binder clip exerts same force as a Raney clip without any tissue injury. Practical application revealed effective scalp hemostasis up to blood pressure of 150 mm Hg. CONCLUSIONS: Stationery binder clips are a cost-effective, ready-to-use alternative for standard Raney clips.

Effectiveness of harmonic scalpel in patients submitted to total thyroidectomy: systematic review with meta-analysis.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of the harmonic scalpel compared to the conventional technique in patients submitted to total thyroidectomy. METHOD: This is a systematic review with inclusion of randomized controlled trials (RCTs) that compared both techniques. An electronic search was carried out in the Medline and Lilacs databases until June 2017. The outcomes analysed were operation time, intraoperative bleeding, surgical morbidity, and costs. RESULTS: Data from 31 primary studies were included. The use of the harmonic scalpel correlates to a shorter operation time (p <0.001) and a lower volume of intraoperative bleeding (p <0.001). There were no differences in the risk of transient (p = 0.53) and permanent (p = 0.70) hypocalcaemia, transient (p = 0.61) and permanent (p = 0.50) dysfunctions of the inferior laryngeal nerve and hematoma (p = 0.14). CONCLUSION: Total thyroidectomy using a harmonic scalpel is effective and safe compared to the conventional technique.

Effectiveness of harmonic scalpel in patients submitted to total thyroidectomy: systematic review with meta-analysis

SUMMARY OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of the harmonic scalpel compared to the conventional technique in patients submitted to total thyroidectomy. METHOD: This is a systematic review with inclusion of randomized controlled trials (RCTs) that compared both techniques. An electronic search was carried out in the Medline and Lilacs databases until June 2017. The outcomes analysed were operation time, intraoperative bleeding, surgical morbidity, and costs. RESULTS: Data from 31 primary studies were included. The use of the harmonic scalpel correlates to a shorter operation time (p <0.001) and a lower volume of intraoperative bleeding (p <0.001). There were no differences in the risk of transient (p = 0.53) and permanent (p = 0.70) hypocalcaemia, transient (p = 0.61) and permanent (p = 0.50) dysfunctions of the inferior laryngeal nerve and hematoma (p = 0.14). CONCLUSION: Total thyroidectomy using a harmonic scalpel is effective and safe compared to the conventional technique.

Estimating the Learning Curve of a Novel Medical Device: Bipolar Sealer Use in Unilateral Total Knee Arthroplasties.

BACKGROUND: The use of cost-effectiveness analysis for medical devices has proven to be challenging because of the existence of the learning effects in the device-operator interactions. The need for the relevant analytical framework for assessing the economic value of such technologies has been recognized. OBJECTIVES: To present a modified difference-in-differences (DID) cost-effectiveness methodology that facilitates visualization of a new health technology's learning curve. METHODS: Using the Premier Perspective database (Premier Inc., Charlotte, NC), we examined the impact of physicians adopting a bipolar sealer (BPS) to control blood loss in primary unilateral total knee arthroplasties on hospital lengths of stay and total hospitalization costs when compared with two control groups. In our DID approach, we substituted month-from-adoption for the calendar-month-of-adoption in both graphical representations and ordinary least-squares regression results to estimate the effect of the BPS. RESULTS: The results clearly demonstrated a learning curve associated with the adoption of the BPS technology. Although the reductions in length of stay were immediate, the first postadoption year costs increased by $1335 (extrahospital controls) to $1565 (within-hospital controls). Importantly, and also consistent with a learning curve hypothesis, these initial higher costs were offset by subsequent cost savings in the second and third years postadoption. CONCLUSIONS: The presented modified DID approach is a suitable and versatile analytical tool for economic evaluation of a slowly diffusing medical device or health technology. It provides a better understanding of the potential learning effects associated with relevant interventions.

Use of a flowable haemostat versus an oxidised regenerated cellulose agent in primary elective cardiac surgery: economic impact from a UK healthcare perspective.

BACKGROUND: Flowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS). METHODS: A cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately. RESULTS: Compared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%. CONCLUSIONS: Despite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period.

Safety and Cost-Effectiveness in Thyroidectomy Using the HARMONIC Scalpel Compared to Traditional Hemostasis: A Controlled Clinical Assay.

INTRODUCTION: The aim of this clinical control trial is to analyze the cost-effectiveness and to understand the efficacy of the HARMONIC FOCUS®+ (Ethicon Inc., Somerville, New Jersey) scalpel as the only system to cut and coagulate in thyroidectomy. MATERIALS AND METHODS: One hundered patients of the thyroid clinic of the Mexico City General Hospital were included. All patients underwent surgery and were divided into two randomized groups. In Group 1, the HARMONIC scalpel was the only device used for cut and coagulate (50 patients), and in Group 2 clamp, tie, and electrocautery (50 patients) were used. Surgical bleeding, operative time, complications, diagnosis, thyroid size, and hospital stay were evaluated in both groups. The statistical analysis was done using central trend measurements, Student's t-, chi-squared, and Fisher's exact test, with a significance level of p < 0.05. The cost-effectiveness analysis was completed by determining the total cost of the surgical procedure per hour in US dollars, and the evolution to compare efficacy will be the number of re-interventions due to postoperative bleeding. RESULTS: The use of the HARMONIC scalpel in thyroid surgery had the same results as the traditional method when comparing complications, reoperation, hospital stay, and hypoparathyroidism. In total thyroidectomy patients, the bleeding in Group 1 was 55.16ml ( ± 32.97) and 85.4ml ( ± 69.41) in Group 2 , p=0.034. Operative time in Group 1 was 74.6 minutes (± 23.39) and 104.09 minutes (± 34.66) in Group 2, p= 0.0001. In both groups, there were no statistical differences in lobectomy. Cost-effectiveness analysis implies an adequate hemostasis if we are using a hemostatic device, and above all, the avoidance of a re-intervention due to hematoma, and the cost-effectiveness with regard to the re-intervention as a result of a hematoma implies that $161 US more is spent for each re-intervention. CONCLUSION: The utilization of the HARMONIC scalpel device is similar to the traditional technique of ligature and knots as far as cost-effectiveness is concerned, due to the fact that the greater expense of the device is compensated by the lower expense in time and surgical re-intervention.

[Application of fibrin sealant in patients operated on for differentiated thyroid cancer. What do we improve?]. / Aplicación de sellante de fibrina en pacientes operados por cáncer diferenciado de tiroides. ¿Qué mejoramos?

BACKGROUND: In recent years, several publications have shown that new adhesives and sealants, like Tissucol(®), applied in thyroid space reduce local complications after thyroidectomies. STUDY AIMS: To demonstrate the effectiveness of fibrin glue Tissucol(®) in reducing the post-operative hospital stay of patients operated on for differentiated thyroid carcinoma in which total thyroidectomy with central and unilateral node neck dissection was performed (due to the debit drains decrease), with consequent cost savings. MATERIAL AND METHODS: A prospective randomised study was conducted during the period between May 2009 and October 2013 on patients with differentiated thyroid carcinoma with cervical nodal metastases, and subjected to elective surgery. Two groups were formed: one in which Tissucol(®) was used (case group) and another where it was not used (control group). Patients were operated on by surgeons specifically dedicated to endocrine surgical pathology, using the same surgical technique in all cases. RESULTS: A total of 60 total thyroidectomies with lymph node dissection were performed, with 30 patients in the case group, and 30 patients in control group. No statistically significant differences were observed in most of the studied variables. However, the case group had a shorter hospital stay than the control group with a statistically significant difference (p<0.05). CONCLUSION: Implementation of Tissucol(®) has statistically and significantly reduced the hospital stay of patients undergoing total thyroidectomy with neck dissection, which represents a significant reduction in hospital costs. This decrease in hospital stay has no influence on the occurrence of major complications related to the intervention.

Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study).

BACKGROUND: Reduction of blood transfusion in cardiac surgery is an important target. The aim of this study was to investigate the cost-effectiveness of the use of CryoSeal®, an allogeneic single-donor fibrin sealant, in patients undergoing coronary artery bypass grafting (CABG). METHODS: This randomized clinical study involved seven cardiac surgery centres in the Netherlands. Patients undergoing elective isolated CABG with the use of at least one internal thoracic artery (ITA) graft were assigned randomly to receive either CryoSeal® (5 ml per ITA bed) or no CryoSeal®. Primary efficacy endpoints were units of transfused red blood cells, fresh frozen plasma and platelet concentrates, and duration of intensive care unit stay. Secondary efficacy endpoints were 48-h blood loss, reoperation for bleeding, mediastinitis, 30-day mortality and duration of hospital stay. RESULTS: Between March 2009 and January 2012, 1445 patients were randomized. The intention-to-treat (ITT) population comprised 1436 patients; the per-protocol (PP) population 1292. In both the ITT and the PP analysis, no significant difference between the treatment groups was observed for any of the primary and secondary efficacy endpoints. In addition, no significant difference between the groups was seen in the proportion of transfused patients. Estimated CryoSeal® costs were €822 (95 per cent c.i. €808 to €836) per patient, which translated to €72,000 per avoided transfusion (unbounded 95 per cent c.i.). CONCLUSION: The use of the fibrin sealant CryoSeal® did not result in health benefits. Combined with the high cost per avoided transfusion, this study does not support the implementation of routine CryoSeal® use in elective isolated CABG. REGISTRATION NUMBER: NTR1386 ( http://www.trialregister.nl).

Cost of Bleeding in Trauma and Complex Cardiac Surgery.

PURPOSE: Trauma and complex cardiac surgery are associated with a high risk of bleeding complications. The difference in costs between patients who require bleeding control measures and those who do not is poorly understood. Our goal was to assess the cost of care and outcomes for patients in these settings. METHODS: Patients >18 years of age, who were discharged between January 2010 and December 2012, were retrospectively identified in the Premier Hospital Database based on International Classification of Disease, Ninth Revision codes. These patients were categorized as having received blood products ("bleeding patients") or not ("nonbleeding patients"). Patients with costs and length of stay (LOS) of zero were excluded. Differences in treatment costs and outcomes were assessed using univariate analysis and multivariate modeling. FINDINGS: Bleeding trauma patients (n = 8800) had a 150% higher total cost of care (P < 0.001; 146% after excluding costs of agents used for bleeding control, P < 0.001), an 81.3% longer hospital LOS (P < 0.001), and a 65.2% longer intensive care unit (ICU) LOS (P < 0.001) than nonbleeding patients (n = 53,727). Bleeding complex cardiac surgery patients (n = 82,832) had a 133.2% higher total cost of care (P < 0.001; 128.7% after excluding costs of agents used for bleeding control, P < 0.001), a 155.6% longer hospital LOS (P < 0.001), and an 89.3% longer ICU LOS (P < 0.001) than nonbleeding patients (n = 380,902). IMPLICATIONS: Trauma and cardiac surgery patients who experienced bleeding and received allogeneic blood product transfusions had significantly worse outcomes, including longer LOS, greater inpatient mortality, and higher costs of care (even when excluding costs of agents used for bleeding control) than those who did not.

The use of energy devices for thyroid surgical procedures. Harmonic Focus versus Biclamp 150.

BACKGROUND: Thyroidectomy is the most frequently performed endocrine surgery, and in recent years, the surgical instruments and techniques used in this surgery have greatly evolved. New devices are created to facilitate dissection, haemostasis increasing the intraoperative cost. MATERIAL AND METHOD: We prospectively examined patients undergoing to traditional thyroidectomy using reusable vs disposable devices (BiClamp 150, ERBE ® - group A vs. Harmonic Focus, ETHICON® - group B). The patients were treated for benign and malignant diseases from two experienced surgeons. The two groups were separated based on age, sex, skin-to-skin operative time, the number of parathyroid glands identified by the surgeon during the operation, preand post-operative serum calcium levels evaluated with PTH until 24 hours after surgery, the mean hospital stay, the evaluation of the content of the drainages at 6 hours and 24 hours, and the thyroid gland volume calculated via ultrasound preoperatively. The patients were asked to complete a form at 24 hours post-op to self-evaluate dysphagia to liquids and pain on a scale from 0 to 10. RESULTS: The patients analysed were 80 pts. Analysis of the data showed no significant differences between the groups with respect to age, (p = 0:48), or gender, 9 males and 31 females in group A and 8 males and 32 females in group B.The thyroid volume (in ml), calculated on the basis of preoperative ultrasonography, was 43.89 ± 37.10 in group A vs. 54.54 ± 51.92 in group B (p = 0.35). The skin-to-skin operative time was equal to 50.16 ± 10.43 min.vs. 52.39 ± 11:54 min.(p = 0.36) in groups A and B, respectively. No statistically significant differences in pre e postoperative calcium levels. The amount of drainage at 6 hours after surgery was 16.63 ± 15.24ml. in group A and 23.72 ± 21.93ml. in group B (p = 0.07). At 24 hours after surgery, the amount was 57.84 ± 32.56ml. in group A and 66.79 ± 39.94ml. in group B (p = 0.28). For group A and group B, we analysed dysphagia for liquids on a scale from 0 to 10 (4.5 ± 2.35 vs. 4.18 ± 2.4, p = 0.48, respectively), alterations in patients' tone of voice (1.97 ± 2.51 vs. 1.43 ± 0:48, p = 0.29, respectively), and postoperative pain at 24 hours after surgery (2.76 ± 1.99 vs. 2.68 ± 2.12, p = 0.87, respectively). The average cost for group A was equal to € 25 × 40 = 1000 vs. € 450 × 40 = 18000 for Group B. The hospital stay in days was equal to 1.70 ± 0.46 (Group A) vs. 1.66 ± 0.53 (Group B) (p = 0.69). CONCLUSIONS: One limitation of the current study is its small sample size. Both devices are effective and safe for total thyroidectomy because they have similar effects on the operative time, postoperative bleeding and patient outcomes in endocrine experienced surgical team. On the other hand, in a time of the spending review and the standardisation of surgical techniques to ensure the highest quality of services offered, the BiClamp is a viable alternative tool with a high security standard and low cost that offers significant savings to the health care system. KEY WORDS: Energy devices, Health care, Thyroidectomy.

The use fibrinogen/thrombin-coated equine collagen patch in children requiring reoperations for congenital heart disease. A single center clinical experience.

AIM: The aim of this study was to evaluate the efficacy and cost-effectiveness of fibrinogen/thrombin-coated collagen patch (FTCCP)(TachoSil®) during intraoperative hemostasis in patients with congenital heart disease, who required a reoperation during childhood. METHODS: We reviewed data on the intraoperative blood product requirements and hospital costs of children (age <16 years) who underwent a reoperation for treating their congenital heart disease between January 2009 and December 2011. RESULTS: One-hundred and seventeen patients were included. Median age at surgery was 2.1 years (range 3 days-14.1 years). Main causes of intraoperative bleeding were: 1) reinforcement of suture lines (106 patients, 90.6%); 2) lung lesions (5 patients, 4.2%); 3) epicardial lesions (3 patients, 2.6%); and 4) chest wall lesions (3 patients, 2.6%). At logistic regression the amount of packed red blood cells (PRBC) requirement was significantly higher in patients with preoperative cyanosis (P=0.008, OR=3.85) and in patients who required the use of cardiopulmonary bypass (P=0.005, OR=21.19). The use of FTCCP (N.=90 patients) as first line treatment was significantly associated with a lower PRBC requirement (P=0.0003, OR=0.1) which in addition to the avoidance of other hemostatic/sealant agents, leads to lower hospital cost. CONCLUSION: FTCCP is an effective hemostatic agent which can be safely used during the hemostasis of children requiring reoperations for their congenital heart malformations. When used as first line treatment, with specific indications, FTCCP limited the intraoperative PRBC requirement and the use of other hemostatic/sealant agents thus reducing hospital costs.

Retrospective comparison of Traditional vs. LigaSure impact dissection during pancreatoduodenectomy: how to save money by using an expensive device.

Pancreatoduodenectomy is an exceptional procedure that requires an extensive dissection of the supramesocolic region extended to the first jejunal limb. Lymphadenectomy, required for cancer, increases the dissection surface. The extensive preparation of the area is traditionally conducted with bipolar ormonopolar instruments, while clips, ligatures, and sutures are used for haemostasis. LigaSure™ vessel sealing(LSVS; Valleylab, Boulder, CO) is a technology that obtains vessel closure by using the body's own collagen and elastin to create a permanent fusion zone. This is obtained by a combination of forceps pressure and radio frequency. This effect has been improved by the introduction of the Force Triad™ (Valleylab, Boulder,CO) energy platform, controlled by TissueFect™ (Valleylab, Boulder, CO) sensing technology. With this device, the surgeon is able to fuse vessels up to 7 mm, lymphatics, tissue bundles, and pulmonary vasculature in a fast-seal cycle of almost 4 seconds. In our daily practice of open surgery we observe a rapid improvement of abdominal drainage output with a drastic reduction of protein loss. Its practical significance is, in our opinion, that we obtain a rapid recovery of normal serum protein levels with a low number of blood/plasmasac transfusions and a real improvement of anastomosis healing. Moreover, the efficacy and the speed of work of the device allow us to reduce the operating time significantly but safely. We performed a retrospective analysis of the data of 20 pancreatic resections conducted both with traditional dissection and with the Liga-Sure Impact device with Force Triad platform in order to verify whether observed data were real. Our clinical results show that the use of the LigaSure Impact device with Force Triad energy platform is really useful in open surgery to save operating time, number of postoperative days, and hemoderivate administration.

Finger tourniquets: two safe and cost effective techniques and a discussion of the literature.

Finger tourniquets are used in a variety of operative procedures in both the trauma and elective setting. A wide range of methods are used in clinical practise as there is no standardised method. Many of the methods in use have significant drawbacks such as the inability to exsanguinate the digit or the more concerning problem of inadvertently leaving the tourniquet on the digit on completion of the procedure. We discuss two techniques that are quick, cheap and easy that do not have these drawbacks. There is a brief discussion of the literature assessing the various attributes of published methods. We feel that the adoption of these methods could result in easier and safer finger exsanguination and haemostasis.

Saline-coupled bipolar sealing in revision total knee arthroplasty for infection.

Blood conservation with saline-coupled bipolar sealing devices in primary total knee arthroplasty (TKA) has had mixed results. Moreover, investigators have not studied these devices in infected TKA cases in which conventional methods of blood management cannot be used. We conducted a single-surgeon, case-control study to evaluate how the choice of an electrocautery device affects total blood loss, transfusion requirements, and total cost in revision TKA for infection. Each of the 80 patients in the study had an infected TKA and underwent surgery that involved the use of a saline-coupled bipolar sealing device at our institution. Results were compared with those of a control group of 40 patients immediately predating use of this device. Groups were matched for age, body mass index, American Society of Anesthesiologists (ASA) classification, and surgery type. We then compared the groups on multiple variables, including total blood loss, transfusion requirements, operative time, and hemoglobin decrease. The groups did not differ with respect to blood loss or transfusion requirements. However, operative time was significantly lower in the bipolar sealer group. This difference translated to an average net additional cost of about $70 per case. Given the results of this study, use of a saline-coupled bipolar sealing device in patients with infected TKAs is not clinically or economically justified.

Electrothermal bipolar vessel sealing system (LigaSure) for hemostasis during thyroid surgery: a comprehensive review.

Conventional hemostatic technologies utilized in thyroid surgery include clamp-and-tie, clips and monopolar and bipolar diathermy. Over the last decade, there has been a major shift towards utilizing newer hemostatic technologies, most notably the electrothermal bipolar vessel sealing systems (EBVS) and the Harmonic Scalpel (Ethicon Endosurgery, OH, USA), for thyroid surgery. Since the first report of EBVS thyroidectomy in 2003, more than 50 studies have been published evaluating EBVS utilization for thyroid surgery. In addition to providing a historical perspective and exploring the principles of EBVS technology, this review aims to evaluate the current published data regarding EBVS utilization for thyroid surgery. In particular, a focus is given to LigaSure (Covidien, Dublin, Ireland) technology because it has been studied most thoroughly in the literature. This review will also evaluate studies comparing the EBVS with Harmonic Scalpel technology for thyroid surgery.

Transection of the liver parenchyma with an ultrasound dissector or a stapler device: results of a randomized clinical study.

BACKGROUND: Perioperative hemorrhage and postoperative bile leakage are severe complications of liver surgery. They may be related to the techniques used to divide the tissue. We designed a randomized clinical trial to compare the cavitron ultrasonic surgical aspirator (CUSA) and an endoscopic stapler device applied in routine clinical hepatic surgical practice. METHODS: All consecutive patients admitted for elective hepatic resective surgery--at least bisegmentectomy of the liver--were assessed for enrollment in the study. A total of 100 patients were subsequently randomized. There was a good balance between the study groups concerning issues that may be of relevance for the perioperative and postoperative courses. The primary objective of the study was to achieve an approximately 25 % reduction in perioperative blood loss and postoperative bile leakage. Secondary outcome variables were operating time, general postoperative morbidity, length of hospital stay, and direct medical costs. RESULTS: The amount of perioperative or postoperative blood loss did not differ significantly between the two groups. We observed a trend toward shorter transection and operating time for patients in whom staplers were used, but the difference did not reach statistical significance. The postoperative courses were close to identical in the respective study arms with no difference in bile leakage rates or in the total morbidity profiles. The direct medical costs were nonsignificantly lower in the group where staplers were used for liver transection. CONCLUSIONS: The results show that the use of endoscopic vascular staplers in liver surgery is feasible and safe. It offers an attractive alternative for division of the liver parenchyma during routine hepatic surgery, being comparable to the use of CUSA without adding extra costs.

Ultrasonic scalpel for gastric cancer surgery: a prospective randomized study.

BACKGROUND: The aim of the study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in gastric cancer surgery. METHODS: Patients with resectable adenocarcinoma of the stomach were randomly assigned to ultrasonic scalpel or conventional technique. We used the HARMONIC FOCUS (Ethicon Endo-Surgery, Inc.) as ultrasonic scalpel. RESULTS: Between February 2010 and December 2010, 60 patients with resectable gastric cancer were enrolled into the study. Operative time was significantly shorter with the ultrasonic arm than with the conventional arm (median 238.5 vs. 300.5 min; P = 0.0004). Blood loss was also significantly lower in the ultrasonic arm than in the conventional arm (median 351.0 vs. 569.5 ml; P = 0.016). Clavien-Dindo grades of postoperative complications were similar in the two groups. From a questionnaire survey of operators, the ultrasonic scalpel significantly reduced the stress of lymph node dissection (3.67 vs. 2.87; P = 0.0006). However, in assisting surgeons, the contributions to surgery, study, and technical improvement of the ultrasonic group were lower than in the conventional group. CONCLUSIONS: This study shows that the ultrasonic scalpel is a reliable and safe tool for open gastric cancer surgery.

Intraoperative use of low-dose recombinant activated factor VII during thoracic aortic operations.

BACKGROUND: Numerous studies have supported the effectiveness of recombinant activated factor VII (rFVIIa) for the control of bleeding after cardiac procedures; however safety concerns persist. Here we report the novel use of intraoperative low-dose rFVIIa in thoracic aortic operations, a strategy intended to improve safety by minimizing rFVIIa exposure. METHODS: Between July 2005 and December 2010, 425 consecutive patients at a single referral center underwent thoracic aortic operations with cardiopulmonary bypass (CPB); 77 of these patients received intraoperative low-dose rFVIIa (≤60 µg/kg) for severe coagulopathy after CPB. Propensity matching produced a cohort of 88 patients (44 received intraoperative low-dose rFVIIa and 44 controls) for comparison. RESULTS: Matched patients receiving intraoperative low-dose rFVIIa got an initial median dose of 32 µg/kg (interquartile range [IQR], 16-43 µg/kg) rFVIIa given 51 minutes (42-67 minutes) after separation from CPB. Patients receiving intraoperative low-dose rFVIIa demonstrated improved postoperative coagulation measurements (partial thromboplastin time 28.6 versus 31.5 seconds; p=0.05; international normalized ratio, 0.8 versus 1.2; p<0.0001) and received 50% fewer postoperative blood product transfusions (2.5 versus 5.0 units; p=0.05) compared with control patients. No patient receiving intraoperative low-dose rFVIIa required postoperative rFVIIa administration or reexploration for bleeding. Rates of stroke, thromboembolism, myocardial infarction, and other adverse events were equivalent between groups. CONCLUSIONS: Intraoperative low-dose rFVIIa led to improved postoperative hemostasis with no apparent increase in adverse events. Intraoperative rFVIIa administration in appropriately selected patients may correct coagulopathy early in the course of refractory blood loss and lead to improved safety through the use of smaller rFVIIa doses. Appropriately powered randomized studies are necessary to confirm the safety and efficacy of this approach.

Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review.

BACKGROUND: Adequate hemostatic techniques are essential for optimal intra- and postoperative results. A number of different hemostatic techniques and devices have been developed over the past few years, but which device should be preferred during laparoscopic and open abdominal procedures? METHODS: We conducted a systematic search for randomized controlled trials (RCTs) that compared the effectiveness and costs of vessel-sealing devices with those of other electrothermal or ultrasonic devices in abdominal surgical procedures. RESULTS: Seven RCTs that included 554 patients met the inclusion criteria. Various procedures that used a vessel-sealing device (LigaSure™) (n = 264) were compared to ultrasonic devices (n = 139) and mono- (n = 20) or bipolar devices (n = 130). LigaSure was favored in two studies with respect to less blood loss, shorter operating time, and lower costs. However, no differences were observed in the other studies. Considering the relatively low number of complications, all hemostatic devices used may be considered relatively safe. None of the studies reported on quality of life or cost effectiveness. CONCLUSIONS: Vessel-sealing devices may be considered safe and their use may reduce costs due to reduced blood loss and shorter operating time in some abdominal surgical procedures compared to mono- or bipolar electrothermal devices. Wider-ranging RCTs of sufficient quality that assess (cost) effectiveness are required to make firm conclusions.