Assessment of the effect of the Aquamantys® system on local recurrence after hepatectomy for hepatocellular carcinoma through propensity score matching.

OBJECTIVE: To assess the effect of the intraoperative application of the Aquamantys® system to treat the hepatic resection margin on local and overall recurrence of HCC. METHODS: We retrospectively analyzed 101 patients admitted from November 2016 to June 2018 who underwent hepatectomy using the Aquamantys® as hemostatic device, who were matched with 101 patients (control group) using conventional hemostatic devices through PSM. Univariate and multivariate analyses of recurrence-free survival (RFS) and local recurrence-free survival (LRFS) were performed using the Cox proportional hazard model. RESULTS: There were no significant differences in baseline data and surgical procedures between the two groups. The Aquamantys® group showed less blood loss (P = 0.005) and a lower blood transfusion rate (P = 0.036), while the incidences of postoperative complications of the two groups showed no difference (P = 0.266). OS rates of the Aquamantys® group and the control group were 82.6% and 84.2%, respectively (P = 0. 446), and RFS rates were 65.5% and 58.2%, respectively (P = 0.153), with no significant differences. The Aquamantys® group and the control group had two cases and 11 cases of local recurrence, respectively, with LRFS rates of 98% and 87.9%, respectively, in the follow-up period, corresponding to a significant difference (P = 0.011). Multivariate analysis showed that microvascular invasion (MVI), tumor diameter > 5 cm, and the control group were independent risk factors for LRFS. CONCLUSION: Our results indicate that application of the Aquamantys® system in hepatectomy can reduce local recurrence, but it can neither reduce overall recurrence nor improve OS.

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.

The invention of microwave surgical scissors for seamless coagulation and cutting.

PURPOSE: We developed a microwave energy-based scissors device (MWCX) that is capable of performing cutting and coagulation using 2.45 GHz microwave energy. This paper aims to present the concept of the device and assess the basic functions including the hemostasis, cutting, and sealing abilities. METHODS: Seven beagle dogs were used in our experiments. In six dogs, we measured the coagulation time (CT), lateral thermal injury (LTI), bursting pressure (BP). The dogs were then subjected to re-laparotomy 1 week later to allow us to investigate the results. In one dog, the same factors and the quantities of smoke and mist emitted were compared to those observed when using a Harmonic Focus (HF) device. RESULTS: At 60 W, the MWCX could cut and seal small (5 s, diameter 1-2 mm) and medium-sized (10 s, 3-4 mm) vessels with complete hemostasis. The liver (length 2 cm) was cut for 30 s. Harvested vessels were sealed for 10 s (artery, 17 times; vein, six times). The mean BP was 887. 8 ± 41.5 mmHg in the medium arteries and 457.2 ± 118.0 mmHg in veins, with a mean diameter of 4.5 ± 1.3 mm. In a comparative study, the MWCX showed similar results to the HF with regard to the CT, BP and LTI, and emitted less smoke and mist. CONCLUSION: The MWCX showed similar levels of functionality and safety to HF, as well as the advantages offered by the use of microwave energy. Microwave devices might be used in the majority of applications for which traditional energy devices are used.

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.

New generation cut-and-seal devices in oral and oropharyngeal cancer resection: clinical and cost-effectiveness study.

OBJECTIVES: To evaluate the clinical efficacy and cost-effectiveness of ultrasonic shears and the electrothermal bipolar vessel sealing system, in comparison to the traditional cold knife and bipolar forceps, in oral and oropharyngeal cancer surgery. METHODS: Patients who underwent oral or oropharyngeal cancer resection and neck dissection with either ultrasonic shears (n = 36) or electrothermal bipolar vessel sealing (n = 32) were enrolled. Surgical time, intra-operative bleeding, blood drainage, post-operative pain, neck oedema, complications and hospitalisation duration were compared to those of an historical cohort of 36 patients treated using a cold knife and bipolar forceps. Additionally, a cost-effectiveness evaluation was performed. RESULTS: Ultrasonic shears and, in particular, electrothermal bipolar vessel sealing, were advantageous compared to the traditional techniques. The cost of ultrasonic shears and electrothermal bipolar vessel sealing was completely offset by declining time-driven costs for the surgical team and operating theatre. CONCLUSION: Ultrasonic shears and, in particular, electrothermal bipolar vessel sealing, are more advantageous compared to the traditional techniques, from both a clinical and economic point of view.

Safety assessment of the use of ultrasonic energy in the proximity of the recurrent laryngeal nerve in a porcine model.

BACKGROUND: Advanced bipolar and ultrasonic energy have demonstrated reduction of operating time and blood loss in thyroidectomy. However, these devices generate heat and thermal dispersion that may damage adjacent structures such as the recurrent laryngeal nerve (RLN). This study was designed to evaluate the safety profile of the Harmonic Focus+® (HF+) device through the evaluation of thermal injury to the RLN using different algorithms of distance and time with state of the art technology. METHODS: 25 Vietnamese pigs underwent activation of HF+ in the proximity of their RLN. They were divided into 4 groups according to activation distance (3 mm, 2 mm, 1 mm and on the RLN). Time of activation, time between tones of the ultrasonic generator, changes in the electromyographic signal using continuous nerve neuromonitoring, vocal fold mobility assessed by direct laryngoscopy and histological thermal damaged were evaluated. RESULTS: None of the pigs had loss of signal in the electromyography during the procedure; only one pig had isolated transient decrease in amplitude and one increase in latency. One pig had transient vocal fold paresis in the group with activation on the nerve. Evaluation of the nerves by histology and immunohistochemistry did not show significant changes attributed to thermal injury. CONCLUSIONS: The use of ultrasonic energy close to the RLN is safe, provided that activation time does not exceed the necessary time to safely transect the tissue.

Histological Gingival Assessment after Conventional and Laser Gingivectomy.

BACKGROUND: Gingivectomy is a procedure often performed in everyday clinical practice using numerous instruments. AIM: To evaluate and compare the gingival cut surface after gingivectomy with 6 different surgical instruments - a surgical scalpel, an Er:YAG laser, a CO2 laser, a ceramic bur, an electrocautery device, and a diode laser. MATERIALS AND METHODS: Gingivectomy using the above listed instruments was performed in 18 patients. The histological samples excised with a surgical scalpel were assigned as a control group and the other five types - as test groups. The following histological parameters were measured: coagulation layer thickness (in µm); presence or absence of a microscopic rupture and presence or absence of hemostasis in-depth. RESULTS: The best instrument of the above listed ones which demonstrated excellent results is the CO2 laser. The Er:YAG laser has a thin coagulation layer and lack of hemostasis in-depth. The diode laser has the widest coagulation layer which is an advantage from a clinical point of view. Electrocautery proved to be as effective as the diode laser, but it should not be used around metal restorations. The ceramic bur has less pronounced hemostasis in-depth. CONCLUSIONS: Modern dentistry uses a wide variety of methods that are designed to be applied in everyday practice. Good knowledge of the ways to use them, their advantages and disadvantages is essential to obtaining the optimal result depending on the clinical case.

Harmonic scalpel impact on blood loss and operating time in major head and neck surgery: a randomized clinical trial.

BACKGROUND: Long operating time and high blood loss contribute to post-surgical morbidity. Therefore, strategies to reduce these factors should to be tested using robust methods. The purpose of this study was to evaluate the impact of using the harmonic scalpel on operating time and blood loss in patients undergoing resection for advanced oral cancer (OSCC). METHODS: Thirty-six adult head and neck cancer patients with advanced OSCC requiring primary tumor resection with uni- or bi- lateral selective neck dissection from July 2012 to September 2014 were randomized to either the control group (traditional surgery) or the experimental group (harmonic surgery). Patients older than 18 years who were able to provide informed consent were eligible. Primary outcomes of interest were: intraoperative blood loss (mL) and operative time (minutes) for the ablative part of the surgery. RESULTS: Mean blood loss in the experimental group was 260 mL versus 403 mL in the control group (p = 0.08). Mean operative time was 140 min in the experimental group and 159 min in the control group (p = 0.2). CONCLUSIONS: In this randomized controlled trial, use of the harmonic scalpel did not effect intraoperative blood loss or OR time in patients undergoing surgery for advanced OSCC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02017834 .

Is laparoscopic appendectomy going to be standard procedure for acute appendicitis; a 5-year single center experience with 1,788 patients.

PURPOSE: To evaluate whether laparoscopic appendectomy can be the gold standard for acute appendicitis regarding the applicability and cost effectivity. MATERIALS AND METHODS: The study included patients who were operated by laparoscopically for acute appendicitis between January 2008 and September 2012. Patients' sex, ages, hospitalization time, the type for closure of the appendiceal stump, complication rate, surgery time and other parameters were recorded. RESULTS: 1,788 patients with acute appendicitis on laparoscopic evaluation constituted the study population. Average age of the patient group was 30.1 ± 2.3 years old. Average hospitalization time was 1.2 ± 1.1 days. Metal clips were used in 1,100 (61.5%) patients, intracorporeal knotting was performed in the remaining. Total complication rate was 3.8%. CONCLUSION: By the using of metal clips and increased experience; laparoscopy may be gold standard for acute appendicitis.

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.

Radiofrequency dissection versus 'knot tying' in conventional total thyroidectomy.

OBJECTIVE: To evaluate the safety and effectiveness of radiofrequency dissection in conventional 'open' total thyroidectomy. METHODS: Thirty-nine patients scheduled for conventional total thyroidectomy were included in a prospective randomised study. Patients were randomly assigned to one of two groups: a radiofrequency dissection method was used in one group, and a knot tying technique was used in the other. RESULTS: Significantly fewer surgical instruments and materials were required for the radiofrequency dissection group than the knot tying group (p < 0.01). There were no significant differences between the two groups in mean operative time, blood loss, post-operative drainage and pain, recurrent palsy, and hypocalcaemia (p > 0.05). CONCLUSION: Radiofrequency dissection is a safe alternative to the knot tying technique, and enables a significant reduction in the number of surgical instruments required for the operation.

Use of a bipolar sealer in total hip arthroplasty: medical resource use and costs using a hospital administrative database.

Perioperative blood loss during total hip arthroplasty (THA) increases patient morbidity, length of stay (LOS), medical resource use (MRU), and costs. Minimizing blood loss may reduce postoperative anemia, the need for blood transfusions, and the increased risk of infections and longer hospital stays associated with blood transfusions. Pharmacologic agents and bipolar sealer devices can minimize perioperative bleeding. A retrospective, comparative cohort study in the US hospital setting was conducted to assess MRU and associated costs and the incidence of transfusion and complications among patients undergoing THA with or without the use of a bipolar sealer. Using a nationwide all-payer hospital administrative database, THA procedures from January 1, 2008, to March 31, 2011, were identified using International Classification of Diseases, Ninth Revision, Clinical Modification procedure code 81.51. The bipolar sealer cohort (n=2683) and matched control cohort (n=2683) had a mean age of 65 years from 38 hospitals. The 2 groups had similar incidences of pre-operative anemia and medical comorbidities. Patients in the bipolar sealer group required significantly fewer blood transfusions (21.3% vs 23.8%; P=.0286) and had significantly lower incidence of hematomas (0.2% vs 0.9%; P=.0015) and significantly shorter LOS (2.90 vs 3.31 days; P<.0001) overall. The bipolar sealer group had higher supply costs, which were offset by reduced hospital inpatient room and board and operating room costs; there was no significant difference in total hospital costs between the 2 groups ($18,937 vs $18,734; P=.56). A bipolar sealer decreases postoperative blood transfusions and LOS during primary THA without increasing total hospital costs.

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.

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.

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.

Which hemostatic device in thyroid surgery? A network meta-analysis of surgical technologies.

BACKGROUND: Energy-based hemostatic devices are increasingly being used in thyroid surgery. However, there are several limitations with regard to the existing evidence and a paucity of guidelines on the subject. The goal of this review is to employ the novel evidence synthesis technique of a network meta-analysis to assess the comparative effectiveness of surgical technologies in thyroid surgery and contribute to enhanced governance in the field of thyroid surgery. METHODS: Articles published between January 2000 and June 2012 were identified from Embase, Medline, Cochrane Library, and PubMed databases. Randomized controlled trials of any size comparing the use of ultrasonic coagulation (harmonic scalpel) or Ligasure either head-to-head or against the "clamp-and-tie" technique were included. Two reviewers independently critically appraised and extracted the data from each study. The number of patients who experienced postoperative events was extracted in dichotomous format or continuous outcomes. Odds ratios were calculated by a Bayesian network meta-analysis, and metaregression was used for pair-wise comparisons. Indirect and direct comparisons were performed and inconsistency was assessed. RESULTS: Thirty-five randomized controlled trials with 2856 patients were included. Ultrasonic coagulation ranked first (followed by Ligasure and then clamp-and-tie) with the lowest risk of postoperative hypoparathyroidism (odds ratio 1.43 [95% confidence interval (CI) 0.77-2.67] and 0.70 [CI 0.43-1.13], ultrasonic coagulation vs. Ligasure and ultrasonic coagulation vs. clamp-and-tie, respectively), least blood loss (-0.25 [CI -0.84 to -0.35] and -1.22 [CI -1.85 to -0.59]), and drain output (0.28 [CI -0.35 to -0.91] and -0.36 [CI -0.70 to -0.03]). From a health technology viewpoint, ultrasonic coagulation was associated with the shortest operative time (-0.66 [CI -1.17 to -0.14] and -1.29 [CI -1.59 to -1.00]) and hospital stay (-0.28 [CI -0.78 to 0.22] and -0.56 [CI -1.28 to 0.15]). The only exception occurs with the clinically important complication of recurrent laryngeal nerve paralysis, where the reverse trend applies (1.36 [CI 0.25-7.46] and 1.74 [CI 0.94-3.26]). CONCLUSIONS: The comparative effectiveness of ultrasonic coagulation in thyroid surgery outcomes seems superior to other techniques with the exception of recurrent laryngeal nerve injury. This network meta-analysis, one of a handful in a surgical field, offers preliminary and robust evidence to guide clinical decisions and policy makers to adopt safer thyroid operations.

Needs analysis for developing a virtual-reality NOTES simulator.

UNLABELLED: INTRODUCTION AND STUDY AIM: Natural orifice translumenal endoscopic surgery (NOTES) is an emerging surgical technique that requires a cautious adoption approach to ensure patient safety. High-fidelity virtual-reality-based simulators allow development of new surgical procedures and tools and train medical personnel without risk to human patients. As part of a project funded by the National Institutes of Health, we are developing the virtual transluminal endoscopic surgery trainer (VTEST) for this purpose. The objective of this study is to conduct a structured needs analysis to identify the design parameters for such a virtual-reality-based simulator for NOTES. METHODS: A 30-point questionnaire was distributed at the 2011 National Orifice Surgery Consortium for Assessment and Research meeting to obtain responses from experts. Ordinal logistic regression and the Wilcoxon rank-sum test were used for analysis. RESULTS: A total of 22 NOTES experts participated in the study. Cholecystectomy (CE, 68 %) followed by appendectomy (AE, 63 %) (CE vs AE, p = 0.0521) was selected as the first choice for simulation. Flexible (FL, 47 %) and hybrid (HY, 47 %) approaches were equally favorable compared with rigid (RI, 6 %) with p < 0.001 for both FL versus RI and HY versus RI. The transvaginal approach was preferred 3 to 1 to the transgastric. Most participants preferred two-channel (2C) scopes (65 %) compared with single (1C) or three (3C) or more channels with p < 0.001 for both 2C versus 1C and 2C versus 3C. The importance of force feedback and the utility of a virtual NOTES simulator in training and testing new tools for NOTES were rated very high by the participants. CONCLUSION: Our study reinforces the importance of developing a virtual NOTES simulator and clearly presents expert preferences. The results of this analysis will direct our initial development of the VTEST platform.

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.