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BACKGROUND: Advanced vessel sealing electrosurgical systems have been widely adopted for grasping, cutting, and sealing vessels. Data remain sparse with regard to its use in thoracic procedures. Thus, a prospective case series, utilizing the ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) and its companion energy source, the Generator 11 (GEN11), in thoracic procedures was performed in a Japanese cohort. METHODS: Subjects were recruited at two Japanese surgical sites. The primary endpoint of this post-market study was the achievement of hemostasis (≤ Grade 3) for each thoracic vessel transection. Performance endpoints included scores for tasks completed with X1CJ (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection); hemostasis grading vessel transected; additional products required to achieve hemostasis for Grade 4 vessel transections. Safety was evaluated by evaluating device-related adverse events. All endpoint data were summarized. RESULTS: Forty subjects (50.0% female) of Asian ethnicity with a mean age of 67.6 ± 11.3 years underwent a lung resection. Estimated mean blood loss was 39.5 mL. Hemostasis was achieved in 97.5% of vessel transections. Thirty-seven vessel sealings resulted in a hemostatic Grade 1 (92.5%). All surgeons reported satisfaction/neutral in terms of tissue grasping (100.0%) while most reported satisfaction/neutral with tissue cutting (95.7%). One device-related serious adverse event was reported (2.5%), a chylothorax requiring an extension of hospitalization. There was no post-operative bleeding or deaths reported during the study period. CONCLUSION: The X1CJ demonstrated safe and effective performance without any reports of significant intra-operative or post-operative hemorrhage in thoracic vessel sealing.

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Background Surgical removal of hemorrhoids is the gold-standard treatment for symptomatic grade III and IV hemorrhoid disease. There are numerous ways the hemorrhoidectomy surgical procedure is done but the most effective and least painful way is still to be elucidated. Objective To compare the outcomes of ENSEAL® (Ethicon, Inc., Raritan, USA) versus gold standard Milligan-Morgan hemorrhoidectomy in patients presenting with grade-III and IV hemorrhoids Materials and methods After ethical approval, the Randomized Controlled Trial was conducted at the Department of Surgery, Unit III, Lahore General Hospital, Lahore, Pakistan, between January 2020 and January 2022. In this study, 140 patients who met the inclusion criteria were recruited after informed consent. Patients were split randomly into two equal groups using a lottery technique. In group A, hemorrhoidectomy was carried out with ENSEAL®, whereas in group B, open hemorrhoidectomy was performed by the Milligan-Morgan method. the surgery duration and blood loss were noted. After the operation, patients were transferred to and discharged from the post-anesthesia recovery room. Patients were further followed up for pain scores after 24 hours. Data was analyzed by using Statistical Package for Social Sciences (SPSS) v25 (IBM Corp., Armonk, USA). Data was categorized for age, gender, body mass index (BMI), degree of hemorrhoids, and duration of hemorrhoids. A p-value <0.05 was considered significant. Results 140 patients were included in this study. Group A patients underwent ENSEAL® hemorrhoidectomy, and group B was formed from those who underwent the Milligan-Morgan procedure. In group A, there were 41 (58.5%) males and 29 (41.4%) females, while in group B, there were 43 (61.4%) males and 27 (38.5%) females. The mean age of group A patients was 49.97 ± 7.36 years and 43.2 ± 8.01 years in group B. In group A, the mean operative time was 20.87 ± 3.05 min, while 27.10 ± 3.42 min in group B, which is statistically significant with a p-value of <0.001. In group A, mean blood loss was 9.79 ± 2.87 ml, while 13.36 ± 3.73 ml in group B, which is statistically significant with a p-value of <0.001. In group A, the mean pain score was 2.7 ± 1.08, while 3.34 ± 1.16 in group B, which is statistically significant with a p-value of <0.001. Conclusion When considering the length of the procedure and blood loss, ENSEAL® hemorrhoidectomy has been determined to be an effective treatment that the patients tolerated well. Therefore, ENSEAL® hemorrhoidectomy can be a safe and efficient alternative to conventional treatment for hemorrhoids that are causing symptoms.

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Three electrosurgical tissue-sealing devices (EnSeal ETSDRC-01, LigaSure LS1500 and Thunderbeat TB-0535PC) were compared regarding sealing time (ST), maximum working temperature (WTmax) and the total (MTZtotal) as well as the collateral microscopic thermal injury zone (MTZcollat) using laparoscopic handpieces 5 mm in diameter on four types of tissue (liver, mesentery, cross striated muscle and spleen) in an in vivo porcine model. LigaSure had the lowest mean ST in spleen, mesentery, muscle and liver, followed by Thunderbeat and EnSeal with significant differences between all types of tissues and devices. The significantly lowest mean WTmax was obtained for EnSeal in mesentery, muscle and liver. LigaSure and EnSeal operated at the lowest temperature in spleen without a significant difference between them. Thunderbeat produced significantly higher temperature peaks in all cases. The lowest mean MTZtotal was caused by LigaSure and EnSeal in spleen, mesentery and muscle without significant differences between them, followed by the significantly higher values of Thunderbeat. Nevertheless, Thunderbeat produced the significantly lowest mean MTZtotal in the liver. EnSeal produced the lowest mean MTZcollat in the liver, followed by LigaSure and Thunderbeat showing significant differences. EnSeal and LigaSure produced the lowest mean MTZcollat in the spleen, mesentery and muscle without significant differences between them, followed by the significantly higher values of Thunderbeat. Based on the results of this study, Thunderbeat seems to be more invasive to tissue integrity (even without the activation of the ultrasonic scissor function) than EnSeal or LigaSure, that operate at lower temperatures and were found to cause negligible collateral thermal damage.

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OBJECTIVES: The objective of this study is to analyze and report the institution's experience using the Enseal bipolar tissue sealing device to perform endoscopic Zenker's diverticulotomy. Safety and early functional outcomes are presented as primary endpoints of the study. MATERIALS & METHODS: This is a retrospective study of consecutive patients with Zenker's diverticulum (ZD) treated via a transoral approach using a rigid endoscope and a bipolar tissue sealer between 2011 and 2019. Demographic data, ZD size, complications and preoperative versus postoperative symptoms were assessed. The Eating Assessment Tool-10 (EAT-10) questionnaire was used to evaluate functional outcomes, and statistical comparisons were made using the student's t-test. RESULTS: Nineteen ZD patients were identified who underwent rigid endoscopic diverticulotomy using a bipolar tissue sealer. The mean age was 71 years and 74% were male. The mean diverticulum size was 3.1 cm. There were no intraoperative or postoperative complications identified. Average pre-operative EAT-10 score was 21 and post-operative EAT-10 score was 12 at one to two weeks after surgery (p = .05). CONCLUSIONS: Evidence from this preliminary study of endoscopic Zenker's diverticulotomy using the Enseal device indicates that it is both safe and effective. Several features of the device, including its narrow profile, articulation and rotation capability, rapid repeatable activation, and low risk of collateral thermal injury, make it an appealing option for endoscopic Zenker's diverticulotomy.

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INTRODUCTION: We evaluated and compared five currently available energy-based vessel sealing devices to assess typical surgical metrics. METHODS: We tested Caiman 5 (C5), Harmonic Scalpel Ace Plus (HA), Harmonic Ace +7 (HA7), LigaSure (LS), and Enseal G2 (ES) on small (2-5 mm), medium (5.1-7 mm), and large (7.1-9 mm) vessels obtained from 15 Yorkshire pigs. Vessels were randomly sealed and transected. We recorded sealing and transection time, charring and carbonization, thermal spread, and bursting pressure (BP). Specimens were sent for histopathologic evaluation of seal quality and thermal spread. RESULTS: A total of 246 vessels were evaluated: 125 were arteries and 121 were veins. There was no difference in BPs for small size arteries. For medium arteries, C5 provided the highest BP (proximal and distal jaw), followed by HA7, ES, LS, and HA [1740, 1600, 1165, 1165, 981, and 571 mm Hg, respectively, HA250 mm Hg.

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BACKGROUND: The sealing and transection of mesenteric vessels is a crucial step in minimally invasive colorectal surgery. We examined the sealing quality of the ENSEAL® G2 Articulating Tissue Sealer in three different articulations in mesenteric vessels. METHODS: This was a prospective experimental study within a tertiary healthcare center, and 30 patients were recruited. Burst pressures for each specimen were measured as the primary outcome. Ten specimens at each of the three articulations were also histologically assessed for the quality of seal. RESULTS: We evaluated 54 sets of specimens from 30 patients for bursting pressure, all of which were harvested and sealed in the operating room. No statistical difference was seen in burst pressures from seals recorded at no angulation, half-maximal angulation, or maximal angulation (1604, 1507, 1478 mmHg; p = 0.07). Histological analysis showed no statistical differences in the average vessel diameter (p = 0.57), lateral extent of thermal injury (p = 0.48), degree of vascular sclerosis, or the integrity of seal at the three articulations. No cases of intraoperative or postoperative bleeding were observed in any of the patients. Five (16.7%) of the ENSEAL® devices developed breaks in the black, heat-shrink, polyethylene covering as a result of repeated articulation and disarticulation. Electrical arcing did not appear to have occurred as a result of the break, although this was not formally examined. CONCLUSIONS: The maximum sustainable pressure in mesenteric vessels sealed with a bipolar electrothermal device is supraphysiological, and consequently, the device can be safely used at various articulations to seal vessels during colorectal surgery.

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Over the last decade, the use of electrosurgical devices has become commonplace across all surgical specialities. The current market is large enough to warrant a comparative review of each device. This has even more impetus given the budgetary constraints of NHS organisations. This review aims to compare the benefits and drawbacks of the most popular electrosurgical devices, whilst conducting a critical review of the literature. Structured searches using databases Medline and EMBASE were conducted. The search was restricted to English language papers only. Due to the abundance of literature, this review will focus on common general surgical procedures alone. Despite a plethora of available devices, individual preference still dictates use. Conventional diathermy may always have its place, but may see a decline in use if costs improve. Newer devices have shown comparable precision and added advantages.

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OBJECTIVES: The aim of this study was to evaluate two commonly used advanced bipolar devices (ENSEAL(®) G2 Tissue Sealers and LigaSure™ Blunt Tip) for compression uniformity, vessel sealing strength, and consistency in bench-top analyses. METHODS: Compression analysis was performed with a foam pad/sensor apparatus inserted between closed jaws of the instruments. Average pressures (psi) were recorded across the entire inside surface of the jaws, and over the distal one-third of jaws. To test vessel sealing strength, ex vivo pig carotid arteries were sealed and transected and left and right (sealed) halves of vessels were subjected to burst pressure testing. The maximum bursting pressures of each half of vessels were averaged to obtain single data points for analysis. The absence or presence of tissue sticking to device jaws was noted for each transected vessel. RESULTS: Statistically higher average compression values were found for ENSEAL(®) instruments (curved jaw and straight jaw) compared to LigaSure™, P<0.05. Moreover, the ENSEAL(®) devices retained full compression at the distal end of jaws. Significantly higher and more consistent median burst pressures were noted for ENSEAL(®) devices relative to LigaSure™ through 52 firings of each device (P<0.05). LigaSure™ showed a significant reduction in median burst pressure for the final three firings (cycles 50-52) versus the first three firings (cycles 1-3), P=0.027. Tissue sticking was noted for 1.39% and 13.3% of vessels transected with ENSEAL(®) and LigaSure™, respectively. CONCLUSION: In bench-top testing, ENSEAL(®) G2 sealers produced more uniform compression, stronger and more consistent vessel sealing, and reduced tissue sticking relative to LigaSure™.

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A hybrid technique of robot-assisted, laparoscopic hysterectomy using the ENSEAL(®) Tissue Sealing Device is described in a retrospective, consecutive, observational case series. Over a 45 month period, 590 robot-assisted total laparoscopic hysterectomies +/- oophorectomy for benign and malignant indications were performed by a single surgeon with a bedside assistant at a tertiary healthcare center. Patient demographics, indications for surgery, comorbidities, primary and secondary surgical procedures, total operative and surgical time, estimated blood loss (EBL), length of stay (LOS), complications, transfusions and subsequent readmissions were analyzed. The overall complication rate was 5.9% with 35 patients experiencing 69 complications. Mean (SD) surgery time, operating room (OR) time, EBL, and LOS for the entire cohort were 75.5 (39.42) minutes, 123.8 (41.15) minutes, 83.1 (71.29) millilitres, and 1.2 (0.93) days, respectively. Mean surgery time in the first year (2009) was 91.6 minutes, which declined significantly each year by 18.0, 19.0, and 24.3 minutes, respectively. EBL and LOS did not vary -significantly across the entire series. Using the cumulative sum method, an optimization curve for surgery time was evaluated, with three distinct optimization phases observed. In summary, the use of an advanced laparoscopic tissue-sealing device by a bedside surgical assistant provided an improved operative efficiency and reliable vessel sealing during robotic hysterectomy.

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BACKGROUND: The Enseal (Ethicon Endo-Surgery, Blue Ash, Ohio) tissue-sealing device has proven efficacy for ligation of vessels<7 mm in diameter, even with significant supraphysiologic bursting pressures. We aimed to evaluate the safety of Enseal in porcine vessels>7 mm. MATERIALS AND METHODS: The lumbar aortas of pigs that were euthanized for unrelated procedures were harvested. A 5- to 6-cm segment of aorta was sealed using the Enseal device. The opposite end was attached to a pressure-testing device to measure pressures at leak or bursting. The bivariate Pearson correlation was used to determine the relationship between diameter and bursting pressure. One-way analysis of variance was used to determine differences between the groups of vessels on the basis of their diameter. RESULTS: Ninety samples of 5-cm aorta segments were used to assess bursting pressure. The median diameter was 14 mm (range, 7-18) and bursting pressure was 85 mm Hg (range, 24-650). The Pearson test showed a negative correlation between vessel diameter and bursting pressure (P=.25). One-way analysis of variance did not show any significant difference between vessel diameters grouped by size (P=.517), and neither did the Scheffe post hoc test when comparing diameter with bursting pressure; 31% of specimens failed to seal. CONCLUSIONS: Bursting pressures are low and inconsistent after tissue sealing with the Enseal device in porcine vessels>7 mm. These vessels also demonstrated a higher rate of failure to seal. The histologic results of the aorta segments (ie, a low collagen-elastin ratio) may be the cause of the low bursting pressures.

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STUDY OBJECTIVE: There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy. The aim of the study was to compare the use of LigaSure (Valleylab, Boulder, CO), HALO PKS cutting forceps (Gyrus-ACMI, Maple Grove, MA), and ENSEAL tissue sealer (SurgRx, Inc. Redwood City, CA) in total laparoscopic hysterectomy with respect to operation time and blood loss as main outcomes. Perioperative complications, return of gastrointestinal activity, and hospitalization time were assessed as secondary outcomes. DESIGN: Randomized prospective study (Canadian Task Force classification I). SETTING: Adana Numune Training and Research Hospital. PATIENTS: Forty-five patients with the indication of hysterectomy were randomized into 3 groups for total laparoscopic hysterectomy. Patients with malignancies, having 3 or more previous abdominal surgeries, a uterus larger than 12 weeks of gestation, and who had to undergo additional surgical procedures during the same operation were excluded. INTERVENTIONS: Total laparoscopic hysterectomy. MEASUREMENTS AND MAIN RESULTS: Operations were completed in all 15 patients in the LigaSure and HALO PKS Cutting Forceps groups with the planned instruments. In 2 patients in the ENSEAL group, bleeding could not be controlled with ENSEAL, and additional instruments were used. One patient in the ENSEAL group had bladder injury. The mean operation time and blood loss were 52.4 ± 12.8, 51.86 ± 14.11, and 55.7 ± 15.7 minutes (p > .05) and 138 ± 54.3, 118 ± 63.3, and 218 ± 115.9 mL (p < .05) in the LigaSure, HALO PKS, and ENSEAL groups, respectively. Changes in hemoglobin/hematocrit levels, return of gastrointestinal activity, and hospitalization time did not differ between groups. CONCLUSION: These 3 novel bipolar platforms had similar results in total laparoscopic hysterectomy. These instruments were not determined to be independent predictors of operating time and amount of blood loss.

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OBJECTIVE: To compare the EnSeal device with standard bipolar coagulation forceps in laparoscopic supracervical hysterectomy (LASH). DESIGN: Prospective, randomized, controlled trial (Canadian Task Force classification I). SETTING: University hospital. PATIENTS: One hundred sixty patients who underwent LASH. INTERVENTION: Eighty patients underwent LASH using the EnSeal device (experimental group), and 80 patients underwent LASH using standard bipolar coagulation forceps (control group) (www.clinicaltrials.gov; study identifier NCT01806012). MEASUREMENTS AND MAIN RESULTS: Mean (SD) total operative time was 78.18 (33.96) minutes in the experimental group and 86.30 (35.34) minutes in the control group (p = .03). Documented blood loss was <50 mL in 72 patients in the experimental group and 62 patients in the control group (p = .03), and was 50 to 100 mL in 8 patients in the experimental group and 18 patients in the control group (p < .001). Postoperative hospital stay was significantly shorter for patients in the experimental group compared with the control group: 2.01 (0.44) days vs 2.17 (0.47) days, respectively (p = .03). There was no difference in postoperative pain scores and complications between the two treatment groups. CONCLUSION: Total resection time was shorter in the experimental group, and the other investigated clinical parameters were not inferior in the experimental group compared with the control group. The results of the present study indicate that use of the EnSeal device is at least as reliable as the conventional electrocoagulation technique in LASH.

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PURPOSE: Use of bipolar electocoagulation devices becomes popular in the laparoscopic surgical field. However, several studies comparing energy-based devices for use in performance of mechanical sealing and cutting techniques have reported various results. The aim of this study was to evaluate feasibility and efficacy of new commercially available bipolar electocoagulation devices: EnSeal(TM) device (Ethicon Endo-Surgery, Cincinnati, OH, USA) by comparison with LigaSure(TM) atlas 5 mm (COVIDIEN, Boulder, CO, USA), for use in performance of coagulation and cutting techniques during performance of laparoscopic colorectal cancer surgery. METHODS: Between June 2010 and February 2011, 50 consecutive patients who underwent curative laparoscopic surgery for right colon cancer or rectal cancer were enrolled. Time and number of device activations were compared during omentectomy in cases of right colectomy and mesorectal trimming procedure in cases of anterior resection. Pathologic data and short-term clinical outcomes were also compared. RESULTS: No significant differences in terms of clinicopathologic comparison were observed between the EnSeal and LigaSure groups. No significant difference in mean operative time (207.6+/-45.3 vs. 198.9+/-57.2; p=0.558), mean time of omentectomy (11.0+/-4.5 vs. 12.6+/-8.6; p=0.293), mean time of m esorectal trimming (18.6+/-10.0 vs. 16.1+/-6.9; p=0.418), mean number of device activations during omentectomy (43.5+/-10.2 vs. 51.6+/-39.2; p=0.586), and mean number of device activations during performance of mesorectal trimming (44.8+/-22.3 vs. 49.1+/-23.7; p=0.597) were observed between the two groups. CONCLUSION: Bipolar electocoagulation devices were adapted for use in laparoscopic surgery, resulting in reduced operative time and blood loss. EnSeal(TM) Device and LigaSure(TM) atlas 5 mm were useful during performance of sealing and cutting techniques in laparoscopic colorectal cancer surgery.

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