Evaluation of Safety and Feasibility of Using LigaSure During Clipless Single-Incision Laparoscopic Cholecystectomy: A Prospective Clinical Study.

Background: Single-incision laparoscopic cholecystectomy (SILC) is a minimally invasive procedure designed to minimize the number and size of the incisions needed for cholecystectomy. Titanium clips are traditionally used to close the cystic duct and artery. Although it is considered safe, dislodgement can result in bleeding and biliary leakage. Using LigaSure for duct sealing is still controversial. The aim of this study was to evaluate the safety and feasibility of using LigaSure to close the cystic duct during SILC. Methods: A prospective study over two years was conducted at the General Surgery Department, Mansoura University Hospital, on 102 patients, 51 in each group. They underwent SILC using LigaSure (Group 1) or titanium clips (Group 2) to control the cystic duct and artery. Results: The data analyzed included demographic data, operative time, intra- and postoperative complications, postoperative pain, and hospital stay. The operative time was significantly shorter in LigaSure group (68.5 ± 9.8 versus 72.9 ± 10.6 minutes in the clips group, P .03). There was no significant difference between the two groups regarding postoperative bile leak or bleeding. However, two cases in Group 1 and four cases in Group 2 were converted to multiple port laparoscopic cholecystectomy; this was statistically nonsignificant. Postoperative pain and hospital stay showed no significant difference between the two groups. Two patients in each group developed port-site incisional hernia. Conclusions: Clipless SILC using LigaSure is a feasible and safe procedure with acceptable morbidity with shorter operative time than SILC using clips. Nevertheless, the risk of port-site incisional hernia should be explained to the patients.

Histomorphological evaluation of thermal injury following palatoplasty performed with CO2 laser or LigaSure device in dogs with brachycephalic obstructive airway syndrome.

The elongated soft palate is an abnormality that characterizes most brachycephalic dogs and contributes to the brachycephalic obstructive airway syndrome (BOAS). Palatoplasty is routinely performed in brachycephalic dogs; several surgical techniques exist. The use of surgical instruments such as monopolar electrocoagulation, CO2 or diode laser, bipolar vessel sealing device and harmonic shears has become routine to reduce the operating time, the intraoperative risk of bleeding and the postoperative oedema. This prospective study aimed to compare the histomorphological effect of a CO2 laser and LigaSure device in palates of dogs undergoing palatoplasty. Twenty owned brachycephalic dogs were included, 10 palatoplasties were performed using CO2 laser and 10 using LigaSure™ device. The dogs were positioned in sternal recumbency. A transoral approach was performed: the elongated soft palate was grasped with Allis forceps and brought rostrally, the palatoplasty was performed using the tonsillar crypts as anatomical landmarks. Surgical specimens were routinely fixed in 10 % formalin. Two sections perpendicular to the surgical margins were trimmed from each sample, paraffin-embedded and stained with hematoxylin and eosin (H&E). Tissue damage induced by the two types of surgical devices was graded (1-4, from minimal to severe) and the depth of thermal injury measured in µm on captured images (using an image analysis program - ImageJ). Mean values and standard deviations (SD) were calculated based on six measurements for each sample. The tissue damage was graded 3.7±0.48 in group LigaSure™ and 2.8±1 in group Laser. The mean depth of thermal injury was 874.94±184.92 µm in the LigaSure™ group and 451,76±137,86 µm in the Laser group. The comparison between the two groups showed significant lower grade and extension of thermal injury in the palate samples obtained with CO2 laser (p<0.05). Additionally, there is a lack of literature that correlates the histological changes with the clinical outcomes of the different palatoplasty methods in brachycephalic dogs. By comparing histological changes and clinical outcomes, we aim to provide valuable insights for optimizing the surgical approach for palatoplasty in brachycephalic dogs, ultimately improving postoperative outcomes for these patients.

Efficacy and Safety Evaluation of Energy Devices in Bench Surgery for Pancreas Transplantation.

INTRODUCTION: Bench surgery for the preparation of deceased donor pancreatic grafts is labor-intensive and time-consuming. We hypothesized that energy devices could be used during bench surgery to decrease the bench surgery time. However, because bench surgery has two unique characteristics, wet conditions and no blood flow in the vessels, it is necessary to verify the safety and efficacy under such conditions. METHODS: In an animal tissue model, we validated both ultrasonic and bipolar energy devices: Harmonic Shears and the LigaSure (LS) vessel-sealing device by evaluating heat spread and pressure resistance under bench surgery conditions. In a clinical evaluation of the LS, we compared the outcomes of 22 patients in two different bench surgery groups: with and without the use of the LS. RESULTS: Clinically, the bench surgery time was significantly shorter in the LS group than that in the conventional group (P < 0.001). In the animal tissue experiments, the highest temperature in bench surgery conditions was 60.4°C after 1 s at a 5-mm distance in the LS group. Pressure resistance of ≥ 750 mmHg was achieved in almost all trials in both veins and arteries, with no difference between Harmonic Shears and LS. There was more surgical smoke visually in bench conditions versus in dry conditions and under half bite versus full bite conditions. CONCLUSIONS: The encouraging results of our exploratory clinical and animal studies of the energy devices suggest that they may be useful in the setting of bench surgery.

Total Sealing Technique (TST) with a bipolar vessel sealing system reduces lymphorrhea and seroma formation for axillary lymph node dissection in primary breast cancer.

Background: The purpose of this study is to evaluate the potential of a novel surgical procedure, the Total Sealing Technique (TST), using the latest bipolar vessel sealing system (BVSS; LigaSure™ Exact Dissector) to reduce lymphatic leakage and seroma formation after electrocautery axillary lymph node dissection (ALND) in breast cancer surgery. Prolonged drainage is a common occurrence after ALND, primarily due to lymphatic leakage. In addition, the presence of seroma often leads to delays in the administration of postoperative adjuvant chemotherapy even after drain removal. Methods: We conducted a comparative analysis of 36 patients who underwent total mastectomy with ALND using conventional electrocautery technique (CONV) during the first 3 years, and 35 patients who underwent the same procedure using TST during the subsequent 3 years. The following factors were compared to assess the impact of TST: operation time, blood loss, total drainage volume, mean time to drain removal, postoperative hospital stay, mean time to initiation of postoperative chemotherapy, and postoperative complications in each group. Results: TST significantly reduced drainage volume (360.5 vs. 820.6 mL, p < 0.001), days to drain removal (4.8 vs. 6.8 days, p < 0.001), postoperative hospital stay (5.9 vs. 9.6 days, p < 0.001), the incidence of seroma (28.6 % vs. 65.9 %, p = 0.001), and time to chemotherapy initiation (33.1 vs. 61.4 days, p < 0.001) compared to CONV. Conclusions: TST in total mastectomy with ALND effectively decreases the incidence of lymphorrhea and seroma formation; thus, it can be recommended for total mastectomy with ALND.

Use of a vessel-sealing device compared with Jaboulay's technique for adult hydrocelectomy surgery: a retrospective cohort study.

Hydrocele is a common benign scrotal condition affecting adult men. The gold standard of treatment includes hydrocelectomy, with the use of Winkelman's/Jaboulay's technique or Lord's procedure. The vessel-sealing device (VSD) is a blood vessel-sealing system, known to enhance patient's postoperative outcomes in multiple different surgeries. The aim of this study was to compare the procedural and postoperative outcomes of a novel hydrocelectomy method using a VSD to the conventional hydrocelectomy using the Jaboulay's technique. We performed A retrospective review for all adult cases who underwent surgical hydrocelectomy at Hillel Yaffe Medical Center between 2011 and 2022. Study cases were grouped into one of two groups, patients undergoing conventional hydrocelectomy, or patients undergoing hydrocelectomy with the use of a VSD. Patients operated using other techniques were excluded. Data collected included demographic data and operative and postoperative parameters. Among 102 patients, 47 underwent Jaboulay's technique and 55 underwent hydrocelectomy using a VSD. We observed significantly shorter duration of hospitalization (1.18 vs 1.53, P = 0.038) and shorter surgery time (31.87 vs 37.4, P = 0.003) when using the VSD during a hydrocelectomy compared to conventional surgical hydrocelectomy. Both techniques indicated low complication rates and no recurrent hydrocele was observed in either group. We report our experience with a novel surgical technique that includes hydrocelectomy with the use of VSD. Our findings demonstrated shorter surgery time and length of hospitalizations, which may indicate improved patient's postoperative outcomes with the use of the VSD for hydrocelectomy.

Efficacy of LigaSure Versus Harmonic Devices in Laparoscopic Sleeve Gastrectomy: A Systematic Review and Meta-Analysis.

Our goal is to conduct a thorough systematic review and meta-analysis of comparative studies to evaluate the efficacy of LigaSure (Valleylab, Boulder, CO) compared with Harmonic (Ethicon Endo-Surgery, Inc., Cincinnati, OH) devices in patients undergoing laparoscopic sleeve gastrectomy (LSG). Our search strategy, from inception until March 1, 2024, involved multiple databases, including the Cochrane Controlled Register of Trials (CENTRAL), Web of Science (WOS), PubMed, Scopus, and Google Scholar. We evaluated randomized clinical trials using the Cochrane Risk of Bias tool for randomized trials (RoB-2) tool and non-randomized studies using the Risk of Bias In Non-randomized Studies for Interventions (ROBINS-I) tool. The primary outcomes assessed were operative time, mean length of hospital stay, and the rates of intraoperative complications such as bleeding, organ injury, leakage, and hematoma formation. Additionally, we collected data on postoperative complications, including bleeding, abscess formation, leakage, fever (>38°C), and reoperation rates. Data were analyzed using random-effects models and reported as mean difference (MD) or risk ratio (RR) with a 95% confidence interval (CI) using Review Manager software (RevMan, version 5.4 for Windows, The Cochrane Collaboration, 2020). Four studies, comprising two randomized clinical trials (RCTs) and two retrospective cohort studies, involving a total of 692 patients, were included in the analysis. Both the operative time and length of hospital stay did not significantly differ between the LigaSure and Harmonic groups (p>0.05). The pooled analysis also revealed no significant difference between the LigaSure and Harmonic groups in terms of intraoperative and postoperative complications (p>0.05). In conclusion, our systematic review and meta-analysis found no significant statistical or clinical differences between LigaSure and Harmonic devices in terms of operative outcomes and complication rates in patients undergoing LSG.

Comparing adverse events associated with LigaSure and Harmonic devices in head and neck surgery.

OBJECTIVE: To characterize adverse events, provide a safety profile, and understand patient outcomes after complications arising from LigaSure and Harmonic use in the head and neck region. METHODS: Retrospective analysis of adverse events from the Manufacturer and User Facility Device Experience (MAUDE) between January 2013 and 2023. RESULTS: A total of 158 LigaSure and 159 Harmonic events were extracted. There were significantly more reports of Harmonic device overheating (6.9% vs. 0.6%, p = 0.003) and spontaneous self-activation (4.4% vs. 0%, p = 0.032). Although intra-operative and post-operative complications were similar among both groups, there were significantly more intra-operative bleeding events for LigaSure as compared to Harmonic (8.2% vs. 0.0%, p = 0.001). CONCLUSION: Understanding technical complications and adverse events attributable to LigaSure and Harmonic devices enables the development of clinically relevant risk mitigation strategies. Surgeons should avoid improper use by remaining vigilant of device functionality and temperature changes.

Comparison of Pedicle Coagulation Hemorrhoidectomy With LigaSure Versus Conventional Milligan Morgan Hemorrhoidectomy in Reducing Post-operative Pain: A Randomized Controlled Trial.

Background Hemorrhoids refer to the abnormal enlargement of the anal cushions. They are a common anorectal problem with a prevalence of 5% in the general population aged greater than 40 years. The objective of this study was to compare Milligan-Morgan open hemorrhoidectomy with pedicle ligation with LigaSure (Medtronic, Dublin, Ireland) in terms of postoperative pain on day 1 and day 7. It is important to assess the technique that is associated with lower postoperative pain because both of these techniques are still practiced in the developing world. Methods It was a randomized controlled trial conducted in the Department of Surgery, Rawalpindi, Pakistan. A total of 100 patients were selected and were allotted into the two groups by lottery method. Patients aged from 15 to 60 years who presented with symptomatic third and fourth-degree hemorrhoids were included after taking informed consent. Patients who had a previous or concomitant anorectal disease, patients who had undergone previous surgery for hemorrhoids, and those who were anesthetically unfit for surgery (American Society of Anesthesiologists (ASA) class 3 or above) were excluded from the study. Pain was assessed using the Visual Analogue scale (VAS). Data was entered and analyzed using SPSS v. 23.0 (IBM Corp., Armonk, USA). Chi-square tests were applied. P-value <0.05 was taken as statistically significant. Results Out of 100 patients, 68 (68%) were males while 32 (32%) were females. The mean age was 40.56±9.24 years. Postoperative pain at day 1 was 9.24±0.51 in the Milligan-Morgan group while that in the LigaSure group was 8.44±0.64 (p<0.0001). Postoperative pain at day 7 was 5.00±0.85 in the Milligan-Morgan group while it was 3.04±1.08 in the LigaSure group (p<0.0001). Conclusion LigaSure is a newer technique that helps to reduce complications as compared to other traditional hemorrhoidectomy procedures. Many patients avoid hemorrhoidectomy as it is associated with painful postoperative recovery. Pedicle coagulation with LigaSure was better than conventional Milligan-Morgan hemorrhoidectomy in terms of reducing the mean postoperative pain on 1st day and 7th day. Reducing the postoperative pain helps in greater patient satisfaction and lesser requirement of analgesia among patients of 3rd and 4th-degree hemorrhoids undergoing hemorrhoidectomy.

A retrospective comparative study of hemorrhoidal artery ligation versus ligasure hemorrhoidectomy for the third degree hemorrhoidal disease.

BACKGROUND: Hemorrhoidal disease (HD) is the most common disease of the anorectal region. Excision of pathological hemorrhoidal structures by providing bipolar energy transfer with Ligasure, which is basically an electrosurgical device, is one of the treatment methods Ligasure hemorrhoidectomy (LH). In another method applied for the first time by Morinaga, the vascular plexus is provided by Doppler-guided ligation of the hemorrhoidal arteries (ADHL). In our study, we aimed to compare and evaluate the results of these two minimally invasive treatment methods. MATERIALS AND METHODS: Patients treated with ADHL and LH for HD in our Surgery Clinic were included in the study. Demographic data, complaints, number of hemorrhoidal structures, location, complications, operation time, bleeding during and after the operation, length of hospital stay, postoperative pain scoring, and postoperative results were evaluated from the patient files. RESULTS: The number of patients included in the study was 91. While 54 patients were treated with ADHL (group 1), 37 patients (group 2) were treated with LH. Although the gender distribution between the groups was similar, there was male predominance in both groups. The mean operative time was shorter in group 1. The number of packages was 2.7 in group 1 and 2.4 in group 2. The mean hospital stay was 1.5 days in the ADHL-treated group, compared to. 3.05 days in the LH group. In the postoperative period, bleeding was not observed after an average of 1.4 days in group 1, while this period was 4.9 days in group 2. While recurrence occurred in 4 patients in the ADHL group, recurrence developed in 3 patients who underwent LH. CONCLUSION: ADHL and LH techniques have advantages and disadvantages over each other. Although the ADHL technique seems to be superior to LH in terms of post-defecation pain and shorter hospital stay, prospective randomized controlled studies are needed to determine which method should be chosen in which patient.

Which combination cause less inflammatory response during laparoscopic hysterectomy? Ligasure plus monopolar cautery or harmonic plus bipolar cautery?

Objective: We aimed to compare the inflammatory response with alterations in hemogram parameters, in patients who underwent laparoscopic hysterectomy and bilateral salpingo-oophorectomy for benign gynecologic conditions with ligasure plus monopolar cautery or harmonic plus conventional bipolar cautery. Methods: Patients who underwent Laparoscopic hysterectomy with bilateral salpingo-oophorectomy between January 2017 and January 2022 for benign gynecologic pathology were identified. Patients were divided into two group, according to instruments used during surgery. Instruments were used according to surgeons preference. Preoperative and postoperative in the first 24 hours hematocrit (HCT), WBC, trombocyt, neutrophil- lymphocyte (NLR), platelet-lymphocyte (PLR) ratio, mean platelet volume- lymphocyte ratio (MPVLR) and red cell distribution width- platelet ratio (RPR) values were compared. Results: During study period, a total of 462 patients underwent hysterectomy for benign gynecologic pathology. After exclusion, 212 patients were included in the study. In the study group, 147 patients were operated with ligasure plus monopolar electrocauter and 65 with harmonic scalpel plus bipolar electrocautery. In the postoperative period, regardless of the procedure, WBC and RPR count increase, hematocrit and trombocyt decrease in both group but the inflammatory markers lymphocyte count, neutrophyl, NLR, PLR and MPVLR count changed less in the harmonic plus bipolar cautery group which shows less inflamatuar response in this group. Conclusions: Ligasure plus monopolar cautery group compared with harmonic plus bipolar cautery group cause more inflammatory changes in complete blood count values. However, further studies are needed to show whether these changes in laboratory findings affect clinical situations.

Laser Hemorrhoidoplasty Versus Ligasure Hemorrhoidectomy: A Comparative Analysis.

Background and objective Minimally invasive techniques in the surgical treatment of hemorrhoids have been gaining in popularity. Laser hemorrhoidoplasty (LHP) and LigaSure™ (LigH; Medtronic, Dublin, Ireland) hemorrhoidectomy methods are the most recent innovative methods that are increasingly used. In this study, we aimed to compare the effectiveness of these two innovative techniques. Methods The data of patients who underwent LHP or LigH for grade III hemorrhoidal disease at our clinic between January 2022 and June 2023 were retrospectively analyzed. Postoperative pain levels, time to return to work or daily activities, complication rates, and recurrence rates of the treated patients were recorded. Results A total of 100 patients were included in the study. Of these, 48 patients had LHP surgery and 52 had LigH surgery. The demographic characteristics of both groups were similar. The mean operation time was statistically significantly shorter in the LHP group (p<0.001). The visual analog scale (VAS) scores on postoperative days one and seven were lower in favor of the LHP (2.4 ± 0.7 and 1.2 ± 0.9 vs. 6.2 ± 1.5 and 3.8 ± 1.3, respectively; p< 0.001). The median time to return to daily activity was 2.3 (range: one to three) days in the LHP group and 4.6 (range: 3-11) days in the LigH group (p<0.001). Recurrence was observed in 11 (22%) patients in the LHP group and in three (6%) patients in the LigH group (p<0.001). Conclusion Based on our findings, LHP is an effective procedure for the surgical treatment of hemorrhoidal disease as it is associated with less morbidity, less pain, early return to work, and acceptable recurrence rates.

Comparison of postoperative bleeding using harmonic scalpel and LigaSure in thyroid surgery: a 15-year single-centre retrospective study.

Aim Thyroidectomy is the most common operation in the field of endocrine surgery. The aim of this study was to compare the use of LigaSure vessel (LS) and harmonic scalpel (HS) in 1653 total thyroidectomies between January 2008 and March of 2023, with regards to analysis of surgical bleeding complications duration the hospital stay and operative surgical time. Methods It is a retrospective analysis of a prospectively maintained database. Patients have been categorized into two groups: Group A included 718 patients from January 2008 to May 2013 when LS was used, and the Group B included 935 patients from June 2013 to March 2023 when HS was used. Results From the total of 14 postoperative bleeding cases that occurred in patients of Group A, only in 4 of them it was necessary to have a reoperation. The other 10 cases involved minor haemorrhages, while from the total of 6 postoperative bleeding cases that happened to patients of Group B, there were 4 cases that needed a reoperation (p-value >0.05) and 2 patients with minor haemorrhages. The postoperative evaluation of minor bleedings revealed statistically significant differences between the two groups (p-value < 0.05). The average hospital stay was similar in the two groups. Conclusion Both devices exhibit identical safety profiles in thyroidectomies specifically regarding major bleeding complications that require reoperation. Additionally, HS was found to be more effective at achieving haemostasis, especially in the subgroup of patients with thyroid carcinoma. The results of the present study may be useful for high-volume centres performing numerous thyroidectomies every day.

Postoperative Bleeding Two Weeks After Longitudinal Vaginal Septum Resection with the LigaSure Device: A Case Report.

BACKGROUND: A longitudinal vaginal septum (LVS) is a rare congenital anomaly often identified during adolescence. Surgical removal is a mainstay in treatment of symptomatic cases; however, there is variation in the techniques used. Little is known about the risk for postoperative complications associated with novel methods. CASES: We present the cases of 2 adolescent females, ages 15 and 22, diagnosed with an LVS who elected to undergo surgical removal. A LigaSure device was used for resection, and both individuals experienced significant postoperative bleeding almost 2 weeks following resection. SUMMARY AND CONCLUSIONS: This report outlines two occurrences of postoperative bleeding after LVS resection, which may suggest inadequate surgical site hemostasis with use of the LigaSure apparatus. Further research on outcomes related to this technique is needed.

Identification of Factors Related to the Quality of Lymphadenectomy for Lung Cancer: Secondary Analysis of Prospective Randomized Trial Data.

The outcomes of non-small cell lung cancer surgery are influenced by the quality of lymphadenectomy. This study aimed to evaluate the impact of different energy devices on lymphadenectomy quality and identify additional influencing factors. This secondary analysis of the prospective randomized trial data (clinicaltrials.gov: NCT03125798) compared patients who underwent thoracoscopic lobectomy with the LigaSure device (study group, n = 96) and monopolar device (control group, n = 94). The primary endpoint was the lobe-specific mediastinal lymphadenectomy. Lobe-specific mediastinal lymphadenectomy criteria were met in 60.4% and 38.3% of patients in the study and control groups, respectively (p = 0.002). In addition, in the study group, the median number of mediastinal lymph node stations removed was higher (4 vs. 3, p = 0.017), and complete resection was more often achieved (91.7% vs. 80.9%, p = 0.030). Logistic regression analysis indicated that lymphadenectomy quality was positively associated with the use of the LigaSure device (OR, 2.729; 95% CI, 1.446 to 5.152; p = 0.002) and female sex (OR, 2.012; 95% CI, 1.058 to 3.829; p = 0.033), but negatively associated with a higher Charlson Comorbidity Index (OR, 0.781; 95% CI, 0.620 to 0.986; p = 0.037), left lower lobectomy (OR, 0.263; 95% CI, 0.096 to 0.726; p = 0.010) and middle lobectomy (OR, 0.136; 95% CI, 0.031 to 0.606, p = 0.009). This study found that using the LigaSure device can improve the quality of lymphadenectomy in lung cancer patients and also identified other factors that affect the quality of lymphadenectomy. These findings contribute to improving lung cancer surgical treatment outcomes and provide valuable insights for clinical practice.

Evaluation of the Appropriate LigaSure™ Device to Transect the Appendix-A Comparison between 5 mm and 10 mm Laparoscopic Devices in an Ex Vivo Trial.

Background and Objectives: A topic of greatinterest in the surgical field comprises cost and time reduction operative techniques with high efficiency rates. Thus, the aim of this paper is to evaluate whether a transection of the appendix using only a laparoscopic LigaSure™ device is feasible and, if so, which size of the laparoscopic device is optimal. Materials and Methods: Appendectomy specimens were sealed and cut using LigaSureTM V (5 mm) and LigaSure AtlasTM (10 mm) devices ex vivo. Analysis criteria included handling, resistance to bursting pressure of the appendicular stump (adequacy), eligibility, durability and airtightness. Results: Twenty sealed areas were measured. While the 5 mm instrument was not able to transect the appendix in one attempt in any of the cases, the 10 mm device could be applied successfully without any handling difficulties. The adequacy of the sealed area was rated as complete and dry in all 10 cases using the 10 mm device and as oozing in 8 of the cases using the 5 mm device. There was no leakage in terms of air and liquid tightness using the 10 mm device, in contrast to six sealed segments with air and liquid leakage when using the 5 mm device. The resistance to bursting pressure was on average 285 mmHg and 60.5 mmHg with the 10 mm and 5 mm devices, respectively. The durability and eligibility of the 10 mm device were rated as very sufficient in 9 of 10 cases (1 perforation) in contrast to the 5 mm device, where the sealing in 9 of 10 cases was not sufficient (9 perforations). Conclusions: Using the 10 mm laparoscopic LigaSure™ device for the transection of the appendix seems to be feasible, safe and resistant to 300 mmHg bursting pressure. The 5 mm LigaSure™ instrument is inadequate to seal the appendix in humans.

Complications associated with energy-based devices during thyroidectomy from 2010-2020.

Objective: Harmonic Focus (Ethicon, Johnson and Johnson, Cincinnati, OH, USA), LigaSure Small Jaw (Medtronic, Covidien Products, Minneapolis, MN, USA), and Thunderbeat Open Fine Jaw (Olympus, Japan) are electrosurgical instruments used widely in head and neck surgery. The study aims to compare device malfunctions, adverse events to patients, operative injuries, and interventions related to Harmonic, LigaSure, and Thunderbeat use during thyroidectomy. Methods: The US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database was queried for adverse events associated with Harmonic, LigaSure, and Thunderbeat from January 2005 to August 2020. Data were extracted from reports pertaining to thyroidectomy. Results: Of the 620 adverse events extracted, 394 (63.5%) involved Harmonic, 134 (21.6%) LigaSure, and 92 (14.8%) Thunderbeat. The reported device malfunctions most frequently associated with Harmonic was damage to the blade (110 (27.9%)), LigaSure was inappropriate function (47 (43.1%)), Thunderbeat was damage to the tissue or Teflon pad (27 (30.7%)), respectively. Burn injury and incomplete hemostasis were the most commonly reported adverse events. The operative injury reported most frequently when using Harmonic and LigaSure was burn injury. No operator injuries were reported with Thunderbeat use. Conclusion: The most frequently reported device malfunctions were damage to the blade, inappropriate function, and damage to the tissue or Teflon pad. The most frequently reported adverse events to patients was a burn injury and incomplete hemostasis. Interventions aimed at improving physician education may help reduce adverse events attributed to improper use.

Clinical Benefits of LigaSure™ for Surgical Amputation Without Tourniquet Use in Patients With Musculoskeletal Tumor.

BACKGROUND/AIM: Amputation is still a viable option for musculoskeletal tumors that are multi-compartmental, adjacent to neurovascular structures, and involving pathological fractures. Complications such as poor surgical margins, local recurrence and infection after limb salvage surgery are also indications for secondary amputation. An effective hemostatic technique is vital for preventing complications of massive blood loss and prolonged operative time. The use of LigaSure™ in the field of musculoskeletal oncology has not been well documented. PATIENTS AND METHODS: This retrospective study included 27 patients with musculoskeletal tumor who underwent amputation using either LigaSure™ system (n=12) or traditional hemostatic technique (n=15) from 1999 to 2020. The purpose of this study was to evaluate the effect of LigaSure™ in terms of intra-operative blood loss, blood transfusion rates, and duration of surgery. RESULTS: The use of LigaSure™ resulted in a significant decrease in intraoperative blood loss (p=0.027) and blood transfusion rates (p=0.020). There was no significant difference for the duration of surgery between the two groups (p=0.634). CONCLUSION: The LigaSure™ system can potentially improve clinical outcomes in patients with musculoskeletal tumor undergoing amputation surgeries. The LigaSure™ system is a safe and effective hemostatic tool for musculoskeletal tumor amputation surgeries.

Electrothermal Vessel Sealing Versus Conventional Suturing in Abdominal Hysterectomy: A Randomised Trial.

INTRODUCTION: The present randomised controlled trial was conducted to compare haemostatic efficiency, operative time, and overall performance of the electrothermal bipolar vessel sealing (EBVS) system with conventional suturing in abdominal hysterectomy. MATERIALS AND METHODS: The trial was designed with standard parallel arms, i.e., vessel sealing and suture ligature arms. Sixty patients were block randomised into either arms with 30 patients in each. A hand-held vessel sealing instrument was used to perform a hysterectomy in the vessel sealing arm and the quality of the uterine artery seal achieved at the first attempt was graded on an ordinal scale of 1-3 to quantify haemostatic efficiency. Operative time, intra-operative blood loss, and peri-operative complications were compared between the two arms. RESULTS: Significantly reduced mean operative time (26.97±8.92 vs 33.67±8.62 minutes; p=0.005) and intra-operative blood loss (111±53.31 mL vs 320±193.90 mL; p=0.001) was observed in the Vessel Sealing Arm compared to Suture Ligature Arm. Of total 60 uterine seals (from bilateral uterine artery transaction in 30 hysterectomies in the Vessel Sealing Arm), 83.34% were Level 1 with Complete Seal and no residual bleeding, 8.33% were Level 2 or Partial Seals with minimal bleeding, requiring the use of vessel sealers for a second time, while 8.33% had Seal Failure (Level 3) with significant bleeding requiring additional re-security of stumps with sutures. Modal pain scores on the first three postoperative days and duration of hospital stay were significantly less in the Vessel Sealer Arm, reflecting reduced postoperative morbidity. Outcomes were comparable across operators. CONCLUSION: Vessel Sealing System gives superior surgical results with lesser operative time, minimal blood loss, and reduced morbidity.

Comparison of the LigaSure™ bipolar vessel sealer to monopolar electrocoagulation for thoracoscopic lobectomy and lymphadenectomy: a prospective randomized controlled trial.

BACKGROUND: High-energy devices allow better vessel sealing compared with monopolar electrocautery and could improve the outcomes of surgical operations. The objective of the study was to compare tissue dissection by the LigaSure™ device with that by monopolar electrocoagulation for thoracoscopic lobectomy and lymphadenectomy. METHODS: This pragmatic, parallel group, prospective randomized controlled trial was funded by the Medtronic External Research Program (ISR-2016-10,756) and registered at www. CLINICALTRIALS: gov (NCT03125798). The study included patients aged 18 years or older, who had undergone thoracoscopic lobectomy with lymphadenectomy at the Department of Thoracic Surgery of Poznan University of Medical Sciences between May 3, 2018, and November 4, 2021. Using simple randomization, the patients were assigned to undergo tissue dissection with either the LigaSure device (study group) or monopolar electrocautery (control group). Participants and care givers, except operating surgeons, were blinded to group assignment. The primary outcome was postoperative chest drainage volume. Secondary outcomes were change of the esophageal temperature during subcarinal lymphadenectomy and C-reactive protein level 72 h after surgery. RESULTS: Study outcomes were analyzed in 107 patients in each group. We found no differences between the study and control groups in terms of chest drainage volume (550 vs. 600 mL, respectively; p = 0.315), changes in esophageal temperature (- 0.1 °C vs. - 0.1 °C, respectively; p = 0.784), and C-reactive protein levels (72.8 vs. 70.8 mg/L, respectively; p = 0.503). The mean numbers of lymph nodes removed were 12.9 (SD: 3.1; 95% CI, 12.4 to 13.5) in the study group and 11.6 (SD: 3.2; 95% CI, 11.0 to 12.2) in the control group (p < 0.001). CONCLUSIONS: The use of the LigaSure device did not allow to decrease the chest drainage volume, local thermal spread, and systemic inflammatory response. The number of lymph nodes removed was higher in patients operated with the LigaSure device, which indicated better quality of lymphadenectomy.