Clinical evaluation of CoolSeal - a new, safe, and fast vessel sealing device in total thyroidectomy.

Objective. CoolSeal is a new vessel sealing system for dissection and hemostasis during surgery. No clinical studies have investigated safety, advantages or disadvantages regarding the use of this device. The aim of the present study was to investigate the safety of CoolSeal and compare it with conventional ligation technique or LigaSure during the total thyroidectomy. We hypothesized that the use of CoolSeal would reduce the operating time and bleeding without complications increase. Study design represents a retrospective cohort study with a tertiary reference center setting. Methods. We analyzed total thyroidectomy data from January 2021 to June 2023. We recorded patients' characteristics, surgical information, and postoperative outcome. Results. We performed 221 total thyroidectomies in the study period. Analysis was restricted to 171 patients operated by only two surgeons. Hemostasis was secured by conventional ligation in 117 patients (68%), LigaSure in 34 patients (20%) and CoolSeal in 20 patients (12%). Median thyroid weight and bleeding were 67 g and 50 ml, respectively. Procedures using LigaSure or Cool-Seal were on larger glands (median 205 g) without increased bleeding (50 ml). Operating time was shortest with CoolSeal (96 min, p=0.003) compared with LigaSure (117 min) or conventional ligation (115 min). Bleeding was reduced with CoolSeal compared with LigaSure (45 vs. 100 ml, p=0.003). With CoolSeal, median hospitalization was one postoperative day, no patients required re-operation. There was no palsy of recurrent laryngeal nerves and no permanent hypoparathyroidism. Conclusion. In our first clinical experience, CoolSeal was safe and efficient for total thyroidectomy. With a small sample size, we saw a clinical benefit with reduced operating time without post-operative complications increase.

Comparison of two haemostasis techniques on procedural duration, postoperative pain and gastrointestinal function in pet rabbits undergoing ovariohysterectomy.

Ovariohysterectomy is a common surgical procedure in pet rabbits and one of its potential complications is postoperative gastrointestinal stasis, possibly exacerbated by prolonged surgery time. The objective of this prospective clinical study was to compare two techniques for surgical haemostasis with respect to procedural duration, postoperative pain, and return of gastrointestinal function, in 22 female rabbits undergoing ovariohysterectomy. Rabbits were assigned to one of two groups: conventional vessel ligation (CVL) and haemostasis with a vessel sealing device (VSD). The outcome variables for comparison between the two groups, recorded at 60-, 120-, 180-, and 360-minutes post anaesthesia, were duration of anaesthesia and surgery, postoperative Rabbit Grimace Scale scores, and measured food intake and faecal output. The vessel sealing device caused no appreciable blood loss. The duration of both surgery and anaesthesia was shorter in group VSD (20 ± 4 and 31 ± 6 minutes, respectively) than in group CVL (43 ± 9 and 54 ± 9 minutes, respectively) (p < 0.001). There were no differences between groups in time elapsed from the end of anaesthesia to both first food intake and first defecation. In both groups, the score of the Rabbit Grimace Scale decreased over time with statistically significant differences between 60 minutes and all the subsequent time points (p < 0.001). Vessel sealing devices may be recommended over conventional haemostasis for rabbit ovariohysterectomy to decrease the duration of surgery and anaesthesia, with potential beneficial effects on sustainability and practice workflow.

Comparison of exsanguination and hemostasis devices for Limb surgery: a multicenter randomized controlled study.

BACKGROUND: Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). METHODS: This randomized controlled trial evaluates the exsanguination tourniquet ring's effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. RESULTS: The experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device. CONCLUSIONS: The exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries. TRIAL REGISTRATION: Comparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial.

BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery. METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. DISCUSSION: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .

Utilization of harmonic scalpel for the bloodless surgical management of a vascular lesion of the tongue and review of the literature.

A constant search for methods to limit blood loss, especially the vascular lesions of the tongue, has led to the acceptance of ultrasonic harmonic scalpels.The harmonic scalpel's reliability exists in its ability for lasting hemostasis with minimal heat dispersion to the surrounding structures.Surgical removal of the vascular pathology in a restricted area of the oral cavity and oropharynx dictates a bloodless surgical field, further allowing increased visibility of the lesion and the surrounding anatomical structures, subsequently narrowing the surgical time frame.We report a rare case of haemangioma of the lateral border of the tongue managed with complete resection of the tumor achieved using the harmonic scalpel with reduced intraoperative blood loss, increased visibility, evidently reduced post-operative necrosis and highly preserved tissue for the histopathological examination.

Comparative Analysis of Hemostasis and Staple-Line Integrity between Medtronic Tri-StapleTM with Preloaded Buttress Material and the AEONTM Stapler in Bariatric Surgery.

Background and Objectives: Haemostasis-related complications associated with Medtronic Tri-stapleTM with preloaded buttress material and the novel, naked AEONTM gastrointestinal staplers have not been extensively studied in bariatric surgery. The study aimed to assess and compare the 30-day haemostasis-related complications between Medtronic Tri-stapleTM and AEONTM GIA staplers. Methods: A retrospective analysis was performed on data from patients who underwent primary or revision sleeve gastrectomy (SG) or the sleeve component of single anastomosis duodeno-ileal bypass with SG (SADI-S) in a private hospital in Australia between November 2021 and December 2022. The surgeries were performed by a single surgeon, using either Medtronic Tri-stapleTM or AEONTM staplers. Results: The analysis included 250 patients, with the first 125 consecutive patients receiving staple line using the Medtronic Tri-stapleTM GIA stapler and the subsequent 125 patients receiving staple line using the AEONTM GIA stapler. Statistical analysis revealed no significant differences in the distribution of surgical procedures between the Medtronic and AEON groups. In the AEON group, there were statistically higher numbers of diabetics and former tobacco users, while other preoperative characteristics did not significantly differ between the two groups. The AEON group had a significantly longer mean operative time, while the length of hospital stay was significantly shorter. No intraoperative or 30-day complications, deaths, emergency room visits, readmissions, or reoperations were observed in either group. Conclusion: The novel, naked AEONTM stapler demonstrated non-inferiority to the established Medtronic Tri-StapleTM with preloaded buttress material in achieving hemostasis and maintaining staple-line integrity in bariatric surgery.

Simultaneous sealing and bisection of porcine renal blood vessels, ex vivo, using a continuous-wave, infrared diode laser at 1470 nm.

Electrosurgical and ultrasonic devices are used in surgical procedures for hemostatic sealing and bisection of vascular tissues. Previous benchtop studies alternatively demonstrated successful infrared laser sealing and cutting of blood vessels, in a sequential, two-step approach. This study describes a smaller, laparoscopic device compatible design, and simultaneous approach to sealing and bisection of vessels, with potential optical feedback. A 1470-nm infrared diode laser sealed and bisected 40 porcine renal arteries, ex vivo. A reciprocating, side-firing, optical fiber, housed in a transparent square quartz optical chamber (2.7 × 2.7 × 25 mm outer dimensions), delivered laser energy over an 11 mm scan length, with a range of incident powers (41-59 W) and treatment times (5-21 s). Vessel diameters ranged from 2.5 to 4.8 mm. Vessel burst pressure measurements were performed on each cut end (n = 80) with success indicated by pressures exceeding 360 mmHg. All vessel ends were successfully sealed and bisected (80/80). The highest incident power, 59 W, yielded short treatment times of 5-6 s. Peak temperatures on the external chamber surface reached 103 oC. Time to cool down to body temperature measured 37 s. Infrared lasers simultaneously seal and bisect blood vessels, with treatment times comparable to, and temperatures and cooling times lower than reported for conventional devices. Future work will focus on integrating the fiber and chamber into a standard 5-mm-outer-diameter laparoscopic device. Customization of fiber scan length to match vessel size may also reduce laser energy deposition, enabling lower peak temperatures, treatment times, and cooling times.

Clinical Safety and Performance of GATT-Patch for Hemostasis in Minimal to Moderate Bleeding During Open Liver Surgery.

INTRODUCTION: Intraoperative blood loss and postoperative hemorrhage affect outcomes after liver resection. GATT-Patch is a new flexible, pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with N-hydroxy-succinimide polyoxazoline. We evaluated safety and performance of the GATT-Patch for hemostasis at the liver resection plane. METHODS: Adult patients undergoing elective open liver surgery were recruited in three centers. GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated bleeding site at 3 min versus a prespecified performance goal of 65.4%. RESULTS: Two trial stages were performed: I (n = 8) for initial safety and II (n = 39) as the primary outcome cohort. GATT-Patch was applied in 47 patients on 63 bleeding sites. Median age was 60.0 (range 25-80) years and 70% were male. Most (66%) surgeries were for colorectal cancer metastases. The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, hemostasis was 82.7% at 30, 93.7% at 60, and 96.8% at 180 s. No reoperations for rebleeding or device-related issues occurred. CONCLUSIONS: When compared to a performance goal derived from state-of-the-art hemostatic agents, GATT-Patch for the treatment of minimal to moderate bleeding during liver surgery successfully and quickly achieved hemostasis with acceptable safety outcomes. (ClinicalTrials.gov Identifier: NCT04819945).

Usefulness of endoscopic endonasal underwater surgery using a combination of coblation and a lens-cleaning system for hemostasis in hereditary hemorrhagic telangiectasia.

Hemostatic procedures for controlling nasal bleeding in refractory diseases such as hereditary hemorrhagic telangiectasia (HHT) can be challenging. In this report, we present a novel technique for underwater endoscopic endonasal hemostatic surgery, which was performed on a 69-year-old man with HHT. The patient had been experiencing frequent episodes of nasal bleeding and had many telangiectasias in the nasal cavity, which were the cause of the bleeding. These telangiectasias were effectively treated using a coblation device in combination with an endoscope lens-cleaning system that supplied saline to create stable underwater conditions. There are several advantages to this technique, including provision of a stable and clear endoscopic field of view, allowing for better visualization of the surgical site. This makes it easier to identify bleeding points and ensure accurate hemostasis. Additionally, the hydrostatic pressure created by the underwater environment helps to reduce bleeding during the procedure. However, it is important to take careful precautions to prevent water from entering the lower airway. With this precautionary measure, this technique is particularly useful in managing bleeding in patients with HHT.

Novel Image-Guided Percutaneous Lung Tissue Excision Device With Integrated Sealing of Blood Vessels and Airways: An In Vivo Preclinical Study.

OBJECTIVE: This study evaluated the efficacy of the Minimally Invasive Targeted Resection (MiTR) device, a novel electrosurgical instrument that allows for targeted excision of a lung abnormality while using bipolar radiofrequency (RF) energy to seal blood vessels and airways. METHODS: The MiTR system was evaluated in 7 acute and 2 chronic porcine (7-day) models to evaluate the efficacy of tissue excision with bipolar RF sealing of blood vessels and airways and application of an autologous blood patch into the excised tissue cavity. Air leak was recorded for all evaluations. The study was approved by the institutional ethical board. RESULTS: Nineteen lung tissue samples, measuring 2.5 cm long × 1.2 cm diameter, were excised. In 8 of 9 animals (89%), hemostasis and pneumostasis were observed visually at the completion of the procedure. In 2 of 2 chronic animals (100%), hemostasis and pneumostasis persisted for the 7-day observation period. Histologic examination of the excised samples showed preservation of the core parenchymal architecture without evident tissue damage of the samples that would impair pathologic analysis. CONCLUSIONS: Percutaneous resection of targeted lung tissue with the MiTR system demonstrated hemostasis and pneumostasis while obtaining a histologically intact sample. After regulatory approval, the use of this device could offer more tissue for analysis than a transthoracic needle biopsy or bronchoscopy and a far less invasive alternative to video-assisted thoracic surgery or thoracotomy. This may also expand patient and physician options for the early diagnosis and treatment of lung cancer.

Resección fría sin clips / Cold resection with no clip placement

Cold resection of colonic polyps is an important tool that reduces the incidence of colon cancer. Cold loop polypectomy is a safe and effective technique in colonic lesions smaller than 10 mm and cold mucosectomy with submucosal injection is a growing technique for the resection of non-pedunculated lesions between 10 and 19 mm. Post polypectomy bleeding is an infrequent complication in cold resection, but its recognition is key to reduce the impact of its consequences. The use of hemostatic clips is one of the methods preferred by endoscopists for the management of immediate post polypectomy bleeding, however its usefulness in the prevention of late bleeding is uncertain. In recent years, both meta-analysis and cost- effectiveness studies have concluded that the use of hemoclips does not reduce the incidence of late post-polypectomy bleeding, so their use should be reserved only for high-risk patients.

La resección fría de pólipos colónicos es una importante herramienta que reduce la incidencia de cáncer de colon. La polipectomía con asa fría es una técnica segura y efectiva en lesiones colónicas menores de 10 mm y la mucosectomía fría con inyección submucosa es una técnica en auge para la resección de lesiones no pediculadas entre 10 a 19 mm. El sangrado pospolipectomía es una complicación infrecuente en la resección fría, pero su reconocimiento es clave para disminuir el impacto de sus consecuencias. El uso de clips hemostáticos es uno de los método preferidos por los endoscopistas para el manejo del sangrado inmediato pospolipectomía, no obstante su utilidad en la prevención del sangrado tardío es incierto. En los últimos años, tanto metaanálisis como estudios de costo efectividad concluyen que el uso de hemoclips no reduce la incidencia de sangrado tardío pospolipectomía por lo que su uso debería reservarse sólo a pacientes de alto riesgo.

Topical Coagulant Agents.

Topical hemostatic agents have continued to develop as knowledge of coagulation physiology and pathophysiology has evolved. The addition of knowledge of hemostatic agents to a surgeon's armamentarium helps to push the boundaries of life-saving care. As the understanding of the complex physiology of coagulation and hemorrhage improves, so will the potential for developing hemostatic agents that are safe, affordable, and readily available. This article discusses topical coagulant agents and hemostatic materials currently available in the surgery. The relevant agents/materials, their characteristics, different utility in surgical hemostasis, and their relevant benefits and drawbacks are reviewed.

Reloadable Stapler Use during Peripartum Hysterectomy for Placenta Accreta Spectrum: A Novel Surgical Technique and Case Series.

OBJECTIVE: This study aimed to describe a novel surgical technique for the management of antenatally suspected placenta accreta spectrum (PAS). STUDY DESIGN: This is a retrospective, case series of patients with suspected PAS undergoing peripartum hysterectomy with a reloadable articulating stapler at a tertiary care center. RESULTS: Eighteen patients with antenatally suspected PAS were identified and underwent peripartum hysterectomy with the aid of a reloadable stapler. Mean gestational age at delivery was 344/7 ± 11/7 weeks. Mean total operative time (skin-to-skin) was 117.3 ± 39.3 minutes, and 79.8 ± 19.8 minutes for the hysterectomy. Mean blood loss for the entire case was 1,809 ± 868 mL. Mean blood loss for the hysterectomy was 431 ± 421 mL. Mean units of intraoperative red blood cells transfused was 3 ± 1 units. Mean units of postoperative red blood cells transfused was 1 ± 0.5 units. Five cases were complicated by urological injury (two intentional cystotomies). Four patients were admitted to the intensive care unit (ICU) for a mean of ≤24 hours. Mean postoperative LOS was 4.11 ± 1.45 days. Three patients had final pathology that did not demonstrate PAS while four were consistent with accreta, six increta, and five percreta. CONCLUSION: Use of a reloadable articulating stapler device as part of the surgical management of antenatally suspected PAS results in a shorter operative time (117 ± 39 minutes vs. 140-254 minutes previously reported), lower average blood loss (1,809 ± 868 mL vs. 2,500-5,000 mL previously reported) and shorter LOS (4.11 ± 1.45 days vs. 9.8 ± 13.5 days previously reported) compared with traditional cesarean hysterectomy. The reloadable stapling device offers an advantage of more rapidly achieving hemostasis in the surgical management of PAS. KEY POINTS: · PAS is associated with severe maternal morbidity.. · Decreased operative time and blood loss have many clinical benefits.. · Reloadable stapler use for PAS decreases operative time.. · Reloadable stapler use for PAS decreases operative blood loss..

Extra Peritoneal Packing for Exsanguinating Pelvic Hemorrhage: Should We Do It in the Emergency Department?

BACKGROUND: Extra peritoneal packing (EPP) is a quick and highly effective method to control pelvic hemorrhage. OBJECTIVES: To determine whether EPP can be as safely and efficiently performed in the emergency department (ED) as in the operating room (OR). METHODS: Retrospective study of 29 patients who underwent EPP in the ED or OR in two trauma centers in Israel 2008-2018. RESULTS: Our study included 29 patients, 13 in the ED-EPP group and 16 in the OR-EPP group. The mean injury severity score (ISS) was 34.9 ± 11.8. Following EPP, hemodynamic stability was successfully achieved in 25 of 29 patients (86.2%). A raise in the mean arterial pressure (MAP) with a median of 25 mmHg (mean 30.0 ± 27.5, P < 0.001) was documented. All patients who did not achieve hemodynamic stability after EPP had multiple sources of bleeding or fatal head injury and eventually succumbed. Patients who underwent EPP in the ED showed higher change in MAP (P = 0.0458). The overall mortality rate was 27.5% (8/29) with no difference between the OR and ED-EPP. No differences were found between ED and OR-EPP in the amount of transfused blood products, surgical site infections, and length of stay in the hospital. However, patients who underwent ED-EPP were more prone to develop deep vein thrombosis (DVT): 50% (5/10) vs. 9% (1/11) in ED and OR-EPP groups respectively (P = 0.038). CONCLUSIONS: EPP is equally effective when performed in the ED or OR with similar surgical site infection rates but higher incidence of DVT.

How we do it: 'tonsil swabs please' - an alternative use in open neck surgery.

BACKGROUND: Thyroid and parathyroid surgery often involves the use of heated instruments for dissection. Whilst these are beneficial, accidental thermal damage to the exposed skin edges can occur, resulting in an unsatisfactory cosmetic outcome. Tonsil swabs can be used in head and neck surgery intra-operatively to control bleeding. This paper describes an alternative use for them in protecting wound edges during the procedure. METHOD: Damp tonsil swabs are sutured onto the wound edges after the initial skin incision. They remain present for the duration of the surgery and are removed at the time of skin closure. RESULTS: The tonsil swabs provide protection and help avoid accidental injury to the skin. No complications with this technique have been experienced. CONCLUSION: This paper describes a simple, effective and practical technique for protecting the skin during neck procedures using resources readily available in a standard ENT operating theatre.

The accuracy of dry surgical field sublabial biopsy in the diagnosis of sicca syndrome.

BACKGROUND: Sublabial gland biopsy is the 'gold standard' in establishing the diagnosis of primary Sjögren's syndrome. Bleeding and nerve damage are complications. Our centre has adopted the use of the chalazion clamp to provide a dry surgical field to address these challenges. This study aimed to assess the accuracy of minor salivary gland harvest rate using this technique. METHOD: A retrospective review of all minor salivary gland biopsies was carried out in a single tertiary referral centre over a five-year period. RESULTS: Forty-one biopsy patients were identified, with a mean age of 56.1 years. There was 100 per cent accuracy in harvest rate in our series. Twelve patients (29 per cent) were positive for primary Sjögren's syndrome. No patients had a complication immediately or at one month follow up. CONCLUSION: Dry surgical field sublabial gland biopsy is a safe and highly effective technique in the diagnosis of primary Sjögren's syndrome. Initial results indicate it may provide a higher harvest rate with fewer complications than traditional non-ischaemic techniques.

Haemostatic devices in parotid surgery: a systematic review.

OBJECTIVE: The Harmonic Scalpel and Ligasure (Covidien) devices are commonly used in head and neck surgery. Parotidectomy is a complex and intricate surgery that requires careful dissection of the facial nerve. This study aimed to compare surgical outcomes in parotidectomy using these haemostatic devices with traditional scalpel and cautery. METHOD: A systematic review of the literature was performed with subsequent meta-analysis of seven studies that compared the use of haemostatic devices to traditional scalpel and cautery in parotidectomy. Outcome measures included: temporary facial paresis, operating time, intra-operative blood loss, post-operative drain output and length of hospital stay. RESULTS: A total of 7 studies representing 675 patients were identified: 372 patients were treated with haemostatic devices, and 303 patients were treated with scalpel and cautery. Statistically significant outcomes favouring the use of haemostatic devices included operating time, intra-operative blood loss and post-operative drain output. Outcome measures that did not favour either treatment included facial nerve paresis and length of hospital stay. CONCLUSION: Overall, haemostatic devices were found to reduce operating time, intra-operative blood loss and post-operative drain output.

Use of 8Fr angio-seal for closure of femoral arteriotomy following use of 8Fr and 9Fr sheaths in patients undergoing mechanical thrombectomy for acute ischaemic stroke.

BACKGROUND: Little is known about the safety of off-label use of an 8Fr Angio-Seal VIP for large-bore arteriotomies in patients treated with mechanical thrombectomy (MT) and intravenous thrombolysis (IVT) for acute ischaemic stroke (AIS). We aimed to identify differences in the groin complication rate using an 8Fr Angio-Seal VIP for common femoral arteriotomy closures following the use of 8Fr and 9Fr sheaths. METHODS: All AIS patients who underwent MT at our tertiary neuroscience unit between January 2018 and March 2020 were retrospectively reviewed. RESULTS: 161 patients were included in the study, of whom 56 and 105 patients underwent an arteriotomy using an 8Fr sheath (36 of them receiving IVT) and a 9Fr sheath (57 of them receiving IVT). Overall, 17 groin complications were identified (10.5%) in 5 patients (8.9%) who had had 8Fr sheaths inserted and 12 patients (11.4%) who had had 9Fr sheaths inserted. Major complications were identified in only 2 patients (1.2%), one patient in each of the 8Fr and 9Fr cohorts suffering a pseudoaneurysm requiring intervention. No retroperitoneal haematoma, infection, acute limb ischaemia or ipsilateral DVT was identified. No significant difference in groin complications was observed between the 8Fr and 9Fr femoral arteriotomy cohorts or between the MT patients that did or did not receive adjunctive IVT. CONCLUSION: In the setting of MT with IVT, off-label use of an 8Fr Angio-Seal VIP for closure of a femoral arteriotomy following use of a 9Fr sheath has a similar safety profile to the licensed use of an 8Fr Angio-Seal VIP for closure of a femoral arteriotomy following use of an 8Fr sheath or smaller.

Comparison of Surgical Complications Rates Between LigaSure Small Jaw and Clamp-and-Tie Hemostatic Technique in 1,000 Neuro-Monitored Thyroidectomies.

Over the past decade, the use of neuromonitoring in thyroid surgery has become well established and is increasing accepted across the world. In addition, new developments in energy devices have significantly improved efficacy in achieving hemostasis in thyroid surgery. Few studies focused on the complication rates in energy device-assisted sutureless neuro-monitored thyroidectomy. This study investigates a novel LigaSure Small Jaw (LSJ) technique for sutureless thyroidectomy and compares the surgical complication rates between LSJ and conventional clamp-and-tie technique in one thousand consecutive neuro-monitored thyroidectomy patients. Five hundred patients received sutureless thyroidectomy performed with LSJ (Group L), and 500 patients received surgery performed with conventional clamp-and-tie technique (Group C). Complication rates of postoperative hematoma, hypocalcemia and recurrent laryngeal nerve (RLN) palsy were compared between groups. The overall complication rates of hematoma, hypocalcemia (temporary/ permanent), and RLN (temporary/ permanent) palsy were 0.9%, 24.9% (24.6%/0.3%), and 1.7% (1.5%/0.2%), respectively. Group L and Group C significantly differed in postoperative hematoma rate (0.0% vs. 1.8%, respectively; p = 0.0026) and in postoperative hypocalcemia rate (20.1% vs. 30.0%, respectively; p = 0.0032). The incidence of RLN palsy did not significantly differ between Group L and Group C (1.38% vs. 2.08%; p = 0.2652). The overall surgical complication rates are low in neuro-monitored thyroidectomy. The LSJ is feasible for performing completely sutureless thyroidectomy and obtains superior outcomes of postoperative hematoma and hypocalcemia in comparison with clamp-and-tie hemostatic technique. The novel LSJ technique using double or overlapped sealing is useful for sutureless thyroidectomy. However, surgeons must carefully observe the tissue contraction that may reduce the LSJ-RLN distance and increase the risk of thermal injury during the LSJ activation.