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Background: The advent of ultrasonic scalpels has remarkably advanced minimally invasive surgery; however, the Chinese market's reliance on imports highlights the urgent need for a cost-effective, efficient, and domestically produced surgical scalpel. This study aimed to compare SanAgile TM SA01 with the Johnson & Johnson GEN11, and HAR36 surgical devices., Research Design and Methods: In total, 152 participants requiring urological or general laparoscopic surgery were randomly and equally divided between the two hospitals and randomized to the test and control groups. Clinical outcomes, adverse event rates, intraoperative bleeding, and surgery duration were compared between the two devices., Results: The clinical application rate of both devices was 100%. There were no significant differences between the two groups in intraoperative bleeding, surgery duration, and incidence of adverse events. In the test group, five device-related adverse events occurred (6.58%), compared to two (2.63%) in the control group (no significant difference). The device-related adverse events did not result in any sequelae., Conclusions: The clinical performance of the SanAgile TM SA01 was comparable to that of the Johnson & Johnson GEN11 and HAR36. The SanAgile TM SA01 device may serve as a viable alternative ultrasonic surgical tool, thereby providing clinicians with additional options., Trial Registration: Registration number of Shanghai Medical Equipment Preparation 20,190,114.

Background: Ultrasonic scalpel has been reported to be superior to conventional electrocautery in many studies. However, with respect to transaxillary endoscopic breast augmentation, few studies on the effect of ultrasonic scalpel are available in the literature., Methods: The medical records of 173 female patients who underwent breast augmentation via endoscopic transaxillary approach from January 2018 to December 2020 were reviewed retrospectively. The patients were divided into two groups according to the implant pocket dissection instruments. In group A, the implant pockets were dissected with conventional electrocautery (EC group) on 81 patients, and in group B, ultrasonic scalpel (US group) was used for implant pockets on 92 patients. All operations were performed by the same senior plastic surgeon and the same surgical team. The operation time, intraoperative blood loss, postoperative total drainage volume, days of drainage, postoperative surgical site pain and hospital stay time of the two groups were compared and analyzed statistically., Results: The average operation time of the US group (83.82 ± 11.57 min) was significantly shorter than that of the EC group (101.40 ± 14.36 min), intraoperative blood loss in the US group was significantly less than that of the EC group (18.67 ± 6.20 ml vs. 21.59 ± 6.44 ml), the mean hospital stay days (2.96 ± 0.69 vs. 4.30 ± 1.11), total drainage volume (122.24 ± 43.81 vs. 232.37 ± 99.15), and duration of drain (2.52 ± 0.54 vs. 3.77 ± 1.10), mean VAS score for surgical site pain on 3 postoperative days (5.08 ± 1.35 vs. 6.51 ± 1.36, 4.08 ± 1.16 vs. 5.40 ± 1.32, 3.04 ± 0.91 vs. 4.06 ± 1.11) were significantly lower in the US group compared to the EC group., Conclusions: The ultrasonic scalpel reduces operative time, intraoperative blood loss, postoperative drainage, postoperative pain, hospital stay time, and incidence of complications. The ultrasonic scalpel is safe and reliable for transaxillary endoscopic breast augmentation., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2023. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

Surgical smoke is a common chemical hazard produced from the use of electrocautery, laser, or ultrasonic scalpels during surgery. It has been proved harmful to medical personnel. Thus, it is important to monitor surgical smoke concentrations in the operating room. In the past decade, many researches regarding surgical smoke were discussed in different professional healthcare fields, but few showed the correlation between surgical smoke and otolaryngology surgery. In this study, the concentrations of particulate matter and formaldehyde were measured during thirty cases of several types of otolaryngology surgery in a regional research hospital in Taiwan. The concentrations of 0.3 µm and 0.5 µm particulate matter raised rapidly in the main knife range at the beginning of the electrocautery knife used, and then decreased by half after 5-10 min of use. The concentrations of formaldehyde were ranged from 1 to 2 ppm during the surgery, which is higher than the permissible exposure limit. While many medical staffs are working in the operating room and are exposed to the smoke hazard, effective strategies for collecting and eliminating the smoke should be taken in all medical facilities., (© 2022. The Author(s).)

Objective: In current literature, no studies evaluated effect of energy-based vessel-sealing-devices on quality of life after sutureless total thyroidectomies. This study aimed to identify any potential differences between two energy-based vessel-sealing-devices (Harmonic Focus, Ligasure LF1212) in patients with benign thyroid disorders who underwent sutureless total thyroidectomy., Materials and Methods: Differences in quality of life of patients were evaluated using data obtained by Thy-PRO-39-Tr questionnaire prior to and four-week after surgery. Total and domain-based alterations in quality of life were compared between groups according to energy-based vessel-sealing-devices type (Group L, Group H). Additionally, data including demographics, height, weight, body mass index, neck circumference, sternomental distance were collected., Results: Of 1032 patients, 200 were eligible for study, at the end 193 were analysed. There were no differences between groups in terms of age, sex, body mass index, tobacco use. Analysis did not reveal any differences in overall quality of life between groups (P = .42). However, in "eye symptoms" (P < .001) and "cognitive functions" (P = .002) domains, Harmonic provided statistically improved quality of life. Effect on cognitive function was greater in patients of advanced age., Conclusions: Especially in elderly patients with worsening eye conditions and cognitive functions, use of Harmonic may enhance patients' outcome by increasing quality of life in addition to optimizing surgical outcome when compared to Ligasure., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: Ultrasonic bone removal devices (UBD) are capable of cutting through bony tissue without injury to adjacent soft tissue. The feasibility and safety of using this technology for removal of bone from an intact ossicular chain (as might be required for otosclerosis or congenital fixation) was investigated in an animal model., Methods: This was a prospective animal study conducted on seven anesthetised adult chinchillas. An UBD was used to remove bone from the malleus head in situ. Pre and post-operative distortion product otoacoustic emission (DPOAE) levels and auditory brainstem response (ABR) thresholds were recorded. Scanning electron microscopy (SEM) was used to assess cochlear haircell integrity., Results: Precise removal of a small quantity of bone from the malleus head was achieved by a 30s application of UBD without disruption of the ossicular chain or tympanic membrane. DPOAEs became undetectable after the intervention with signal-to-noise ratios (SNR) < 5 dB SPL in all ears. Furthermore, ABR thresholds were elevated > 85 dB SPL in 13 ears. SEM showed significant disruption of structural integrity of the organ of Corti, specifically loss and damage of outer haircells., Conclusions: Although UBD can be used to reshape an ossicle without middle ear injury, prolonged contact with the ossicular chain can cause structural and functional injury to the cochlea. Extensive cochlea pathology was found, but we did not investigate for recovery from any temporary threshold shift. In the authors' opinion, further study should be undertaken before consideration is given to use of the device for release of ossicular fixation.

Aim of this study is the evaluation of the periodontal status of impacted canines treated by closed approach with ultrasonic surgery and orthodontic treatment compared with contralateral spontaneously erupted teeth. The periodontal conditions of the teeth adjacent to the canines (lateral incisors and first premolar) were also considered. 17 patients (9 females and 8 males; mean age: 15.2 years) with unilateral palatal impaction of maxillary canine were selected. All patients were treated by closed-flap surgery with ultrasonic instruments. Periodontal status was evaluated by assessing probing depth (PD), gingival recession and width of keratinized tissue (KT) 4.6 months after the end of the orthodontic treatment, on average. Test group was composed by impacted elements and adjacent teeth and control group by contralateral spontaneously erupted canines and adjacent teeth. Student's t-test was used to compare test and control group values of PD and width of KT. Significance threshold for Student's t-test was set at p < 0.05. The average probing depth values show no significant clinical differences between the test and control groups. Probing depths recorded at the mesiovestibular and distopalatal sides of the impacted canine were statistically significant compared to the control elements (p < 0.05). No gingival recession was detected on the treated canines. The measurement of KT did not differ significantly between the test and the control groups. In conclusion, the ultrasonic surgery for disinclusion associated with a closed approach and orthodontic traction allows the alignment of an impacted palatal canine without damaging the periodontium.

Aim: This study aimed to investigate the safety and effectiveness of ultrasonic osteotome in cervical anterior vertebral subtotal resection., Methods: Retrospective clinical data were collated for 81 patients with cervical spondylotic myelopathy who required cervical anterior vertebral subtotal resection., Results: Group A (n=40) was treated with an ultrasonic osteotome and group B (n=41) with a high-speed burr. Vertebrectomy time, intraoperative blood loss, surgical complications, Japanese Orthopedic Association (JOA) scores and JOA score improvement were compared. Group A showed significantly shorter vertebrectomy time and significantly less intraoperative blood loss (P<0.05). In group A, dysphagia occurred in one patient, and superior laryngeal nerve injury in one. Urinary tract infection occurred in one patient in group B. JOA score in both groups significantly increased 3 days after surgery (P<0.05), and at last follow-up compared with 3 days after surgery (P<0.05)., Conclusion: Ultrasonic osteotome was a safe and effective tool for subtotal anterior cervical vertebral resection., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

This report details a single-center experience of using magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) for whole-gland prostate treatment. Nine men with organ-confined low-to-intermediate-risk prostate cancer underwent the TULSA procedure. The primary endpoint of reduction of more than 75% was achieved in 8 of 9 patients, and all patients demonstrated a histologic benefit at 12-month biopsy. No major urinary or gastrointestinal side effects were observed, and there were no postprocedural changes in erectile firmness. These findings suggest that TULSA is potentially safe and efficacious for patients with low-to-intermediate-risk disease., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: The purpose of this study was to establish a standardized in vitro phacoemulsification damage model for future investigations of the effects of phacoemulsification, surgical devices, protective ophthalmic viscoelastic devices (OVDs), irrigation solutions and other aspects related to cataract phacoemulsification surgery on the corneal endothelium using porcine eyes., Methods: Thirty-four porcine eyes were randomly assigned to three groups (phacoemulsification (n = 13), irrigation (n = 9), control (n = 12)). A total of 5 min of ultrasound energy with intermittent irrigation/aspiration was applied in the eyes of the phacoemulsification group. The eyes of the irrigation group received the identical treatment, but without the application of ultrasound energy. The control group was left untreated. All eyes were then prepared to split corneal buttons followed by 15 days of cultivation. Endothelial cell density (ECD) was assessed blinded on day 15., Results: Endothelial cell density declined significantly more until day 15 in the phacoemulsification group (2567 ± 317/267 cells/mm² (median ± 25%/75%-quartiles), -32.5 ± 7.0/6.4%) compared to the irrigation (3450 ± 350/383 cells/mm², -11.8 ± 5.3/2.6%; p < 0.001) and the control group (3650 ± 288/258 cells/mm², -10.2 ± 3.2/4.6%; p < 0.001)., Conclusion: The phacoemulsification damage model presented in this study is sensitive to phacoemulsification energy and may reliably be used to investigate various factors involved in phacoemulsification with regard to their influence on corneal endothelial cells. This method is able to replace animal experiments or in vitro cell culture experiments that often do not translate well to the in vivo situation in humans., (© 2019 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Background: Recurrent laryngeal nerve (RLN) paralysis is a frequently observed complication after esophagectomy, and thermal injury is considered to be one of the causes. The difference in the lateral thermal spread associated with the grasping range of various energy devices remains unknown., Methods: Ultrasonic devices (Harmonic® HD1000i and Sonicision™) and a vessel-sealing device (Ligasure™) were studied. We evaluated the temperature of these devices, the activation time required, and the thermal spread on porcine muscle when the devices were used with different grasping ranges (thermal spread study). In addition, we evaluated the influence of thermal spread by short grasping use of the energy devices on the viability of RLN in a live porcine model (NIM study)., Results: In the thermal spread study, the temperature of the ultrasonic devices lowered as grasping range increased, whereas the highest temperature of Ligasure was observed when used with two-thirds grasping. The activation time of ultrasonic devices became longer as grasping range increased, whereas the grasping range did not influence the activation time of Ligasure. Thermal spreads 1 mm from the energy devices were unaffected by the grasping ranges. Although the temperature of the Ligasure was lower than that of the ultrasonic devices, thermal spread by Ligasure was significantly greater than that induced by the ultrasonic devices. In the NIM study, the activation of the Sonicision with one-third grasping range did not cause EMG changes at distances of up to 1 mm from the RLN, whereas applying Ligasure with a one-third grasping range 1 mm away from the RLN led to a critical result., Conclusions: The grasping range did not influence the thermal spread induced by the energy devices. Ultrasonic devices may be safer in terms of lateral thermal spread to the RLN than Ligasure.

Purpose: The purpose of this study was to investigate the thermal injuries caused by ultrasonic pars plana phacoemulsification and aspiration (PPPEA) using pig eyes., Method: Using a 20-gauge (G) vitrectomy system (Accurus ® , Fragmatome; Alcon Laboratories) in both the 'open-tip' and 'closed-tip' techniques, PPPEA was performed in pig eyes and the subsequent thermal injuries generated around the scleral wound were measured by infrared thermal imaging (thermography). Post surgery, the state of the scleral wound was observed under a microscope, and a tissue slice containing the scleral wound was then prepared and observed under an optical microscope., Results: Thermography measurements revealed a slight temperature rise around the scleral wound in the open-tip case, yet a marked temperature rise in the closed-tip case. The scleral wound incision produced by the open tip was linear, while that produced by the closed tip was expanded. Histological examination revealed mild degeneration of the sclera around the wound in the open-tip case, yet marked tissue degeneration by thermal injuries in the closed-tip case., Conclusion: Our findings showed that in PPPEA, the temperature of the tip of a 20G vitrectomy system rapidly increases due to the closed-tip technique, thus producing obvious thermal damage to the scleral wound. In order to prevent thermal injuries to the scleral wound during PPPEA, it is important to shorten the time of ultrasonic oscillation during surgery as much as possible while the tip is occluded with nuclear fragments.

Background: Intraoperative bleeding and postoperative pain are two commonest concerns for both patient and surgeon in tonsillectomy. This study was aimed to compare intraoperative blood loss and early postoperative pain between ultrasonic device and bipolar diathermy tonsillectomy in children., Methods: Prospective, interventional, single blinded, comparative study was carried out from September 2016 to September 2017 including children up to age 15 years who underwent tonsillectomy either by bipolar diathermy or ultrasonic device. Intraoperative blood loss was recorded using standard sized gauge technique. Post-tonsillectomy pain on first five postoperative days (early postoperative pain) was assessed using Visual analog scale for children older than 5 years and FLACC score for children up to 5 years respectively.Means were compared., Results: 38 children (76 tonsils) were included in the study out of which 31 were boys (62 tonsils) and 7 were girls (14 tonsils). The mean intraoperative blood loss in ultrasonic dissection group was 13.94 ml and 13.91 ml in bipolar diathermy group. This difference was not statistically significant (p=0.974). Post-operative pain on 1st, 2nd, 3rd and 4th days were significantly less (p<0.05) in ultrasonic device group compared to bipolar diathermy group. Post-operative pain was less also on 5th post-operative day in ultrasonic device but was not statistically significant (p=0.172)., Conclusions: Tonsillectomy in children using ultrasonic device did not differ from bipolar diathermy tonsillectomy in respect to intraoperative blood loss. However, early postoperative pain was significantly lower in ultrasonic device group.

Objective: One patient for whom an MR-guided focused ultrasound (MRgFUS) pallidotomy was attempted was discovered to have multiple new skull lesions with the appearance of infarcts on the MRI scan 3 months after his attempted treatment. The authors conducted a retrospective review of the first 30 patients treated with MRgFUS to determine the incidence of skull lesions in patients undergoing these procedures and to consider possible causes., Methods: A retrospective review of the MRI scans of the first 30 patients, 1 attempted pallidotomy and 29 ventral intermediate nucleus thalamotomies, was conducted. The correlation of the mean skull density ratio (SDR) and the maximum energy applied in the production or attempted production of a brain lesion was examined., Results: Of 30 patients treated with MRgFUS for movement disorders, 7 were found to have new skull lesions that were not present prior to treatment and not visible on the posttreatment day 1 MRI scan. Discomfort was reported at the time of treatment by some patients with and without skull lesions. All patients with skull lesions were completely asymptomatic. There was no correlation between the mean SDR and the presence or absence of skull lesions, but the maximum energy applied with the Exablate system was significantly greater in patients with skull lesions than in those without., Conclusions: It is known that local skull density, thickness, and SDR vary from location to location. Sufficient energy transfer resulting in local heating sufficient to produce a bone lesion may occur in regions of low SDR. A correlation of lesion location and local skull properties should be made in future studies.

Purpose: Anterior cervical corpectomy and fusion (ACCF) is a technically challenging surgery. Use of conventional instruments like high-speed burr and kerrison rongeurs is associated with high complication rates such as increased blood loss and incidental durotomy. Use of ultrasonic bone scalpel (UBS) in cervical corpectomy helps to minimize such adverse events., Methods: We performed a retrospective study based on the data of 101 consecutive patients who underwent cervical corpectomies with UBS for different cervical spine pathologies from December 2014 to December 2016. Total duration of surgery, time taken for corpectomy, estimated blood loss, and incidental durotomies were noted., Results: Total surgical time was 30-80 min (59.36 ± 13.21 min) for single-level ACCF and 60-120 min (92.74 ± 21.04 min) for double-level ACCF. Time taken for single-level corpectomy was 2 min 11  ± 10 s and 3 min 41  ± 20 s for double-level corpectomy. Estimated blood loss ranged from 20-150 ml (52.07 ± 29.86 ml) in single level and 40-200 ml (73.22 ± 41.64 ml) in double level. Four (3.96%) inadvertent dural tears were noted, two during single-level corpectomy and other two during double-level corpectomy., Conclusions: Use of UBS is likely to provide a safe, rapid, and effective surgery when compared to conventional rongeurs and high-speed burr. The advantages such as lower blood loss and lower intra-operative incidental dural tears were noted with the use of UBS.

Background: Both radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have proven clinical efficacy for the treatment of hypertension. We performed a head-to-head comparison of these technologies., Methods: Patients with resistant hypertension were randomly assigned in a 1:1:1 manner to receive either treatment with (1) radiofrequency RDN of the main renal arteries; (2) radiofrequency RDN of the main renal arteries, side branches, and accessories; or (3) an endovascular ultrasound-based RDN of the main renal artery. The primary end point was change in systolic daytime ambulatory blood pressure at 3 months., Results: Between June 2015 and June 2018, 120 patients were enrolled (mean age, 64±9 years±SD; mean daytime blood pressure, 153/86±12/13 mm Hg). Of these, 39 were randomly assigned to radiofrequency main renal artery ablation, 39 to combined radiofrequency ablation of the main artery and branches, and 42 to ultrasound-based treatment. Baseline daytime blood pressure, clinical characteristics, and treatment were well balanced between the groups. At 3 months, systolic daytime ambulatory blood pressure decreased by 9.5±12.3 mm Hg ( P<0.001) in the whole cohort. Although blood pressure was significantly more reduced in the ultrasound ablation group than in the radiofrequency ablation group of the main renal artery (-13.2±13.7 versus -6.5±10.3 mm Hg; mean difference, -6.7 mm Hg; global P=0.038 by ANOVA, adjusted P=0.043), no significant difference was found between the radiofrequency ablation groups (-8.3±11.7 mm Hg for additional side branch ablation; mean difference, -1.8 mm Hg; adjusted P>0.99). Similarly, the blood pressure reduction was not found to be significantly different between the ultrasound and the side branch ablation groups. Frequencies of blood pressure response ≥5 mm Hg were not significantly different (global P=0.77)., Conclusions: In patients with resistant hypertension, endovascular ultrasound-based RDN was found to be superior to radiofrequency ablation of the main renal arteries only, whereas a combined approach of radiofrequency ablation of the main arteries, accessories, and side branches was not., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02920034.

Background: We aimed to assess whether the use of the harmonic scalpel (HS) in axillary dissection would reduce long-term shoulder-arm morbidity compared to traditional instruments (TIs)., Materials and Methods: A retrospective analysis on 180 patients who underwent standard axillary dissection for breast cancer between 2007 and 2015 was carried out. All patients were evaluated for postoperative pain, impairment of shoulder-arm mobility, seroma formation in axilla, frozen shoulder, and lymphedema., Results: HS procedure on average was 50% shorter compared to the TI technique. HS reduced by 4.5 times the risk of axillary seroma. TIs were associated with 4 times higher risk of developing a painful frozen shoulder., Conclusions: Use of the HS was associated with reduced costs and a positive long-term effect on shoulder-arm morbidity. Axillary seromas are not the only reason of later postoperative shoulder-arm morbidity: other mechanisms are hypothesized in the onset of this very disabling disorder., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: Lymphadenectomy is crucial for accurate staging in most gynecological malignancies. Serious complications can occur during the surgery. The present study aimed to present the early and late findings associated with obturator nerve injury, which is rarely observed during lymphadenectomy but can result in serious sequela if not noticed., Material and Methods: The files of the patients who underwent lymphadenectomy at our clinic between 2012 and 2018 were examined. Patients with obturator nerve incisions were identified retrospectively., Results: In total, 287 women patients underwent lymphadenectomy at our clinic between 2012 and 2018. Examination of surgical notes revealed that nine patients underwent obturator nerve incisions using a scissor or a harmonic scalpel (energy- activated ultrasonic scissors). With respect to management of obturator nerve damage, no significant difference was found between the use of a harmonic scalpel and scissors (p < 1.000) and the trendelenburg and lithotomy positions (p < 0.167). In addition, no significant difference was found between laparoscopy and laparotomy in terms of surgical type (p < 0.167). At 6 months post-operatively, sensory-motor examinations and EMG findings of the patients were completely normal., Conclusions: Surgeries performed for gynaecological malignancies have high mortality and morbidity rates. Moreover, in the event of a complication such as nerve damage during laparoscopy, successful management of the complication before the patient undergoes laparotomy allows the patient to continue benefitting from the advantages of the laparoscopy. The results of our study show that these high-risk surgeries should be performed in advanced and well-equipped medical centres by teams experienced in gynaecological oncology.

Background: The purpose of this study was to compare the degree of surgical smoke or vapor and lateral thermal damage caused by two different energy-based surgical devices (ESDs) used in colpotomy during total laparoscopic hysterectomy., Methods: Patients undergoing laparoscopic hysterectomy were randomly assigned to an ultrasonic ESD group (n = 20) or monopolar ESD group (n = 20). Colpotomy was performed using the assigned ESD. The degree of surgical smoke or vapor obstructing the laparoscopic view was assessed by two independent reviewers using a 5-point Likert scale, in which a higher score indicates worse visibility. The degree of the lateral thermal damage was measured as the width from the point of instrument application to the margins of the unchanged nearby tissue using a light microscope., Results: The baseline characteristics did not statistically differ between the two groups. The degree of surgical smoke or vapor obstructing vision was 1.2 ± 0.8 points in the ultrasonic group and 3.9 ± 0.7 points in the monopolar groups (p < 0.001). The lateral thermal damage was significantly increased in the monopolar group compared to in the ultrasound group (1500 µm [1200-2500 µm] vs. 950 µm [650-1725 µm], p = 0.037)., Conclusion: Ultrasonic ESD had better laparoscopic visibility and caused less lateral thermal damage during colpotomy compared to monopolar device.

Background: This study aimed to compare the extent of lateral thermal spread of surrounding tissues after the use of advanced bipolar and ultrasonic coagulation and shearing devices. Association between recurrent laryngeal nerve paralysis (RLNP) and such devices was assessed in patients who underwent minimally invasive esophagectomy (MIE)., Methods: LigaSure ™ (LS) and Sonicision ™ (SONIC) were used. In ex vivo experiments using the porcine muscle, blade temperature and tissue temperature were measured using a thermometer after the activation of both devices. For the clinical assessment, 46 consecutive patients who received MIE were retrospectively assessed., Results: The temperature generated at the blade of both devices increased with the activation time. The blade temperature of LS was significantly lower than that of SONIC (P < 0.001). The blade temperature of SONIC exceeded 100 °C after 3-s activation. The temperature of surrounding tissues after a single activation of the devices decreased with the tissue distance from activation blade. The temperatures of tissues at 1 and 2 mm away from the blade side of LS were significantly lower than those of SONIC (P = 0.001 and P < 0.001, respectively). The temperature of tissue 2 mm away from the blade side of LS increased 6.4 °C from the baseline temperature. Furthermore, the incidence of RLNP in the LS group was lower than that in the SONIC group (P = 0.044)., Conclusion: This study highlights the necessity of spatial and temporal recognition of the thermal spread of coagulation and shearing devices to reduce the thermal injuries following MIE.

Complications related to energy sources in the operating room are not well-recognized or published, despite occasionally dramatic consequences for the patient and the responsible surgeon. The goal of this study was to evaluate the risks and consequences related to use of energy sources in the operating room., Patients and Methods: Between 2009 and 2015, 876 adverse events related to health care (AERHC) linked to energy sources in the operating room were declared in the French experience feedback data base "REX". We performed a descriptive analysis of these AERHC and analyzed the root causes of these events and of the indications for non-elective repeat operations, for each energy source., Results: Five different energy sources were used, producing 876 declared AERHC: monopolar electrocoagulation: 614 (70%) AERHC, advanced bipolar coagulation (thermofusion): 137 (16%) AERHC, ultrasonic devices: 69 (8%) AERHC, traditional bipolar electrocoagulation: 32 AERHC, and cold light: 24 AERHC. The adverse events reported were skin burns (27.5% of AERHC), insulation defects (16% of AERHC), visceral burns or perforation (30% of AERHC), fires (11% of AERHC), bleeding (7.5% of AERHC) and misuse or miscellaneous causes (8% of AERHC). For the five energy sources, the root causes were essentially misuse, imperfect training and/or cost-related reasons regarding equipment purchase or maintenance. One hundred and forty-six non-elective procedures (17% of AERHC) were performed for complications related to the use of energy sources in the operating room., Conclusion: This study illustrates the risks related to the use of energy sources on the OR and their consequences. Most cases were related to persistent misunderstanding of appropriate usage within the medical and paramedical teams, but complications are also related to administrative decisions concerning the purchase and maintenance of these devices., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Purpose: To report results of renal denervation (RDN) with the first catheter-based, non-balloon occlusion ultrasonic system in patients with resistant hypertension., Materials and Methods: In a multicenter, single-arm trial, 39 patients with resistant hypertension (defined as uncontrolled hypertension while taking ≥ 3 antihypertensive medications) were treated. The cohort consisted of 4 groups: severe resistant hypertension (office systolic blood pressure [OSBP] ≥ 160 mm Hg) treated with a unidirectional catheter (group 1; n = 14); severe resistant hypertension treated with a multidirectional catheter (group 2; n = 18); moderate resistant hypertension (OSBP 140-159 mm Hg) treated with a multidirectional catheter (group 3; n = 5); and recurrent severe resistant hypertension, after an initial response to RF RDN (group 4; n = 2). Blood pressure monitoring was performed for 6 months., Results: Severe adverse events were not noted immediately after the procedure or during follow-up. Treatment time was longer with unidirectional than with multidirectional catheters (36.7 min ± 9.6 vs 11.9 min ± 5.8; P < .001). Mean reductions in office blood pressure (systolic/diastolic) at 1, 3, and 6 months were -26.1/-9.6 mm Hg, -28.0/-9.9 mm Hg, and -30.6/-14.1 mm Hg (P < .01 for all). Per-group analysis showed significant OSBP reduction for groups 1 and 2. Patients with isolated systolic hypertension had a significantly smaller reduction in OSBP after 6 months compared with patients with combined systolic/diastolic hypertension (-16.2 mm Hg ± 18.5 vs -9.9 mm Hg ± 33.4; P < .005)., Conclusions: Use of the RDN system was feasible and safe in this phase I study. Significant blood pressure reductions were observed over 6 months, although less in patients with isolated systolic hypertension., (Copyright © 2018 SIR. All rights reserved.)

Background/aim: Novel techniques for liver parenchymal transection have emerged and they are available to the hepatobiliary surgeon. The aim of our study was to compare two types of ultrasonic scalpels (Lotus and Harmonic) and examine how they perform either alone or in combination with the SonaStar ultrasonic surgical aspiration system regarding postoperative bleeding and bile leakage., Patients and Methods: Our prospectively maintained database of patients who underwent liver resections in our Department was reviewed. One hundred and two patients with solid liver lesions underwent liver resection by a senior hepatobiliary surgeon in our department during a period of 51 months. They were divided into four groups according to the devices that were used for liver parenchymal transection., Results: Patients were divided into the following groups: group 1: Lotus, 32 patients (31.4%); group 2: Lotus+SonaStar, 27 patients (26.5%); group 3: Harmonic, 27 patients (26.5%); group 4: Harmonic+SonaStar, 16 patients (15.7%). There were 5 cases of postoperative bleeding and 9 cases of postoperative bile leakage. No significant difference was found concerning postoperative bleeding (group 1: 2/32; 6.3%, group 2: 2/27; 7.4%, group 3: 0/27; 0%, group 4: 1/16; 6.3%) (p=0.577). Furthermore, no actual difference was detected in terms of postoperative bile leakage (group 1: 2/32; 6.3%, group 2: 3/27; 11.1%, group 3: 3/27; 11.1%, group 4: 1/16; 6.3%) (p=0.866)., Conclusion: Both Lotus and Harmonic ultrasonic scalpels provide adequate and similar results concerning postoperative hemorrhage and cholorrhea., (Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Purpose: Ultrasonic scalpel (UC) and monopolar electrocautery (ME) are standard equipment for soft tissue surgery. The aim of the present study was to compare intraoperative and postoperative patterns of patients using either UC or ME for skin incisions in neck dissection., Material and Methods: In a prospective randomized study of 30 patients, the thermal effects of UC (n = 15) and ME (n = 15) were examined using real-time infrared thermographic imaging. Additionally, tissue damage was evaluated histopathologically. The other measured variables were operation and bleeding time, postoperative pain score (only neck incision area), in-patient time, and complications., Results: UC significantly reduces the thermal effects, compared to ME (p < 0.001). The mean depth of tissue damage (i.e., necrosis) was 272.7 μm for UC and 284.7 μm for ME with no significant difference (p = 0.285). From the third postoperative day, patients treated using UC had noticeably less pain in the neck incision area (t3 p = 0.010; t4 p < 0.001; t5 p < 0.005). Cutting time was reduced for ME by 36.1 s (p < 0.001) and the bleeding time was decreased by 40.9 s for UC (p < 0.001). The total preparation time was the same (p = 0.402). When comparing in-patient time (p = 0.723), as well as complications, no significant differences were seen., Conclusion: UC results in less postoperative pain and less bleeding in the neck incision area. Accordingly, UC is superior to ME for skin incisions in neck dissection.

Background: Harmonic focus (HF) was introduced in thyroid surgery in an effort to reduce operation time and complications., Objective: The present study aimed to compare function of superior laryngeal nerve and incidence of other postoperative complications in total thyroidectomies using HF and conventional ligation (CL)., Methods: The trial is a randomized single-center, single-blinded study. Patients aged ≥ 18 years scheduled for total thyroidectomy were considered for participation. An ultrasonic dissector was used for coagulation and cutting in the HF group, while the standard technique was used in the CL group. Demographic, surgical data, and complications were recorded. Data were analyzed using SPSS for Windows., Results: Of 244 eligible patients, data of 206 patients who completed the study were analyzed. The groups were similar in terms of age, sex, and indication for operation. The mean operative time in the HF group was significantly shorter than that in CL group (p=0.01). Drain necessity, duration of drainage, duration of postoperative hospitalization, and the incidence of postoperative complications was similar in the groups (p>0.05). The external branch of the superior laryngeal nerve and recurrent laryngeal nerve palsy were noted in three and two patients in the HF group and in two and one patients in the CL group at 6 months., Conclusion: To the best of our knowledge, this is the first study comparing conventional technique with HF in total thyroidectomy, focusing on the function of the external branch of the superior laryngeal nerve using laryngostroboscopy; results showed that HF is as safe as the conventional technique., (Copyright © 2017. Published by Elsevier Taiwan.)

Background: Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease., Methods: This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871., Findings: Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head frame, six patients), and transient high blood pressure (during the procedure, five patients). Transient facial asymmetry (one patient) and moderate impulsivity (two patients) were also recorded. The mean MDS-UPDRS III score in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state (16·6 [SD 2·9] vs 7·5 [3·9]) and by 47% in the on-medication state (11·9 [3·1] vs 5·8 [3·5])., Interpretation: MRI-guided focused ultrasound unilateral subthalamotomy was well tolerated and seemed to improve motor features of Parkinson's disease in patients with noticeably asymmetric parkinsonism. Large randomised controlled trials are necessary to corroborate these preliminary findings and to assess the potential of such an approach to treat Parkinson's disease., Funding: Fundación de investigación HM Hospitales and Insightec., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: To describe the feasibility and assess the safety of using an ultrasonic bone aspirator in endoscopic ear surgery., Methods: Five temporal bones were dissected via endoscopic ear surgery using a Sonopet ultrasonic bone aspirator. Atticoantrostomy was undertaken. Another four bones were dissected using routine endoscopic equipment and standard bone curettes in a similar manner. Feasibility and safety were assessed in terms of: dissection time, atticoantrostomy adequacy, tympanomeatal flap damage, chorda tympani nerve injury, ossicular injury, ossicular chain disruption, facial nerve exposure and dural injury., Results: The time taken to perform atticoantrostomy was significantly less with the use of the ultrasonic bone aspirator as compared to conventional bone curettes., Conclusion: The ultrasonic bone aspirator is a feasible option in endoscopic ear surgery. It enables easy bone removal, with no additional complications and greater efficacy than traditional bone curettes. It should be a part of the armamentarium for transcanal endoscopic ear surgery.

The discovery that ultrasound waves could be focused inside the skull and heated to high temperatures at a focal point goes back to 1944. However, because the skull causes the ultrasound waves to attenuate and scatter, it was believed that application of this technology would be difficult, and that it would be impossible to use this approach in the surgical treatment of intracranial diseases. Eventually, magnetic resonance image guided focused ultrasound (MRgFUS) surgery began being used to treat uterine fibroids, breast cancer and bone metastasis and locally confined prostate cancer. In the first ten years of the 21st century, new developments in this technology have been achieved, broadening the scope of practical application, and treatment is now being performed in various countries around the world. In 2011, third-generation transcranial focused ultrasound made it possible to use thermocoagulation and create intracranial lesions measuring 2 to 6 mm in diameter with a precision of around 1 mm. It was also possible to produce MR images which relay information of temperature changes in real time, enabling a shift from reversible test heating to irreversible therapeutic heating. This gave rise to the possibility of a minimally-invasive treatment with outcomes similar to those of conventional brain surgery. This method is paving the way to a new future not only in functional neurosurgery, but in cranial neurosurgery targeting conditions such as epilepsy and brain tumors, among others. In this paper, we describe the current state and future outlook of magnetic resonance image guided focused ultrasound, which uses computed tomography (CT) bone images in combination with MRI monitoring of brain temperature.

Objective: Pulmonary artery branch sealing in video-assisted thoracoscopic surgical lobectomy is usually achieved with vascular endostaplers. Iatrogenic pulmonary artery injury may be caused by endostaplers. We evaluated the safety of pulmonary artery sealing with an ultrasonic energy vessel-sealing device in a phase I clinical trial evaluating in vivo safety of the device during open lobectomy., Methods: Patients scheduled to undergo elective open (thoracotomy) pulmonary lobectomy were prospectively enrolled. Target sample size was 10 patients. Pulmonary artery diameter was measured intraoperatively. All branches ≤7 mm were divided with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed in a standard fashion. Intraoperative and postoperative bleeding were strictly recorded., Results: Eighteen patients were prospectively enrolled. Eight patients were not amenable to pulmonary artery sealing with the device. In the 10 patients included in the analysis, a total of 14 pulmonary arteries were sealed with the ultrasonic device. The mean vessel diameter was 5 mm (range, 2-7 mm). One patient underwent reoperation for bronchial artery bleeding (vessel not sealed with device). There was no intra- or postoperative bleeding related to ultrasonic pulmonary artery sealing. There was no postoperative mortality., Conclusions: Pulmonary artery sealing for vessels with diameter ≤7 mm was safely achieved with an ultrasonic energy vessel-sealing device in open lobectomy. The use of ultrasonic energy vessel-sealing devices in video-assisted thoracoscopic surgical lobectomy may have the advantage of making small, short, pulmonary artery branch sealing safer than with vascular endostaplers. Further studies are necessary before widespread application in lobectomy, including video-assisted thoracoscopic surgical lobectomy., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To compare the postoperative pain following bipolar diathermy scissors tonsillectomy (higher temperature dissection) with harmonic scalpel tonsillectomy (lower temperature dissection)., Methods: Sixty patients aged 7-40 years planned for tonsillectomy with no other concurrent surgery were randomised to either bipolar diathermy scissors or harmonic scalpel as surgical technique. Blinded to the surgical technique, the patients recorded their pain scores (VAS, 0-10) at awakening and the worst pain level of the day in the postoperative period. All intake of pain medication was also recorded., Results: No statistically significant differences were found between the two groups regarding postoperative pain levels or consumption of pain medication., Conclusion: Usage of the harmonic scalpel does not render less postoperative pain following tonsillectomy when compared with usage of the bipolar diathermy scissors.

Aim: The incidence of non-obstetrical complications after cervical conization is low, and women receive minimal postsurgical attention. In this study, we investigated whether women felt any discomfort after undergoing conization by harmonic scalpel, one of the hot-knife devices widely used in Japan., Methods: Eighty-eight women aged 20-47 years who were still experiencing menstrual cycles and had undergone harmonic conization participated in a questionnaire survey regarding perisurgical complications and postsurgical changes in gynecological issues. Correlations between the occurrence of postoperative complications and clinical characteristics were analyzed., Results: Regarding the complications immediately after the surgery, 37 women (45.1%) complained of postoperative bleeding that was heavier than their usual menstrual bleeding, and 14 (18.2%) reported that the postsurgical bleeding was greater than they had expected. Regarding long-term gynecological changes after conization, 27 women (30.7%) reported that the duration of menstrual bleeding had increased after the surgery, 20 (22.7%) indicated that pain during menstruation had changed, and 40 (45.5%) stated that the amount of menstrual bleeding had changed. Irregular genital bleeding outside of menstruation appeared in 23 women (26.4%). Additionally, 24 (27.6%) of the women reported that the conization procedure negatively impacted their quality of life. Finally, the occurrence of long-term atypical bleeding after the surgery was significantly correlated with the thickness and circumference of the tissue specimen., Conclusion: Several women experienced a significant change in quality of life after harmonic conization. Women who undergo conization should receive a comprehensive preoperative overview of the procedure and attentive postsurgical care., (© 2017 Japan Society of Obstetrics and Gynecology.)

Root end resections play an important role in the success of periapical surgery. Beveling of the root end resections can vary significantly depending on the surgical technique, the root and canal morphology. The intention of this article was to clinically assess the root resections bevels and to estimate their relation to applied periapical surgeries. A prospective clinical study consisted of sixty periapical surgeries performed on teeth with chronic periapical lesions. Thirty periapical surgeries were performed in a conventional manner, while thirty were contemporary ultrasonic surgeries. Following the completion of strictly planned and performed intraoperative procedures, the resection bevels were assessed. To obtain the real bevel angles a compass was used. Root resections were significantly less beveled in all teeth operated with contemporary ultrasonic surgery, with mean values between 2.1° to 7.8°. The number of roots and their dilacerations didn't influence the root resection bevel. For comparison, root resections were significantly beveled in all conventionally operated teeth, with mean values of 46°. Due to the technical limitations of the conventional periapical surgery, mandibular premolars were exclusively operated with ultrasonic periapical surgery, with mean values of resection bevel not exceeding 20.7°. Significantly lesser resection bevel associated with ultrasonic periapical surgery contributes to root preservation and favorable surgical outcome.

To manage primary spontaneous pneumothorax, we use an alternative technique for bleb resection and we induce pleurodesis with an ultrasonic-driven scalpel. This technique was successfully performed in nine consecutive patients with primary spontaneous pneumothorax with small (<20 mm) and limited number of blebs (<2) and without significant underlying lung disease. After identification of air leakage, the jaws of the instrument were clamped onto the bleb and included a margin of normal lung. Power level 3 energy was applied to resect the bleb and to seal the parenchyma. Finally, the parietal pleura was partially scarified using the same instrument to achieve pleurodesis. Histologic findings showed complete sealing of the resection line by coagulative tissue., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Integrated devices incorporating ultrasonic and bipolar technology have been used in laparoscopic surgery, however, are not yet incorporated into open operations. Here, we compare thermal spread and recurrent laryngeal nerve (RLN) functional data of the integrated THUNDERBEAT Open Fine Jaw device, the bipolar Ligasure Small Jaw, and the ultrasonic Harmonic Focus for open thyroidectomy., Materials and Methods: The three energy devices were compared in a live porcine model using three tissue types including liver, muscle, and thyroid. The devices were fired three times on each energy setting, and the thermal spread was measured by thermocouples that were inserted in surrounding tissues at 1-mm intervals. To determine RLN injury, devices were fired at successive 1-mm increments from the RLN until the monitor signal was lost., Results: When comparing heat generated across these devices at 1 mm, the peak temperature (Celsius) reached in liver tissue was observed with the ultrasonic device (115.4 ± 86.7), in muscle tissue with the integrated device (104.2 ± 82.1), and in thyroid with the bipolar device (81.4 ± 41.3). Temperatures generated at individual settings on each device were similar (P = 0.11-0.81). RLN injury occurred after firing on manually approximated tissue 1-mm away from the RLN for all devices; however, there was no signal loss at ≥2 mm., Conclusions: Heat transfer was similar among all devices with the exception of the ultrasonic device when used in the liver, which showed higher temperatures. Liver tissue showed the most consistent results. RLN injury did not occur if the devices were fired on manually approximated tissue ≥2 mm from the nerve., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Iatrogenic diaphragmatic hernia following laparoscopic left colectomy for splenic flexure cancer. An unusual complication Diaphragmatic hernias are a migration of abdominal structures into the thorax via a diaphragmatic defect; they may be classified as congenital or acquired and acquired hernias can be hiatal, traumatic or iatrogenic, generally complications of thoracic or abdominal surgery. We report a case of iatrogenic diaphragmatic hernia after a laparoscopic left colectomy for splenic flexure tumor; to our knowledge, in literature this case is the first reported. A 51-years-old woman was readmitted to our Hospital on 11th post-operative day for bowel occlusion and a CT - scan revealed left diaphragmatic herniation with fluid dilatation of the small bowel that appeared in the left hemithorax. Laparoscopic surgery resolution was decided and after the reduction of the small bowel in the abdomen we closed the defect using two direct absorbable auto-block hemi-continuous sutures that were covered by a synthetic absorbable mesh. Probably we didn't notice a minimal injury of the left diaphragm caused by ultrasonic scalpel and we can suppose that this delay in presentation may be a result of the gradual enlargement of a microscopic lesion. Patient's gas exchanges were good during surgery and during post-operative course., Key Words: Diaphragmatic hernia, Iatrogenic, Laparoscopy, Left colectomy, Ultrasonic scalpel.

Objective: To report postoperative outcomes after rectal shaving for deep endometriosis infiltrating the rectum., Design: Retrospective study using data prospectively recorded in the CIRENDO database., Setting: University tertiary referral center., Patient(s): One hundred and twenty-two consecutive patients whose follow-up observation ranged from 1 to 6 years., Intervention(s): Rectal shaving performed using ultrasound scalpel or scissors and plasma energy in 68 and 54 women, respectively., Main Outcome Measure(s): Postoperative digestive function assessed using standardized gastrointestinal questionnaires: the Gastrointestinal Quality of Life Index (GIQLI) and the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)., Result(s): Nodules were between 1 and 3 cm, <1 cm, and >3 cm in diameter, in 73.7%, 11.5%, and 14.8% of cases, respectively. They were located on the middle (49.2%) and upper rectum (50.8%). Clavien-Dindo 3a, 3b, 4a, and 4b complications occurred in 0.8%, 5.7%, 1.6%, and 0.8% of cases, respectively. Excepting two rectal fistulas (1.6%), the majority of complications were not related to rectal shaving itself. Gastrointestinal scores revealed statistically significant improvement in digestive function and pelvic pain at 1 and 3 years after rectal shaving, but not constipation. Rectal recurrences occurred in 4% of patients, 2.4% of whom had segmental resection, 0.8% shaving, and 0.8% disc excision. Three years postoperatively, the pregnancy rate was 65.4% among patients with pregnancy intention, 59% of whom conceived spontaneously., Conclusion(s): Our data suggest that rectal shaving is a valuable treatment for deep endometriosis infiltrating the rectum, providing a low rate of postoperative complications, good improvement in digestive function, and satisfactory fertility outcomes., (Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Specific complications after thyroid surgery, such as recurrent laryngeal nerve injury (RLN) or hypoparathyroidism, are feared because they may give rise to a lifelong disability for the patient. The aim of this study was to evaluate the possible association between the types of device used (bipolar vs ultrasound-based harmonic scalpel defined Harmonic Focus) and major postoperative complications., Methods: During a 1-year period, between October 2010 and October 2011, Italian Endocrine Surgery Units affiliated with the Italian Endocrine Surgery Units Association collected data on all consecutive patients older than 18 years who had undergone primary total thyroidectomy, near total thyroidectomy, and completion thyroidectomy. The data were included in a dataset, listing demographic variables, details on the surgical procedure, and 2 major complications of the thyroid surgery: postoperative RLN palsy/hypomobility and hypocalcemia., Results: Our population comprised 1,846 subjects (78.6% women, median age 52 years). Six hundred four (32.7%) subjects underwent thyroidectomy by bipolar forceps and 1,242 (67.3%) by ultrasonic device. The risk of hypocalcemia in subjects undergoing thyroidectomy by ultrasonic device was similar to those undergoing thyroidectomy by bipolar after adjusting for sex, type of thyroidectomy, and central lymphadenectomy (odds ratio .94, 95% confidence interval .76 to 1.17). Subjects who underwent thyroidectomy by ultrasonic device had a lower risk of RLN paralysis compared with those undergoing thyroidectomy by bipolar forceps also after adjusting for central lymphadenectomy (odds ratio .39, 95% confidence interval .2 to .7)., Conclusion: This multicenter study acknowledges the value of the ultrasonic device as a protective factor only for RLN palsy, confirming nodal dissection as a risk factor for postoperative hypocalcemia and vocal folds disorders., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Edema and ecchymosis are common complications of rhinoplasty. Modifications to osteotomy may reduce edema and ecchymosis and ameliorate postoperative discomfort in patients who undergo rhinoplasty., Objectives: The authors performed osteotomy with conventional instruments or with an ultrasonic device and compared these methods with respect to the severities of ecchymosis and edema in the early postoperative period., Methods: Fifty-six patients who underwent primary rhinoplasty with medial oblique, low-to-high internal osteotomy performed conventionally or with an ultrasonic device were evaluated in a prospective study. Photographs of the patients on postoperative days 3 and 7 were scored for ecchymosis and edema by 2 physicians who did not perform the operations and were blinded to the osteotomy procedure., Results: Ecchymosis scores on postoperative days 3 and 7 and edema scores on postoperative day 3 were significantly higher for the 22 patients who underwent conventional osteotomy than for the 34 patients who underwent ultrasonic osteotomy, as scored by both examiners. Edema scores on postoperative day 7 were significantly higher for conventional than for ultrasonic osteotomy as assessed by 1 examiner but were not significantly different as determined by the other examiner., Conclusions: The results of this comparative study suggest that rhinoplasty with ultrasonic osteotomy is associated with less edema and ecchymosis in the early postoperative period than is rhinoplasty with conventional osteotomy., Level of Evidence: 3 Therapeutic., (© 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

Objective: Ultrasonic dissection (UsD) has been used in laparoscopic cholecystectomy (LC), though it is not the golden standard technique. Applying UsD to cholecystectomy by minilaparotomy (MC) is less common and there are no prospective randomized trials comparing these two techniques. Therefore, we conducted the present study to investigate the use of the UsD in the MC versus the LC procedure., Material and Methods: Initially 104 patients with non-complicated symptomatic gallstone disease were randomized into MC (n = 53) or LC (n = 51) groups, both groups using UsD, over a period of 2 years (2013-2015). The study groups were similar in terms of age and American Society of Anesthesiologists (ASA) physical status score., Results: The demographic variables and the surgical data were similar in the study groups. Similar low postoperative pain scores were reported in the two study groups during the first four hours after surgery. The incidence of nausea/vomiting was similar between the two study groups, 47% in the MC group versus 42% in the LC group. However, the patients in the MC group were treated more frequently with antiemetics, the incidence being 39% in the MC group versus 21% in the LC group (p = 0.02). The pain at rest at 24h after the surgery was similar in the two study groups, but the LC patients reported less pain at the normal activity, the mean of numerical rating scale (NRS) of 0-10 score being 3.9 in the MC group versus 2.9 in the LC group (p = 0.05), and the pain at the quick movement/coughing, the mean NRS being 4.9 in the MC group versus 3.2 in the LC group (p = 0.005). The length of sick leave was 17.4 days in the MC group and 14.4 days in the LC group (p = 0.05)., Conclusion: Our results suggest that both MC and LC are feasible and safe options for mini-invasive cholecystectomy. A new finding with clinical relevance in the present work is a relatively similar short-term outcome in the MC and LC although the LC patients reported significantly lower pain score 24 hours postoperatively and a shorter convalescence.

Objective: The aim of the study was to evaluate the sympathectomy procedures for primary hyperhidrosis in terms of complications and effectiveness., Methods: From January 2010 to September 2012 we performed 130 sympathectomies in 65 patients, 27 males (42%) and 38 females (58%). Electrocoagulation was used in 20 procedures (15%), ultrasonic scalpel in 54 (42%), and radiofrequency dissector in 56 (43%). Seven patients (11%) underwent bilateral sympathectomy in the same surgical session, while in 58 (89%) the right surgical approach was delayed 30 days from the first procedure., Results: We noticed 12 complications (9%): (a) chest pain in 6 patients (4 with electrocoagulation, 1 with ultrasonic scalpel, and 1 with radiofrequency dissector), which disappeared in 20 ± 1 day; (b) paresthesias in 3 electrocoagulation patients, was solved in 23 ± 5 days; (c) bradycardia in 1 ultrasonic patient, normalized in 4th postoperative hour; (d) unilateral relapse in 2 electrocoagulation patients after the second side approach, positively treated in 1 patient by resurgery in video-assisted thoracoscopy (VAT). The quality-adjusted life year and the quality of life evaluation revealed a statistically significant improvement (p = 0.02) in excessive sweating and general satisfaction after surgery, with Ultracision and LigaSure showing better findings than electrocoagulation., Conclusion: The latest generation devices offered greater efficacy in the treatment of hyperhidrosis, minimizing complications and facilitating the resumption of normal work and social activity of patients., (Georg Thieme Verlag KG Stuttgart · New York.)

Aims: Circumferential ablation of renal sympathetic nerves using catheter-based ultrasound energy was studied in a preclinical in vivo model. The aim was to investigate the benefit of cooling the arterial wall and the extent of renal nerve injury based on histopathology, and to correlate the injury with kidney norepinephrine levels., Methods and Results: Computer simulations of the ultrasound transducer within the cooling balloon demonstrated a circumferentially uniform heating profile. In vivo characterisation was performed in 10 normotensive pigs. Nine were treated bilaterally with ultrasound and survived for seven days (n=8) or were sacrificed acutely (n=1). Acutely, TTC staining of the renal arteries treated with ultrasound energy in the presence of cooling demonstrated viable tissue consistent with preservation of the arterial medial layer. Histological studies demonstrated no endothelial injury and minimal to no injury to the media of the renal arterial wall at seven days. Overall, circumferential nerve damage with up to 76% of nerve bundles affected within 7.5 mm of the arterial lumen was observed. Kidney norepinephrine (NEPI) levels were significantly reduced in all animals compared to a non-treated control animal (n=1) and correlated with the degree of nerve damage. A greater reduction in NEPI and a greater percentage of affected nerves was observed in arteries treated with two or three bilateral ultrasound emissions., Conclusions: Catheter-based ultrasound delivered within a cooling balloon is effective at targeting the majority of the renal nerves circumferentially, resulting in significantly decreased kidney NEPI levels without damaging the arterial wall in a porcine model.

Introduction: Laparoscopic gastrectomy (LG) with D2 or more extended lymphadenectomy for advanced gastric cancer is technically demanding. Collateral thermal damage to the pancreas secondary to energized dissection during lymphadenectomy has been reported. We retrospectively compared the pancreatic damage between LG and open gastrectomy (OG) by measuring the amylase concentration of the drainage fluid and analyzing heat conductance to the pancreas with a porcine model., Methods: We evaluated the data of 105 consecutive patients with gastric adenocarcinoma who underwent LG or OG with lymph node dissection. Digital thermography was used to evaluate the extent of heat conductance to the pancreas during suprapancreatic lymph node dissection by either an ultrasonically activated device or electric cautery in a porcine model., Results: The incidence of clinically relevant pancreatic fistula formation was not statistically significant between the LG and OG groups (3/57 vs 0/48 cases; P = 0.306). However, the median amylase concentrations of the drainage fluid on postoperative days 1 and 3 were 1355.7 and 308.8 IU/L, respectively, in the LG group and 369.0 and 125.8 IU/L, respectively, in the OG group (P < 0.001). In the experimental model, more time was required to cool the surface of the pancreas to < 40°C in the ultrasonically activated device group than in the electric cautery group (10.1 ± 5.2 vs 5.2 ± 3.0 s; P = 0.013)., Conclusions: Unavoidable collateral thermal damage to the pancreas associated with electrosurgical devices might exist during LG. Heat conductance must be given more consideration in extended lymph node dissection., (© 2015 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and Wiley Publishing Asia Pty Ltd.)

Aim: To investigate celiac artery variations in gastric cancer patients and the impact on gastric cancer surgery, and also to discuss the value of the ultrasonic knife in reducing the risk caused by celiac artery variations., Methods: A retrospective analysis was conducted to investigate the difference in average operation time, intraoperative blood loss, number of harvested lymph nodes, average postoperative drainage within 3 d, and postoperative hospital stay between the group with vascular variations and no vascular variations, and between the ultrasonic harmonic scalpel and conventional electric scalpel surgery group., Results: One hundred and fifty-eight cases presented with normal celiac artery, and 80 presented with celiac artery variation (33.61%). The average operation time, blood loss, average drainage within 3 d after surgery in the celiac artery variation group were significantly more than in the no celiac artery variation group (215.7 ± 32.7 min vs 204.2 ± 31.3 min, 220.0 ± 56.7 mL vs 163.1 ± 52.3 mL, 193.6 ± 41.4 mL vs 175.3 ± 34.1 mL, respectively, P < 0.05). In celiac artery variation patients, the average operation time, blood loss, average drainage within 3 d after surgery in the ultrasonic harmonic scalpel group were significantly lower than in the conventional electric scalpel surgery group (209.5 ± 34.9 min vs 226.9 ± 29.4 min, 207.5 ± 57.1 mL vs 235.6 ± 52.9 mL, 184.4 ± 38.2 mL vs 205.0 ± 42.9 mL, respectively, P < 0.05), and the number of lymph node dissections was significantly higher than in the conventional surgery group (25.5 ± 9.2 vs 19.9 ± 7.8, P < 0.05)., Conclusion: Celiac artery variation increases the difficulty and risk of radical gastrectomy. Preoperative imaging evaluation and the application of ultrasonic harmonic scalpel are conducive to radical gastrectomy.

Background: To evaluate the role of an ultrasound (US) debridement system to treat conservatively patients with poor medical conditions who presented with infection of a prosthetic vascular graft in the lower extremities., Methods: Data of all patients who underwent debridement of the grafts and/or surrounding tissue using an ultrasonic generator (Genera, Italia Medica, Milan, Italy) were recorded and retrospectively reviewed. Based on cultures, patients received specific antibiotic therapy. Partial graft removal, sartorius muscle flap rotation, or negative pressure wound treatment (NPWT) was selectively used. Early and late morbidity and mortality and recurrence were analyzed., Results: Thirteen patients (median age, 72 years; range, 57-92 years; 8 men) were treated (12 Szilagyi grade III and 1 grade II infections) with US debridement without removing the graft (8 cases) or with partial excision and "in situ" reconstruction with a silver prosthetic graft (5 cases). Sartorius flap rotation was associated in 6 and NPWT in 1 case. One patient died perioperatively because of pulmonary edema because of sepsis secondary to treatment failure. Estimated freedom from reinfection was 90.9 ± 9% at 6 months and 77.9 ± 14% at 1 and 2 years. Estimated limb survival was 78.7 ± 13% at 6 months, 65.6 ± 16% at 1 year, and 52.5 ± 18% at 2 years., Conclusions: US debridement proved to be a valuable aid in the treatment of patients with infected grafts and poor medical conditions. Used in conjunction with antibiotics, it allowed us to be more conservative without compromising the chance of success., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: Use of ultrasonic surgical instrument is gaining popularity for dissection and coagulation in open surgery. However, there is still no consensus on the efficacy and safety of its use compared with conventional surgical technique in open gastrectomy for gastric cancer. The aim of this meta-analysis was to evaluate the role and surgical outcomes of ultrasonic dissection (UD) compared with conventional electrocautery (EC)., Methods: A systematic literature search was performed to identify all studies comparing UD and EC in gastric cancer surgery. Intraoperative and postoperative outcomes were compared using weighted mean differences (WMDs) and odds ratios (ORs)., Results: Five studies were included in this meta-analysis, comprising 489 patients. Meta-analysis results showed that compared with EC, UD was associated with significantly shorter operation time (P = 0.03), less intraoperative blood loss (P = 0.002), lower morbidity (P = 0.02), and reduced postoperative hospital stay (P = 0.03). However, there was no significant difference between the two surgical techniques with regards to postoperative abdominal drainage (P = 0.17), and total cost in hospital (P = 0.59)., Conclusions: Compared to EC, the use of UD during open gastrectomy can provide several improved outcomes for operation time, intraoperative blood loss, overall morbidity, and postoperative hospital stay. It appears that UD can be used instead of conventional EC in open gastric cancer surgery, although more larger trials with long follow-up should be performed., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background/aims: A soft-coagulation system (SCS) was introduced as an effective device to reduce blood loss in hepatectomy. Here we evaluated the efficacy of a two-surgeon technique using precoagulation by an SCS and the Cavitron Ultrasonic Surgical Aspirator (CUSA) for liver transection., Methodology: The 163 patients with liver tumors were divided into two groups (conventional group and two-surgeon group). Liver transection was conducted using saline-coupled bipolar electrocautery and CUSA in 102 patients (conventional group). In 61 patients (the two-surgeon group), a two-surgeon technique using precoagulation by an SCS and CUSA for liver resection was performed., Results: The median blood loss was significantly less in the two-surgeon group compared to the conventional group (354.8 mL vs. 557.8 mL, respec tively: p = 0.0011). The postoperative hospital stay was significantly shorter in the two-surgeon group compared to the conventional group (12.7 days vs. 15.5 days, p = 0.0035)., Conclusions: The two-surgeon technique using precoagulation by an SCS and CUSA was significantly reduced blood loss during liver transection, and associated with low morbidity and mortality. This technique may be useful for many hepatobiliary surgeons.

Objective: To evaluate the use of ultrasonic advanced energy in reducing the occurrence of symptomatic lymphocele and its related complications in laparoscopic extra-peritoneal para-aortic lymphadenectomy in patients with gynecological cancer., Study Design: A retrospective cohort study of consecutive patients in a tertiary referral center identified 2 groups of patients, undergoing laparoscopic extra-peritoneal para-aortic lymphadenectomy with or without the use of ultrasonic advanced energy. Surgery time, hospital stay, number of retrieved nodes and lymphocele requiring treatment were studied. Results were also compared between trained and trainee surgeons., Results: 163 patients were scheduled for laparoscopic extra-peritoneal para-aortic lymphadenectomy: 81 treated using bipolar energy (control group: group 1) between August 1999 and January 2005, and 82 treated using ultrasonic advanced energy (study group: group 2) between July 2010 and March 2014. The main indication (90% in group 1, 61% in group 2) was advanced cervical carcinoma (stage IB2 and above). Ultrasonic advanced energy significantly decreased operative time (p=0.001) and intra-operative bleeding (p=0.01) and increased the number of para-aortic nodes retrieved (p=0.02). There was no significant difference in hospital stay or lymphocele requiring treatment (8.6% in group 1, 8.5% in group 2: p=0.98). For senior than for junior surgeons, surgery time was shorter but not significantly (p=0.80) and postoperative lymphocele rates were identical., Conclusion: Ultrasonic advanced energy may provide benefit in laparoscopic para-aortic lymphadenectomy, facilitating surgical ergonomics, but did not decrease post-surgery lymphocele., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: An inguinal exposure provides adequate access to the femoral vessels, but with it comes risk of wound complications. Ultrasonic shears and blades have been shown to decrease complications in other anatomic dissections. There remains a paucity of literature on the usage of ultrasonic harmonic dissection techniques in the vascular surgery realm. This study depicts the initial experience using HARMONIC FOCUS(®) (HF) for inguinal exposure in both endovascular abdominal aortic aneurysm repair (EVAR) and thoracic endovascular abdominal aortic aneurysm repair (TEVAR) operations., Methods: Patients who underwent an EVAR or a TEVAR operation with an open inguinal exposure during an 11-month period were included., Results: Over the study period, 30 patients underwent an endovascular aortic aneurysm repair with open inguinal exposure; 25 patients had an EVAR and 5 patients underwent a TEVAR. Conventional electrocautery was used in 32 inguinal exposures and HF was used in 28. Six inguinal wounds developed postoperative complications in the study (10%). These occurred in 5 patients over a 4-month follow-up period. Conventional electrocautery dissection was used in 5 of the wounds (15.6%) and ultrasonic harmonic scalpel was used in 1 (3.6%). The complications consisted of 3 lymphocutaneous fistulas, 1 wound infection and 2 lymphoceles without fistula formation., Conclusions: We present the initial experience of HF dissection in inguinal exposure in a small population of patients who underwent EVAR and TEVAR. In this study, we demonstrate this technique may be associated with a lower incidence of postoperative wound complications when compared with conventional electrocautery inguinal exposure., (Copyright © 2014 Elsevier Inc. All rights reserved.)