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 .

Ultrasonic bone curette-assisted unilateral approach for bilateral decompression with MIS-TLIF for severe lumbar spinal stenosis.

PURPOSE: We aimed to evaluate the clinical efficacy of bilateral decompression with minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) assisted by an ultrasonic bone curette (UBC) for treating severe degenerative lumbar spinal stenosis (DLSS) and traditional tool laminectomy decompression MIS-TLIF for treating severe DLSS. METHODS: The clinical data of 128 patients with single-segment severe DLSS who were admitted between January 2017 and December 2021 were retrospectively analyzed. Among them, 67 patients were treated with unilateral fenestration and bilateral decompression MIS-TLIF using an ultrasonic bone curette (UBC group), whereas 61 patients were treated with unilateral fenestration and bilateral decompression MIS-TLIF using traditional tools (traditional group, control). A visual analog scale (VAS) was used to evaluate back and lower limb pain before the operation,immediate postoperative, and one week, 3, 6, 12, and 24 months after the operation. Oswestry disability index (ODI) and Zurich claudication score (ZCQ) were employed to evaluate the improvement in low back and lower limb function. At the last follow-up, the Bridwell bone graft fusion standard was utilized to evaluate bone graft fusion. RESULTS: The decompression time of laminectomy was significantly shorter in the UBC group than in the traditional group (control group), and the intraoperative blood loss and postoperative drainage volume were significantly less in those in the control group (P < 0.05). The VAS, ODI, and ZCQ scores of the two groups after the operation were significantly improved compared to those before the operation (P < 0.05). The UBC group had better VAS back scores than the control group immediate postoperative and one week after the operation(P < 0.05). The UBC group had better VAS lower limb scores than the control group immediate postoperative (P < 0.05).The incidence of perioperative complications, hospitalization time, dural sac cross-sectional area (CSA), and dural sac CSA improvement rate did not differ significantly between the two groups (P > 0.05). VAS and ODI scores did not differ significantly between the two groups before,three, six months, one year, and two years after surgery (P > 0.05). The ZCQ scores did not differ significantly between the two groups before the operation at one week, six months, one year, and two years after the operation (P > 0.05). According to the Bridwell bone graft fusion standard, bone graft fusion did not occur significantly between the two groups (P > 0.05) at the last follow-up. CONCLUSIONS: UBC unilateral fenestration bilateral decompression MIS-TLIF in treating severe DLSS can achieve clinical efficacy as traditional tool unilateral fenestration bilateral decompression MIS-TLIF and reduce intraoperative blood loss and postoperative drainage. It can also shorten the operation time, effectively reduce the work intensity of the operator, and reduce the degree of low back pain during short-term follow-ups. Therefore, this is a safe and effective surgical method.

Ultrasonic Fasciotomy for the Treatment of Chronic Plantar Fasciopathy: A Prospective Study.

OBJECTIVE: To evaluate the long-term efficacy and safety of an ultrasonic fasciotomy for plantar fasciopathy. DESIGN: Prospective observational study. SETTING: Tertiary care academic medical center. PARTICIPANTS: Patients with chronic plantar fasciopathy refractory to standard, conservative treatments were included in this study. INTERVENTIONS: Patients underwent ultrasonic fasciotomy of the plantar fascia. MAIN OUTCOME MEASURES: The primary outcome measures were change in visual analog scale at 12 and 52 weeks post-procedure compared with baseline as well as patients' self-reported satisfaction with the procedure. RESULTS: Sixty-seven patients were included. There was a significant improvement in visual analog scale at all follow-up time points, with an average overall improvement of 5.87 ( P < 0.0001). 94% of patients reported satisfaction with the outcomes of their procedure at 12 and 52 weeks. No procedural complications were seen. CONCLUSIONS: This study demonstrates that an ultrasonic fasciotomy is a safe and effective treatment option for chronic plantar fasciopathy, with continued symptom improvement and a high degree of patient satisfaction up to 52 weeks post-procedure. CLINICAL RELEVANCE: These findings suggest that an ultrasonic fasciotomy should be considered for patients with chronic plantar fasciopathy refractory to conservative treatments.

The Ultrasonic Bone Scalpel does not Outperform the High-Speed Drill: A Single Academic Experience.

BACKGROUND: Spinal decompression and osteotomies are conventionally performed using high-speed drills (HSDs) and rongeurs. The ultrasonic bone scalpel (UBS) is a tissue-specific osteotome that preferentially cuts bone while sparing the surrounding soft tissues. There is ongoing investigation into its ability to optimize peri- and postoperative outcomes in spine surgery. The purpose of this study was to compare the intraoperative metrics and complications during a transition period from HSD to UBS. METHODS: A single-institution, single-surgeon retrospective analysis was conducted of patients undergoing spine surgery from January 2020 to December 2021. Statistical analyses were performed to detect associations between the surgical technique and outcomes of interest. A P value < 0.05 was considered statistically significant. RESULTS: A total of 193 patients met the inclusion criteria (HSD, n = 100; UBS, n = 93). Multivariate logistic regression revealed similar durotomy (P = 0.10), nerve injury (P = 0.20), and reoperation (P = 0.68) rates. Although the estimated blood loss (EBL) and length of stay were similar, the operative time was significantly longer with the UBS (192.81 vs. 204.72 minutes; P = 0.03). Each subsequent surgery using the UBS revealed a 3.1% decrease in the probability of nerve injury (P = 0.026) but had no significant effects on the operative time, EBL, or probability of durotomy or reoperation. CONCLUSIONS: The UBS achieves outcomes on par with conventional tools, with a trend toward a lower incidence of neurologic injury. The expected reductions in EBL and durotomy were not realized in our cohort, perhaps because of a high proportion of revision surgeries, although these might be dependent on surgeon familiarity, among other operative factors. Future prospective studies are needed to validate our results and further refine the optimal application of this device in spine surgery.

High-Intensity Focused Ultrasound Surgery for Tumor Ablation: A Review of Current Applications.

The management of cancer with alternative approaches is a matter of clinical interest worldwide. High-intensity focused ultrasound (HIFU) surgery is a noninvasive technique performed under US or MRI guidance. The most studied therapeutic uses of HIFU involve thermal tissue ablation, demonstrating both palliative and curative potential. However, concurrent mechanical bioeffects also provide opportunities in terms of augmented drug delivery and immunosensitization. The safety and efficacy of HIFU integration with current cancer treatment strategies are being actively investigated in managing primary and secondary tumors, including cancers of the breast, prostate, pancreas, liver, kidney, and bone. Current primary HIFU indications are pain palliation, complete ablation of localized earlystage tumors, or debulking of unresectable late-stage cancers. This review presents the latest HIFU applications, from investigational to clinically approved, in the field of tumor ablation. Keywords: Ultrasound, Ultrasound-High Intensity Focused (HIFU), Interventional-MSK, Interventional-Body, Oncology, Technology Assessment, Tumor Response, MR Imaging © RSNA, 2023.

Intraoperative Ultrasound-Guided Conserving Surgery for Breast Cancer: No More Time for Blind Surgery.

BACKGROUND: Breast-conserving surgery (BCS) still remains a blind surgery despite all available tumor localization methods. Intraoperative ultrasound (IOUS) allows real-time visualization during all resection phases. METHODS: This was a prospective observational cohort study conducted at the Veneto Institute of Oncology between January 2021 and June 2022. Patients with ductal carcinoma in situ, T1-2 invasive cancer, or post-neoadjuvant tumors, suitable for BCS, were recruited. All breast cancer lesion types were included, i.e. solid palpable, solid non-palpable, non-solid non-palpable, and post-neoadjuvant treatment residual lesions. Eligible participants were randomly assigned to either IOUS or traditional surgery (TS) in a 1:1 ratio. The main outcomes were surgical margin involvement, reoperation rate, closest margin width, main specimen and cavity shaving margin volumes, excess healthy tissue removal, and calculated resection ratio (CRR). RESULTS: Overall, 160 patients were enrolled: 80 patients were allocated to the TS group and 80 to the IOUS group. IOUS significantly reduced specimen volumes (16.8 cm3 [10.5-28.9] vs. 24.3 cm3 [15.0-41.3]; p = 0.015), with wider closest resection margin width (2.0 mm [1.0-4.0] vs. 1.0 mm [0.5-2.0] after TS; p < 0.001). Tumor volume to specimen volume ratio was significantly higher after IOUS (4.7% [2.5-9.1] vs. 2.9% [0.8-5.2]; p < 0.001). IOUS yielded significantly better CRR (84.5% [46-120.8] vs. 114% [81.8-193.2] after TS; p < 0.001), lower involved margin rate (2.5 vs. 15%; p = 0.009) and reduced re-excision rate (2.5 vs. 12.5%; p = 0.032). CONCLUSIONS: IOUS allows real-time resection margin visualization and continuous control during BCS. It showed clear superiority over TS in both oncological and surgical outcomes for all breast cancer lesion types. These results disfavor the paradigm of blind breast surgery.

Clinic efficacy and safety of ultrasound-guided Mammotome-assisted surgery for patients with breast benign tumors.

OBJECTIVE: The aim of this study was to assess the efficacy of ultrasound-guided Mammotome-assisted resection vs. conventional open surgery for benign breast tumors. PATIENTS AND METHODS: From July 2019 to December 2020, 134 suitable patients with benign breast cancers treated at our institution (Breast Surgery Department) were recruited and randomly allocated (1:1) to receive either Mammotome-assisted tumor excision (observation group) or open surgery (control group). The primary endpoint was clinical effectiveness, with surgical outcomes, complications, and satisfaction as secondary endpoints. RESULTS: Mammotome-assisted surgery resulted in shorter operative time, scar length, and postoperative healing time and less intraoperative bleeding volume vs. open surgery (p<0.001). Mammotome-assisted surgery was associated with a significantly higher clinical efficacy vs. open surgery (p<0.05). Patients receiving Mammotome-assisted surgery had a lower incidence of complications vs. those given open surgery (p<0.05). A significantly higher satisfaction was observed in patients given Mammotome-assisted surgery vs. open surgery (p<0.05). CONCLUSIONS: In comparison to standard open surgery, ultrasound-guided Mammotome-assisted surgery provides a viable alternative for breast benign tumor removal with superior efficacy, shorter operating time, less trauma, higher safety, fewer complications, and higher patient satisfaction.

Improvement in Intraoperative Image Quality in Transcranial Magnetic Resonance-Guided Focused Ultrasound Surgery Using Transmitter Gain Adjustment.

INTRODUCTION: Transcranial magnetic resonance-guided focused ultrasound surgery (TcMRgFUS) has the advantage of allowing immediate evaluation of therapeutic effects after each sonication and intraoperative magnetic resonance imaging (MRI) to visualize the lesion. When the image shows that the lesion has missed the planned target and the therapeutic effects are insufficient, the target of the subsequent ablation can be finely adjusted based on the image. The precision of this adjustment is determined by the image quality. However, the current intraoperative image quality with a 3.0T MRI system is insufficient for precisely detecting the lesion. Thus, we developed and validated a method for improving intraoperative image quality. METHODS: Because intraoperative image quality is affected by transmitter gain (TG), we acquired T2-weighted images (T2WIs) with two types of TG: the automatically adjusted TG (auto TG) and the manually adjusted TG (manual TG). To evaluate the character of images with 2 TGs, the actual flip angle (FA), the image uniformity, and the signal-to-noise ratio (SNR) were measured using a phantom. Then, to assess the quality of intraoperative images, T2WIs with both TGs were acquired during TcMRgFUS for 5 patients. The contrast-to-noise ratio (CNR) of the lesion was retrospectively estimated. RESULTS: The images of the phantom with the auto TG showed substantial variations between the preset and actual FAs (p < 0.01), whereas on the images with the manual TG, there were no variations between the two FAs (p > 0.05). The total image uniformity was considerably lower with the manual TG than with the auto TG (p < 0.01), indicating that the image's signal values with the manual TG were more uniform. The manual TG produced significantly higher SNRs than the auto TG (p < 0.01). In the clinical study, the lesions were clearly detected in intraoperative images with the manual TG, but they were difficult to identify in images with the auto TG. The CNR of lesions in images with manual TG was considerably higher than in images with auto TG (p < 0.01). CONCLUSION: Regarding intraoperative T2WIs using a 3.0T MRI system during TcMRgFUS, the manual TG method improved image quality and delineated the ablative lesion more clearly than the current method with auto TG.

Magnetic Resonance-Guided focused ultrasound surgery for Parkinson's disease: A mini-review and comparison between deep brain stimulation.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a new surgical treatment for Parkinson's disease (PD). Previous experience with radiofrequency lesionectomy and deep brain stimulation (DBS) has identified several candidate targets for MRgFUS intended to alleviate the motor symptoms of PD. The main advantage of MRgFUS is that it is incisionless. MRgFUS has certain limitations and is associated with adverse effects. The present study reviews the literature on conventional surgical interventions for PD, discusses recent studies on MRgFUS, and the comparison between DBS and MRgFUS for PD. The reviews aims to provide an essential reference for neurologists to select the appropriate treatments for patients with PD.

A Systematic Review Comparing Focused Ultrasound Surgery With Radiosurgery for Essential Tremor.

BACKGROUND: Focused ultrasound (FUS-T) and stereotactic radiosurgery thalamotomy (SRS-T) targeting the ventral intermediate nucleus are effective incisionless surgeries for essential tremor (ET). However, their efficacy for tremor reduction and, importantly, adverse event incidence have not been directly compared. OBJECTIVE: To present a comprehensive systematic review with network meta-analysis examining both efficacy and adverse events (AEs) of FUS-T vs SRS-T for treating medically refractory ET. METHODS: We conducted a systematic review and network meta-analysis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, using the PubMed and Embase databases. We included all primary FUS-T/SRS-T studies with approximately 1-year follow-up, with unilateral Fahn-Tolosa-Marin Tremor Rating Scale or Clinical Rating Scale for Tremor scores prethalamotomy/post-thalamotomy and/or AEs. The primary efficacy outcome was Fahn-Tolosa-Marin Tremor Rating Scale A+B score reduction. AEs were reported as an estimated incidence. RESULTS: Fifteen studies of 464 patients and 3 studies of 62 patients met inclusion criteria for FUS-T/SRS-T efficacy comparison, respectively. Network meta-analysis demonstrated similar tremor reduction between modalities (absolute tremor reduction: FUS-T: -11.6 (95% CI: -13.3, -9.9); SRS-T: -10.3 (95% CI: -14.2, -6.0). FUS-T had a greater 1-year adverse event rate, particularly imbalance and gait disturbances (10.5%) and sensory disturbances (8.3%). Contralateral hemiparesis (2.7%) often accompanied by speech impairment (2.4%) were most common after SRS-T. There was no correlation between efficacy and lesion volume. CONCLUSION: Our systematic review found similar efficacy between FUS-T and SRS-T for ET, with trend toward higher efficacy yet greater adverse event incidence with FUS-T. Smaller lesion volumes could mitigate FUS-T off-target effects for greater safety.

A radiomics nomogram model for predicting prognosis of pancreatic ductal adenocarcinoma after high-intensity focused ultrasound surgery.

OBJECTIVE: To develop and validate a radiomics nomogram for predicting the survival of patients with pancreatic ductal adenocarcinoma (PDAC) after receiving high-intensity focused ultrasound (HIFU) treatment. METHODS: A total of 52 patients with PDAC were enrolled. To select features, the least absolute shrinkage and selection operator algorithm were applied, and the radiomics score (Rad-Score) was obtained. Radiomics model, clinics model, and radiomics nomogram model were constructed by multivariate regression analysis. The identification, calibration, and clinical application of nomogram were evaluated. Survival analysis was performed using Kaplan-Meier (K-M) method. RESULTS: According to conclusions made from the multivariate Cox model, Rad-Score, and tumor size were independent risk factors for OS. Compared with the clinical model and radiomics model, the combination of Rad-Score and clinicopathological factors could better predict the survival of patients. Patients were divided into high-risk and low-risk groups according to Rad-Score. K-M analysis showed that the difference between the two groups was statistically significant (p < 0.05). In addition, the radiomics nomogram model indicated better discrimination, calibration, and clinical practicability in training and validation cohorts. CONCLUSION: The radiomics nomogram effectively evaluates the prognosis of patients with advanced pancreatic cancer after HIFU surgery, which could potentially improve treatment strategies and promote individualized treatment of advanced pancreatic cancer.

Magnetic Resonance Imaging-guided Focused Ultrasound Surgery in a Swine Adenomyosis Model.

RATIONALE AND OBJECTIVES: The purpose of this study was to explore the feasibility of magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS) for the treatment of an adenomyosis model of Bama pigs and the changes in the level of oxytocin receptor (OTR), vascular endothelial growth factor (VEGF), and cyclooxygenase-2 (COX-2) in the myometrium tissues of Bama pigs after MRgFUS. MATERIALS AND METHODS: Three Bama pig models of adenomyosis were established by autologous endometrial implantation and evaluated by magnetic resonance imaging, computed tomography, and hematoxylin-eosin (H&E) staining. After the successful construction of the model, the pigs underwent MRgFUS. Before the modeling surgery, three months after the modeling, and two months after ablation, the myometrium tissues were clipped, then embedded and H&E stained for immunohistochemical examination. The average optical density of OTR, VEGF, and COX-2 were semi-quantitatively analyzed. RESULTS: The adenomyosis models were established in all Bama pigs and confirmed by magnetic resonance imaging, computed tomography and H&E staining. Magnetic resonance imaging and computed tomography examination showed that the uterine wall at the modeling site was significantly thickened with uneven enhancement after contrast injection. All Bama pigs with adenomyosis lesions underwent MRgFUS without complications. The expression level of OTR and COX-2 in the myometrium increased three months after modeling surgery and decreased two months after MRgFUS. The expression level of VEGF decreased two months after MRgFUS. CONCLUSION: Autologous endometrial implantation is effective in establishing the adenomyosis model of Bama pigs. It is feasible to treat adenomyosis in the Bama pig model with MRgFUS. The levels of OTR, COX-2 and VEGF in the local myometrium decreased after MRgFUS, which may be associated with symptom relief after treatment.

Mid-term efficacy grading evaluation and predictive factors of magnetic resonance-guided focused ultrasound surgery for painful bone metastases: a multi-center study.

OBJECTIVES: MR imaging-guided focused ultrasound surgery (MRgFUS) is an emerging non-invasive treatment. It is helpful in investigating the mid-term grading efficacy and safety of MRgFUS, and possible risk factors in participants with painful bone metastases. METHODS: This four-center prospective study enrolled 96 participants between June 2016 and May 2019 with painful bone metastases. The Numerical Rating Scale (NRS), Brief Pain Inventory-Quality of Life (BPI-QoL) score, morphine equivalent daily dose (MEDD), and the adverse events (AEs) were recorded before and at 1 week, 1 month, 2 months, and 3 months after MRgFUS. The repeated ANOVA tests were used to analyze the change in NRS and BPI-QoL, and logistic regression analysis was used to analyze the possible risk factors. RESULTS: A total of 82 participants completed the 3-month follow-up period. And 16 (19.5%) participants were complete responders (CR), 46 (56.1%) participants were effective responders (ER), and the other 20 (24.4%) participants were non-responders (NR). The NRS (2.67 ± 2.47 at 3 months compared to 6.38 ± 1.70 before treatment) and BPI-QoL score (3.11 ± 2.51 at 3 months compared to 5.40 ± 1.85 before treatment) significantly decreased after the treatment at all time points (p < 0.001). Eleven adverse events were recorded and they were all cured within 1 to 52 days after treatment. The non-perfused volume (NPV) ratio (p = 0.001) and the bone metastases lesion type (p = 0.025) were the key risk factors. CONCLUSIONS: MRgFUS can be used as a non-invasive, effective, and safe modality to treat painful bone metastases. NPV ratio and the lesion type may be used as affecting factors to predict the mid-term efficacy of MRgFUS. KEY POINTS: • MRgFUS can be considered a non-invasive, effective, and safe modality to treat painful bone metastases. • The NRS and BPI-QoL score at 1 week, 1 month, 2 months, and 3 months all decreased significantly (p < 0.001) after receiving MRgFUS. Among 82 participants, 16 (19.5%) were complete responders, 46 (56.1%) were effective responders, and the other 20 (24.4%) were non-responders. • According to logistic regression analysis, non-perfused volume ratio and the bone metastases lesion type were the affecting factors to predict the mid-term efficacy of MRgFUS. The adjusted OR of non-perfused volume ratio was 0.86 (p = 0.001), and osteoblastic lesion type was 0.06 (p = 0.025).

Transoral endoscopic ultrasonic surgery (TOUSS) in head & neck unknown primary carcinoma investigation.

Metastatic carcinoma of unknown primary (CUP) to cervical lymph nodes represents less than 5% of all head and neck malignancies. Recent publications support the use of transoral surgery during the diagnosis work-up, and transoral endoscopic ultrasonic surgery represent a recently described alternative technique in transoral surgery. A pilot study to assess the feasibility of trans-oral ultrasonic base of tongue (BOT) mucosectomy and bilateral tonsillectomy approach in CUP diagnosis work-up was conducted. Ten patients were included consecutively. In 2 cases (20%) the primary was found, in one case in the right tonsil, and another one in the left BOT. According to our results, the use of trans-oral ultrasonic surgery to perform the base of tongue mucosectomy and bilateral tonsillectomy in CUP patient's during the diagnosis work-up represents an effective option in patients with good anatomical exposure.

Investigating surgical smoke in otolaryngology operating rooms.

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.

Comparison of effects of energy based devices on quality of life after sutureless thyroidectomy.

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.

TransOral UltraSonic surgery (TOUSS) for oral cavity, oropharyngeal and supraglottic malignancy: A prospective study of feasibility, safety, margins, functional and survival outcomes.

INTRODUCTION/BACKGROUND: With the advent of TransOral Robotic Surgery (TORS) the ease of transoral procedures has been dramatically improved. TORS is already established for its feasibility, functional and oncological outcomes for selected lesions of oral cavity, oropharynx and laryngopharynx. This study reports on preliminary results with TransOral UltraSonic Surgery (TOUSS) for oncologic resections of oral cavity, oropharyngeal and supraglottic malignancies. MATERIALS AND METHODS: Eighteen patients with malignancies of oral cavity, oropharynx and supraglottis underwent TOUSS with simultaneous neck dissection and adjuvant therapy as indicated, from January 2018 to April 2019. Essential equipment included the FK-retractor (Gyrus Medical, Tuttilngen, Germany) for TransOral exposure, the Olympus ENDOEYE Flex 5 mm 2D/10 mm 3D deflecting tip video laparoscopes, and 35 cm long ultrasonic harmonic scalpel (Thunderbeat). Parameters evaluated include tumor staging, mouth opening, TOUSS setup time, TOUSS primary removal time, surgical margins, blood transfusions, tracheostomy, postoperative complications, enteral feeding and resumption of oral diet, duration of hospital stay, and survival outcomes. RESULTS: Eighteen patients underwent complete TransOral UltraSonic Surgery (TOUSS), with simultaneous unilateral or bilateral neck dissection. No procedure was abandoned intraoperatively due to difficulty in extirpation of the tumor. Margins were negative for ten patients (55.6%), close in five (27.8%), and positive in three patients (16.7%). Average TOUSS set-up time was 22.5 min (range, 10-30 min) and average TOUSS primary tumor removal time was 35.3 min (range, 15-60 min). Patients started tolerating oral feeds even in the second post op day (mean 6 days), and transitioning to complete oral feeds with removal of the nasogastric tube was achieved in all (mean, 16 days). The average hospital stay was 7.4 days (range 2-16 days). Secondary hemorrhage occurred in two cases and required an emergency tracheostomy and ligation of lingual artery. Minor cervicopharyngeal fistula occurred in four cases and settled in all with conservative non-surgical treatment. Overall survival at 3 years was 70.5%, and disease-specific survival was 94.4%. CONCLUSION: TransOral UltraSonic Surgery (TOUSS) is a safe and sound alternative method of endoscopic surgical treatment of oral cavity, oropharynx and supraglottic neoplasms. Advantages of this technique include faster resection time, intraoperative assistance from Narrow Band Imaging, easy affordability compared to TORS, and excellent functional outcomes.