Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial

xlomafota13 shared this article with you from Inoreader Single-arm, open-label, multicentre first in human study to <u>e</u>valuate the safety and performa<u>nc</u>e of dur<u>al</u> sealant patch in reducing C<u>S</u>F leakag<u>e</u> following elective cranial surgery: the ENCASE trial Via leak of cerebrospinal fluid BMJ Open. 2021 Jul 28;11(7):e049098. doi: 10.1136/bmjopen-2021-049098. ABSTRACT OBJECTIVE: The dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. DESIGN: First in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up. SETTING: Three large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland. PARTICIPANTS: Forty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations. INTERVENTION: Each patient received one DSP after cranial surgery and closure of the dura mater with sutures. OUTCOME MEASURES: Primary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction. RESULTS: No patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application. CONCLUSIONS: DSP, later officially named Liqoseal, is a safe and potentially efficacious devic e for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage. TRIAL REGISTRATION NUMBER: NCT03566602. PMID:34321304 | PMC:PMC8320247 | DOI:10.1136/bmjopen-2021-049098 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial

xlomafota13 shared this article with you from Inoreader Manual Therapy for Fibrosis-Related Late Effect Dysphagia in head and neck cancer survivors: the pilot MANTLE trial Via swallowing exercises BMJ Open. 2021 Aug 4;11(8):e047830. doi: 10.1136/bmjopen-2020-047830. ABSTRACT INTRODUCTION: Late dysphagia that develops or persists years after head and neck cancer (HNC) is a disabling survivorship issue. Fibrosis is thought to stiffen connective tissues and compress peripheral nerve tracts, thereby contributing to diminished strength, flexibility, and in some cases denervation of swallowing muscles. Manual therapy (MT) is used in cancer survivors for pain and other indications, but it is unknown if increasing blood flow, flexibility and cervical range of motion (CROM) in the head and neck may improve late dysphagia. METHODS AND ANALYSIS: Manual Therapy for Fibrosis-Related Late Effect Dysphagia (MANTLE) is a National Cancer Institute-funded prospective single-arm pilot trial evaluating the feasibility, safety and therapeutic potential of MT in patients with late dysphagia after radiotherapy (RT) for HNC. Disease-free survivors ≥2 years after curative-intent RT for HNC with at least moderate dysphagia and grade ≥2 Common Terminology Criteria for Adverse Events version 4.0 fibrosis are eligible. The target sample size is 24 participants who begin the MANTLE programme. MANTLE is delivered in 10 MT sessions over 6 weeks with an accompanying home exercise programme (HEP). Patients then transition to a 6-week post-washout period during which they complete the HEP and then return for a final post-washout evaluation. Feasibility (primary endpoint) and s afety will be examined. Serial assessments include CROM, modified barium swallow studies, quantitative MRI, electromyography (optional) and patient-reported outcomes as secondary, tertiary and exploratory endpoints. ETHICS AND DISSEMINATION: The research protocol and informed consent document was approved by the Institutional Review Board at the University of Texas MD Anderson Cancer Center. Findings will be disseminated through peer-reviewed publication that will be made publicly available on PubMed Central on acceptance for publication, in compliance with NIH public access policy. TRIAL REGISTRATION NUMBER: NCT03612531. PMID:34348950 | DOI:10.1136/bmjopen-2020-047830 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Clinical Observations of a Surgical Method Comprising a Combination of Cross Flap and Autologous Auricular Cartilage Transplantation in the Treatment of Type I to III Congenital Concha-Type Microtia

xlomafota13 shared this article with you from Inoreader Clinical Observations of a Surgical Method Comprising a Combination of Cross Flap and Autologous Auricular Cartilage Transplantation in the Treatment of Type I to III Congenital Concha-Type Microtia Via ear nose throat Ear Nose Throat J. 2021 Aug 4:1455613211038079. doi: 10.1177/01455613211038079. Online ahead of print. ABSTRACT OBJECTIVES: The present study attempted to investigate the clinical efficacy of a surgical method involving a combination of cross flap with autologous auricular cartilage transplantation in the treatment of type I to III congenital concha-type microtia. METHODS: The present retrospective study was conducted on the clinical and postoperative data of 50 patien ts with unilateral type I to III concha-type microtia treated with a combination of cross flap and autologous auricular cartilage transplantation at the Plastic Surgery Hospital of Chinese Academy of Medical Sciences from January 2018 to December 2021. RESULTS: The postoperative perimeters of malformed ears were significantly larger than the preoperative perimeters (P < .05). Of the total, 2 patients exhibited incision dehiscence, 3 patients exhibited incision infection, 2 patients exhibited flap hematoma, and 1 patient exhibited ischemic necrosis at the flap tip. The satisfaction rate of the patients and their families was 100%. CONCLUSIONS: The surgical method involving a combination of cross flap and autogenous auricular cartilage transplantation was effective in treating patients with type I to III congenital concha-type microtia, and therefore, this surgical approach can be applied widely to correct this deformity. PMID:34348512 | DOI:10.1177/01455613211038079 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Patient perceptions on the use of cocaine in sinonasal surgery

xlomafota13 shared this article with you from Inoreader Patient perceptions on the use of cocaine in sinonasal surgery Via Clinical Otolaryngology Abstract Medicinal cocaine has been used as a local anaesthetic since the 1880s, and the alkaloid is one of the first recorded anaesthetic agents. Some rhinologists use cocaine for its vasoconstriction properties to improve the endoscopic field of vision by reducing bleeding during endoscopic sinus surgery. The European Medicines Compendium advises on a maximum dose of 1.5mg/kg in fit adults (topical mucosal Cocaine Hydrochloride Solution 10% w/v) (1) (2). The addition of adrenaline will reduce systemic absorption of cocaine, lowering the solution's toxicity while simultaneously offering more significant local vasoconstriction (3). Increasing the solution's pH via sodium bicarbonate increases the anaesthetic properties while having no effect on toxicity. A solution of cocaine, adrenaline and sodium bicarbonate is eponymously termed Moffett's (4). View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Patient perceptions on the use of cocaine in sinonasal surgery

xlomafota13 shared this article with you from Inoreader Patient perceptions on the use of cocaine in sinonasal surgery Via Clinical Otolaryngology Abstract Medicinal cocaine has been used as a local anaesthetic since the 1880s, and the alkaloid is one of the first recorded anaesthetic agents. Some rhinologists use cocaine for its vasoconstriction properties to improve the endoscopic field of vision by reducing bleeding during endoscopic sinus surgery. The European Medicines Compendium advises on a maximum dose of 1.5mg/kg in fit adults (topical mucosal Cocaine Hydrochloride Solution 10% w/v) (1) (2). The addition of adrenaline will reduce systemic absorption of cocaine, lowering the solution's toxicity while simultaneously offering more significant local vasoconstriction (3). Increasing the solution's pH via sodium bicarbonate increases the anaesthetic properties while having no effect on toxicity. A solution of cocaine, adrenaline and sodium bicarbonate is eponymously termed Moffett's (4). View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery

xlomafota13 shared this article with you from Inoreader Assessment of Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery Via JAMA Otolaryngology–Head & Neck Surgery Online First This multi-institutional, nonblinded randomized clinical trial compares the efficacy of different analgesic regimens after endoscopic sinus surgery. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Reducing Opioid Prescribing and Consumption After Surgery

xlomafota13 shared this article with you from Inoreader Reducing Opioid Prescribing and Consumption After Surgery Via JAMA Otolaryngology–Head & Neck Surgery Online First Many patients receive their first opioid prescription from a surgeon. While surgery is a large concern for most patients, receiving an opioid prescription may seem more incidental. Yet 1 of every 17 patients who uses an opioid after otolaryngologic surgery continues to require opioids long after postoperative care has been completed. Overall, 1 of every 25 adults in the US regularly uses prescription opioid medications. For years, opioids have been assumed to be the de facto choice for pain management after surgery, but evidence is accumulati ng that nonopioid medications are highly effective for postoperative pain and may offer substantial advantages compared with opioids in improved safety. Despite this growing awareness, in a 2018 survey of American Rhinological Society members, 94% of respondents reported prescribing opioids after endoscopic sinus surgery, with an average of 27 opioid tablets prescribed. If prescribing opioids means opening a Pandora's box without additional efficacy, then what should be their legitimate role after surgery? View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Association of Laryngeal Botulinum Neurotoxin Injection With Work Productivity for Patients With Spasmodic Dysphonia

xlomafota13 shared this article with you from Inoreader Association of Laryngeal Botulinum Neurotoxin Injection With Work Productivity for Patients With Spasmodic Dysphonia Via JAMA Otolaryngology–Head & Neck Surgery Online First This case series examines whether employed patients with spasm odic dysphonia experience voice-related work productivity impairment before with treatment botulinum neurotoxin injection. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

A dosing algorithm for individualized radioiodine treatment of cats with hyperthyroidism

xlomafota13 shared this article with you from Inoreader A dosing algorithm for individualized radioiodine treatment of cats with hyperthyroidism Via radioactive iodine J Vet Intern Med. 2021 Aug 5. doi: 10.1111/jvim.16228. Online ahead of print. ABSTRACT BACKGROUND: Radioiodine (131 I) is the treatment of choice for hyperthyroidism in cats, but current 131 I-dosing protocols can induce iatrogenic hypothyroidism and expose azotemia. OBJECTIVES: To develop a cat-specific algorithm to calculate the lowest 131 I dose to resolve hyperthyroidism, while minimizing risk of iatrogenic hypothyroidism and subsequent az otemia. ANIMALS: One thousand and four hundred hyperthyroid cats treated with 131 I. METHODS: Prospective case series (before-and-after study). All cats had serum concentrations of thyroxine (T4 ), triiodothyronine (T3 ), and thyroid-stimulating hormone (TSH) measured (off methimazole ≥1 week). Using thyroid scintigraphy, each cat's thyroid volume and percent uptake of 99m Tc-pertechnatate (TcTU) were determined. An initial 131 I dose was calculated by averaging dose scores for T4 /T3 concentrations, thyroid volume, and TcTU; 80% of that composite dose was administered. Twenty-four hours later, percent 131 I uptake was measured, and additional 131 I administered, as needed, to deliver an adequate radiation dose to the thyroid tumor(s). Serum concentrations of T4 , TSH, and creatinine were determined 6 to 12 months later. RESULTS: The median calculated 131 I dose was 1.9 mCi (range, 1.0-10.6 mCi); 1380 cats required additional 131 I administration on day 2. Of the cats, 1047 (74.8%) became euthyroid, 57 (4.1%) became overtly hypothyroid, 240 (17.1%) became subclinically hypothyroid, and 56 (4%) remained hyperthyroid. More overtly (71.9%) and subclinically (39.6%) hypothyroid cats developed azotemia than euthyroid cats (14.2%; P < .0001). CONCLUSIONS AND CLINICAL IMPORTANCE: Our algorithm for calculating individual 131 I doses resulted in cure rates similar to historical treatment rates, despite much lower 131 I doses. This algorithm appears to lower prevalence of both 131 I-induced overt hypothyroidism and azotemia. PMID:34351027 | DOI:10.1111/jvim.16228 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Outcomes of endoscopic and open resection of sinonasal malignancies: a systematic review and meta-analysis

xlomafota13 shared this article with you from Inoreader Outcomes of endoscopic and open resection of sinonasal malignancies: a systematic review and meta-analysis Via Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial Braz J Otorhinolaryngol. 2021 Jul 20:S1808-8694(21)00127-0. doi: 10.1016/j.bjorl.2021.06.004. Online ahead of print. ABSTRACT OBJECTIVE: To compare the efficacy of endoscopic and open resection of sinonasal malignancies. METHODS: The search was performed using PubMed (1950-2020), Embase (1974-2020), the Cochrane library, and the website clinicaltrials.gov. The hazard ratio, HR, 95% confidence interval, CI, of the rates of overall survival and disease-free survival and the demographic characteristics of the included studies were extracted and analyzed. Pooled analysis was conducted with the studies' individual patient data, using log-rank test, Kaplan-Meier survival, and Cox regression analysis. RESULTS: Of 1939 articles retrieved, 23 articles were included. Overall, 1373 cases were incorporated into the final analysis, 653 (47.56%) of which underwent the surgery through an endoscopic approach, whereas 720 (52.44%) cases uti lized the open approach. The overall survival was comparable between endoscopic and open resection (HR = 0.84 [95% CI: 0.65-1.07], p = 0.16; random effects analysis). Pooled analysis with Cox regression revealed signifcant differences in overall survival (HR = 0.568 [95%CI:0.380-0.849], p = 0.006) and disease-free survival (HR = 0.628 [95%CI:0.424-0.929], p = 0.02) between endoscopic and open approaches. CONCLUSION: The aggregated evidence suggests the survival outcome of endoscopic resection is comparable or greater than that of open resection of sinonasal malignancies. PMID:34348855 | DOI:10.1016/j.bjorl.202 1.06.004 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Determining attributed factors of hearing handicap in individuals with auditory sensory and neural pathology

xlomafota13 shared this article with you from Inoreader Determining attributed factors of hearing handicap in individuals with auditory sensory and neural pathology Via Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial Braz J Otorhinolaryngol. 2021 Jul 21:S1808-8694(21)00126-9. doi: 10.1016/j.bjorl.2021.06.003. Online ahead of print. ABSTRACT INTRODUCTION: There is a modest relationship between speech perception skills and perceived hearing handicap in individuals with hearing loss. In this study, an attempt is made at linking psychoacoustic results and speech perception skills to understand the subjective handicap and quality of life. OBJECTIVE: To investigate how speech perception in noise (signal to noise ratio-50), difference limen frequency, temporal modulation transfer function, hearing handicap inventory for adults, and quality of life in auditory neuropathy spectrum disorder differs from sensorineural hearing loss. Further we attempt to discern attributed factors of hearing handicap in auditory neuropathy spectrum disorder and sensorineural hearing loss. METHODS: A cross-sectional study with comparative and correlational research designs were utilized. Eighty-four participants were grouped into sensorineural hearing loss (n = 49), and auditory neuropathy spectrum disorder (n = 35) was sub-grouped into mild, moderately severe, and severe. We evaluated signal to noise ratio-50, difference limen frequency, and temporal modulation transfer function. In addition, hearing handicap inventory for adults, and quality of life questionnaires were administered. RESULTS: Mild auditory neuropathy spectrum disorder showed impairment in speech perception and discriminating frequency, which were similar to the severe sensory neural hearing loss. Temporal resolution impairment in auditory neuropathy spectrum disorder mild was significantly higher than in each sub-groups of sensorineural hearing loss. The severity of the hearing handicap in was similar to severe sensorineural hearing loss, quality of life was equally affected in sensorineural hearing loss and auditory neuropathy spectrum disorder. In sensorineural hearin g loss, signal to noise ratio-50 was positively related, and quality of life was negatively related to hearing handicap. In auditory neuropathy spectrum disorder, no contributory factors were related to hearing handicap. CONCLUSION: Mild auditory neural pathology demonstrates impairment in speech recognition and psychoacoustic skills similar to severe cochlear pathology. In sensorineural hearing loss, hearing handicap is predicted from quality of life and speech perception, but none of the contributory factors predicted hearing handicap in auditory neuropathy spectrum disorder. PMID:34348857 | DOI:10.1016/j.bj orl.2021.06.003 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.