A standardized marking procedure for ENT operations to prevent wrong-site surgery: development, establishment and subsequent evaluation among patients and medical personnel.

PURPOSE: Wrong-site surgeries are rare but potentially serious clinical errors. Marking the surgical site is crucial to preventing errors, but is hindered in the ENT field by the presence of many internal organs. In addition, there is no standardized marking procedure. METHODS: Here, an ENT surgical-marking procedure was developed and introduced at a clinic. The procedure was evaluated through anonymized questionnaires. This study was conducted over a 6-month period by interviewing patients and, at the beginning and end of this period, doctors and other surgical staff. RESULTS: The internal organ-marking problem was solved by applying a fixed abbreviation for each procedure onto the shoulder in addition to marking the skin surface as close to the organ as possible. The procedure was described as practicable by 100% of the interviewees; 75% of the ENT physicians and 96.3% of the other surgical staff considered the procedure highly important for preventing site confusion, and 75% of the physicians had a consequently greater feeling of safety. Of the 248 patients surveyed, 96.0% considered the marking procedure useful, and 75.8% had a consequently greater feeling of safety. For 52.0%, the marking reduced their fear of the operation. CONCLUSIONS: For the first time, a standardized procedure was developed to mark the site of ENT surgery directly, uniformly and safely on patients. The procedure was judged to be useful and practicable and was also deemed crucial for preventing site confusion. Patients felt safer and less fearful of the operation due to the marking.

Tobacco use in patients with ENT tumours: Deficits in the provision of education and smoking cessation support.

PURPOSE: Smoking is not only one of the main risk factors for the development of most malignant and numerous benign ENT tumours but also has an important influence on therapy and prognosis. Even quitting smoking at the time of diagnosis significantly reduces mortality. Patients have a particularly strong desire to stop smoking when they are diagnosed. The present study investigated to what extent patients were aware of the relationships between smoking and the development and prognosis of tumours and how much information and smoking cessation support they were offered by physicians. METHODS: A total of 194 patients (74.7% male, 62.0 ±10.6 a) with malignant primary ENT tumours, pre-cancerous tumours, Reinke's oedema and salivary gland tumours were interviewed. RESULTS: 22.7% were nonsmokers, 49.5% were cigarette smokers and 27.8% were ex-smokers. A total of 57.0% of the smokers said they would have quit before the onset of the disease if they had known about the association. Forty-one percent did not receive information about the association between smoking and the development of their disease, while 45.5% did not receive information about the relationship with their prognosis. The provision of information lasted less than 5 min for 40.4% of the patients and more than 10 min for only 13.5%. In total, 50.7% of the patients were directly requested not to smoke. A total of 7.7% received offers of smoking cessation support from otolaryngologists and 18.2% received such offers from family physicians. CONCLUSIONS: There is a pronounced need for improvements in the provision of medical information about the health risks associated with smoking and offers to support patient efforts to stop smoking. In particular, the appointment during which the diagnosis is communicated to the patient should be considered a 'teachable moment' that can lead to smoking cessation.

Randomized phase-III-trial of concurrent chemoradiation for locally advanced head and neck cancer comparing dose reduced radiotherapy with paclitaxel/cisplatin to standard radiotherapy with fluorouracil/cisplatin: The PacCis-trial.

BACKGROUND AND PURPOSE: This multicenter, phase 3 trial investigates whether the incorporation of concurrent paclitaxel and cisplatin together with a reduced total dose of radiotherapy is superior to standard fluorouracil-cisplatin based CRT. MATERIALS AND METHODS: Patients with SCCHN, stage III-IVB, were randomized to receive paclitaxel/cisplatin (PacCis)-CRT (arm A; paclitaxel 20 mg/m2 on days 2, 5, 8, 11 and 25, 30, 33, 36; cisplatin 20 mg/m2, days 1-4 and 29-32; RT to a total dose of 63.6 Gy) or fluorouracil/cisplatin (CisFU)-CRT (arm B; fluorouracil 600 mg/m2; cisplatin 20 mg/m2, days 1-5 and 29-33; RT: 70.6 Gy). Endpoint was 3-year-disease free survival (3y-DFS). RESULTS: A total of 221 patients were enrolled between 2010 and 2015. With a median follow-up of 3.7 years, 3y-DFS in the CisFU arm and PacCis arm was 58.2% and 48.4%, respectively (HR 0.82, 95% CI 0.56-1.21, p = 0.52). The 3y-OS amounted to 64.6% in the CisFU arm, and to 59.2% in the PacCis arm (HR 0.82, 95% CI 0.54-1.24, p = 0.43). In the subgroup of p16-positive oropharyngeal carcinomas, 3y-DFS and 3y-OS was 84.6% vs 83.9% (p = 0.653), and 92.3% vs. 83.5% (p = 0.76) in arm A and B, respectively. Grade 3-4 hematological toxicities were significantly reduced in arm A (anemia, p = 0.01; leukocytopenia, p = 0.003), whereas grade 3 infections were reduced in arm B (p = 0.01). CONCLUSION: Paclitaxel/cisplatin-CRT with a reduced RT-dose is not superior to standard fluorouracil/cisplatin-CRT. Subgroup analyses indicate that a reduced radiation dose seems to be sufficient for p16+ oropharyngeal cancer or non-smokers. CLINICAL TRIAL INFORMATION: NCT01126216; EudraCT Number 2005-003484-23.

Use of sodium fluorescein solution for detection of cerebrospinal fluid fistulas: an analysis of 420 administrations and reported complications in Europe and the United States.

BACKGROUND: Localization of dural fistulas in the region of the anterior or lateral skull base may be difficult. For many years, a sodium fluorescein solution of 0.5 to 5% (2.5-50 mg) has been administered intrathecally by way of the lumbar space. However, fluorescein is not commercially available for this stated purpose in either Germany or the United States. METHODS: Retrospectively, 420 fluorescein applications by the authors were retrospectively analyzed. Under the Freedom of Information Act, the United States Federal Drug Administration and the manufactures of fluorescein were queried for adverse reaction reports. RESULTS: Four hundred twenty fluorescein applications in 305 patients could be evaluated. Mean age of recipients was 46.9 years, ranging from 1 to 82 years. At a concentration of 5% fluorescein, 26 patients on the day of surgery and 69, 37, 34, and 14 patients on days 2 through 4 suffered from minor side effects that may or may not have been related to this drug. Two of these patients had grand mal seizures, which were attributable to simultaneous intrathecal application of contrast medium. All other side effects were thought to be the result of a postspinal headache and related lumbar puncture. At a concentration of 0.5%, the intraoperative intrathecal administration of 0.5 to 2 mL of fluorescein followed by 4 to 5 days of lumbar drainage resulted in some degree of spinal headache without other complications. In both groups, no patient had sequelae longer than 4 weeks. An additional seven complications were reported to the Federal Drug Administration and the fluorescein manufacturers at doses of 100 to 700 mg. CONCLUSIONS: Complications from intrathecal application of fluorescein appears to be dose dependent. At concentrations of 5%, or preferably lower, side effects are transient. A grand mal seizure can be minimized when following the general cautions of lumbar puncture and dose. The patient should be supervised for 24 hours. A written informed consent from patients for use of fluorescein is recommended.

[Chronic bilateral necrotizing and destructive granulomatous inflammatory process in the region of the paranasal sinuses and the orbita as manifestation of localized Wegener's granulomatosis]. / Chronisch granulomatöser nekrotisierender und destruierender Entzündungsprozess im Bereich der Nasennebenhöhlen und der Orbita beidseits als Ausdruck eines lokalisierten Morbus Wegener.

CASE REPORT: Granulomatous infectious processes have a wide differential diagnosis. This report describes the case of a 73-year-old woman who had gone through an 8-year ordeal involving several paranasal sinus operations, development of chronic facial pain, orbital exenteration of the left eye, and now threatening loss of the remaining right eye on account of progression of the chronic inflammation. Despite repeated histologic examination of ENT material by various pathologic institutes, neither the histology nor laboratory parameters were able to point us in the right direction. In the end, it was the clinical course which led to the diagnosis of Wegener's granulomatosis. CONCLUSION: In chronic necrotizing granulomatous inflammatory processes in the region of the paranasal sinuses with involvement of the surrounding anatomic structures (orbit, skull base), Wegener's granulomatosis should be included in the differential diagnosis at an early stage, even if the typical signs of vasculitis and the typical antibodies are absent. The clinical course calls for an interdisciplinary treatment approach in conjunction with internists experienced in immunosuppressant therapy.