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Background Human papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. Methods/Design The study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology group will receive no adjuvant treatment, as in standard practice. Patients in the intermediate-risk pathology group will be randomised to receive either standard dose post-operative radiotherapy (control) or reduced dose radiotherapy. Patients in the high-risk pathology group will be randomised to receive either post-operative chemoradiotherapy (control) or radiotherapy alone. The primary outcome of the phase II study is patient reported swallowing function measured using the MD Anderson Dysphagia Inventory score at 12 months post-treatment. If the phase II study is successful, PATHOS will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint. Discussion PATHOS is a prospective, randomised trial for Human papillomavirus-positive oropharyngeal cancer, which represents a different disease entity compared with other head and neck cancers. The trial aims to demonstrate that long-term dysphagia can be lessened by reducing the intensity of adjuvant treatment without having a negative impact on clinical outcome. The study will standardise transoral surgery and post-operative intensity-modulated radiotherapy protocols in the UK and develop a gold-standard swallowing assessment panel. An associated planned translational research programme, underpinned by tumour specimens and sequential blood collected as part of PATHOS, will facilitate further empirical understanding of this new disease and its response to treatment. Trial registration This study is registered with ClinicalTrials.gov identifier NCT02215265 .

Background Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. Methods This is a multicenter phase II study randomizing one hundred and forty patients with T1–2 N0–2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50–60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. Discussion This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials. Trial Registration Clinicaltrials.gov identifier: NCT03210103 . Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.

Background For loco-regionally advanced, but transorally resectable oropharyngeal cancer (OPSCC), the current standard of care includes surgical resection and risk-adapted adjuvant (chemo) radiotherapy, or definite chemoradiation with or without salvage surgery. While transoral surgery for OPSCC has increased over the last decade for example in the United States due to transoral robotic surgery, this treatment approach has a long history in Germany. In contrast to Anglo-Saxon countries, transoral surgical approaches have been used frequently in Germany to treat patients with oro-, hypopharyngeal and laryngeal cancer. Transoral laser microsurgery (TLM) has had a long tradition since its introduction in the early 70s. To date, the different therapeutic approaches to transorally resectable OPSCC have not been directly compared to each other in a randomized trial concerning disease control and survival. The goal of this study is to compare initial transoral surgery to definitive chemoradiation for resectable OPSCC, especially with regards to local and regional control. Methods TopROC is a prospective, two-arm, open label, multicenter, randomized, and controlled comparative effectiveness study. Eligible patients are ≥18 years old with treatment-naïve, histologically proven OPSCC (T1, N2a-c, M0; T2, N1–2c, M0; T3, N0-2c, M0 UICC vers. 7) which are amenable to transoral resection. Two hundred eighty patients will be randomly assigned (1:1) to surgical treatment (arm A) or chemoradiation (arm B). Standard of care treatment will be performed according to daily routine practice. Arm A consists of transoral surgical resection with neck dissection followed by risk-adapted adjuvant therapy. Patients treated in arm B receive standard chemoradiation, residual tumor may be subject to salvage surgery. Follow-up visits for 3 years are planned. Primary endpoint is time to local or locoregional failure (LRF). Secondary endpoints include overall and disease free survival, toxicity, and patient reported outcomes. Approximately 20 centers will be involved in Germany. This trial is supported by the German Cancer Aid and accompanied by a scientific support program. Discussion This study will shed light on an urgently-needed randomized comparison of the strategy of primary chemoradiation vs. primary surgical approach. As a comparative effectiveness trial, it is designed to provide data based on two established regimens in daily clinical routine. Trial registration NCT03691441 Registered 1 October 2018 - Retrospectively registered.

To determine which nostril is more suitable for nasotracheal intubation in patients with normal patency of both nostrils. Prospective, randomized clinical trial. Operating room of a university medical center. 191 ASA physical status 1 and 2 patients scheduled for elective oral surgery requiring general anesthesia with nasotracheal intubation. Patients were randomized to two groups to undergo nasotracheal intubation through the right nostril (Group R; n = 96) or the left nostril (n = 95). Standard traditional nasotracheal intubation was performed using the Macintosh laryngoscope. Tube rotation was attempted for alignment toward the glottis, and Magill forceps were then used to assist intubation, as necessary. Epistaxis was inspected in the pharynx after the tube tip was passed through the nasal cavity and 15 minutes after nasotracheal intubation was completed. Intubation time was the interval between when the anesthesiologist opened the patient’s mouth with the cross finger maneuver and when the tube was connected to the anesthetic circuit after nasotracheal completion. The frequency of epistaxis was significantly lower in Group R than Group L (P = 0.0006). Although there was no significant difference in nasal passage time between two groups, the intubation time in Group R (24.5 ± 9.4 sec) was shorter than in Group L (30.5 ± 15.6 sec; P = 0.0015). Nasal intubation via the right nostril is more safely performed than with the left nostril. Because of less epistaxis and faster intubation.

We conducted a prospective, randomized, controlled study to investigate the influence of pharyngeal pack placement on postoperative nausea, vomiting, and throat pain after minor oral surgery. Our study group was made up of 80 patients-45 men and 35 women, aged 19 to 52 years (mean: 27.3)-who underwent a minor oral surgical procedure under general anesthesia. Patients were randomly assigned to one of three groups: 20 patients who received a pharyngeal pack under videolaryngoscopic guidance (video guidance group), 20 who had a pack placed blindly (blind insertion group), and 40 patients who received no pack at all (control group). Postoperative nausea occurred in only 4 patients (20%) in the blind insertion group (p < 0.007). No patient experienced postoperative vomiting. Postoperative throat pain occurred in all 20 video guidance patients (100%), in 17 of the blind insertion patients (85%), and in 20 of the controls (50%). The difference between the controls and each of the two pack groups was statistically significant (p < 0.006); the difference between the two pack groups was not significant.

Purpose Epistaxis is a common complication of nasal intubation. Ease of insertion of the tracheal tube may be influenced by bevel orientation and tip bending. We examined ease of insertion and epistaxis with two tubes with different orientations and with or without a stylet to modify tip bending. Methods Two hundred patients scheduled to undergo oral or maxillofacial surgery were randomized into four groups according to method of nasal intubation used after induction of anesthesia. In one group, a Portex ® tracheal tube was inserted with bevel facing left (Portex Group). In the second group, a Parker Flex-Tip ® tube (Parker Group) was inserted with the bevel facing posteriorly, and in the last two groups, a stylet bent at 60° anteriorly was used with the Portex tube (Stylet-Portex Group) or Parker tube (Stylet-Parker Group). When the tube advanced without resistance, insertion was defined as “smooth”, and when resistance was encountered, insertion was defined as “impinged”. Severity of epistaxis was evaluated as none, mild, moderate, or severe. Results Smooth insertion was observed in 60% of patients in the Portex Group; 80% in the Parker Group; 100% in the Stylet-Portex Group; and 100% in the Stylet-Parker Group. Epistaxis was found in 50%, 24%, 20%, and 4% of patients, respectively. The styletted tip (difference: 30%; 95% confidence interval [CI]: 20.3 to 38.5; P  < 0.0001) was found to improve ease of insertion. Both the posterior-facing bevel (difference: 21%; 95% CI: 9.0 to 32.1; P  = 0.0005) and stylet (difference: 25%; 95% CI: 13.1 to 35.9; P  < 0.0001) contributed significantly to absence of epistaxis. Conclusions Using a styletted tracheal tube with a posterior-facing bevel improves ease of insertion through the nasopharynx and decreases the severity of epistaxis during nasal intubation. Clinical trial registration number: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000011327.

Objective: The objective of the study was to compare the clinical efficacy of use of a diode laser (DL) (810 nm) as an adjunct to modified Widman flap (MWF) surgery to that of MWF alone. Materials and Methods: Twenty-five patients between the ages of 20 and 50 years with generalized chronic periodontitis were selected for the study. Control sites (Group A) were randomly selected to receive an MWF, and the contralateral test sites (Group B) received MWF in conjunction with low-level laser therapy. The energy density of 4 J/cm 2 was applied to the gingival surface after periodontal treatment. The study tooth/site was treated along with any additional teeth in the quadrant in which the site was located if needed. Randomization was done using a coin flip. The DL was used to de-epithelialize the inner part of the periodontal flap and photo-biostimulate the surgical area. Plaque index (PI), papillary bleeding index (PBI), probing depth (PD), and clinical attachment level (CAL) scores were recorded at baseline and at 6 and 9 months. Statistical Analysis: Data were expressed as the mean +- standard deviation. Statistical analyzes were performed using paired Student's t-testfor intragroup comparisons and unpaired Student's t-test for intergroup comparisons.Results: No significant difference was observed in PI scores between the two groups at baseline, 6 and 9 months. PBI scores were significantly lower in Group B versus Group A at 6 months (P < 0.01). However, no significant difference was observed between the two groups in PBI scores at the end of 9 months. PD reduction in Group B versus Group A was statistically significant at the end of 9 months (P < 0.01). Gains in CAL were significantly greater in Group B versus Group A at 6 and 9 months. Conclusion: The use of an 810 nm DL provided additional benefits to MWF surgery in terms of clinical parameters.

Background: Pain is an inevitable outcome of any periodontal surgery. Controlling postoperative pain is of utmost importance so as to increase patient compliance. The present study aims to compare the degree of postoperative analgesia with the use of oral diclofenac sodium and transdermal diclofenac patch following periodontal flap surgery in patients with chronic periodontitis. Materials and Methods: A total of 20 patients requiring full mouth flap surgery were selected for this study. Flap surgery was performed quadrant-wise and transdermal diclofenac patch was applied on the right arm following surgery of one of the quadrants and 100 mg oral diclofenac sodium twice daily was prescribed following surgery of the subsequent quadrant. The postoperative pain was recorded on visual analog scale and pain intensity scale 24 h after the surgery. Results: Both the statistical and clinical observation showed that diclofenac sodium administered transdermally has equal efficacy as compared to drug administered orally. Conclusion: The study concludes that the diclofenac administered transdermally has equal potency in relieving postoperative pain as compared to orally administered diclofenac sodium following modified flap surgery. Transdermal patch has an added advantage of better patient compliance as it does not cause gastric disturbance.

Objectives: We compared the efficacies of cold knife excision and carbon dioxide (CO2) laser fiber excision of oral cavity leukoplakia. Methods: Between August 2009 and June 2011, 45 patients who underwent excision of oral cavity leukoplakia were assessed for operative time, use of bipolar cautery, blood loss, and number of intraoperative margins needed. Patients were assigned randomly to either a cold knife group (23 procedures) or a CO2 laser fiber group (24 procedures) at the time of the procedure. Results: The times of excision were similar in the CO2 laser fiber group (1.64 min/cm2) and the cold knife group (1.70 min/cm2). There were large differences between the CO2 laser fiber group and the cold knife group in the categories of bipolar cautery uses per square centimeter (0.34 uses versus 3.32 uses) and blood loss (0.19 g/cm2 versus 2.55 g/cm2). The average number of margins needed to clear a specimen by frozen section was 1.21 for the CO2 laser fiber group and 1.83 for the cold knife group. Conclusions: The CO2 laser fiber did not show an advantage in operative time. The CO2 laser fiber did show better outcomes in the areas of blood loss, bipolar cautery use, and intraoperative margins needed.

Aim: To evaluate and compare the effect of flapless and \"open flap\" techniques of implant placement on crestal bone height (CBH) around implants. Materials and Methods: This prospective study comprised of 32 implants placed in 16 subjects with a bilateral missing mandibular first molar. In each subject, one implant was placed with \"flapless\" and other using \"open flap\" technique. Radiographic assessment of CBH was carried out using standardized intraoral periapical radiograph of the site at baseline, 3 months, 9 months and 15 months after implant placement. Statistical Analysis: Data were analyzed using STATA 11.0 statistical software. To determine the changes in CBH from baseline, at 3-, 9-, and 15-month, repeated measures analysis of variance followed by post-hoc Bonferroni was used for each of the two techniques for mesial and distal aspects separately. For both techniques, changes in CBH from baseline to 15 months were compared using an independent t-test with a confidence interval of 95%. Results: For \"flapless\" technique, there was no statistically significant (P > 0.05) reduction of CBH in initial 9 months but was significant for the 9-15 months period while for \"open flap\" technique, statistically significant (P < 0.05) reduction was observed up to 15 months. Comparison of both techniques showed significantly lesser reduction with \"flapless\" than \"open flap\" technique. The overall average crestal bone loss was 0.046 +- 0.008 mm on mesial aspect, 0.043 +- 0.012 mm on distal aspect with \"flapless\" technique and 1.48 +- 0.085 mm on mesial aspect, 1.42 +- 0.077 on distal aspect \"open flap\" technique. Conclusions: Both techniques showed a reduction in CBH with time but the flapless technique showed a lesser reduction. Therefore, the flapless technique can be considered as a better treatment approach for placement of implants, especially where adequate width and height of available bone are present.