Oncologic Safety of Close Margins in Patients With Low- to Intermediate-Grade Major Salivary Gland Carcinoma.

Importance: Postoperative radiation therapy for close surgical margins in low- to intermediate-grade salivary carcinomas lacks multi-institutional supportive evidence. Objective: To evaluate the oncologic outcomes for low- and intermediate-grade salivary carcinomas with close and positive margins. Design, Setting, and Participants: The American Head and Neck Society Salivary Gland Section conducted a retrospective cohort study from 2010 to 2019 at 41 centers. Margins were classified as R0 (negative), R1 (microscopically positive), or R2 (macroscopically positive). R0 margins were subclassified into clear (>1 mm) or close (≤1 mm). Data analysis was performed from June to October 2023. Main Outcomes and Measures: Main outcomes were risk factors for local recurrence. Results: A total of 865 patients (median [IQR] age at surgery, 56 [43-66] years; 553 female individuals [64%] and 312 male individuals [36%]) were included. Of these, 801 (93%) had parotid carcinoma and 64 (7%) had submandibular gland carcinoma, and 748 (86%) had low-grade tumors and 117 (14%) had intermediate-grade tumors, with the following surgical margins: R0 in 673 (78%), R1 in 168 (19%), and R2 in 24 (3%). Close margins were found in 395 of 499 patients with R0 margins (79%), for whom margin distances were measured. A total of 305 patients (35%) underwent postoperative radiation therapy. Of all 865 patients, 35 (4%) had local recurrence with a median (IQR) follow-up of 35.3 (13.9-59.1) months. In patients with close margins as the sole risk factor for recurrence, the local recurrence rates were similar between those who underwent postoperative radiation therapy (0 of 46) or observation (4 of 165 [2%]). Patients with clear margins (n = 104) had no recurrences. The local recurrence rate in patients with R1 or R2 margins was better in those irradiated (2 of 128 [2%]) compared to observed (13 of 64 [20%]) (hazard ratio [HR], 0.05; 95% CI, 0.01-0.24). Multivariable analysis for local recurrence found the following independent factors: age at diagnosis (HR for a 10-year increase in age, 1.33; 95% CI, 1.06-1.67), R1 vs R0 (HR, 5.21; 95% CI, 2.58-10.54), lymphovascular invasion (HR, 4.47; 95% CI, 1.43-13.99), and postoperative radiation therapy (HR, 0.10; 95% CI, 0.04-0.29). The 3-year local recurrence-free survivals for the study population were 96% vs 97% in the close margin group. Conclusions and Relevance: In this cohort study of patients with low- and intermediate-grade major salivary gland carcinoma, postoperative radiation therapy for positive margins was associated with decreased risk of local recurrence. In isolation from other risk factors for local recurrence, select patients with close surgical margins (≤1 mm) may safely be considered for observation.

Complications following salvage transoral robotic surgery with and without reconstruction: A systematic review of the literature.

BACKGROUND: Transoral robotic surgery (TORS) has been used in the salvage setting for head and neck cancers both with and without reconstruction. The complications of salvage TORS and the effect of reconstruction on complications has not been studied. OBJECTIVE: To study the complications of salvage TORS and examine the effect of reconstruction on complication rates. METHOD: An electronic search of the English- language literature using PubMed, Medline, and the Cochrane database was conducted and a systematic review performed in accordance with PRISMA guidelines (CRD42020181057). RESULTS: A total of 23 studies including 533 patients have been published on salvage TORS.The average patient age was 61.2 years.Prior treatment was described for 420 patients.205 (48.8%) underwent prior definitive radiotherapy (RT).160 (38.1%) underwent definitive chemoradiotherapy (CRT).Only 55 (13.1%) had prior surgery.Overall, there were 158 complications with a pooled rate of 33.6% (95%CI: 25.4-42.3%).77 were major complications requiring surgical intervention with a pooled rate of 18.9% (95% CI: 14.8-23.3%).The number of patients undergoing reconstruction among salvage cases in the literature is 59 (9.19%), with 24 local flaps and 25 microvascular free flaps.Reconstruction was associated with lower overall hemorrhage rates but had no impact on major hemorrhage rates. CONCLUSIONS: The pooled incidence rates of major complications, major POH and emergency tracheostomy following salvage TORS are 18.9%, 10.5%, and 4.4%.The rate of death following salvage TORS is 3.6%. Reconstruction was associated with lower overall hemorrhage rate after salvage TORS but had no impact on major postoperative hemorrhage rates.

Margins in Stage I and II Oral Cavity Squamous Cell Carcinoma: A Review From the American Head and Neck Society.

Importance: The assessment and management of surgical margins in stage I and II oral cavity squamous cell carcinoma is one of the most important perioperative aspects of oncologic care, with profound implications for patient outcomes and adjuvant therapy. Understanding and critically reviewing the existing data surrounding margins in this context is necessary to rigorously care for this challenging group of patients and minimize patient morbidity and mortality. Observations: This review discusses the data related to the definitions related to surgical margins, methods for assessment, specimen vs tumor bed margin evaluation, and re-resection of positive margins. The observations presented emphasize notable controversy within the field about margin assessment, with early data coalescing around several key aspects of management, although studies are limited by their design. Conclusions and Relevance: Stage I and II oral cavity cancer requires surgical resection with negative margins to obtain optimal oncologic outcomes, but controversy persists over margin assessment. Future studies with improved, well-controlled study designs are required to more definitively guide margin assessment and management.

Excision of massive left branchial cleft cyst with secondary hypertension.

Branchial anomalies are heterogeneous congenital malformations that form secondary to incomplete closure of pharyngeal clefts and pouches. There have been no reports of branchial cleft cysts causing carotid artery compression and hypertension. We report a large branchial cleft cyst causing suspected secondary hypertension from carotid artery compression.

Effect of 2 Teams and Operative Time on Complications After Oral Cavity Free Flap Reconstruction.

OBJECTIVE: Evaluate the effects of operative time and 2 team approach on complications after soft tissue free flap reconstruction for oral tongue cancer. METHODS: Patients with oncologic glossectomy with myocutaneous or fasciocutaneous free flap reconstruction were included from the 2015 to 2018 American College of Surgery National Surgical Quality Improvement Program. The primary predictive variables assessed were operative time and 2 team approach; control variables included age, sex, body mass index (BMI), 5-question-modified frailty index (mFI-5), American Society of Anesthesiologists (ASA) class, and total work relative value units (wRVU). Outcomes assessed included 30-day mortality, 30-day reoperation, hospital length of stay beyond 30 days, readmission, medical and surgical complications, and non-home discharge. Multivariable logistic/linear regression models were used to predict surgical outcomes. RESULTS: Microvascular soft tissue free flap reconstruction of the oral cavity after glossectomy was performed on 839 patients. Operative time was independently associated with readmission, prolonged length of stay, surgical complications, medical complications, and non-home discharge. A 2-team approach was independently associated with prolonged length of stay and medical complications. The mean operative time of the 1-team and 2-team approach was 8.73 and 9.13 hours. The 1-team approach did not significantly increase operative time (P = .16). CONCLUSIONS: In the largest study to date of operative time on post-surgical outcomes after glossectomy and soft tissue free flap reconstruction, we found longer operative times increased rates of postoperative complications and non-home discharge. The 1-team approach is non-inferior to the 2-team approach with respect to operating time and complications.

Optimizing Reversal of Muscle Relaxation with Sugammadex to Accelerate Discharge Readiness in Operative Laryngoscopy: A Randomized Clinical Trial.

IMPORTANCE: Operative laryngoscopy is a commonly performed ambulatory procedure in patients with significant co-morbidity. Optimal anesthetics for surgical exposure with rapid return to baseline after the procedure enhances postoperative patient safety. OBJECTIVE: To determine whether sugammadex hastens recovery in patients undergoing operative laryngoscopy under general anesthesia with rocuronium-induced paralysis. DESIGN: Prospective clinical intervention randomized single-blinded, single-center study in an academic tertiary care center. Approved by the institutional review board and registered with ClinicalTrials.gov. SETTINGS: Single center tertiary care academic institution. PARTICIPANTS: 18 years or older, American Society of Anesthesiology physical status I-III with ability to give written informed consent undergoing operative laryngoscopy. INTERVENTION: Participants were randomized into two groups. Both groups received inhaled anesthetic: sevoflurane, remifentanil, and rocuronium at 0.6-1.2 mg/kg for intubation and anti-nausea prophylaxis. Group 1 received reversal with neostigmine (0.04 mg/kg) and glycopyrrolate (0.01 mg/kg). Group 2 received reversal with sugammadex (4 mg/kg). Vital signs were maintained at 20% of baseline in both groups. Post anesthesia care unit nurses were blinded to the reversal agent and were the evaluators of the discharge criteria and times. Primary end point was time to extubation after the procedures and secondary end points were: Subjective interpretation of surgical conditions by the surgeon, hemodynamic, respiratory parameters, anesthetics, and opioids used, operative time, and duration to achieve discharge readiness. RESULTS: A total of eighty-four participants, who were similar in age, sex, and weight in both groups. The primary end point and secondary end points were similar except time to meet discharge criteria in the two groups. 65% in the sugammadex versus 35% in the neostigmine group met Aldrete criteria of 18 or higher on arrival at the post anesthesia care unit. CONCLUSIONS: Optimizing the anesthetic regimen, along with stable intraoperative hemodynamics and reversal with sugammadex improves discharge readiness in patients undergoing operative laryngoscopy.

18 F-fludeoxyglucose positron emission computed tomography (18 F-FDG-PET/CT) versus 68 Ga-DOTATATE-PET/CT in patients with head and neck cancer: Comparisons and implications for treatment.

BACKGROUND: Tumor-specific molecular imaging in head and neck squamous cell carcinoma (HNSCC) is not well established. Somatostatin receptors (SSTRs) are found in solid tumors, including HNSCC. 68 Ga-DOTATATE, a commercially available radionuclide that binds SSTRs, may have utility in imaging HNSCC. METHODS: Patients with HNSCC received pretreatment imaging with 18 F-FDG-PET/CT and 68 Ga-DOTATATE. Imaging was compared for concordance. When available, surgical resection specimens were compared to pretreatment imaging findings. Historic HNSCC tumor specimens were assessed for both SSTR and p16/human papilloma virus (HPV) expression. RESULTS: Twenty patients were imaged. Fifteen had oropharyngeal cancer. Primary tumor site was concordant between imaging modalities for all patients. One of 45 lymph nodes was discordant. Retrospective specimen review showed a significant correlation with SSTR expression and HPV/p16 expression. No adverse events occurred. CONCLUSIONS: 68 Ga-DOTATATE imaging is safe and effective in HNSCC. SSTR expression may be increased in HPV-mediated tumors. Targeted therapies to SSTR should be explored.

Preoperative low-molecular weight heparin chemoprophylaxis in head and neck free flap reconstruction.

BACKGROUND: The safety of presurgical thromboprophylaxis using low molecular weight heparin (LMWH) has not been well described in head and neck oncologic surgery with free tissue transfer (HNS-FTT). METHODS: Retrospective chart review of HNS-FTT patients receiving versus not receiving presurgical subcutaneous enoxaparin (Px-LMWH) was performed. Outcomes included estimated blood loss (EBL), hematoma, flap compromise, DVT or pulmonary embolus (PE). Fisher's exact test and Wilcoxon Rank Sum test were performed to compare groups. Odds ratios and associated 95 % confidence intervals were provided as appropriate. RESULTS: 43 of 128 patients (34 %) received Px-LMWH. There was no significant difference in EBL, hematoma, or flap complications between groups. Patients without Px-LMWH had higher rates of DVT and PE, although the difference did not reach statistical significance (p = 1.00, 0.095, respectively). CONCLUSION: Presurgical Px-LMWH can be used in major head and neck reconstructive surgery without increased intraoperative blood loss or postoperative complications. Larger studies will need to be done to determine the impact of Px-LMWH on DVT and PE in this patient population.

Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: The ORATOR2 Phase 2 Randomized Clinical Trial.

Importance: The optimal approach for treatment deescalation in human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is unknown. Objective: To assess a primary radiotherapy (RT) approach vs a primary transoral surgical (TOS) approach in treatment deescalation for HPV-related OPSCC. Design, Setting, and Participants: This international, multicenter, open-label parallel-group phase 2 randomized clinical trial was conducted at 9 tertiary academic cancer centers in Canada and Australia and enrolled patients with T1-T2N0-2 p16-positive OPSCC between February 13, 2018, and November 17, 2020. Patients had up to 3 years of follow-up. Interventions: Primary RT (consisting of 60 Gy of RT with concurrent weekly cisplatin in node-positive patients) vs TOS and neck dissection (ND) (with adjuvant reduced-dose RT depending on pathologic findings). Main Outcomes and Measures: The primary end point was overall survival (OS) compared with a historical control. Secondary end points included progression-free survival (PFS), quality of life, and toxic effects. Results: Overall, 61 patients were randomized (30 [49.2%] in the RT arm and 31 [50.8%] in the TOS and ND arm; median [IQR] age, 61.9 [57.2-67.9] years; 8 women [13.6%] and 51 men [86.4%]; 31 [50.8%] never smoked). The trial began in February 2018, and accrual was halted in November 2020 because of excessive toxic effects in the TOS and ND arm. Median follow-up was 17 months (IQR, 15-20 months). For the OS end point, there were 3 death events, all in the TOS and ND arm, including the 2 treatment-related deaths (0.7 and 4.3 months after randomization, respectively) and 1 of myocardial infarction at 8.5 months. There were 4 events for the PFS end point, also all in the TOS and ND arm, which included the 3 mortality events and 1 local recurrence. Thus, the OS and PFS data remained immature. Grade 2 to 5 toxic effects occurred in 20 patients (67%) in the RT arm and 22 (71%) in the TOS and ND arm. Mean (SD) MD Anderson Dysphagia Inventory scores at 1 year were similar between arms (85.7 [15.6] and 84.7 [14.5], respectively). Conclusions and Relevance: In this randomized clinical trial, TOS was associated with an unacceptable risk of grade 5 toxic effects, but patients in both trial arms achieved good swallowing outcomes at 1 year. Long-term follow-up is required to assess OS and PFS outcomes. Trial Registration: Clinicaltrials.gov Identifier: NCT03210103.

Factors Associated With a Prolonged Diagnosis-to-Treatment Interval in Laryngeal Squamous Cell Carcinoma.

OBJECTIVE: Evaluate factors associated with treatment delays and their effect on survival in laryngeal squamous cell carcinoma. STUDY DESIGN: Retrospective cohort study. SETTING: National Cancer Database. METHODS: Patients receiving primary radiation or surgery for laryngeal squamous cell carcinoma were included from 2004 to 2017. The primary outcomes were the diagnosis-to-treatment interval (DTI) and 5-year survival. Variables of prolonged DTI (>30 days) were assessed via logistic regression models. Survival was then assessed through Cox proportional hazards models. Candidate variables for both outcomes included age, sex, race, ethnicity, distance to treatment facility, insurance coverage, treatment facility type, TNM T stage, nodal status, and DTI (in models estimating survival). RESULTS: An overall 136,203 patients with laryngeal cancer were identified, from which 51,747 remained after exclusions were applied: 18,499 received primary surgery and 33,248 received primary radiation. Being a member of a racial or ethnic minority, advanced age, female sex, ≥30 miles from treatment facility, lack of insurance, treatment at an academic cancer center, and primary radiation were associated with a prolonged DTI. However, in spite of a faster DTI, treatment at a community cancer center was independently associated with higher mortality (hazard ratio, 1.2; P < .0001). CONCLUSIONS: Despite being associated with prolonged DTI, receiving treatment at a high-volume academic facility was associated with significantly improved survival. Our results indicate that improved referral pathways or outreach may help improve survival in laryngeal cancer, especially in high-risk populations.

Transoral Chondrolaryngoplasty: Scarless Reduction of the Adam's Apple.

The purpose of our study is to test the feasibility of transoral thyroid chondrolaryngoplasty using a similar approach to transoral thyroidectomy. This approach would allow for gender-affirming surgery while avoiding an external neck scar. We carried out our cadaveric feasibility study in an anatomy laboratory at an academic center. Five fresh cadavers were used for this study. We used a lower oral vestibular incision, along with retractors and an endoscope to dissect and gain access to the laryngeal prominence of the thyroid cartilage. Portions of the laryngeal prominence were then removed using scissors to achieve a satisfactory neck contour. Endoscopic as well as extracorporeal photographs were taken to demonstrate the approach. We were able to remove the laryngeal prominence successfully in all of our cadaveric specimens with this transoral approach.

Functional outcomes of the modified submandibular gland transfer procedure.

OBJECTIVES: Treatment for advanced head and neck cancers typically includes surgery followed by radiation therapy (RT). Radiation-induced xerostomia is a common sequela of these treatments. The modified submandibular gland transfer (M-SGT) procedure was developed to decrease xerostomia in the treatment of oral cavity cancer by sparing one submandibular gland (SMG) from radiation. This study's objectives were to: 1) elucidate the radiation-sparing capacity of the M-SGT, and 2) study the xerostomia-reducing potential of the M-SGT based on the University of Washington Quality-of-Life Questionnaire (UW-QOL). METHODS: Radiation therapy treatment plans were reviewed for all patients treated with surgery and RT who had a M-SGT at the University of Alberta Hospital during the study period. Outcomes included: 1) radiation dose received by the transferred SMG within the periparotid area compared to the submandibular triangle (ST), and 2) patient-reported saliva scores on the UW-QOL compared to historical controls without a gland transfer. RESULTS: Twenty-two patients were included. The mean radiation dose received by the transferred SMG was 29.00 grays (Gy) (standard deviation 14.59 Gy), thus reducing the mean radiation dose to the SMG by a statistically significant 18.34 Gy (confidence interval 95% (13.37, 23.32), P < 0.01) compared to the ST and below the D50 of the SMG (34 Gy). Sixty-five percent of patients rated their saliva as normal or mildly reduced on the UW-QOL as compared to 16% of controls (P = 0.01). CONCLUSION: The M-SGT technique is successful at reducing the radiation dose sustained by the SMG during adjuvant treatment and provides a significant improvement in xerostomia-related functional outcomes as compared to historical controls not receiving a gland transfer. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:925-929, 2020.

Improving exposure for transoral oropharyngeal surgery with the floor of mouth window: a cadaveric feasibility study.

BACKGROUND: Transoral robotic and laser surgery is rising in popularity due to the increasing incidence of Human Papilloma Virus (HPV) related oropharyngeal cancer. However, adequate exposure of the tongue base remains a major hurdle in many cases. This study introduces a novel surgical technique called the Floor of Mouth Window, which can be used to improve tongue base exposure at the time of transoral surgery. METHODS: This is a preclinical anatomic cadaver study. Seven fresh cadavers were used for this study. Exposure of the tongue base was compared between conventional mouth gags - the Feyh-Kastenbauer and McIvor - and our novel procedure, the Floor of Mouth Window. Exposure was compared subjectively using endoscopic and extracorporeal photographs, as well as objective measurements of inter-incisor distance, and oral cavity volume. RESULTS: The exposure achieved by the Floor of Mouth Window technique was superior to the mouth gags. Inter-incisor distance and oral cavity volume measurements were all more favorable with the Floor of Mouth Window. This technique allowed for successful transoral laser tongue base and tonsil resection without the use of gags or scopes. CONCLUSION: The Floor of Mouth Window is an adjunctive procedure that simply and reliably improved exposure for transoral oropharyngeal surgery in this cadaveric feasibility study. This improved exposure may help increase the adoption of transoral surgery and reduce the number of aborted cases due to anatomic limitations.

Experience with key indicator cases among otolaryngology residents.

OBJECTIVE: To describe the resident experience with respect to key indicator cases for each year of training. STUDY DESIGN: Multi-institution, cross-sectional assessment. METHODS: Using an electronic survey, current otolaryngology residents were solicited to complete a survey regarding their experiences with the key indicator cases to that point. The survey was sent to this cohort in the winter of 2017-2018. RESULTS: Three hundred and three residents responded, with 293 completing the survey. Twenty-three percent were PGY1, 19% PGY2, 21% PGY3, 18% PGY4, and 19% PGY5 or higher. The majority of residents progress from resident assistant as a PGY2, to resident surgeon as a PGY3 and self-assessed competent surgeon as a PGY4 for the majority of the key indicator cases. Less than 50% of the surveyed PGY5 residents had reached independent practice in all the key indicator cases, with stapedectomy (16%), rhinoplasty (18%), and paramedian forehead flap (14.5%) being the cases least frequently performed independently. Ninety-five percent of the respondent residents felt their program provided adequate training, but 20% of the respondents were either unsure or believed that they would be unable to perform all the key indicator cases by the completion of their training. CONCLUSIONS: The majority of otolaryngology residents feel confident in their training, but experience with certain cases lags behind and may not currently be taught as resident level cases. These findings raise the question of whether the current key indicator cases are the best option for assessing breadth and depth of residency training. LEVEL OF EVIDENCE: NA.

Remarkable Presentation: Anaplastic Thyroid Carcinoma Arising from Chronic Hyperthyroidism.

BACKGROUND: Undifferentiated anaplastic carcinoma rarely develops from chronic hyperthyroidism. Although acute hyperthyroidism can develop prior to anaplastic transformation, chronic hyperthyroidism was thought to be a protective measure against thyroid malignancy. METHODS: A 79-year-old female presented acutely to the hospital with dyspnea. She had been taking methimazole for chronic hyperthyroidism due to toxic thyroid nodules, previously biopsied as benign. Upon admission, imaging showed tracheal compression, requiring a total thyroidectomy with tracheostomy for airway management. RESULTS: Pathology demonstrated undifferentiated anaplastic thyroid carcinoma. The patient passed away shortly after hospital discharge. Despite treatment with methimazole for many years, abrupt enlargement of her toxic multinodular goiter was consistent with malignant transformation. Chronic hyperthyroidism and toxic nodules are rarely associated with thyroid malignancy, with only one previous report documenting association with anaplastic thyroid carcinoma. CONCLUSION: Progressive thyroid enlargement and acute worsening of previously controlled hyperthyroidism should promote concern for disease regardless of baseline thyroid function.

The effect of topically applied tissue expanders on radial forearm skin pliability: a prospective self-controlled study.

BACKGROUND: The use of pre-operatively applied topical tissue expansion tapes have previously demonstrated increased rates of primary closure of radial forearm free flap donor sites. This is associated with a reduced cost of care as well as improved cosmetic appearance of the donor site. Unfortunately, little is known about the biomechanical changes these tapes cause in the forearm skin. This study tested the hypothesis that the use of topically applied tissue expansion tapes will result in an increase in forearm skin pliability in patients undergoing radial forearm free flap surgery. METHODS: Twenty-four patients scheduled for head and neck surgery requiring a radial forearm free flap were enrolled in this prospective self-controlled observational study. DynaClose tissue expansion tapes (registered Canica Design Inc, Almonte, Canada) were applied across the forearm one week pre-operatively. Immediately prior to surgery, the skin pliability of the dorsal and volar forearm sites were measured with the Cutometer MPA 580 (registered Courage-Khazaka Electronic GmbH, Cologne, Germany) on both the treatment and contralateral (control) arms. Paired t-tests were used to compare treatment to control at both sites, with p < 0.025 defined as statistically significant. RESULTS: There was a statistically significant increase in pliability by a mean of 0.05 mm (SD = 0.09 mm) between treatment and control arms on the dorsal site (95% CI [0.01, 0.08], p = 0.018). This corresponded to an 8% increase in pliability. In contrast, the volar site did not show a statistically significant difference between treatment and control (mean difference = 0.04 mm, SD = 0.20 mm, 95% CI [-0.04, 0.12], p = 0.30). CONCLUSIONS: This result provides evidence that the pre-operative application of topical tissue expansion tapes produces measurable changes in skin biomechanical properties. The location of this change on the dorsal forearm is consistent with the method of tape application. While this increase in skin pliability may account for the improved rate of primary donor site closure reported using this technique, the results did not reach our definition of clinical significance.

The effect of probe placement on inter-trial variability when using the Cutometer MPA 580.

There is limited data independently assessing the optimal use of the Cutometer MPA580. The purpose of this study is to test the hypothesis that the assessment of elastic recoil is significantly different when utilizing two different probe placement protocols. In protocol A, four trials were performed, in which the probe was removed from the skin between trials. In protocol B, the probe was not removed from the skin between trials. Fifty-four patients were enrolled and all completed the testing. When assessing elasticity (Ua/Uf), the inter-class correlation was 0.83 for protocol A and 0.48 for protocol B (p <0.001). There was no significant difference between individual trials for protocol A. Trial one of protocol B was significantly different (p < 0.001) than trials 2-4 for protocol B. Trial one of protocol B was not significantly different than any trial in protocol A. The results of this study suggest that the method in which a clinician performs repeated measure testing has a significant effect on the outcome measures when using the Cutometer. Removing the probe between trials appears to result in measures with higher reliability.

The effect of probe to skin contact force on Cutometer MPA 580 measurements.

The purpose of this study is to test the hypothesis that increasing the force applied on the skin by the Cutometer MP580 probe will result in a decrease in the skin elasticity measures. Specifically, this study assessed the probe intrinsic weight plus the addition of a light mass (10 g and 20 g), a moderate mass (50 g and 100 g) and a high mass (200 g and 500 g) on skin elasticity measures. Primary outcome measures Uv, Ur, Uf, Ue and Ua, along with calculated measures Uv/Uf, Ua/Uf and Ur/Uf were assessed under each loading condition. A general linear model ANOVA with repeated measures was used to assess for differences in each outcome measure between each loading condition. Thirty-two patients were enrolled and all completed the testing. For all primary variables except Uv (p < 0.001), there was no statistically significant effect of adding a light mass to the probe. There was a significant effect of the addition of a moderate and heavy mass for all variables (p < 0.005) except Ue/Uf. These results suggest that the addition of a low mass results in no significant effect on outcome measures. However, if moderate-to-heavy additional force is applied to the probe, the outcome measures are significantly altered. Of all the variables, Ue/Uf appears to be influenced the least by alterations in force. Users should ensure light contact is made between the skin and probe during testing to avoid a false alteration in outcome measures of skin elasticity.

Success of supraglottoplasty for severe laryngomalacia: the experience from Northeastern Ontario, Canada.

OBJECTIVES: To review the outcomes of supraglottoplasty performed in children with severe laryngomalacia at a pediatric university teaching hospital and to determine if these outcomes are influenced by gender, age at time of supraglottoplasty, or medical comorbidities. METHODS: Retrospective chart review of children who underwent supraglottoplasty for severe laryngomalacia between 2001 and 2010 at the Children's Hospital of Eastern Ontario in Ottawa, Canada. Statistical significance was obtained using 2-tailed Fisher's exact test. The outcome measures were resolution of laryngomalacia symptoms or persistence of laryngomalacia symptoms with or without additional surgery. RESULTS: Among 26 post-primary supraglottoplasty patients, 46.2% had resolution and 53.8% had persistence, including 19.2% with partial improvement and 34.6% requiring revision supraglottoplasty and/or tracheostomy. Resolution was present in 35.7% of males and 58.3% of females (p = 0.43); in 33.3% of all patients ≤2 months old and 52.9% of all patients >2 months old (p = 0.43); and in 50.0% of non-comorbid patients ≤2 months old and 80.0% of non-comorbid patients >2 months old (p = 0.52). 71.4% of persistence cases were found in comorbid patients. 83.3% of comorbid patients had persistence, compared to 28.6% of non-comorbid patients (p=0.008). Of the 3 patients with overlapping comorbid categories, 2 required at least 2 revision supraglottoplasties and ultimately required a tracheostomy. CONCLUSIONS: Persistence of laryngomalacia symptoms post-primary supraglottoplasty was not associated with gender or age at time of surgery, and was more commonly found in children with comorbidities. Patients with coexisting medical conditions appear to require more aggressive surgical management, beyond one revision supraglottoplasty.