Product comparison model in otolaryngology: Equivalency analysis of absorbable hemostatic agents after endoscopic sinus surgery.

OBJECTIVES/HYPOTHESIS: Evidence-based medicine in otolaryngology literature continues to be lacking, especially with regard to new products brought to market. The marketing of products often includes statements of benefit that have limited objective support in research or literature. To address this, and to adequately determine product equivalency/superiority, careful evaluation must be made. In order to establish standards for this process in rhinology products, we directly compare three different absorbable hemostatic agents in patients with chronic rhinosinusitis (CRS) after undergoing endoscopic sinus surgery (ESS), using both objective and subjective outcomes. STUDY DESIGN: Double-blinded prospective (level 1) comparison and equivalency analysis of three plant-based absorbable hemostatic agents (carboxymethylcellulose [CMC] gel, mucopolysaccharide hemospheres (MPH), and potato starch wafer) in patients undergoing bilateral ESS. METHODS: Patients with medically refractory CRS who underwent bilateral ESS were recruited and prospectively followed. At the conclusion of ESS, one of three different hemostatic agents was applied to each nasal passage. Subjective patient data was obtained using rated symptoms compared between the two sides (nasal obstruction, bleeding, pain, and nasal discharge) at baseline and on postoperative days 1, 7, and 14. Objective data was obtained by blinded endoscopic scoring to rate mucosal edema, inflammation, granulation, crusting, infection, and synechiae formation on postoperative weeks 1, 3, and 6. RESULTS: Forty-eight patients who underwent ESS for CRS were included. There is no statistical difference in subjective scores for any of the variables measured, although (MPH) nearly reached statistical significance at postoperative day 7 for increased pain (P = 0.06) and obstruction (P = 0.22). Objective measures showed equivalency between all products, except the CMC gel approached significance at week 3 for increased crusting (P = 0.10), granulation (P = 0.24), and debridement (P = 0.07). At 6 weeks, increased debridement (P = 0.14) also approached significance. CONCLUSION: Careful and deliberate consideration should be taken when choosing products to assist our surgical endeavors. Subjectively, patients treated with MPH showed near-significant increases in pain and obstruction. In objective measures, CMC gel nearly reaches significance for more postoperative debridement, with increased crusting and inflammation. Product choice could consider these factors, although it remains at the discretion of the surgeon. This model of comparison allows careful product comparison and should be applied to other hemostatics, as well as other materials in use in otolaryngology. LEVEL OF EVIDENCE: 1b. Laryngoscope, 126:S5-S13, 2016.

The body as a living bioreactor: a feasibility study of pedicle flaps for tracheal transplantation.

Reconstruction of long-segment tracheal stenosis remains problematic. Ex vivo transplantation of stem cell-derived tracheas has been established in humans using external tissue bioreactors. These bioreactors, however, are not widely accessible. Thus, we are developing a rotational flap-based "internal bioreactor" to allow in vivo stem cell engraftment in a pre-vascularized recipient bed. This muscle will also then serve as a carrier for the transplanted trachea during rotation into position for airway reconstruction. Herein, we present a study investigating the feasibility of two pedicle muscle flaps for implantation and subsequent tracheal transplantation. Trapezius and latissimus flaps were raised using established surgical techniques. The length and width of each flap, along with the distance from the pedicle takeoff to the trachea, were measured. The overall ability of the flaps to reach the trachea was assessed. Twelve flaps were raised in 5 fresh adult human cadavers. For the trapezius flap, averages were: flap length of 16.4 cm, flap width of 5.95 cm at the tip, and distance from the pedicle takeoff to the trachea of 11.1 cm. For the latissimus dorsi flap, averages were: flap length of 35.4 cm, flap width of 7.25 cm at the tip, and distance from the pedicle takeoff to the trachea of 27.3 cm. All flaps showed sufficient durability and rotational ability. Our results show that both trapezius and latissimus dorsi flaps can be transposed into the neck to allow tension-free closure of tracheal defects. For cervical tracheal transplantation, both flaps are equally adequate. We believe that trapezius and latissimus dorsi muscle flaps are potential tracheal implantation beds in terms of vascular supply, durability, and rotational ability.

What is the Best Route to the Meckel Cave? Anatomical Comparison between the Endoscopic Endonasal Approach and a Lateral Approach.

Background Traditionally, a pterional approach is utilized to access the Meckel cave. Depending on the tumor location, extradural dissection of the Gasserian ganglion can be performed. An endoscopic endonasal access could potentially avoid a craniotomy in these cases. Methods We performed an endoscopic endonasal approach as well as a lateral approach to the Meckel cave on six anatomic specimens. To access the Meckel cave endoscopically, a complete sphenoethmoidectomy and maxillary antrostomy followed by a transpterygoid approach was performed. For lateral access, a pterional craniotomy with extradural dissection was performed. Results The endoscopic endonasal approach allowed adequate access to the Gasserian ganglion. All the relevant anatomy was identified without difficulty. Both approaches allowed for a similar exposure, but the endonasal approach avoided brain retraction and improved anteromedial exposure of the Gasserian ganglion. The lateral approach provided improved access posterolaterally and to the superior portion. Conclusion The endoscopic endonasal approach to the Meckel cave is anatomically feasible. The morbidity associated with brain retraction from the open approaches can be avoided. Further understanding of the endoscopic anatomy within this region can facilitate continued advancement in endoscopic endonasal surgery and improvement in the safety and efficacy of these procedures.

Sexuality after treatment of head and neck cancer: findings based on modification of sexual adjustment questionnaire.

OBJECTIVES/HYPOTHESIS: Evaluate sexual dysfunction in patients after treatment for head and neck cancer. STUDY DESIGN: Single-institution cross-sectional study. METHODS: Our modified Sexual Adjustment Questionnaire was administered to 42 patients (mean age, 55.1 years) and included seven questions (total score, 7-35). Based on sexual satisfaction ratings, we categorized three groups as unsatisfied (7-16), satisfied (17-25), and very satisfied (26-35). Clinical information was obtained by reviewing medical records. Bivariate analysis tested associations between sexual satisfaction and patient-related factors (e.g., sex, age, site/cancer stage, treatment, time between treatment and survey, partner, alcohol/tobacco consumption). Pearson correlation was used to analyze two continuous variables, and multivariate logistic regression analysis was used to evaluate the independent impact of each factor. RESULTS: All 42 patients rated that head and neck cancer negatively impacted their sexual relationships, including 21 (50%) rating effects as negative or extremely negative. Men reported higher satisfaction scores with sexual function (mean ± standard deviation) than women (19.9 ± 5.0 vs. 16.3 ± 6.5, respectively; P = .06). Respondents with partners reported higher scores than those without partners (19.9 ± 5.3 vs. 14.1 ± 4.4, respectively; P = .01). When the survey was administered (median, 12 months; range, 4-33 months) after the first treatment, mean score was 19; 57% of respondents were sexually satisfied, 31% were unsatisfied, and 12% were very satisfied. Instrument reliability was .82 (Cronbach alpha). CONCLUSIONS: Patients who are male and ≤ 60 years have a higher probability of sexual satisfaction during recovery. Our sexual dysfunction questionnaire will be administered in further prospective studies in patients with head and neck cancer.