Sinonasal inverted papilloma and predictors of health-related quality of life after endonasal endoscopic surgery: A prospective cohort study.

OBJECTIVES: Existing knowledge on health-related quality of life (HRQoL) after surgical removal of sinonasal inverted papilloma (IP) is limited. Moreover, predictors for a better or worse post-operative HRQoL outcome are not known. Our aim was to assess HRQoL in all three health domains (physical, psychological, and social), track its post-operative trajectory, investigate if pre-operative observations could predict distinct post-operative HRQoL outcomes, and evaluate whether physicians' interventions could contribute to improved post-operative HRQoL. DESIGN: Prospective cohort study. SETTING: Tertiary referral hospital. PARTICIPANTS: Seventy-four patients who underwent surgery for an IP were included. They were asked to fill in the Endonasal Endoscopic Sinus and Skull-Base Surgery Questionnaire (EES-Q) pre-operatively, and then 2 weeks, 3 months, and 1 year post-operatively. MAIN OUTCOME MEASURES: Linear mixed models analyses were performed to evaluate the overall post-operative HRQoL and the separate health domains, as well as the impact of specific variables (sex, age, American Society of Anaesthesiologists [ASA] classification, smoker, Krouse staging, pre-operative EES-Q score, type of surgery, and post-operative antibiotics) on HRQoL improvement. RESULTS: The total EES-Q score (p < .001) as well as the physical (p < .001), psychological (p = .049), and the social (p = .002) domains significantly improved post-operatively. ASA classification (p = .049), pre-operative EES-Q score (p < .001) and post-operative antibiotics (p = .036) were significant variables. CONCLUSIONS: Overall HRQoL, as well as each of the three health domains, improved significantly. A higher ASA score, a higher pre-operative EES-Q score, and the administration of post-operative antibiotics were significant predictors for better HRQoL recovery post-operatively. Further research is necessary to confirm these results.

Prospective evaluation of multidimensional health-related quality of life after endoscopic endonasal surgery for pituitary adenomas using the endoscopic endonasal sinus and skull base surgery questionnaire.

Objective: Social functioning is an important factor in the evaluation of postoperative health-related quality of life (HRQoL) for pituitary adenoma patients. In a prospective cohort study multidimensional HRQoL of non-functioning (NFA) and functioning (FA) pituitary adenoma patients were evaluated following endoscopic endonasal surgery using the endoscopic endonasal sinus and skull base surgery questionnaire (EES-Q). Methods: Prospectively, 101 patients were included. The EES-Q was completed preoperatively and postoperatively (2 weeks, 3 months, 1 year). Sinonasal complaints were completed daily during the first week postoperatively. Preoperative and postoperative scores were compared. A generalized estimating equation (uni- and multivariate) analysis was performed to identify significant HRQoL changes related to selected covariates. Results: Two weeks postoperatively, physical (p < .05) and social (p < .05) HRQoL are worse and psychological (p < .05) HRQoL improved compared with preoperatively. Three months postoperatively, psychological HRQoL (p = .01) trended back to baseline and no differences in physical or social HRQoL were reported. One year postoperatively, psychological (p = .02) and social (p = .04) HRQoL improved while physical HRQoL remained stable. FA patients report a worse HRQoL preoperatively (social, p < .05) and 3 months postoperatively (social, p < .02 and psychological, p < .02). Sinonasal complaints peak in the first days postoperatively and gradually return to presurgical levels 3 months postoperatively. Conclusions: The EES-Q provides meaningful information on multidimensional HRQoL to improve patient-centred health care. Social functioning remains the most difficult area in which to achieve improvements. Despite the relatively modest sample size, there is some indication that the FA group continues to show a downward trend (and thus improvement) even after 3 months, when most other parameters reach stability. Level of evidence: Level II-B.

Extending the use of the Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire in a cross-sectional study: Patients with chronic rhinosinusitis versus healthy controls.

OBJECTIVES: There are several instruments to assess health-related quality of life (HRQoL) in chronic rhinosinusitis (CRS). Unfortunately, none of them evaluates all three health domains (physical, social and psychological) important to assess the overall well-being of the patient. The Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire (EES-Q) does assess all these elements. Initially, the EES-Q is validated to evaluate the impact of endoscopic endonasal surgery (EES) on HRQoL. The aim of this study is to assess whether EES-Q outcomes differ in patients with CRS compared with healthy individuals. Therefore, extending the use of the EES-Q for all CRS patients. DESIGN: Cross-sectional study. SETTING: Tertiary referral hospital. PARTICIPANTS: One hundred patients with uncontrolled CRS (50% with nasal polyps) scheduled to receive EES. The questionnaire was completed preoperatively. Healthy control subjects (n = 100) without any history of sinusitis or a known current medical treatment at a hospital were included. MAIN OUTCOME MEASURES: Mann-Whitney U test was performed to identify differences in EES-Q scores (domain scores and EES-Q score). RESULTS: The median EES-Q score in CRS patients (33.8) was significantly higher (p < 0.001) than in the control group (10.4). As well as the physical (52.5 vs. 16.4, p < 0.001), psychological (13.8 vs. 5.0, p < 0.001) and social (37.5 vs. 2.5, p < 0.001) domain scores. CONCLUSIONS: With this study, we are extending the use of the EES-Q. It indicates that the EES-Q can be a valuable clinical tool to assess multidimensional HRQoL in all patients with CRS.

Detection by fluorescence of pituitary neuroendocrine tumour (PitNET) tissue during endoscopic transsphenoidal surgery using bevacizumab-800CW (DEPARTURE trial): study protocol for a non-randomised, non-blinded, single centre, feasibility and dose-finding trial.

INTRODUCTION: Achieving gross total resection and endocrine remission in pituitary neuroendocrine tumours (PitNET) can be challenging, especially in PitNETs with cavernous sinus (CS) invasion, defined as a Knosp grade of 3 or 4. A potential target to identify PitNET tissue is vascular endothelial growth factor A (VEGF-A), which expression is known to be significantly higher in PitNETs with CS invasion. METHODS AND ANALYSIS: The aim of this non-randomised, non-blinded, single centre, feasibility and dose-finding phase 1 trial is to determine the feasibility of intraoperative fluorescence imaging detection of PitNET tissue during endoscopic transsphenoidal surgery using the VEGF-A targeting optical agent bevacizumab-800CW (4, 5, 10 or 25 mg). Nine to fifteen patients with a PitNET with a Knosp grade of 3 or 4 will be included. Secondary objectives are: (1) To identify the optimal tracer dose for imaging of PitNET tissue during transsphenoidal surgery for further development in a phase 2 fluorescence molecular endoscopy trial. (2) To quantify fluorescence intensity in vivo and ex vivo with multidiameter single-fibre reflectance, single-fibre fluorescence (MDSFR/SFF) spectroscopy. (3) To correlate and validate both the in vivo and ex vivo measured fluorescence signals with histopathological analysis and immunohistochemical staining. (4) To assess the (sub)cellular location of bevacizumab-800CW by ex vivo fluorescence microscopy. Intraoperative, three imaging moments are defined to detect the fluorescent signal. The tumour-to-background ratios are defined by intraoperative fluorescence in vivo measurements including MDSFR/SFF spectroscopy data and by ex vivo back-table fluorescence imaging. After inclusion of three patients in each dose group, an interim analysis will be performed to define the optimal dose. ETHICS AND DISSEMINATION: Approval was obtained from the Medical Ethics Review Board of the University Medical Centre Groningen. Results will be disseminated through national and international journals. The participants and relevant patient support groups will be informed about the results. TRIAL REGISTRATION NUMBER: NCT04212793.

The effect of three-dimensional visualisation on performance in endoscopic sinus surgery: A clinical training study using surgical navigation for movement analysis in a randomised crossover design.

OBJECTIVES: Endoscopic imaging techniques and endoscopic endonasal surgery (EES) expertise have evolved rapidly. Only few studies have assessed the effect of three-dimensional (3D) endoscopy on endoscopic sinus surgery (ESS). The present study aimed to objectively and subjectively assess the additional value of 3D high-definition (HD) endoscopy in ESS. DESIGN: A randomized crossover study of endoscopic surgery performance, using five ESS tasks of varying complexity, performed on Thiel embalmed human specimens. SETTING: Simulated surgical environment. PARTICIPANTS: Thirty participants, inexperienced in ESS. MAIN OUTCOME MEASURES: Performance was assessed using video imaging, surgical navigation and questionnaires. Main outcome measures were as follows: efficiency (defined by time to task completion), distance covered inside the nose, average velocity towards target, accuracy (measured by error rate), and subjective assessment of endoscope characteristics. RESULTS: During ESS tasks, both efficiency and accuracy did not differ significantly between 2D HD and 3D HD endoscopy. Subjectively, imaging characteristics of the 3D HD endoscope were rated significantly better. CONCLUSIONS: ESS performance of inexperienced participants was not significantly improved by the use of 3D HD endoscopy during ESS tasks, although imaging characteristics of the 3D HD endoscope were rated significantly better. Surgical field characteristics and surgical techniques are likely to influence any additional value of 3D HD endoscopy.

Evaluation of the psychometric properties of the endoscopic endonasal sinus and skull base surgery questionnaire (EES-Q) in a prospective cohort study.

OBJECTIVES: The patients' perspective on health has become increasingly important when assessing treatment outcomes. Recently, the Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire (EES-Q) was developed to determine the impact of endoscopic endonasal surgery on health-related quality of life (HRQoL). The aim of this study was to evaluate the test-retest reliability, construct validity and responsiveness of the EES-Q. DESIGN: Prospective cohort study. SETTING: University Medical Center Groningen, tertiary referral hospital, the Netherlands. PARTICIPANTS: One hundred patients who underwent endoscopic endonasal surgery because of sinus or anterior skull base pathology. MAIN OUTCOME MEASURES: Test-retest reliability, construct validity and responsiveness. RESULTS: The EES-Q domains exhibited good test-retest reliability (ICC > 0.90). Construct validity was corroborated by significant positive and negative correlations between the EES-Q and the Sino-Nasal Outcome Test-22 (SNOT-22) and postoperative health status (P < 0.01) respectively. The correlation between the social EES-Q domain and the ability to move and perform usual activities (EuroQol-5D-3L [EQ-5D-3L]) was significant positive (P < 0.01). In patients with paranasal sinus pathology, the EES-Q was responsive to clinical change (Cohen's d = 0.6). CONCLUSION: The EES-Q is a reliable and acceptable responsive disease-specific HRQoL instrument. The expected construct validity of the EES-Q is supported by the results in this study. Inconveniences in social functioning had the greatest negative impact on postoperative health status rating. This reflects the importance of a multidimensional HRQoL assessment after EES. The results indicate that the EES-Q is a promising disease-specific tool for the HRQoL assessment after endoscopic endonasal sinus or anterior skull base surgery.

Development of the Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire.

BACKGROUND: The patients' perspective of health outcomes has become important input for assessing treatment effects. However, existing endoscopic endonasal surgery (EES) instruments are not fully aligned with the concept of health-related quality of life (HRQoL). A prospective cohort study was therefore conducted to develop a suitable quality-of-life tool to assess nasal morbidity after EES: the Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire (EES-Q). METHODS: The study included 300 patients: 207 with sinus pathology and 93 with anterior skull base pathology. The EES-Q was administered prior to surgery and postoperatively (2 weeks, 3 months, and 1 year). Psychometric instrument properties were tested and relevant health domains were formulated. Seventy-two items were generated by the conventional psychometric approach. An exploratory factor analysis was used to test construct validity. The optimal number of factors to retain was determined by using the eigenvalues-greater-than-1 rule and scree plot. Orthogonal varimax rotation was used to enhance interpretability. Internal consistency was assessed using the Cronbach α. RESULTS: The factor analysis yielded a 3-factor solution, representing physical, psychological, and social functioning. The final version of the instrument consisted of 30 items with a high internal consistency (>0.80) for all 3 HRQoL domains. CONCLUSIONS: The EES-Q is a comprehensive, multidimensional, disease-specific instrument. A distinguishing characteristic is that, apart from the physical and psychological domains, the EES-Q also encompasses a social domain. Understanding different HRQoL aspects in patients undergoing EES may help caregivers restore, improve, or preserve the patient's health through individualized care, which depends on identifying their specific needs.

Calculating nasoseptal flap dimensions: a cadaveric study using cone beam computed tomography.

We hypothesize that three-dimensional imaging using cone beam computed tomography (CBCT) is suitable for calculating nasoseptal flap (NSF) dimensions. To evaluate our hypothesis, we compared CBCT NSF dimensions with anatomical dissections. The NSF reach and vascularity were studied. In an anatomical study (n = 10), CBCT NSF length and surface were calculated and compared with anatomical dissections. The NSF position was evaluated by placing the NSF from the anterior sphenoid sinus wall and from the sella along the skull base towards the frontal sinus. To visualize the NSF vascularity in CBCT, the external carotic arteries were perfused with colored Iomeron. Correlations between CBCT NSFs and anatomical dissections were strongly positive (r > 0.70). The CBCT NSF surface was 19.8 cm(2) [16.6-22.3] and the left and right CBCT NSF lengths were 78.3 mm [73.2-89.5] and 77.7 mm [72.2-88.4] respectively. Covering of the anterior skull base was possible by positioning the NSF anterior to the sphenoid sinus. If the NSF was positioned from the sella along the skull base towards the frontal sinus, the NSF reached partially into the anterior ethmoidal sinuses. CBCT is a valuable technique for calculating NSF dimensions. CBCT to demonstrate septum vascularity in cadavers proved to be less suitable. The NSF reach for covering the anterior skull base depends on positioning. This study encourages preoperative planning of a customized NSF, in an attempt to spare septal mucosa. In the concept of minimal invasive surgery, accompanied by providing customized care, this can benefit the patients' postoperative complaints.

Cochlear aqueduct flow resistance is not constant during evoked inner ear pressure change in the guinea pig.

Inner ear fluid pressure was measured during 6.25 mHz square wave middle ear pressure manipulation, with a perforated tympanic membrane. After a negative-going middle ear pressure change the calculated flow resistance of the inner ear pressure release routes (mainly the cochlear aqueduct) was approximately constant, with a value of 12 Pa s/nl (averaged over two ears), when values for the inner ear window compliance are taken from the literature. After a positive-going middle ear pressure change the calculated flow resistance changed with round window position and with the pressure difference across the cochlear aqueduct. It reached an average maximum value of 114 Pa s/nl. The change of flow resistance during inner ear pressure variation can be explained by a permeability change of the cochlear aqueduct, caused by a change of structures filling the aqueduct and its entrance in scala tympani.