Long-term effects of the titanium butterfly implant on quality of life: a prospective cohort study.

PURPOSE: Nasal valve insufficiency is known to have a negative impact on both nasal patency and quality of life. The titanium butterfly implant is a surgical treatment proven to have a positive effect on these aspects up to 6 months postoperative. This study aimed to determine the long-term effects of the titanium butterfly implant on nasal obstruction symptoms and quality of life in adult patients with nasal valve insufficiency up to 5 years after procedure. METHODS: A prospective single cohort study was performed including 29 patients that underwent the titanium butterfly implant in one tertiary medical center. Data was obtained before and at least 5 years after surgery using three questionnaires: the Nasal Obstruction and Septoplasty Effectiveness questionnaire, the Sino-Nasal Outcome Test 22 and the Glasgow Benefit Inventory questionnaire. RESULTS: A significant decrease in total NOSE score was seen compared to baseline measurements. The SNOT-22 scores also showed a significant decrease, whereas the GBI scores showed no significant changes at the late follow-up. CONCLUSION: Seven years after placement the titanium butterfly implant still has a statistically significant improvement on otorhinologic-related quality of life compared to preoperative measurements.

Septoplasty versus non-surgical management for nasal obstruction in adults with a deviated septum: economic evaluation alongside a randomized controlled trial.

BACKGROUND: For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown. METHODS: We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. RESULTS: A total of 203 adults were randomly assigned to septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI - 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI - 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. CONCLUSIONS: Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. TRIAL REGISTRATION: Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.

[Dental impression material left in patients with a palatal defect: a case series]. / Achterblijven van tandheelkundig afdrukmateriaal bij schisispatiënten met een palatumdefect.

Inattention while taking dental impressions of the upper jaw of patients with a palatal defect can lead to dental impression material being left behind. Two patients with a cheilognathopalatoschisis and a full arch prosthesis in the upper jaw were referred with complaints characteristic of chronic sinusitis and recurrent epistaxis, lasting several years. A facial cone beam computer tomogram revealed dental impression material left behind in the palatal defect and the nasal cavity. In the case of both patients, the foreign bodies were removed under general anaesthesia. One of the patients twice brought up a residual fragment of dental impression material left in the palatal defect after surgery.

Patient-reported outcome measurement in upper blepharoplasty: How to measure what the patient sees.

BACKGROUND: Blepharochalasis is very common and affects not only appearance but also visual function. Upper blepharoplasty is therefore the most frequently performed facial cosmetic procedure worldwide. It is generally seen as a small procedure with good patient acceptance and postoperative satisfaction. Research concerning the outcome of this procedure in terms of satisfaction and quality of life is lacking, as well as a recommendation on which assessment tools to use in this patient group. METHOD: A prospective study was performed on patients who underwent blepharoplasty. They were requested to complete a questionnaire preoperatively and at 3-6 months postoperatively. The Blepharoplasty Outcome Evaluation (BOE) and the Derriford Appearance Scale (DAS59) were used preoperatively and postoperatively. Visual analog scales (VAS) were also used preoperatively and postoperatively to measure visual impairment and aesthetic aspects of the eyelids. The Glasgow Benefit Inventory (GBI) was used postoperatively. SUBJECTS: Thirty-six patients completed all questionnaires. They had a mean age of 55 years (range 25-73 years) and 31 were female. MAIN FINDINGS: Reliability of all questionnaires was moderate to good. Both satisfaction with the eyes and self-esteem improved significantly. Patients reported significant benefits afterwards. All scales showed significant correlations with the exception of several DAS59 subscales. CONCLUSIONS: Upper blepharoplasty can result in great improvement in patient satisfaction, self-consciousness of appearance and benefit in daily life. Only the general subscale of the DAS59 seems relevant to use in this patient group. The BOE and GBI are brief but excellent tools to use in patients who underwent blepharoplasty to measure satisfaction and benefit in daily life.

The effect of the titanium butterfly implant on nasal patency and quality of life.

OBJECTIVE: The titanium butterfly implant seems to be a powerful technique to repair nasal valve insufficiency. However, the effect of these implants on nasal patency and quality of life has been controversial due to a lack of evidence. The purpose of this study is to evaluate the objective and subjective effect of the titanium butterfly implant on nasal patency and corresponding quality of life. METHODS: Nasal patency and quality of life of 32 patients undergoing a titanium butterfly implant were evaluated by measuring peak nasal inspiratory flow (PNIF) and completing three validated questionnaires: the NOSE, SNOT-22 and GBI, before surgery, six weeks and six months after surgery. RESULTS: The mean PNIF increased significant after 6 weeks, as well as after 6 months. Both the NOSE and SNOT-22 questionnaire scores showed a significant decrease at both post-operative measurements. The GBI indicated a significant increase at 6 weeks and 6 months. There were no significant differences between both of the post-operative measurements. CONCLUSION: This is the first study indicating that the titanium butterfly implant provides a significant and clinically relevant increase in nasal patency and corresponding quality of life in patients with nasal valve insufficiency.

Does self-consciousness of appearance influence postoperative satisfaction in rhinoplasty?

BACKGROUND: Facial plastic surgeons and patients benefit from knowledge about how psychological aspects can influence the outcome of cosmetic surgery. The influence of preoperative self-consciousness of appearance and its effect on benefit after surgery in rhinoplasty patients has not been explored before in other studies. METHOD: A prospective study was conducted on patients undergoing (septo)rhinoplasty for a combination of cosmetic and functional problems. Before the operation subjects were asked to complete two questionnaires, the Derriford Appearance Scale (DAS59) to measure distress associated with self-consciousness of appearance and the Rhinoplasty Outcome Evaluation (ROE) to measure satisfaction with their nose. Three months after surgery, they were asked to complete the ROE again and the Glasgow Benefit Inventory to measure benefit of the surgery in daily life. Scores of the pre- and postoperative questionnaires were analyzed and compared. Statistical analysis was performed to determine change after surgery and correlations between the scores. SUBJECTS: Fifty-five consecutive patients undergoing (septo)rhinoplasty received a letter in which they were asked to participate in the study. Thirty-three patients completed both pre- and postoperative questionnaires. Their mean age was 28 years. MAIN FINDINGS: Patient satisfaction improved significantly after the surgery. Lower self-consciousness of appearance before surgery was positively correlated with more benefit after the surgery and a greater change in patient satisfaction with their nose. Males have a lower benefit scores than females. CONCLUSIONS: Patients seeking rhinoplasty have more distress associated with self-consciousness of appearance than a general unconcerned population. They can benefit a lot from a well-executed procedure. A significant improvement in quality of life can be achieved by rhinoplasty. Although males are equally satisfied as females, they benefit less from the surgery in daily life.

Clinimetric properties of the Glasgow Health Status Inventory, Glasgow Benefit Inventory, Peak Nasal Inspiratory Flow, and 4-Phase Rhinomanometry in adults with nasal obstruction.

BACKGROUND: The validity of many measurement instruments frequently used in rhinology is unknown. This study describes clinimetric properties of well-known subjective and objective outcomes, i.e., the Glasgow Health Status Inventory, Glasgow Benefit Inventory, Peak Nasal Inspiratory Flow, and 4-Phase Rhinomanometry, in adults with nasal obstruction. METHODOLOGY: Construct validity and responsiveness were determined in 111 patients. Inter-rater and intra-rater reliability were analysed in 30 patients. We assessed content validity by interviewing patients and ENT-surgeons; construct validity by comparing hypothesised associations to calculated correlations between the outcomes; inter-rater reliability by having two researchers perform objective measurements in the same patients; intra-rater reliability by having one rater administer all instruments twice within a two-week interval; and responsiveness by comparing patients scores at baseline and three months after septoplasty or non-surgical management. RESULTS: All instruments demonstrated adequate content validity, inter-, and intra-rater reliability. Analyses of construct validity yielded low Pearsons correlations between the subjective and objective outcomes. Comparing septoplasty to non-surgical management, only the Glasgow Health Status Inventory scores were different between the two groups (mean difference 10.4, 95% CI 6.9 - 13.9). CONCLUSION: All measurement instruments scored appropriately on content validity and reliability, but only the subjective GHSI scored well on responsiveness.

Effectiveness of septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: study protocol for a randomized controlled trial.

BACKGROUND: Septoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform septoplasty is nasal obstruction. However, the effectiveness of septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures. METHODS/DESIGN: The study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis. DISCUSSION: With the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty. TRIAL REGISTRATION: Nederlands Trial Register/Dutch Trial Registry ( www.trialregister.nl ), trial identifying number: NTR3868 . Registered on 21 February 2013.

Three-dimensional changes in nose and upper lip volume after orthognathic surgery.

Orthognathic surgery aims to improve both the function and facial appearance of the patient. Translation of the maxillomandibular complex for correction of malocclusion is always followed by changes to the covering soft tissues, especially the nose and lips. The purpose of this study was to evaluate the changes in the nasal region and upper lip due to orthognathic surgery using combined cone beam computed tomography (CBCT) and three-dimensional (3D) stereophotogrammetry datasets. Patients who underwent a Le Fort I osteotomy, with or without a bilateral sagittal split osteotomy, were included in this study. Pre- and postoperative documentation consisted of 3D stereophotogrammetry and CBCT scans. 3D measurements were performed on the combined datasets and analyzed. Anterior translation and clockwise pitching of the maxilla led to a significant volume increase in the lip. Cranial translation of the maxilla led to an increase in the alar width. The combination of CBCT DICOM data and 3D stereophotogrammetry proved to be useful in the 3D analysis of the maxillary hard tissue changes, as well as changes in the soft tissues. Measurements could be acquired and compared to investigate the influence of maxillary movement on the soft tissues of the nose and the upper lip.

Which techniques are relevant in the surgical management of the nasal tip?

In this article, we give an overview of safe and consistent techniques for nasal tip surgery. A change in the morphology of the tip has an impact on the profile of the face. A knowledge of facial proportions is therefore important when performing rhinoplastic surgery. We prefer an external approach because it provides the best overview and because the possibility of bimanual working makes manipulation of the lower lateral cartilages easier. The techniques described here can be used to alter the nasal tip in a controllable way.

Long-term ventilation tubes: results of 726 insertions.

Patients with chronic or recurrent otitis media with effusion who do not respond to treatment with conventional ventilation tubes are often treated with long-term ventilation tubes. The aim of this retrospective study was to determine the extrusion and complication rates of long-term ventilation tubes. The median ventilation time of the tubes was 31.5 months. The most common complication was otorrhoea. One episode of otorrhoea occurred after 24% of all tube insertions, and recurrent otorrhoea occurred in 29%. A persisting perforation developed in 19% after extrusion or removal of the tube. Other, mostly minor, complications occurred in 36% with the tube in situ and in 3% after extrusion or removal of the tube. Long-term ventilation tubes provided prolonged ventilation of the middle ear, but also resulted in a considerable number of complications. For each individual case, one should therefore determine whether the advantages of long-term ventilation tubes outweigh the possible complications in view of the available alternatives for middle ear ventilation.

Reliability of manometric eustachian tube function tests in children.

OBJECTIVE: To assess the reliability of manometric eustachian tube function tests in children with ventilation tubes in situ. STUDY DESIGN: Repeated manometric eustachian tube function tests during one session. SETTING: The study took place at a secondary referral hospital and a tertiary referral hospital. PATIENTS: Ninety-nine children with ventilation tubes in situ because of persistent otitis media with effusion. MAIN OUTCOME MEASURES: Opening pressure (Po), closing pressure (Pc), and tubal function group. RESULTS: Analysis of Po and Pc showed a decrease with repeated measurement (p = 0.0001 and p = 0.001, respectively). The effect of repeated measurement on Po was more pronounced than the effect on Pc. The results of the first and second pressure equilibration tests showed 99% agreement. CONCLUSIONS: This study showed good reproducibility of the categorized results of the pressure equilibration test, whereas the results of the forced-response test seemed to be less reproducible and showed a downward shift with repeated measurement. A single measurement using wet swallowing and starting pressures of 100 and -100 daPa and the mean of the first three measurements of the Po and Pc are sufficient to determine tubal function. Further studies are needed to determine the discriminative power of these tests in children with different degrees of middle ear disease.

A comprehensive model for the aetiology of otitis media with effusion.

Otitis media with effusion is highly prevalent among young children. Adverse effects of this disorder are mainly restricted to the group of children with a history of recurrent or persistent otitis media with effusion. Early identification, assessment and intervention might prevent these adverse effects. Up to now it is not possible to distinguish these children from those with transient otitis media with effusion. This article presents a comprehensive model for the aetiology of otitis media with effusion. Eustachian tube functioning and the immunological response to environmental pathogens are the two core elements. This model can be used to formulate specific hypotheses about the interaction of several factors that may lead to the early identification of children who are likely to develop persistent or recurrent otitis media with effusion.

Eustachian tube function in children after insertion of ventilation tubes.

This study was performed to assess the effect of the insertion of ventilation tubes and the subsequent aeration of the middle ear on eustachian tube (ET) function in children. Manometric ET function tests were performed repeatedly for 3 months after the placement of ventilation tubes in 83 children with otitis media with effusion (OME). Opening and closing pressures (passive tubal function) and active tubal function were measured. Analysis of the results showed a significant increase in opening pressure over time, whereas the closing pressure did not change. The active tubal function did not change and remained at the same poor level. Therefore, the opening pressure and closing pressure and, especially, the poor active tubal function, were more likely to be a causal factor of OME than a result. Certain children may have poor intrinsic ET function that makes them more susceptible to OME.

The guide wire dilating forceps technique of percutaneous tracheostomy.

BACKGROUND: Prospective evaluation of the percutaneous tracheostomy by the guide wire dilating forceps (GWDF) technique. METHODS: In 50 selected patients percutaneous tracheostomy with fiberscopic control was performed and evaluated. RESULTS: Most percutaneous tracheostomies were performed without any adverse effect. No life-threatening complications or deaths were related to the procedure. The procedure was successful in 49 of 50 patients (98%). In 1 patient the procedure was converted to an open tracheostomy because significant bleeding occurred. Five perioperative complications, including this significant bleeding and four minor complications, occurred in 50 patients (10%). Early complications occurred in 6 of 48 patients (13%), including one significant bleeding and five minor complications. A subglottic stenosis occurred in 2 of 36 successfully decannulated patients (6%). In one case this was certainly due to prolonged endotracheal intubation. CONCLUSIONS: The GWDF technique is a safe and efficient bedside alternative to open tracheostomy. Fiberscopic control is recommended to increase the safety of the procedure. Although studies of late complications are necessary, it appears to be justifiable to consider percutaneous tracheostomy for patients who require tracheostomy.