Botulinum toxin A treatment in facial palsy synkinesis: a systematic review and meta-analysis.

BACKGROUND: Synkinesis is defined as involuntary movements accompanying by voluntary movements and can occur during the aftermath of peripheral facial palsy, causing functional, aesthetic and psychological problems in the patient. Botulinum toxin A (BTX-A) is frequently used as a safe and effective treatment; however, there is no standardized guideline for the use of BTX-A in synkinesis. The purpose of this article is to review and summarize studies about the BTX-A treatment of synkinesis in patients with a history of peripheral facial palsy; including given dosages, injection sites and time intervals between injections. MATERIALS AND METHODS: A multi-database systematic literature search was performed in October 2020 using the following databases: Pubmed, Embase, Medline, and The Cochrane Library. Two authors rated the methodological quality of the included studies independently using the 'Newcastle-Ottawa Quality Assessment Scale' for non-randomised studies' (NOS). RESULTS: Four-thousand-five-hundred-and-nineteen articles were found of which 34 studies met the inclusion criteria, in total comprising 1314 patients. Most studies were assessed to be of 'fair' to 'good' methodological quality. The Cohen's kappa (between author FJ and AS) was 0.78. Thirty-one studies investigated the reported dosage injected, 17 studies reported injection location and 17 studies investigated time intervals. A meta-analysis was performed for three studies comprising 106 patients, on the effects of BTX-A treatment on the Synkinesis Assessment Questionnaire (SAQ) scores. The mean difference was 11.599 (range 9.422-13.766), p < 0.01. However, due to inconsistent reporting of data of the included studies, no relationship with the dosage and location could be assessed. CONCLUSIONS: Many treatment strategies for synkinesis exist, consisting of varying BTX-A brands, dosages, time intervals and different injection locations. Moreover, the individual complaints are very specific, which complicates creating a standardized chemodenervation treatment protocol. The BTX-A treatment of long-term synkinesis is very individual and further studies should focus on a patient-tailored treatment instead of trying to standardize treatment.

Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial.

BACKGROUND: Septoplasty (surgical correction of the deviated nasal septum) is the most frequently performed ear, nose, and throat operation in adults, but no randomised controlled trials or non-randomised comparative studies on the effectiveness of septoplasty have been published. Consequently, health-care providers, health insurance companies, and policy makers are concerned about the effectiveness of the procedure. We aimed to assess the effectiveness of septoplasty for nasal obstruction in adults with a deviated septum. METHODS: We did this open, multicentre, pragmatic, randomised controlled trial in 16 secondary and two tertiary referral hospitals in the Netherlands. Adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have septoplasty done were randomly allocated (1:1) to receive either septoplasty with or without concurrent turbinate surgery or non-surgical management. Patients were stratified by sex, age (<35 years or ≥35 years), and deviation severity (mild, moderate, or severe). The primary outcome was health-related quality of life, measured with the validated Glasgow Health Status Inventory at 12 months. Analyses were done on an intention-to-treat basis. The trial is registered with the Netherlands Trial Register, number NTR3868. FINDINGS: Between Sept 2, 2013, and Dec 12, 2016, we randomly assigned 203 participants to receive either septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101). 189 participants were analysed at 12 months. At 12 months, mean score on the Glasgow Health Status Inventory of patients assigned to septoplasty was 72·2 (SD 12·2) and for those assigned to non-surgical management was 63·9 (SD 14·5, mean difference 8·3 [95% CI 4·5-12·1], favouring septoplasty). Septal abscess occurred in one surgical patient and septal perforation in two surgical patients. No side-effects of nasal medication were reported. INTERPRETATION: Septoplasty is more effective than non-surgical management for nasal obstruction in adults with a deviated septum. This effect was sustained up to 24 months of follow-up. FUNDING: The Netherlands Organisation for Health Research and Development (ZonMw).

Morpho-Functional Septorhinoplasty in Adult Patients With Unilateral Cleft Lip Nasal Deformity: A Comprehensive Approach.

PURPOSE: The aim of this study was to introduce a morpho-functional technique of rhinoplasty for correction of defective nasal morphology of the secondary unilateral cleft lip and improvement of air passage through the nose. MATERIALS AND METHODS: The described comprehensive approach follows the rule of 5 R's: relieve, resect, reposition, restructure, and restrengthen. The extended septal graft serves as a columellar strut on the one hand and as a spreader graft on the other hand. RESULTS: The described morpho-functional septorhinoplasty technique is effective for correction of the unilateral cleft lip nasal deformity because it improves the symmetry of the nose, improves the morphology of the alar cartilage, and increases the nasal tip projection. An improvement in breathing occurs as a result of restored symmetry of the ala and nasal vestibule. CONCLUSIONS: Morpho-functional septorhinoplasty is a practical tool to handle adult patients with secondary cleft nasal deformities.

Septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: A modelling study of cost-effectiveness.

OBJECTIVE: The objective of this study was to demonstrate how decision-analytic modelling can help to determine circumstances under which surgery may become cost-effective, using septoplasty as an example. DESIGN: We developed a decision-analytic model comparing septoplasty to non-surgical management for nasal obstruction in adults with a deviated septum. Based on the estimated cost difference between both treatments, we calculated the minimal (a) gain in quality-adjusted life-years, or (b) reduction in productivity losses needed for septoplasty to be cost-effective. Input was derived from literature and publicly available data sources. The time horizon of our model was one year, and the willingness-to-pay per quality-adjusted life-year was €20 000, in accordance with current guidelines. RESULTS: The cost difference between septoplasty and non-surgical management for nasal obstruction due to a deviated nasal septum was €2227 per patient from a healthcare perspective (including direct healthcare costs) and €3288 per patient from an extended perspective (additionally including travel expenses and productivity losses due to poor health). In comparison with non-surgical management, septoplasty needed to gain 0.11 to 0.16 QALYs or save 13 sick days for nasal obstruction. The longer septoplasty's effect lasts, the more time it will have to compensate its extra costs. CONCLUSION: This study shows that the known cost difference between treatments can be used as the starting point to determine beneficial effects needed for cost-effectiveness of surgical interventions. The effect required by septoplasty from a healthcare perspective seems potentially achievable, meaning that it would be useful to perform an RCT assessing the actual benefits of septoplasty.

External Auditory Canal Stenosis After Traumatic Auricular Amputation.

BACKGROUND: The auricles are easily injured or amputated in case of head trauma. Inadequate treatment of the external auditory canal (EAC) after auricular injury is often seen and can lead to significant complications of the EAC. CASE REPORT: The authors report 4 cases of auricular injury or amputations. In all patients inadequate first treatment led to stenosis of the EAC. Three patients required recanalization of the EAC because of hearing loss and the risk of further complications. CONCLUSION: Treatment of auricular injury should consist of (pre-emptive) packing of the EAC with antibiotic gauzes followed by thorough examination of the EAC to prevent canal stenosis and subsequent complications.

Cosmetic appreciation of lateralization of peripheral facial palsy: 'preference for left or right, true or mirror image?'.

There have been several studies in the past depicting asymmetry in 'normal' human faces. Evidence supports the fact that the right hemisphere is superior in the recognition of emotions expressed by the human face and indicates a right hemispheric specialization for processing emotional information. The primary aim of this study is to determine whether there is a difference in cosmetic appreciation of a left peripheral facial palsy compared to a right peripheral facial palsy? Pictures of patients with a facial palsy with House-Brackmann II-VI were reversed as a mirror image and offered as a pair of pictures, together with the true image. Forty-two patients and 24 medical professionals familiar with facial palsy were asked to choose the most attractive photograph. The primary 'end' point was the most attractive side in the pictures chosen by medical professionals and patients. The secondary 'end' points consisted of the preferences for the mirror or true image, and influences of the House-Brackmann score and age. Medical professionals preferred the photographs from patients with a right and left peripheral facial palsy (PFP) in, respectively, a mean of 44 % (41-48 %) and 56 % (52-59 %) of the pictures (p = 0.02). When comparing mirror and true image, patients with a left-sided facial palsy chose their mirror and true image as most attractive in 90 and 10 %, respectively (p < 0.05). Patients with a right-sided facial palsy chose their mirror and true image in 30 and 70 %, respectively (p > 0.05). Subanalysis of patients with a PFP House-Brackmann score V and VI showed that medical professionals did not have a significant preference for a left nor right-sided facial palsy. Patients with a left-sided facial palsy chose their mirror image in all cases and patients with a right-sided palsy chose their mirror and true image in resp. 33 and 67 %. The House-Brackmann score (p = 0.52) and age (p = 0.73) of the patients did not influence preferences. This study, demonstrating that medical professionals find a right-sided facial palsy cosmetically less attractive than a left-sided, has clinical relevance. Patients, especially with a left-sided facial palsy, tend to choose for their mirror image, although this choice seems to be influenced by hemispheric specialization and familiarity.

Bacterial colonisation of surface and core of palatine tonsils among Tanzanian children with recurrent chronic tonsillitis and obstructive sleep apnoea who underwent (adeno)tonsillectomy.

OBJECTIVE: Acute and chronic tonsillitis are frequently treated with antibiotics. This study aimed to understand the presence of pathogenic micro-organisms on the surface and core of chronically infected tonsils among Tanzanian children. METHODS: The study enrolled children undergoing adenotonsillectomy. Surface and core tonsillar swabs were taken. Quantitative polymerase chain reaction was performed for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Neisseria meningitidis and Pseudomonas aeruginosa. RESULTS: Surface and core combined, isolated N meningitidis (86.1 per cent) was found the most, followed by H influenzae (74.9 per cent), S pneumoniae (42.6 per cent) and S aureus (28.7 per cent). M catarrhalis and P aeruginosa were only found in a few patients, 5.6 per cent and 0.8 per cent respectively. CONCLUSION: Colonisation of the tonsillar surface and core has been found. Potentially pathogenic micro-organisms are likely to be missed based on a throat swab. Hence, the practice of surface tonsillar swabbing may be misleading or insufficient.

Usage and parental knowledge of antibiotics in children undergoing (adeno) tonsillectomy in northern Tanzania.

Introduction: Antimicrobial Resistance (AMR) is a growing concern globally, mostly being contributed by a limited understanding of antibiotic utilization as a result of inappropriate acquisition and prescription. Parental awareness is essential in optimizing their usage and preserving the effectiveness of these crucial medications. The current study investigates the usage and parental knowledge of antibiotics in children undergoing (adeno) tonsillectomy ((A)TE) in Northern Tanzania. Methods: a cross-sectional survey was conducted among parents/caregivers of children who underwent (A)TE in Northern Tanzania. A modified and well-structured questionnaire, which was adapted from a World Health Organization (WHO) questionnaire and used to assess the parents´ knowledge of antibiotics and antibiotic use. Results: the study included 157 participants. About 54% of the children under the age of 5 years. As of 88% of children had already received antibiotics prior to surgery, 92% of the used antibiotics were prescribed by a clinician, and 5% of parents to used leftovers antibiotics for their children. While 88% of the parents reported adhering to prescriptions, 8% of reported buying the same antibiotic (as prescribed before) without consulting a clinician again when their children are sick. Conclusion: the use of antibiotics, including broad-spectrum antibiotics, was found to be high in our study group. Parents demonstrate a relatively good understanding of antibiotic usage. It is plausible to speculate that a higher prevalence of non-insured, unemployed, and less educated parents may lead to an increased incidence of misuse and misinterpretation of antibiotics.

Effect of prophylactic amoxicillin on tonsillar bacterial pathogens after (adeno)tonsillectomy in children.

OBJECTIVES: Unnecessary and inappropriate antibiotic use is an increasing global health challenge. In limited resource settings, prophylactic antibiotics are still often used in (adeno)tonsillectomy (AT), despite evidence against their effectiveness. This study aimed to investigate the effect of prophylactic amoxicillin, given after AT in children. METHODS: This is a secondary analysis from a two-center, double-blinded, randomized controlled, non-inferiority trial to study the effect of prophylactic amoxicillin on post-AT morbidity. Children aged 2-14 years with recurrent chronic tonsillitis and/or obstructive sleep apnea were randomly assigned to receive either placebo or amoxicillin for 5 days after the operation. Pre- and postoperative samples were collected for polymerase chain reaction (PCR) analyses to detect the five most important pathogens known to be common causes of tonsillitis. PCR results were compared before and after surgery as well as between placebo and amoxicillin. RESULTS: PCR results were obtained, 109 in the amoxicillin group and 115 in the placebo group. In the amoxicillin group, 91% of patients had at least one positive PCR test before surgery and 87% after surgery. In the placebo group, the respective percentages were 92% and 90%. In both groups, a decrease in the total number of pathogens was found after surgery. CONCLUSION: Prophylactic amoxicillin given after AT in children did not show a clinically relevant effect with respect to the number of oropharyngeal microorganisms as compared to placebo.

The surgical anatomy of the deep temporal nerve: A cadaveric study.

BACKGROUND: The aims of this study were to investigate the surgical anatomy of the deep temporal nerve (DTN) and find (fixed/static) anatomical landmarks that could be used during surgery to localise the DTN branches. METHODS: Ten hemifaces of Dutch cadavers were dissected at the Department of Anatomy of the Radboudumc. Landmarks and measurements of interest were number of branches of the DTN, distance from the tragus to the DTN, and distance from the cranial and caudal parts of the posterior root of the zygomatic bone until the DTN. RESULTS: In this cadaveric study, 10 hemifaces were dissected (male, n = 6 [60%]; female, n = 4 [40%]) with an equal left/right side division. The number of deep temporal branches varied from 2 (30%) to 3 (70%) per side. The mean distance to the tragus varied from 40 to 53 mm, with a mean distance of 44.3 ± 4.4 mm. The mean distance from the cranial part of the posterior root of the zygomatic bone to the DTN varied from 29 to 35 mm, with a mean distance of 31.3 ± 2.1 mm. The distance from the caudal part of the posterior root of the zygomatic bone to the DTN varied from 8 to 17 mm, with a mean distance of 13.4 ± 3.4 mm. CONCLUSION: This study investigated the surgical anatomy and landmarks used for identification of the DTN and its branches. It suggested using firm landmarks for nerve identification, such as the posterior root of the cranial and/or the caudal zygomatic bone.

Effect of placebo versus prophylactic postoperative amoxicillin on post-(adeno) tonsillectomy morbidity in Tanzanian children: a two-centre, double-blind randomized controlled non-inferiority trial.

Introduction: to date in Africa, there is limited evidence regarding the role of prophylactic antibiotics to prevent post (adeno) tonsillectomy ((A)TE) morbidity in children. As (A)TE is the most performed surgery in the pediatric population, the use of prophylactic antibiotics is likely a major factor in the development of AMR. In Tanzania, as in many other settings with limited resources antibiotics are misused and overprescribed. Potential reasons include limited stewardship and widespread use of postsurgical prophylactic antibiotics. Misuse of antibiotics might contribute significantly to the development of antimicrobial resistance (AMR). Methods: a two-centre, double-blinded randomized controlled non-inferiority trial. Subjects included children from 2-14 years of age with recurrent chronic tonsillitis and/or obstructive sleep apnoea due to adenotonsillar hypertrophy who were electively scheduled for (A)TE in two tertiary hospitals. Participants were randomly allocated to receive either placebo or amoxicillin for five days postoperatively. Primary outcome was non-inferiority of placebo compared with amoxicillin for postoperative haemorrhage (margin 5%; at 14 days) postoperative fever (margin 5%; at 7 days), and pain (margin 1 point; at 7 days). Secondary outcomes included the times required for resumption of normal diet and normal activities, and microbial recolonization of the tonsillar beds. Data were analysed according to intention-to-treat principle. Follow-up was 14 days. Results: between March 13, 2019 and September 20, 2019 270 children were enrolled. All children were randomly assigned to receive placebo (n = 136) or amoxicillin (n = 134). By 14t hday post-operatively, total of 8 children were lost to follow-up in each arm. No major postoperative haemorrhage was registered. By 14th day post-operatively, 22 (17.5%) children in the amoxicillin arm and 19 (14.8%) children in the placebo arm had reported minor haemorrhage (risk difference (RD) -2.6% (95%CI -10.2 - 5.0); pnon-inferiority = 0.045). By 7th day post operatively, 8 (6.3%) children in amoxicillin arm and 4 (3.1%) children in placebo arm reported fever during the first week (RD -3.2% (95%CI -7.6 - 1.2); pnon-inferiority = 0.001). By 7th day post operatively, mean pain score (mean (SD)) was 3.25 (1.53) in the amoxicillin arm and 3.56 (1.68) in the placebo arm (mean difference 0.31, (95% CI -0.02 - 0.65); pnon-inferiority < 0.001). No statistically significant differences between the two groups were found in any of the secondary outcomes. Findings shows, placebo is non-inferior to amoxicillin for post-operative morbidities in Tanzanian children undergoing (A)TE. Conclusion: it is recommended that antibiotics should only be used when clinically necessary to treat a specific infection. Unnecessary use of antibiotics contributes to the development of antimicrobial resistance. Trial Registration: Pan African Clinical Trials Registry PACTR201905466349317. Retrospectively registered on 15 May 2019.

Quantitative analysis of aesthetic outcomes of morphofunctional septorhinoplasty for secondary cleft lip nasal deformity.

The main aim of this study was to assess nasal symmetry after morphofunctional septorhinoplasty, more specifically, symmetry of the alar base and nostrils, and nasal projection, in patients with unilateral and bilateral cleft nasal deformities. Secondary cleft rhinoplasty was performed using morphofunctional septorhinoplasty techniques in 150 patients with unilateral and bilateral cleft lip and nose deformities. Nasal changes were analysed by measuring nasal tip projection, nostril height, nostril width, alar base width, and nasal gap area preoperatively and postoperatively on standard submentovertex view 2-dimensional photographs. In the unilateral cleft group there were statistically significant improvements (p<0.001) in ratios of nasal height and width (p=0.024) and nasal gap area, and in nasal tip projection and alar base width. In the bilateral cleft group there were statistically significant improvements in nasal gap area ratio (p=0.009), nasal tip projection, and alar base width. The morphofunctional septorhinoplasty technique improved aesthetic outcomes.

Deep temporal nerve transfer: A systematic review of anatomy, anatomical landmarks and clinical applications.

Background: Facial paralysis has a debilitating impact on facial function, especially the eyebrow. Static procedures have long been the standard treatment strategy, but in more recent years, dynamic procedures are being developed. To reconstruct the upper branches of the facial nerve (temporal and zygomatic branches), the deep temporal nerve (DTN) and its branches, with its close proximity to the eyebrow, can be used as a possible donor nerve for reinnervation. This systematic review provides an overview of the DTN anatomy and possible surgical treatment strategies. Materials and methods: A PubMed systematic literature search was performed in October 2021. Studies on cadavers and clinical studies providing anatomical or surgical information on the dissection of the DTN as well as surgical treatment strategies using the DTN were included. Results: The literature search produced 311 results, including 36 duplicates. After screening on title and abstract, 11 studies were found possibly relevant and underwent a full-text critical appraisal, resulting in 4 exclusions. In total seven studies were included. The data gathered were used to adequately describe the DTN anatomy, surgical approaches and landmarks used during surgery. Conclusion: The DTN and its branches prove to be a viable donor for the reconstruction of facial nerve branches, since the location and anatomical consistency can be relied upon through a multitude of studies, especially of the middle branch. Our study describes anatomy and nerve characteristics for its use in facial reanimation.

Postoperative volume increase of facial soft tissue after percutaneous versus endonasal osteotomy technique in rhinoplasty using 3D stereophotogrammetry.

BACKGROUND: When lateral osteotomies are performed as part of a rhinoplasty, the nose and paranasal region invariably change in three dimensions. The PURPOSE of this study is to compare the effect of the percutaneous perforating and endonasal continuous osteotomy techniques concerning the degree of postoperative swelling using three dimensional (3D) stereophotogrammetry. METHODOLOGY: A prospective follow-up study was conducted. Patients requiring bilateral osteotomies were included and randomly underwent a percutaneous osteotomy on one side and an endonasal osteotomy on the other side. Pre- and postoperative 3D photos were acquired using 3D stereophotogrammetry. Volumetric measurement data were acquired from the paranasal region using 3D software. Measurements were compared using Student`s t-test and Wilcoxon signed rank test statistics. RESULTS: Twenty patients were included. A percutaneous osteotomy was performed on the right side in nine patients and on the left side in 11 patients. The total volume, the volume of the right paranasal and left paranasal region were significantly larger postoperative. No difference was found between the sides. CONCLUSIONS: No difference concerning swelling is found between the percutaneous and endonasal osteotomy technique sides. With 3D stereophotogrammetry volumetric data can be acquired and compared to evaluate soft-tissue changes.

3D stereophotogrammetric analysis of lip and nasal symmetry after primary cheiloseptoplasty in complete unilateral cleft lip repair.

BACKGROUND: The aim of this study was to evaluate symmetry of the lip and nose in patients with CUCLP after primary cheiloseptoplasty (Afroze technique), in comparison to non-cleft controls. METHODOLOGY: In this prospective study, forty-four patients with operated non-syndromic CUCLP were included. The control group consisted of 44 volunteers without cleft defects of approximately the same age and sex. Primary septoplasty was performed in conjunction with the cleft lip (CL) repair using the Afroze incision. 3D facial images were acquired using 3D stereophotogrammetry. After a 3D cephalometric analysis of the lip and nose was performed in both groups, linear and volumetric data were acquired. Lip and nose symmetry were calculated and compared using Student`s t-tests as well as the Chi square test. RESULTS: For all measurements, the control group was up to 36% closer to perfect symmetry compared to the CUCLP group after primary surgery. This difference was statistically significant. CONCLUSIONS: After primary cheiloseptoplasty according to the Afroze technique in patients with CUCLP, asymmetry in the nose and lip area still exists as compared to non-cleft controls. Although non-cleft individuals also show some degree of asymmetry, the results of this study stress the difficulty in obtaining near normal symmetrical relations.

Berberine and Obatoclax Inhibit SARS-Cov-2 Replication in Primary Human Nasal Epithelial Cells In Vitro.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged as a new human pathogen in late 2019 and it has infected over 100 million people in less than a year. There is a clear need for effective antiviral drugs to complement current preventive measures, including vaccines. In this study, we demonstrate that berberine and obatoclax, two broad-spectrum antiviral compounds, are effective against multiple isolates of SARS-CoV-2. Berberine, a plant-derived alkaloid, inhibited SARS-CoV-2 at low micromolar concentrations and obatoclax, which was originally developed as an anti-apoptotic protein antagonist, was effective at sub-micromolar concentrations. Time-of-addition studies indicated that berberine acts on the late stage of the viral life cycle. In agreement, berberine mildly affected viral RNA synthesis, but it strongly reduced infectious viral titers, leading to an increase in the particle-to-pfu ratio. In contrast, obatoclax acted at the early stage of the infection, which is in line with its activity to neutralize the acidic environment in endosomes. We assessed infection of primary human nasal epithelial cells that were cultured on an air-liquid interface and found that SARS-CoV-2 infection induced and repressed expression of specific sets of cytokines and chemokines. Moreover, both obatoclax and berberine inhibited SARS-CoV-2 replication in these primary target cells. We propose berberine and obatoclax as potential antiviral drugs against SARS-CoV-2 that could be considered for further efficacy testing.

Three dimensional measurement of rhinoplasty results.

BACKGROUND: Pre- and postoperative imaging is important and essential for evaluation of the results of rhinoplasty surgery. Two-dimensional photographs are used routinely for this purpose, but have several disadvantages as opposed to three-dimensional imaging techniques, such as stereophotogrammetry. This study is the first to describe the measurement of rhinoplasty results using stereophotogrammetry. The aim of this study was to evaluate the ability of 3D imaging to measure and objectify rhinoplasty results. METHODS: During a 6-month period all consecutive hump reduction patients were included in this prospective study. Pre- and postoperative 3D photographs were taken and compared. RESULTS: Twelve patients were studied. In ten of these twelve patients a significant volume reduction in the area of the nasal dorsum was found with stereophotogrammetry. The maximum decrease (i.e. lowering) of the nasal dorsum ranged from 0.8 to 4.4 mm. In two patients no reduction of the nasal dorsum was found. In both patients this was due to additional changes made to the nose during surgery. These changes, increased tip rotation and dorsal augmentation respectively, were also documented with stereophotogrammetry. CONCLUSIONS: Both pronounced as well as subtle postoperative changes of rhinoplasty surgery can be objectified and measured with stereophotogrammetry. This tool can be used to study whether surgical techniques have the desired effect on the nose, and to compare different techniques with each other.

The effect of antibiotics on post-adenotonsillectomy morbidity in Tanzanian children: study protocol for a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades, prophylactic antibiotics have been prescribed to limit postoperative complications. The effect of this antibiotic use has been refuted in a Cochrane Review. However, all reviewed studies were carried out in developed countries. In Tanzania, like many other developing countries with limited resources and a high burden of infectious diseases, postoperative antibiotic prescription is still very common to decrease the supposed higher postoperative morbidity. However, as a consequence of this widespread use of postoperative antibiotics, cross-resistance and risk of allergic side effects rise. Well-designed randomized controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance. AIM: The aim of this study is to analyse the prophylactic role of postoperative antibiotics on morbidity following adenotonsillectomy in children in Tanzania. DESIGN: The double-blinded, randomized, placebo-controlled trial was set in northern Tanzania. Participating centres are the Department of Otolaryngology at Kilimanjaro Christian Medical Centre in Moshi and the Department of Paediatric Surgery at the Arusha Lutheran Medical Centre in Arusha. METHODS: Around 270 children aged 2-14 years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5 days of antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, fever and pain. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed and the occurrence of adverse events and microbial recolonization of the tonsillar beds. DISCUSSION: This study will enhance an increase of proper antimicrobial prescription in Tanzanian institutions as well as other resource-limited countries where prescription of antibiotics is still very common. In addition, it might augment current knowledge about surface and core tonsillar micro-organisms and sensitivity patterns. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR201905466349317. Retrospectively registered on 15 May 2019. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8119.