Endoscopic nasal recording mp4 download
The participant may refuse to have the assigned surgery or discontinue the conservative treatment, which serves as control. The group assigned surgery will be operated on within 2 weeks after enrolment, so by looking after proper criteria for study entry, we will minimize the risk of refusal.
The waiting time here, which is within the normal limits for our hospital, decrease the risk of participants seeking the operation elsewhere. For these reasons, no standard criteria for discontinuations are designed. In case of participants discontinuing their assigned intervention, we still aim at collecting the outcome data as planned to prevent missing data.
As suggested by Little et al. The target population of RARS patients is prior to the study not adequately served by treatments and hence has an incentive to remain in the study. The control group is allowed a flexible treatment regimen that accommodates individual differences in efficacy and side effects in order to reduce the dropout rate because of lack of efficacy or tolerability. The follow-up period for the primary outcome will be relatively short. We select investigators who have a good track record with respect to enrolling and following participants and collecting complete data in previous trials.
We limit the burden and inconvenience of data collection on the participants and make the study experience as positive as possible. We train investigators and study staff that keeping participants in the trial until the end is important, regardless of whether they continue to receive the assigned treatment.
We also convey this information to study participants. We collect information from participants regarding the likelihood that they will drop out and use this information to attempt to reduce the incidence of dropout.
We keep contact information for participants up to date. One of the study nurses will call the participants at three months follow-up to remind them of data collection as well as their treatment plan. During the follow-up period, the participants in both groups are allowed standard treatment of rhinosinusitis symptoms, including antibiotics, topical, and systemic medications.
Typically, these include nasal lavages with normal saline solution, topical nasal or per oral steroids e. These medications are used during the acute episodes or continuously if the symptoms are chronic or recur frequently.
There is no anticipated harm and compensation related specifically to trial participation. The assigned treatments are ordinary, and the participants are covered by the regular malpractice insurance. We will collect background information with a questionnaire. This includes data on age, gender, weight and height, smoking status, education, illnesses, performance status, allergic rhinitis, immunotherapy for allergic diseases, domestic animals, exposures to moldy buildings and irritants, number of rhinosinusitis episodes per year, presence of respiratory symptoms and medications used during the prior month, and number of medical visits during the prior month.
Sensitivity to the most common aeroallergens is explored using either skin prick testing or serum immunoglobulin E assay. The participants are given a study notebook, which includes information about the study and written instructions for their general practitioners of recording the date, clinical findings, diagnoses, and treatments in case participants seek medical care for respiratory symptoms.
SNOT is developed specifically for measuring the impact of chronic rhinosinusitis on QoL [ 19 , 20 ], and it records patient-reported symptoms and disability from the previous two weeks. SNOT is regarded as a reliable, valid, and responsive disease-specific instrument [ 20 , 21 , 22 ]. SNOT produces a summary score between zero and , with higher values indicating poorer disease-specific QoL. RAND is a short-form health survey developed as a tool for outcome measurement in the Medical Outcomes Study [ 23 ].
We used the Finnish translations of both instruments, which have been translated, culturally adapted, and validated [ 24 , 25 ]. Difference in the numbers of rhinosinusitis episodes, medical visits, antimicrobial treatments, and days lost from work or studies between the ESS and control groups during the follow-up. Difference in the numbers of days with nasal obstruction, nasal discharge, facial pain or pressure, nasal pain, nasal bleeding, and fever between the ESS and control groups during the follow-up.
Frequency of postoperative synechia formations, postoperative infections, and orbital and intracranial complications in the ESS group during the follow-up. As RARS mainly lowers quality of life, an effective treatment should primarily enhance it without substantial harms. Therefore, we chose the quality of life change after ESS as our primary outcome and recorded the clinically relevant possible harms and health utilization change as secondary outcomes.
Participants in the intervention ESS group will be operated as soon as practically possible which we estimate to be within 2 weeks of assignment. For the control group, follow-up will finish before the participants are operated. The enrolment, interventions, assessments, and study visits of our trial are presented in Table 1. We consider a 2-sided p value of 0. A two-step method proposed by Borm et al.
First, the sample size is calculated as if a t test on the follow-up scores is carried out. To compensate any loss to follow-up, we decide to enroll 80 participants. Our trial team includes five research members from the department of ear, nose, and throat who will be in charge of the recruitment process.
We expect the contested sample size of 80 participants to be recruited by The research team follow-ups the actualized recruitment rate regularly during the bimonthly meetings. No financial or non-financial incentives are provided to trial investigators or participants for enrolment. Eligible participants will be randomly assigned to ESS or control group ratio as per a computer-generated randomization schedule using permuted blocks of random sizes.
The block sizes will not be disclosed, to ensure concealment. The allocation sequence will be concealed from the investigators enrolling participants by putting the assigned treatments in sequentially numbered, opaque, sealed envelopes.
As suggested in the SPIRIT Statement, we strive for complete separation of the individuals involved in the steps before enrolment from those involved in the implementation of study group assignments [ 27 ].
A biostatistician, not involved in assignment or care of the trial participants, generates the randomization sequence with a computerized random number generator. A research assistant, not involved in any other aspect of this study, will place the assigned treatments in the sealed envelopes. Participants who fulfill the inclusion criteria will be recruited by the ear, nose, and throat specialists involved in the trial. Blinding of the participants and care providers is not feasible because of the obvious differences between the interventions.
As patients are usually referred to our clinics with the expectation of surgical intervention, sham operations would make recruiting difficult. Study candidates are evaluated at the ear, nose, and throat outpatient department of the Oulu University Hospital by the trial investigators. Data from interviews, referral letters, patient files, blood samples, and nasoendoscopical and radiological examinations are used to evaluate whether these candidates fulfill the eligibility criteria.
The endoscopic and radiologic findings are scored according to suggested guidelines [ 15 , 16 ]: endoscopic findings are assessed with Lund-Kennedy scores and radiological findings with Lund-Mackay stages.
Baseline information is gathered with a questionnaire and allergy testing. Allergy testing includes serum immunoglobulin E and an immunofluorometric assay of the most common allergen-specific IgEs in Finland Cladosporium herbarum , Dermatophagoides pteronyssinus ; horse, cat and dog dandruff; birch, mugwort and timothy pollen.
Outcome data is collected with study notebook, which includes anchor questions, and data on medical visits, sick leaves, and various symptoms during the follow-up. The Finnish versions of the quality of life instruments have been found to be reliable, valid, and responsive [ 24 , 25 ].
Possible ESS complications are collected at the postoperative visits and at the end of the follow-up from the notebook and patient files. For the baseline questionnaire and study notebook, see Additional files 1 and 2 , respectively.
For the radiological and endoscopical assessment forms, see Additional file 3. To promote retention, we stress the importance of this trial to RARS patients and physicians treating them, provide the participants feedback from the results of the medical examinations made, and call them to remind to fill the study logbook and about the follow-up visit.
Laryngoscope 1 — Article PubMed Google Scholar. Acta Otorhinolaryngol Ital — Huang J, Malek J, Chin D et al Systematic review and meta-analysis on outcomes for endoscopic versus external dacryocystorhinostomy. Orbit 33 2 — Eur Arch Otorhinolaryngol — Lee KC Outcomes of posterior lacrimal sac approach in endoscopic dacryocystorhinostomy: review of 35 cases.
Am J Rhinol 22 2 — Otolaryngol Head Neck Surg — Saudi J Ophthalmol 25 1 — Int J Oral Maxillofac Surg. Here you will find the list of officially supported devices and instructions for installing TWRP on those devices.
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Djuraev J. The work carried out made it possible to substantiate the need to apply a method for studying the frequency of beating of cilia of the mucous membrane of the nasal cavity and paranasal sinuses in patients with chronic rhinosinusitis when choosing treatment tactics in an ENT hospital.
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