FES: FESS Effectiveness Study: a multi-centre randomised controlled trial studying the effectiveness of functional endoscopic sinus surgery (FESS) in adult patients with chronic rhinosinusitis/nasal polyps unresponsive to medical therapy

2012 ◽  
Author(s):  
W.J. Fokkens
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Medical Therapy ◽  
Endoscopic Sinus Surgery ◽  
Nasal Polyps ◽  
Controlled Trial ◽  
Functional Endoscopic Sinus Surgery ◽  
Sinus Surgery ◽  
Effectiveness Study ◽  
Randomised Controlled

Prospective, randomised, controlled trial comparing delivery of patient information for functional endoscopic sinus surgery via website versus printed leaflet

2014 ◽  
Vol 128 (3) ◽  
pp. 249-254 ◽  
Author(s):  
S Henney ◽  
R Irving
Keyword(s):  
Randomised Controlled Trial ◽  
Patient Information ◽  
Endoscopic Sinus Surgery ◽  
Controlled Trial ◽  
Functional Endoscopic Sinus Surgery ◽  
Sinus Surgery ◽  
Group Meeting ◽  
Inclusion Criteria ◽  
Randomised Controlled ◽  
To Receive

AbstractObjective:To compare the efficacy of two modes of delivery of information for patients undergoing functional endoscopic sinus surgery: website and printed leaflet.Methods:A two-centre, prospective, single-blinded, randomised, controlled trial was conducted, comparing mode of information delivery. Adult patients were randomly allocated to receive pre-operative information regarding functional endoscopic sinus surgery, either via a website or a printed leaflet. Primary outcomes, measured by questionnaire, were: readability, usability and recall of complications.Results:Fifty-eight patients were recruited. Fifty met the inclusion criteria, of which 40 were analysed in the study (20 patients per group), meeting the power criteria set. There were 18 male and 22 female patients, ranging in age from 21 to 76 years (mean, 47 years). Patients found both the printed leaflet and the website readable, and were satisfied with the usability of both modes. There were similar rates for recall of complications in both study arms.Conclusion:Patient information on functional endoscopic sinus surgery can be provided either as a printed leaflet or a website, with similar rates for usability, readability and recall of complications. These findings could help tailor the provision of pre-operative information for patients undergoing functional endoscopic sinus surgery, based on patient preference.

scholarly journals Effects of preconditioning by nasal splint and mouth breathing on emergence delirium after functional endoscopic sinus surgery in Chinese adults: a study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e033803
Author(s):  
Hongjiao Xu ◽  
Xiang Li ◽  
Bin Yang ◽  
Zhenyuan Shen ◽  
Weiwen Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Endoscopic Sinus Surgery ◽  
Controlled Trial ◽  
Original Data ◽  
Functional Endoscopic Sinus Surgery ◽  
Mouth Breathing ◽  
Sinus Surgery ◽  
Breathing Training ◽  
Nasal Splint ◽  
Randomised Controlled

IntroductionEmergence delirium (ED) is a common adverse manifestation after general anaesthesia and may result in undesirable consequences. Its causes and mechanisms are diverse and complex, and it is still unavoidable in clinical work. There is a high incidence of ED after otorhinolaryngology surgery, which may result from the sudden loss of functional senses and discomfort of surgical organs. This study aims to test a non-invasive, non-drug treatment modality of nose clamping and mouth-breathing training before surgery to reduce ED.Methods and analysisThis prospective randomised controlled trial (RCT) will include 200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China. Study participants will be randomly assigned in two groups with a 1:1 ratio. The pretreatment group (P-group) will receive an intervention by nasal splint and mouth-breathing training before surgery, while the control group (C-group) will not receive any intervention; following which both groups will undergo FESS under general anaesthesia in accordance with the same anaesthesia scheme. After surgery, we will perform a single-blinded assessment of ED occurrence with stratification. IBM SPSS Statistics V.20 statistical software will be used for statistical analyses. A X2 test will be used to compare the two groups, and t-tests will determine the statistical significance of continuous variables.Ethics and disseminationThis RCT was designed in accordance with the principles of the Declaration of Helsinki and has been approved by the Ethics Committee of Shanghai General Hospital, ID: 2019KY039.We expect to release the original data in February 2022 on the ResMan original data sharing platform (IPD sharing platform) of the China clinical trial registry, which can be viewed at the following website:http://www.medresman.org.cn/pub/cn/proj/projectshow.aspx?proj=6293.Trial registration numberChiCTR1900024925

scholarly journals Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042413
Author(s):  
Shaun Kilty ◽  
Kednapa Thavorn ◽  
Arif Janjua ◽  
John Lee ◽  
Kristian MacDonald ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Chronic Rhinosinusitis ◽  
Nasal Polyps ◽  
Controlled Trial ◽  
Sinus Surgery ◽  
Endoscopic Polypectomy ◽  
Research Ethics Board ◽  
Randomised Controlled

IntroductionChronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.Methods and analysisWe designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period.Ethics and disseminationThis study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board.Trial registration numberNCT02975310.

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