Evaluation of the Medical and Surgical Treatment Of Chronic Rhinosinusitis: A Prospective, Randomised, Controlled Trial

2004 ◽  
Vol 114 (5) ◽  
pp. 923-930 ◽  
Author(s):  
Sameh M. Ragab ◽  
Valerie J. Lund ◽  
Glenis Scadding
Keyword(s):  
Surgical Treatment ◽  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Controlled Trial ◽  
Randomised Controlled

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.

scholarly journals Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e033150 ◽  
Author(s):  
Flavia K Borges ◽  
P J Devereaux ◽  
Meaghan Cuerden ◽  
Mohit Bhandari ◽  
Ernesto Guerra-Farfán ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Surgical Treatment ◽  
Hip Fracture ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Surgery

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

scholarly journals Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028537 ◽  
Author(s):  
Flavia K Borges ◽  
Mohit Bhandari ◽  
Ameen Patel ◽  
Victoria Avram ◽  
Ernesto Guerra-Farfán ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Hip Fracture ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Perioperative Complications ◽  
Public Awareness ◽  
Controlled Trial ◽  
Early Surgery ◽  
All Cause Mortality ◽  
Randomised Controlled

IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.

scholarly journals Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme).

2019 ◽  
Author(s):  
Jane Vennik ◽  
Helen Blackshaw ◽  
Carl Philpott ◽  
Mike Thomas ◽  
Caroline Eyles ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Trial Design ◽  
Review Process ◽  
Expert Panel ◽  
Controlled Trial ◽  
Best Management ◽  
Oral Steroids ◽  
Panel Review ◽  
Randomised Controlled

Abstract Background MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention. Methods An expert panel consisting of the MACRO programme management group, independent advisors, and patient contributors, was convened to review current evidence and the mixed method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of oral steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design. Results A 12-week course of clarithromycin was agreed as the main trial comparator, due to its increasing use as a first and second line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Oral steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure the MACRO trial is both pragmatic and generalisable to primary care. A modified 3-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that patients recruited would be considered eligible for the treatment offered in the trial, due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation. Conclusion The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.

scholarly journals Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Helen Blackshaw ◽  
Jane Vennik ◽  
Carl Philpott ◽  
Mike Thomas ◽  
Caroline Eyles ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Expert Panel ◽  
Controlled Trial ◽  
Randomised Controlled
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