Study to Compare Resection Versus Preservation of the Middle Turbinate in Surgery for Nasal Polyps

Study Overview
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Brief Summary
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Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The goal of surgery is now to widely marsupialize the sinus cavities in order to optimize topical steroid irrigation treatment in the postoperative period. With that being said, the true extent of surgery needed for optimal patient outcome has yet to be elucidated. More specifically, in the last 30 years, people have argued about the best way to manage the middle turbinate. Some state that it should be preserved at all times to protect the sinus cavities from inhaled irritants and allergens and keep this surgical landmark untouched for future surgeries. On the other hand, there are defenders of routine resection of this turbinate, whether it is affected by polypoid changes or not. Many studies have looked at the potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis, anosmia, or atrophic rhinitis but the more recent literature does not show such significant associations. A recent topic of debate is whether partial removal of the anterior and inferior portion of the middle turbinate affects nasal polyps recurrence or improves long-term outcomes by further facilitation of post-operative topical therapies. Some retrospective data has shown that its resection could prolong the time before the need for revision surgery and improve both endoscopic and olfaction scores. A few prospective studies have also been published but unfortunately none of these were randomized, thus introducing a significant selection bias. Thus, there is a need for a formal randomized, controlled trial to elucidate this question.

Official Title
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A Randomized Controlled Trial Comparing Partial Resection Versus Preservation of the Middle Turbinate in Surgery for Chronic Rhinosinusitis With Polyposis (CRSwP)

Conditions
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Nasal Polyps, Sinusitis

Intervention / Treatment
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* Procedure: Middle turbinate resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic rhinosinusitis with nasal polyposis Obtained consent for bilateral complete endoscopic sinus surgery (maxillary antrostomy, complete sphenoethmoidectomy and frontal recess surgery) Primary or revision surgery Exclusion Criteria: Allergic fungal sinusitis Patients with previous surgery which included partial or complete middle turbinectomy, uni- or bilateral Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Middle turbinate resection<br>Resection of one middle turbinate | Procedure: Middle turbinate resection<br> <br> |
| No Intervention: Middle turbinate preservation<br>Preservation of one middle turbinate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the PeriOperative Sinus Endoscopy (POSE) score |  | Postoperative evaluations at 1, 3 and 6 months |