Clinical trial NCT02855931: Study to Compare Resection Versus Preservation of the Middle Turbinate in Surgery for Nasal Polyps
Official title: A Randomized Controlled Trial Comparing Partial Resection Versus Preservation of the Middle Turbinate in Surgery for Chronic Rhinosinusitis With Polyposis (CRSwP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Polyps
Sinusitis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the PeriOperative Sinus Endoscopy (POSE) score
timeFrame: Postoperative evaluations at 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke, Département de chirurgie
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Marie Bussières, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudon MA, Wright ED, Fortin-Pellerin E, Bussieres M. Resection versus preservation of the middle turbinate in surgery for chronic rhinosinusitis with nasal polyposis: a randomized controlled trial. J Otolaryngol Head Neck Surg. 2018 Nov 8;47(1):67. doi: 10.1186/s40463-018-0313-8.