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

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855931
• Other study ID #: 2016-1318
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Procedure:
• Middle turbinate resection

Locations

Country	Name	City	State
Canada	Université de Sherbrooke, Département de chirurgie	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the PeriOperative Sinus Endoscopy (POSE) score		Postoperative evaluations at 1, 3 and 6 months