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

U

Université de Sherbrooke

Status

Completed

Conditions

Nasal Polyps
Sinusitis

Treatments

Procedure: Middle turbinate resection

Study type

Interventional

Funder types

Other

Identifiers

NCT02855931
2016-1318

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Middle turbinate resection
Experimental group
Description:
Resection of one middle turbinate
Treatment:
Procedure: Middle turbinate resection
Middle turbinate preservation
No Intervention group
Description:
Preservation of one middle turbinate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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