CClinicalTrials.gg
CompletedNCT02855931Updated May 1, 2018

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

An interventional study of Middle turbinate resection in Nasal Polyps and Sinusitis, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasal Polyps
  • Sinusitis
03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 16 is below the median of 60 across 313 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Allergic fungal sinusitis
  • Patients with previous surgery which included partial or complete middle turbinectomy, uni- or bilateral
  • Pregnant or lactating women
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Middle turbinate resection

    Resection of one middle turbinate

    Procedure: Middle turbinate resection

  • No intervention
    Middle turbinate preservation

    Preservation of one middle turbinate

Interventions

  • ProcedureMiddle turbinate resection
06

What researchers measure

Primary outcomes

  1. Change in the PeriOperative Sinus Endoscopy (POSE) score

    Time frame: Postoperative evaluations at 1, 3 and 6 months

07

Study locations

1 site
  • Université de Sherbrooke, Département de chirurgie
    Sherbrooke, Quebec J1H 5N4, Canada
08

References and documents

Publications

  • 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. PubMed 30409178 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02855931
Lead sponsor
Université de Sherbrooke
Responsible party
Marie Bussières (Otolaryngologist - head and neck surgeon, Université de Sherbrooke) — Principal investigator
First posted
Aug 4, 2016
Start date
Apr 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
May 1, 2018

Study contacts

Marie Bussières, MD, FRCSC
principal investigator · Université de Sherbrooke
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion