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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02855931
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : May 1, 2018
Information provided by (Responsible Party):
Marie Bussières, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Nasal Polyps Sinusitis Procedure: Middle turbinate resection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Partial Resection Versus Preservation of the Middle Turbinate in Surgery for Chronic Rhinosinusitis With Polyposis (CRSwP)
Study Start Date : April 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: Middle turbinate resection
Resection of one middle turbinate
Procedure: Middle turbinate resection
No Intervention: Middle turbinate preservation
Preservation of one middle turbinate

Primary Outcome Measures :
  1. Change in the PeriOperative Sinus Endoscopy (POSE) score [ Time Frame: Postoperative evaluations at 1, 3 and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02855931

Canada, Quebec
Université de Sherbrooke, Département de chirurgie
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Principal Investigator: Marie Bussières, MD, FRCSC Université de Sherbrooke

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marie Bussières, Otolaryngologist - head and neck surgeon, Université de Sherbrooke Identifier: NCT02855931     History of Changes
Other Study ID Numbers: 2016-1318
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases