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

This study is currently recruiting participants.
Verified August 2016 by Marie Bussières, Université de Sherbrooke
Sponsor:
ClinicalTrials.gov Identifier:
NCT02855931
First Posted: August 4, 2016
Last Update Posted: August 4, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marie Bussières, Université de Sherbrooke
  Purpose
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 Intervention
Nasal Polyps Sinusitis Procedure: Middle turbinate resection

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Marie Bussières, Université de Sherbrooke:

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

Estimated Enrollment: 16
Study Start Date: April 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Middle turbinate resection
Resection of one middle turbinate
Procedure: Middle turbinate resection
No Intervention: Middle turbinate preservation
Preservation of one middle turbinate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02855931


Contacts
Contact: Marie Bussières, MD, FRCSC 1-819-346-1110 ext 14901 marie.bussieres@usherbrooke.ca

Locations
Canada, Quebec
Université de Sherbrooke, Département de chirurgie Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Marie Bussieres, MD FRCSC    1-819-346-1110 ext 14901    marie.bussieres@usherbrooke.ca   
Principal Investigator: Marie Bussieres, MD FRCSC         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Marie Bussières, MD, FRCSC Université de Sherbrooke
  More Information

Responsible Party: Marie Bussières, Otolaryngologist - head and neck surgeon, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02855931     History of Changes
Other Study ID Numbers: 2016-1318
First Submitted: July 29, 2016
First Posted: August 4, 2016
Last Update Posted: August 4, 2016
Last Verified: August 2016

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