search
Back to results

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

Primary Purpose

Nasal Polyps, Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Middle turbinate resection
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Université de Sherbrooke, Département de chirurgie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Middle turbinate resection

Middle turbinate preservation

Arm Description

Resection of one middle turbinate

Preservation of one middle turbinate

Outcomes

Primary Outcome Measures

Change in the PeriOperative Sinus Endoscopy (POSE) score

Secondary Outcome Measures

Full Information

First Posted
July 29, 2016
Last Updated
April 30, 2018
Sponsor
Université de Sherbrooke
search

1. Study Identification

Unique Protocol Identification Number
NCT02855931
Brief Title
Study to Compare Resection Versus Preservation of the Middle Turbinate in Surgery for Nasal Polyps
Official Title
A Randomized Controlled Trial Comparing Partial Resection Versus Preservation of the Middle Turbinate in Surgery for Chronic Rhinosinusitis With Polyposis (CRSwP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps, Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Middle turbinate resection
Arm Type
Experimental
Arm Description
Resection of one middle turbinate
Arm Title
Middle turbinate preservation
Arm Type
No Intervention
Arm Description
Preservation of one middle turbinate
Intervention Type
Procedure
Intervention Name(s)
Middle turbinate resection
Primary Outcome Measure Information:
Title
Change in the PeriOperative Sinus Endoscopy (POSE) score
Time Frame
Postoperative evaluations at 1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bussières, MD, FRCSC
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Sherbrooke, Département de chirurgie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30409178
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs