NCT02855931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

July 29, 2016

Last Update Submit

April 30, 2018

Conditions

Nasal PolypsSinusitis

Outcome Measures

Primary Outcomes (1)

  • Change in the PeriOperative Sinus Endoscopy (POSE) score

    Postoperative evaluations at 1, 3 and 6 months

Study Arms (2)

Middle turbinate resection

EXPERIMENTAL

Resection of one middle turbinate

Procedure: Middle turbinate resection

Middle turbinate preservation

NO INTERVENTION

Preservation of one middle turbinate

Interventions

Middle turbinate resectionPROCEDURE
Middle turbinate resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke, Département de chirurgie

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30409178DERIVED

MeSH Terms

Conditions

Nasal PolypsSinusitis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsParanasal Sinus Diseases

Study Officials

  • Marie Bussières, MD, FRCSC

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Otolaryngologist - head and neck surgeon

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 4, 2016

Study Start

April 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

CA(1)