NCT01680705

Brief Summary

The aim of this study is to determine what the ideal frequency of high-volume sinonasal saline irrigation in the early postoperative period following ESS for medically refractory CRS. We will evaluate once, twice, and three times daily frequency sinonasal saline irrigation protocols. Our hypothesis is that three times a day sinonasal saline irrigations for the first week is ideal with no difference between frequencies after 1 week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

August 30, 2012

Last Update Submit

December 1, 2014

Conditions

Rhinosinusitis

Keywords

Chronic RhinosinusitisEndoscopic Sinus SurgerySinonasal saline irrigationFrequencyPostoperativeHigh VolumeRandomized Control TrialSingle BlindedProspective StudyQuality of LifeEndoscopic Sinus Score

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life

    The SNOT-22 and the nasal and sinus symptoms score will be complete by the patient to assess quality of life. They will be completed preoperatively and 1 week, 3 weeks and 2 months postoperatively.

    Pre and post operative (1, 3 and 8 weeks post operatively)

Secondary Outcomes (1)

  • Change in Endoscopic Score

    Pre and Post-Operative (1, 3 and 8 weeks post operatively)

Study Arms (3)

Frequency: Once Daily

ACTIVE COMPARATOR

Patients will use high volume saline irrigation once daily post operatively.

Other: High Volume Saline Irrigation

Frequency: Twice Daily

ACTIVE COMPARATOR

Patients will use high volume saline irrigation twice daily post operatively.

Other: High Volume Saline Irrigation

Frequency: Three Times Daily

ACTIVE COMPARATOR

Patients will use high volume saline irrigation three times daily post operatively.

Other: High Volume Saline Irrigation

Interventions

High Volume Saline IrrigationOTHER

High volume saline irrigation (240 ml)

Frequency: Once DailyFrequency: Three Times DailyFrequency: Twice Daily

Eligibility Criteria

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

You may qualify if:

  • Adult patients with a diagnosis of CRS as per guidelines (\> 18 years old)
  • Documented failed medical treatment of CRS
  • Planned ESS for the treatment of CRS
  • Able to read and understand English

You may not qualify if:

  • Pregnant
  • Cystic Fibrosis
  • Diagnosed immotile cilia syndrome
  • Diagnosed immunodeficiency syndrome
  • Diagnosed fungal sinusitis
  • Sinonasal tumours or obstructive lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (11)

  • Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Robert Schellenberg R, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S99-193. English, French.

    PMID: 21658337BACKGROUND

  • Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.

    PMID: 12838019BACKGROUND

  • Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhinol Laryngol Suppl. 2004 May;193:3-5. doi: 10.1177/00034894041130s502.

    PMID: 15174752BACKGROUND

  • Ray NF, Baraniuk JN, Thamer M, Rinehart CS, Gergen PJ, Kaliner M, Josephs S, Pung YH. Healthcare expenditures for sinusitis in 1996: contributions of asthma, rhinitis, and other airway disorders. J Allergy Clin Immunol. 1999 Mar;103(3 Pt 1):408-14. doi: 10.1016/s0091-6749(99)70464-1.

    PMID: 10069873BACKGROUND

  • Van Cauwenberge P, Watelet JB. Epidemiology of chronic rhinosinusitis. Thorax. 2000 Oct;55 Suppl 2(Suppl 2):S20-1. doi: 10.1136/thorax.55.suppl_2.s20. No abstract available.

    PMID: 10992549BACKGROUND

  • Tomooka LT, Murphy C, Davidson TM. Clinical study and literature review of nasal irrigation. Laryngoscope. 2000 Jul;110(7):1189-93. doi: 10.1097/00005537-200007000-00023.

    PMID: 10892694BACKGROUND

  • Rabago D, Zgierska A, Mundt M, Barrett B, Bobula J, Maberry R. Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: a randomized controlled trial. J Fam Pract. 2002 Dec;51(12):1049-55.

    PMID: 12540331BACKGROUND

  • Meltzer EO, Hamilos DL. Rhinosinusitis diagnosis and management for the clinician: a synopsis of recent consensus guidelines. Mayo Clin Proc. 2011 May;86(5):427-43. doi: 10.4065/mcp.2010.0392. Epub 2011 Apr 13.

    PMID: 21490181BACKGROUND

  • Morley AD, Sharp HR. A review of sinonasal outcome scoring systems - which is best? Clin Otolaryngol. 2006 Apr;31(2):103-9. doi: 10.1111/j.1749-4486.2006.01155.x.

    PMID: 16620328BACKGROUND

  • Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.

    PMID: 18075447BACKGROUND

  • Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.

    PMID: 17903570BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Luke Rudmik, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 7, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

CA(1)