Adult patients (> 18 years of age) with a current diagnosis of medically
refractory CRS were prospectively enrolled into an on-going, North American,
multi-institutional, observational, cohort study between February, 2011 and January, 2014
to compare the effectiveness of treatment outcomes for this chronic disease process.
Preliminary findings from this cohort have been previously described.9 (link)-12 (link) A
current diagnosis of CRS was defined by the 2007 Adult Sinusitis Guideline - endorsed by
the American Academy of Otolaryngology-Head and Neck Surgery,1 (link) with subsequent previous treatment with oral, broad spectrum,
or culture directed antibiotics (> 2 weeks duration) and either topical nasal
corticosteroid sprays (> 3 week duration) or a 5-day trial of systemic steroid
therapy during the year prior to enrollment. Enrollment sites consisted of four academic,
tertiary care rhinology practices as part of the Oregon Health & Science University
(OHSU, Portland, OR, USA), the Medical Univeristy of South Carolina (Charleston, SC, USA),
Stanford University (Stanford, CA, USA), and the University of Calgary (Calgary, Alberta,
Canada). The Institutional Review Board at each enrollment location provided oversight and
annual review the informed consent process and all investigational protocols, while
central review and coordination services were conducted at OHSU (eIRB
#7198). Study participation did not change the medical therapy regimen or
follow-up schedule required for any patient.
Study participants elected either one of two treatment options during the
preliminary enrollment meeting as their standard of care. Participants either elected to
continue medical management for control of symptoms associated with CRS or ESS procedures
based on individual disease processes and intraoperative clinical judgement of the
enrolling physician at each site. Surgical procedures consisted of either unilateral or
bilateral maxillary antrostomy, partial or total ethmoidectomy, sphenoidotomy, middle or
inferior turbinate reduction, frontal sinus procedures (Draf I, IIa/b, or III), or
septoplasty. Participants were either primary or revision surgery cases in both treatment
groups.
refractory CRS were prospectively enrolled into an on-going, North American,
multi-institutional, observational, cohort study between February, 2011 and January, 2014
to compare the effectiveness of treatment outcomes for this chronic disease process.
Preliminary findings from this cohort have been previously described.9 (link)-12 (link) A
current diagnosis of CRS was defined by the 2007 Adult Sinusitis Guideline - endorsed by
the American Academy of Otolaryngology-Head and Neck Surgery,1 (link) with subsequent previous treatment with oral, broad spectrum,
or culture directed antibiotics (> 2 weeks duration) and either topical nasal
corticosteroid sprays (> 3 week duration) or a 5-day trial of systemic steroid
therapy during the year prior to enrollment. Enrollment sites consisted of four academic,
tertiary care rhinology practices as part of the Oregon Health & Science University
(OHSU, Portland, OR, USA), the Medical Univeristy of South Carolina (Charleston, SC, USA),
Stanford University (Stanford, CA, USA), and the University of Calgary (Calgary, Alberta,
Canada). The Institutional Review Board at each enrollment location provided oversight and
annual review the informed consent process and all investigational protocols, while
central review and coordination services were conducted at OHSU (eIRB
#7198). Study participation did not change the medical therapy regimen or
follow-up schedule required for any patient.
Study participants elected either one of two treatment options during the
preliminary enrollment meeting as their standard of care. Participants either elected to
continue medical management for control of symptoms associated with CRS or ESS procedures
based on individual disease processes and intraoperative clinical judgement of the
enrolling physician at each site. Surgical procedures consisted of either unilateral or
bilateral maxillary antrostomy, partial or total ethmoidectomy, sphenoidotomy, middle or
inferior turbinate reduction, frontal sinus procedures (Draf I, IIa/b, or III), or
septoplasty. Participants were either primary or revision surgery cases in both treatment
groups.
