Clinical trial NCT02077322: Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery
Official title: Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial Comparing Gloved Merocel and Silastic Middle Meatal Spacers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: Merocel Middle Meatus Spacers
Silastic Middle Meatus Spacers
Functional Endoscopic Sinus Surgery
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 19 years, currently receiving sinus-related care at the St Paul's Sinus Centre for chronic rhinosinusitis and who undergo primary bilateral complete endoscopic sinus surgery will be approached to participate in this clinical trial.

Exclusion Criteria:

* Patients with sino-nasal tumors
* Patients solely undergoing nasal septal reconstruction
* Patients with previous history of endoscopic sinus surgery
* Cystic fibrosis or syndromic patients
* Patients with autoimmune diseases

Primary outcomes:
measure: Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
timeFrame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Secondary outcomes:
measure: Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
timeFrame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Other outcomes:
measure: Sinonasal Outcomes Test-22 (SNOT- 22) score.
timeFrame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital Sinus Centre
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Canada
name: Amin R Javer, MD, FRCSC, FARS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller RS, Steward DL, Tami TA, Sillars MJ, Seiden AM, Shete M, Paskowski C, Welge J. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2003 Jun;128(6):862-9. doi: 10.1016/S0194-59980300460-1.
citation: Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. doi: 10.1016/S0194-59980300469-8.
citation: Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol. 2012 Nov;2(6):477-86. doi: 10.1002/alr.21052. Epub 2012 May 30.