Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery (NCT02627794) | Clinical Trial Compass
TerminatedPhase 3
Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery
Stopped: Due to financial issues of Restora spacer company.
United States3 participantsStarted 2015-12
Plain-language summary
Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with maximal medical therapy.
In some patients, underlying inflammation (discharge, edema and polyposis), compounded by inflammation caused by surgical trauma may lead to an uncontrolled healing response, which results in the synechiae formation in the middle meatus (MM).
Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic visualization of the sinus cavities postoperatively. This may result in difficulty in performing postoperative routine endoscopic debridement and examination, which is paramount to a successful outcome from ESS. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae.
The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing inflammation after sinus surgery than a Silastic spacer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 75 years
✓. Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
✓. Patients who need to undergo primary bilateral complete endoscopic sinus surgery
✓. Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments
✓. Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment