Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery

Stopped early · Phase 3

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT02627794

Run by

Cedars-Sinai Medical Center

People needed

3

Starts

2015-12-01

Expected to finish

2016-04-01

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subject is pregnant or breast feeding
• 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
• Patients who have taken oral steroids less than 30 days prior to surgery
• Patients with a history or diagnosis of glaucoma or ocular hypertension
• Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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