Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sinusitis

Intervention / Treatment
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* Device: Silastic Spacer
* Device: Merocel Spacer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silastic Spacer<br>This study arm receives the experimental treatment, a Silastic spacer. | Device: Silastic Spacer<br>* The Silastic spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.<br>* Other names: Experimental Arm;|
| Active Comparator: Merocel Spacer<br>Merocel spacers are actively being used as the standard of care. | Device: Merocel Spacer<br>* The Merocel spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.<br>* Other names: Control Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups. | The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Incidence of postoperative synechiae will be compared between right and left nasal cavities receiving either silastic or glove finger spacers. | Participants will be followed for the duration of post op standard of care, an expected average of 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups. | The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Secondary comparisons of postoperative synechiae will be compared between subjects in the 6-day vs 14-day spacer removal groups. | Participants will be followed for the duration of post op standard of care, an expected average of 90 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Merocel Middle Meatus Spacers, Silastic Middle Meatus Spacers, Functional Endoscopic Sinus Surgery