Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

N/ACompletedNCT02077322

St. Paul's Hospital, Canada48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Sinusitis

Interventions

Silastic Spacer

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

Secondary Outcomes

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.