Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Device: Silastic Spacer; Device: Merocel Spacer

• Registration Number: NCT02077322
• Lead Sponsor: St. Paul's Hospital, Canada

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-28
• Study Start: 2014-03
• Study First Posted: 2014-03-04
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silastic Spacer	Silastic Spacer	This study arm receives the experimental treatment, a Silastic spacer.
Merocel Spacer	Merocel Spacer	Merocel spacers are actively being used as the standard of care.

Primary Outcome Measures

Name	Time	Method
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.	Participants will be followed for the duration of post op standard of care, an expected average of 90 days.	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.	Participants will be followed for the duration of post op standard of care, an expected average of 90 days.	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.

Trial Locations

Locations (1)

St. Paul's Hospital Sinus Centre; 🇨🇦 Vancouver, British Columbia, Canada