Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

Sinusitis Clinical Trial

— SYNECHIAE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077322
• Other study ID #: Synechiae-2014
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: April 18, 2018
• Start date: March 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2018
• Source: St. Paul's Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• Silastic Spacer
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.
• Merocel Spacer
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.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital Sinus Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. — View Citation

Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol. 2012 Nov;2(6):477-86. doi: 10.1002/alr.21052. Epub 2012 May 30. Review. — View Citation

Miller RS, Steward DL, Tami TA, Sillars MJ, Seiden AM, Shete M, Paskowski C, Welge J. The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2003 Jun;128(6):862-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sinonasal Outcomes Test-22 (SNOT- 22) score.	The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis. SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change12. Responses will be summated and considered as a continuous, numerical variable. Mean, median, standard deviation and inter-quartile range will be reported.; SNOT-22 change between baseline (preoperative score) and 90-days (postoperative score) will be compared between groups having middle meatal spacers removed at 14 days versus 6 days postoperatively.	Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Primary	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	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.