Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

NCT02077322 | Completed

• 1 other identifier: Synechiae-2014
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

Merocel Middle Meatus Spacers; Silastic Middle Meatus Spacers; Functional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• Sinonasal Outcomes Test-22 (SNOT- 22) score.

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

Study Arms (2)

Silastic Spacer

EXPERIMENTAL

This study arm receives the experimental treatment, a Silastic spacer.

Device: Silastic Spacer

Merocel Spacer

ACTIVE COMPARATOR

Merocel spacers are actively being used as the standard of care.

Device: Merocel Spacer

Interventions

Silastic Spacer DEVICE

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.

Also known as: Experimental Arm

Silastic Spacer

Merocel Spacer DEVICE

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.

Also known as: Control Arm

Merocel Spacer

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St. Paul's Hospital Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (3)

• 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. doi: 10.1016/S0194-59980300460-1.

  PMID: 12825038 BACKGROUND

• 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. doi: 10.1016/S0194-59980300469-8.

  PMID: 12825040 BACKGROUND

• 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.

  PMID: 22648984 BACKGROUND

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Amin R Javer, MD, FRCSC, FARS

  St. Paul's Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, St. Paul's Sinus Centre

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

CA (1)