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Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery (SYNECHIAE)

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Silastic Spacer
Merocel Spacer
Sponsored by
St. Paul's Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sinusitis focused on measuring Merocel Middle Meatus Spacers, Silastic Middle Meatus Spacers, Functional Endoscopic Sinus Surgery

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Paul's Hospital Sinus Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silastic Spacer

Merocel Spacer

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2014
Last Updated
April 18, 2018
Sponsor
St. Paul's Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02077322
Brief Title
Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Paul's Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Merocel Middle Meatus Spacers, Silastic Middle Meatus Spacers, Functional Endoscopic Sinus Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silastic Spacer
Arm Type
Experimental
Arm Description
This study arm receives the experimental treatment, a Silastic spacer.
Arm Title
Merocel Spacer
Arm Type
Active Comparator
Arm Description
Merocel spacers are actively being used as the standard of care.
Intervention Type
Device
Intervention Name(s)
Silastic Spacer
Other Intervention Name(s)
Experimental Arm
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Merocel Spacer
Other Intervention Name(s)
Control Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
Description
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 Outcome Measure Information:
Title
Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
Description
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.
Time Frame
Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Other Pre-specified Outcome Measures:
Title
Sinonasal Outcomes Test-22 (SNOT- 22) score.
Description
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.
Time Frame
Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amin R Javer, MD, FRCSC, FARS
Organizational Affiliation
St. Paul's Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital Sinus Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12825038
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. doi: 10.1016/S0194-59980300460-1.
Results Reference
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PubMed Identifier
12825040
Citation
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.
Results Reference
background
PubMed Identifier
22648984
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.
Results Reference
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Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

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