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

April 18, 2018 updated by: Amin Javer, St. Paul's Hospital, Canada

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital Sinus Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Silastic Spacer
This study arm receives the experimental treatment, a Silastic spacer.
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.
Other Names:
  • Experimental Arm
ACTIVE_COMPARATOR: Merocel Spacer
Merocel spacers are actively being used as the standard of care.
Device: 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.
Other Names:
  • Control Arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinonasal Outcomes Test-22 (SNOT- 22) score.
Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Paul's Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 4, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Synechiae-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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