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

This study is currently recruiting participants.
Verified October 2016 by Amin Javer, St. Paul's Hospital, Canada
Sponsor:
ClinicalTrials.gov Identifier:
NCT02077322
First Posted: March 4, 2014
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada
  Purpose
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.

Condition Intervention
Sinusitis. Device: Silastic Spacer Device: Merocel Spacer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Amin Javer, St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Other Outcome Measures:
  • 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.



Estimated Enrollment: 96
Study Start Date: March 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Control Arm

  Eligibility

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077322


Contacts
Contact: Amin R Javer, MD, FRCSC, FARS 604-806-9926 sinusdoc@me.com

Locations
Canada, British Columbia
St. Paul's Hospital Sinus Centre Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Amin R Javer, MD FRCSC FARS    6048069926    sinusdoc@me.com   
Principal Investigator: Amin R Javer, MD FRCSC FARS         
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin R Javer, MD, FRCSC, FARS St. Paul's Hospital, Canada
  More Information

Publications:
Responsible Party: Amin Javer, Director, St. Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT02077322     History of Changes
Other Study ID Numbers: Synechiae-2014
First Submitted: February 27, 2014
First Posted: March 4, 2014
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Merocel Middle Meatus Spacers
Silastic Middle Meatus Spacers
Functional Endoscopic Sinus Surgery

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyvinyl alcohol formaldehyde foam
Formaldehyde
Hemostatics
Coagulants
Disinfectants
Anti-Infective Agents