Skip to main content
OpenTrials
Completed

NCT Number: NCT02077322

Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital Sinus Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Experimental Arm

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.

Other names: Control Arm

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

St. Paul's Hospital, Canada

Other

Registry information

Official study 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.

Acronym: SYNECHIAE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2014
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.