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Experimental Group for Velopharyngeal Insufficiency

N/A
Waitlist Available
Led By Murad Husein, MD, FRCSC
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with velopharyngeal dysfunction undergoing pharyngeal flap surgery for correction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 months post-operatively
Awards & highlights

Study Summary

The investigators want to compare two different surgical techniques for the treatment of a condition called velopharyngeal dysfunction (VPD). VPD is a condition in which the nasal part of the airway does not close properly during speaking and feeding. The current standard surgical management involves taking a pharyngeal flap from the back of the throat comprised of muscle and overlying mucosal tissue to create a functioning valve. The proposed technique would use only the mucosal/submucosal layer of the pharynx for the flap. This technique has been shown to be effective in animal models and it is hoped that it will lead to faster healing, lower complications and improved functional outcome for patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 months post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Hypernasality
Secondary outcome measures
ACPA Perceptual Assessment
complications associated with the procedure
post-operative pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
Procedure: a modified superiorly based pharyngeal flap surgery as per Hogan and Cable and Canady. It is performed trans-orally under general anesthetic. The soft palate is divided midline to visualize the posterior pharyngeal wall. A small flap is dissected via longitudinal incisions with a superior pedicle from the posterior pharyngeal wall at the level of the velum. The flap is then brought anteriorly, the inferior portion is lined with mucosa from the nasal portion of the soft palate and sutured in-place to create an incomplete pharyngeal obstruction that acts as a dynamic valve. Nasal stents are placed in each lateral port to prevent airway compromise and maintain flap integrity. Stents are removed two days post operatively and the patient is discharged after removal of stents and deemed to have a stable airway. Dissection will be carried out only to the level of the superior constrictor muscle and comprised of mucosua/submucosa
Group II: Standard of CareActive Control1 Intervention
Procedure: a superiorly based pharyngeal flap surgery as per Hogan and Cable and Canady. It is performed trans-orally under general anesthetic. The soft palate is divided midline to visualize the posterior pharyngeal wall. A small flap is dissected via longitudinal incisions with a superior pedicle from the posterior pharyngeal wall at the level of the velum. The flap is then brought anteriorly, the inferior portion is lined with mucosa from the nasal portion of the soft palate and sutured in-place to create an incomplete pharyngeal obstruction that acts as a dynamic valve. Nasal stents are placed in each lateral port to prevent airway compromise and maintain flap integrity. Stents are removed two days post operatively and the patient is discharged after removal of stents and deemed to have a stable airway. Dissection will be carried out to the level of the prevertebral fascia and be comprised of mucosa and pharyngeal muscle.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,408 Total Patients Enrolled
Murad Husein, MD, FRCSCPrincipal InvestigatorLawson Heath Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Submucosa/Mucosal Pharyngeal Flap Trial
Murad Husein 2017. "Submucosa/Mucosal Pharyngeal Flap Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03187600.
~3 spots leftby Apr 2025
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