Submucosa/Mucosal Pharyngeal Flap Trial
Single Blinded Randomized Controlled Trial Comparing Muscular Pharyngeal Flap to Mucosal/Submucosal Pharyngeal Flap Surgical Technique for the Treatment of Velopharyngeal Dysfunction
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedStudy Start
First participant enrolled
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedAugust 25, 2017
August 1, 2017
2.9 years
June 11, 2017
August 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in Hypernasality
The primary outcome of the study will be improvement of hypernasality assessed by the ACPA perceptual assessment
3-4 months post-operatively
Secondary Outcomes (3)
ACPA Perceptual Assessment
3-4 months post-operatively
post-operative pain
0-2 months post-operatively
complications associated with the procedure
0-1 month post-operatively
Study Arms (2)
Standard of Care
ACTIVE COMPARATORProcedure: 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.
Experimental Group
EXPERIMENTALProcedure: 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
Interventions
Eligibility Criteria
You may qualify if:
- Patients with velopharyngeal dysfunction undergoing pharyngeal flap surgery for correction.
You may not qualify if:
- Patients suffering VPD secondary to a syndrome. Patients undergoing a revision pharyngeal flap surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens Hospital London Health Sciences Center
London, Ontario, N6A5W9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murad Husein, MD, FRCSC
Lawson Heath Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Patients will not be told what procedure they have received until after completion int he study. Speech language pathologists performing assessments will not be made aware of what procedure the patients have received. Nasovideo endoscopy will be reviewed in a blinded fashion without knowledge of what procedure the patient received.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- aediatric Otolaryngologist Associate Professor and Undergraduate Director, Department of Otolaryngology-Head and Neck Surgery
Study Record Dates
First Submitted
June 11, 2017
First Posted
June 15, 2017
Study Start
July 18, 2017
Primary Completion
June 10, 2020
Study Completion
June 10, 2020
Last Updated
August 25, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share