Recruiting

Pharyngeal Flap vs. Mucosal Flap

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03187600

Conditions

Velopharyngeal Insufficiency

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Mucosa/submucosa Pharyngeal Flap

Standard of Care Pharyngeal Flap

Study Details

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.

Conditions

Velopharyngeal Insufficiency

Study ID

NCT03187600

Start date

Jul 18, 2017

Status verified date

Aug, 2017

Completion date

Jun 10, 2020

Anticipated

Primary completion date

Jun 10, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with velopharyngeal dysfunction undergoing pharyngeal flap surgery for correction.

Exclusion Criteria:

  • Patients suffering VPD secondary to a syndrome. Patients undergoing a revision pharyngeal flap surgery.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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.

experimental: Experimental Group

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

Interventions

Mucosa/submucosa Pharyngeal Flap

Included in study arm description

Standard of Care Pharyngeal Flap

Included in study arm description

Primary outcome measure

  • Improvement in Hypernasality [ Time Frame: 3-4 months post-operatively ]

Central Contacts and Locations

Central contacts

Murad Husein, MD, FRCSC

519 685-8184murad.husein@lhsc.on.ca

Adam Kwinter, Bsc

519 685-8184akwinter@uwo.ca

Locations

Childrens Hospital London Health Sciences Center

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Murad Husein, MD, MSc

519.685.8184murad.husein@lhscs.on.ca

Lesley Ryckman, BSc

519.685.8184Lesley.Ryckman@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Aug 25, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-08-25.