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

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.

Study Overview

• Status: Unknown
• Conditions: Velopharyngeal Insufficiency
• Intervention / Treatment: Procedure: Standard of Care Pharyngeal Flap; Procedure: Mucosa/submucosa Pharyngeal Flap

Detailed Description

Velopharyngeal dysfunction (VPD) results from failure of the airway to close and separate the oropharynx and nasopharynx during speech, eating and drinking as a result of insufficiency of the velum (soft palate) (1). VPD leads to a number of symptoms including difficulty with articulation, nasal regurgitation and excess nasal air emissions. VPD can often be treated through speech language therapy alone, however when refractory to this treatment surgical correction of problematic anatomy is indicated (2). The current surgery of choice at this center is a pedicled, posterior wall pharyngeal flap. During this procedure a small flap comprised of mucosa, submucosa and superior pharyngeal constrictor muscle is pedicled via surgical dissection and attached anteriorly to the inadequate soft palate. This creates an incomplete midline obstruction at the level of the velum allowing for a dynamic valve which can be closed through the medial constriction of the pharyngeal muscles during speech and eating/drinking. While this surgery has a high success rate there can be a high degree of post operative pain and sub-optimal lateral wall motion (2). It is hypothesized that the suboptimal lateral wall motion post-operatively is due to intentional segmentation of the superior constrictor muscle during the operation. Due to the necessary de-innervation of the pedicled pharyngeal flap there is evidence that the muscle atrophies and the bulk it initially adds to the flap is lost over time. Despite this, patients typically have good long-term outcomes with a pharyngeal flap (3,4). For these reasons it has been postulated that a successful surgery could be carried out using a pharyngeal flap comprised only of mucosa and submucosa, sparing the superior constrictor muscle. By sparing the superior constrictor muscle the investigators hope to achieve a decrease in post operative pain, complications and improved lateral wall motion while maintaining the effectiveness of the flap and symptomatic improvement. This novel surgical approach to treating VPD was shown to be effective and safe in animal trial (2). The major concern of the mucosal/submucosal flap procedure was that the flap would atrophy and fail without the inclusion of the muscular portion. However, results of the animal study comparing the standard pharyngeal flap to the experimental flap, indicated that at 12 weeks post-operation, bulk loss in the muscosa/submucosa group was not significantly greater than bulk loss in the muscular flap group.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Murad Husein, MD, FRCSC; Phone Number: 58184 519 685-8184; Email: murad.husein@lhsc.on.ca
• Study Contact Backup: Name: Adam Kwinter, Bsc; Phone Number: t: 58184 519 685-8184; Email: akwinter@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • Recruiting
      • Childrens Hospital London Health Sciences Center
      • Contact: Murad Husein, MD, MSc; Phone Number: 519.685.8184; Email: murad.husein@lhscs.on.ca
      • Contact: Lesley Ryckman, BSc; Phone Number: 519.685.8184; Email: Lesley.Ryckman@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Standard of Care Pharyngeal Flap; Included in study arm description
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	Procedure: Mucosa/submucosa Pharyngeal Flap; Included in study arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACPA Perceptual Assessment	The remainder of the ACPA perceptual assessment (hyponasality, audible nasal emission, articulation proficiency, overall intelligibility, and compensatory articulation),	3-4 months post-operatively
post-operative pain	Post-op pain will be tracked using a validated pain scale as well as medication log.	0-2 months post-operatively
complications associated with the procedure	subjectively assessed	0-1 month post-operatively

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Murad Husein, MD, FRCSC, Lawson Heath Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Anticipated): June 10, 2020
• Study Completion (Anticipated): June 10, 2020

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Velopharyngeal Insufficiency
• Other Study ID Numbers: 109037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No