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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03187600
Enrollment
20
Registered
2017-06-15
Start date
2017-07-18
Completion date
2020-06-10
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Velopharyngeal Insufficiency

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.

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.

Interventions

PROCEDUREMucosa/submucosa Pharyngeal Flap

Included in study arm description

PROCEDUREStandard of Care Pharyngeal Flap

Included in study arm description

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

1 group will receive a pharyngeal flap procedure comprised of pharyngeal muscle while the other group will receive of a procedure with only mucosa/submucosa.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement in Hypernasality3-4 months post-operativelyThe primary outcome of the study will be improvement of hypernasality assessed by the ACPA perceptual assessment

Secondary

MeasureTime frameDescription
ACPA Perceptual Assessment3-4 months post-operativelyThe remainder of the ACPA perceptual assessment (hyponasality, audible nasal emission, articulation proficiency, overall intelligibility, and compensatory articulation),
post-operative pain0-2 months post-operativelyPost-op pain will be tracked using a validated pain scale as well as medication log.
complications associated with the procedure0-1 month post-operativelysubjectively assessed

Countries

Canada

Contacts

Primary ContactMurad Husein, MD, FRCSC
murad.husein@lhsc.on.ca519 685-8184
Backup ContactAdam Kwinter, Bsc
akwinter@uwo.ca519 685-8184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026