Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

March 17, 2018 updated by: Basem Makram, Assiut University
The velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Velopharyngeal dysfunction is the inability to separate the oral and nasal cavities adequately during speech production through the actions of the velum and pharynx. Velopharyngeal dysfunction can be caused due to lack of tissue (velopharyngeal insufficiency) or lack of proper movement (velopharyngeal incompetence) of the walls. While Velopharyngeal dysfunction is commonly associated with cleft lip and palate, it can also be seen with submucous cleft and other noncleft conditions such as ablative palatal lesions, adenoidectomy, deafness or hearing loss, and cerebral palsy. In Velopharyngeal dysfunction, the incompletely closed velopharyngeal valve causes an inability to effectively manage the air stream for continuous speech causing hypernasal speech.

Adenoid hypertrophy may play a role in velopharyngeal closure especially in patients with palatal abnormality.

In 1958, Gibb indicated an incidence of hypernasality postadenoidectomy in approximately 1 of 2000 cases. Closure pattern of velopharyngeal valve in typical patients is velo-adenoidal rather than velopharyngeal closure. Adenoid mass is vital to velopharyngeal closure in such patients and removal necessitates a change in the pattern of velopharyngeal valving.

Trans-oral endoscopic partial (superior) adenoidectomy adenoidectomy enables the surgeon to inspect the velopharyngeal valve during the procedure; thus avoiding occurrence of velopharyngeal dysfunction.

Study Type

Observational

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital, in the period between 1⁄5∕2018 and 1∕5⁄2020.

The study will be carried on 40 consecutive cases.

Description

Inclusion Criteria:

  • Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected).

Exclusion Criteria:

  • Patients who had undergone any secondary corrective surgery for velopharyngeal insufficiency.
  • Patients with craniofacial anomalies.
  • Any associated medical comorbidity that contraindicates general anesthesia.
  • Refusal of enrollment in the research by the patients or care givers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
40 patients diagnosed by velopharyngeal insufficiency will go for partial adenoidectomy completely visualised by 45 degrees, 4 mm nasal endoscope. The adenoid will be removed by using microdeprider.
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 17, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEMM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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