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Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

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ClinicalTrials.gov Identifier: NCT03469973
Recruitment Status : Not yet recruiting
First Posted : March 19, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Basem Makram, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Velopharyngeal Insufficiency Velopharyngeal Incompetence Due to Cleft Palate Procedure: Partial adenoidectomy

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
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids


Intervention Details:
  • Procedure: Partial adenoidectomy

    The procedure will be completely visualized with a 45 degrees, 4- mm nasal endoscope; the upper part of the adenoid will be removed using the microdebrider, while the lower part will be preserves to maintain the velopharyngeal competence.

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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Responsible Party: Basem Makram, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03469973     History of Changes
Other Study ID Numbers: BASEMM
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Jaw Diseases
Cleft Palate
Velopharyngeal Insufficiency
Jaw Abnormalities
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Pharyngeal Diseases
Otorhinolaryngologic Diseases