- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05820529
Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism
- To assess safety of tonsillectomy, adenoidectomy or adenotonsillectomy result toVelopharyngeal Valve Mechanism.
- To predict and prevent post adenotonsillectomy velopharyngeal dysfunction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION The velopharyngeal mechanism consists of a muscular valve that extends from the posterior surface of the hard palate to the posterior pharyngeal wall and includes the velum, lateral pharyngeal walls and the posterior pharyngeal wall .The function of the velopharyngeal mechanism is to create a tight seal between the velum and pharyngeal walls to separate the oral and nasal cavities for various purposes, including speech. Velopharyngeal closure is accomplished through the contraction of several velopharyngeal muscles including the levator veli palatini, musculus uvulae, superior pharyngeal constrictor, palatopharyngeus, palatoglossus, and salpingopharyngeus. The tensor veli palatini is thought to be responsible for eustachian tube function.(1) Velopharyngeal closure patterns may be classified as follows: coronal, where there is predominant soft palate movement toward the posterior pharyngeal wall; sagittal, where there is predominant movement of the lateral pharyngeal walls toward the pharynx midline, circular, where balanced movements of lateral pharyngeal walls and soft palate are observed; circular with Passavant's ridge, where the circular closure is associated with the development of a mucosal fold named Passavant's ridge on the posterior pharyngeal wall.
Velopharyngeal dysfunction (VPD) is a condition where the velopharyngeal valve does not close consistently and completely during the production of oral sounds. Velopharyngeal dysfunction can be caused by abnormal anatomy (velopharyngeal insufficiency), abnormal neurophysiology (velopharyngeal incompetence),or particular articulation errors (velopharyngeal mislearning)(2). Velopharyngeal dysfunction (VPD) is a generic term which describes a set of disorders resulting in the 3 leakage of air into the nasal passages during speech production. As a result, speech samples can demonstrate hypernasality, nasal emissions, and poor intelligibility.(3) Aetiologies of velopharyngeal insufficiency:( Occult submucous cleft palate, Neuromuscular disorder, Residual adenoid tissue, Classical submucous cleft palate, Poor palatal mobility, Behavioural disorder, Normal palate, 22q11 deletion, Postoperative nasopharyngitis, Scarring from tonsillectomy ).(4) Hypertrophic tonsils can be so large that they push against the posterior faucial pillars and intrude into the pharynx. This can easily be seen through nasopharyngoscopy. When this occurs, it can cause both a functional and mechanical interference with lateral pharyngeal wall movement. In rare cases, a tonsil (or both) is so large that it extends up to the area between the velum and posterior pharyngeal wall, thus interfering with velopharyngeal closure. When hypertrophic tonsils interfere with velopharyngeal function (and also affect the airway(5), this can be corrected with a tonsillectomy. Most children actually have veloadenoidal closure because the adenoids are in the place of normal velar contact. Adenoid tissue is most prominent in very young children but begins to slowly atrophy around the age of 6. With the onset of puberty, there can be significant, and sometimes sudden, atrophy of the adenoid tissue, causing an increase in the distance between the velum and posterior pharyngeal wall. If the velum is normal, it stretches to accommodate the difference in the depth of the pharynx; thus, normal velopharyngeal closure is maintained(6). 15 non-cleft palate children who developed velopharyngeal incompetence (VPI) after adenotonsillectomy. Eight boys and 7 girls with a mean age of 6.2 years (range 4.3-11 years) were treated between 1970 and 1993. After 2 years conservative management to allow for spontaneous resolution, only (7 children) 47% achieved normal resonance. Speech therapy was employed mainly for those 4 patients with unrelated articulation errors. Fifty-three percent (8 children) required surgery for persistent hypernasality and in 6 a pharyngoplasty was performed and in one child a posterior pharyngeal cartilage graft was inserted. One case is still to have surgical intervention. Half of the non-cleft children who develop VPI after adenotonsillectomy will respond to conservative management.(7) Retrospective data collection was performed for patients seen in the Great Ormond Street Hospital for Children multidisciplinary VPI clinic from the 1st of January 2015 until 30th of April 2020. Paediatric patients with previous adenotonsillar surgery and no evidence of cleft palate or speech and language disorder were included in the study.29patients met the inclusion criteria, with 16 having previous adenotonsillectomy and 13 isolated adenoidectomy.Severe hypernasality was noted in 3 patients, while in 20 cases moderate or mild hypernasality was found. There were no patients with normal speech. Ten patients were treated with speech therapy alone, whereas surgical intervention was required in seventeen cases. In the population who received treatment and had adequately recorded follow-up, improvement in speech was noted in 86.9%, with 30.4% having oral resonance on last review. Of the patients with severe hypernasality, all improved but had some persistent hyper nasality on last clinic review(8).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatma Mohamed Abdallah, Resdient
- Phone Number: 01023373977
- Email: fatmamohamed18121995@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- ENT department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children patients (aged from 4yrs to 12yrs) who will be undergone adenoidectomy or tonsillectomy or adenotonsillectomy
Exclusion Criteria:
- Clinical diagnosis of cleft palate.
- Clinical diagnosis of submucous cleft palate
- Neuromuscular disorders.
- Patients with craniofacial syndromes.
- Patient with mental retardation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Effect of Adenotonsillectomy in velopharyngeal valve mechanism
We do adenotonsillectomy and show its effect in velopharyngeal valve
|
removal of adenoid,tonsil in one session
removal of adenoid
removal of tonsil
|
Other: Effect of Adenoidectomy in velopharyngeal valve mechanism
We do adenoidectomy and show its effect in velopharyngeal valve
|
removal of adenoid
|
Other: Effect of tonsillectomy in velopharyngeal valve mechanism
We do tonsillectomy and show its effect in velopharyngeal valve
|
removal of tonsil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of post adenotonsillectomy velopharyngeal dysfunction.
Time Frame: one year
|
Velopharyngeal dysfunction will be assessed by doing Fiberooptic endoscopic evaluation preoperative and postoperative.
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Azzam Abdel-Razek, Professor, Assiut University ENT Department
- Study Director: Mahmoud Aly Ragae, Lecturer, Assiut University ENT Department
- Study Director: Hanan Abd El Rashed Mohamed, Lecturer, Assiut University ENT Department
Publications and helpful links
General Publications
- Siegel-Sadewitz VL, Shprintzen RJ. Changes in velopharyngeal valving with age. Int J Pediatr Otorhinolaryngol. 1986 Apr;11(2):171-82. doi: 10.1016/s0165-5876(86)80011-8.
- Perry JL. Anatomy and physiology of the velopharyngeal mechanism. Semin Speech Lang. 2011 May;32(2):83-92. doi: 10.1055/s-0031-1277712. Epub 2011 Sep 26.
- Kummer AW. Types and causes of velopharyngeal dysfunction. Semin Speech Lang. 2011 May;32(2):150-8. doi: 10.1055/s-0031-1277717. Epub 2011 Sep 26.
- Lewis JR, Andreassen ML, Leeper HA, Macrae DL, Thomas J. Vocal characteristics of children with cleft lip/palate and associated velopharyngeal incompetence. J Otolaryngol. 1993 Apr;22(2):113-7.
- Saunders NC, Hartley BE, Sell D, Sommerlad B. Velopharyngeal insufficiency following adenoidectomy. Clin Otolaryngol Allied Sci. 2004 Dec;29(6):686-8. doi: 10.1111/j.1365-2273.2004.00870.x.
- Finkelstein Y, Zohar Y, Nachmani A, Talmi YP, Lerner MA, Hauben DJ, Frydman M. The otolaryngologist and the patient with velocardiofacial syndrome. Arch Otolaryngol Head Neck Surg. 1993 May;119(5):563-9. doi: 10.1001/archotol.1993.01880170089019.
- Ng SK, Lee DL, Li AM, Wing YK, Tong MC. Reproducibility of clinical grading of tonsillar size. Arch Otolaryngol Head Neck Surg. 2010 Feb;136(2):159-62. doi: 10.1001/archoto.2009.170.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Effect of AT on VPV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Velopharyngeal Insufficiency
-
Noel JabbourNational Institute on Deafness and Other Communication Disorders (NIDCD)Not yet recruitingVelopharyngeal Incompetence Due to Cleft Palate | Velopharyngeal Insufficiency | Palatopharyngeal Incompetence | Inadequate Velopharyngeal Closure | HypernasalityUnited States
-
Assiut UniversityUnknownVelopharyngeal Incompetence Due to Cleft Palate
-
Umeå UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; University... and other collaboratorsRecruitingVelopharyngeal Insufficiency in Children With Isolated or Combined Cleft PalateSweden
-
Lawson Health Research InstituteUnknown
-
Assiut UniversityUnknownVelopharyngeal Incompetence Due to Cleft Palate | Velopharyngeal Insufficiency
-
Noel JabbourNational Institute on Deafness and Other Communication Disorders (NIDCD)TerminatedCleft Palate | Tube Disorders Eustachian | Velopharyngeal Incompetence Due to Cleft Palate | Velopharyngeal InsufficiencyUnited States
-
Alaa MamdouhCompletedArticulation Disorders | Velopharyngeal Insufficiency | Hypernasality Syndrome Due to Velopharyngeal WeaknessEgypt
-
Minia UniversityCompletedVelopharyngeal InsufficiencyEgypt
-
University Hospital, RouenTerminatedVelopharyngeal InsufficiencyFrance
-
Assiut UniversityUnknownVelopharyngeal Insufficiency
Clinical Trials on adenotonsillectomy
-
Instituto de Ciências Biomédicas Abel SalazarCompletedInfections | Tonsillitis | Apnea, Obstructive | Tonsillar Hypertrophy | Respiratory Function Impaired | ENT DisorderPortugal
-
University of Roma La SapienzaCompletedObstructive Sleep Apnea of ChildItaly
-
University of California, Los AngelesRecruiting
-
Karolinska University HospitalCompletedObstructive Sleep Apnea Syndrome in ChildrenSweden
-
Western Galilee Hospital-NahariyaCompleted
-
Brigham and Women's HospitalChildren's Hospital of Philadelphia; University of Michigan; University of Texas... and other collaboratorsCompletedSleep Disordered Breathing | Down SyndromeUnited States
-
Assiut UniversityUnknownObstructive Sleep Disordered BreathingEgypt
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)CompletedSleep Apnea Syndromes | Sleep | Sleep Disordered BreathingUnited States
-
University of British ColumbiaCompleted
-
Al-Azhar UniversityCompletedObstructive Sleep ApneaEgypt