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Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism

Primary Purpose

Velopharyngeal Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
adenotonsillectomy
adenoidectomy
tonsillectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Velopharyngeal Insufficiency

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ENT DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Effect of Adenotonsillectomy in velopharyngeal valve mechanism

Effect of Adenoidectomy in velopharyngeal valve mechanism

Effect of tonsillectomy in velopharyngeal valve mechanism

Arm Description

We do adenotonsillectomy and show its effect in velopharyngeal valve

We do adenoidectomy and show its effect in velopharyngeal valve

We do tonsillectomy and show its effect in velopharyngeal valve

Outcomes

Primary Outcome Measures

Assessment of post adenotonsillectomy velopharyngeal dysfunction.
Velopharyngeal dysfunction will be assessed by doing Fiberooptic endoscopic evaluation preoperative and postoperative.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
April 7, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05820529
Brief Title
Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism
Official Title
Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
To assess safety of tonsillectomy, adenoidectomy or adenotonsillectomy result toVelopharyngeal Valve Mechanism. To predict and prevent post adenotonsillectomy velopharyngeal dysfunction.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velopharyngeal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
We will do Adenotonsillectomy by three different technique
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effect of Adenotonsillectomy in velopharyngeal valve mechanism
Arm Type
Other
Arm Description
We do adenotonsillectomy and show its effect in velopharyngeal valve
Arm Title
Effect of Adenoidectomy in velopharyngeal valve mechanism
Arm Type
Other
Arm Description
We do adenoidectomy and show its effect in velopharyngeal valve
Arm Title
Effect of tonsillectomy in velopharyngeal valve mechanism
Arm Type
Other
Arm Description
We do tonsillectomy and show its effect in velopharyngeal valve
Intervention Type
Procedure
Intervention Name(s)
adenotonsillectomy
Intervention Description
removal of adenoid,tonsil in one session
Intervention Type
Procedure
Intervention Name(s)
adenoidectomy
Intervention Description
removal of adenoid
Intervention Type
Procedure
Intervention Name(s)
tonsillectomy
Intervention Description
removal of tonsil
Primary Outcome Measure Information:
Title
Assessment of post adenotonsillectomy velopharyngeal dysfunction.
Description
Velopharyngeal dysfunction will be assessed by doing Fiberooptic endoscopic evaluation preoperative and postoperative.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Mohamed Abdallah, Resdient
Phone
01023373977
Email
fatmamohamed18121995@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Azzam Abdel-Razek, Professor
Organizational Affiliation
Assiut University ENT Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmoud Aly Ragae, Lecturer
Organizational Affiliation
Assiut University ENT Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanan Abd El Rashed Mohamed, Lecturer
Organizational Affiliation
Assiut University ENT Department
Official's Role
Study Director
Facility Information:
Facility Name
ENT Department
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
21948636
Citation
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.
Results Reference
background
PubMed Identifier
21948641
Citation
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.
Results Reference
background
PubMed Identifier
8515508
Citation
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.
Results Reference
background
PubMed Identifier
15533160
Citation
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.
Results Reference
background
PubMed Identifier
8484947
Citation
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.
Results Reference
background
PubMed Identifier
3744698
Citation
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.
Results Reference
background
PubMed Identifier
20157062
Citation
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.
Results Reference
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Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism

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