Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism

NCT05820529 | Unknown

• 1 other identifier: Effect of AT on VPV
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Velopharyngeal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Assessment of post adenotonsillectomy velopharyngeal dysfunction.

  Velopharyngeal dysfunction will be assessed by doing Fiberooptic endoscopic evaluation preoperative and postoperative.

  one year

Study Arms (3)

Effect of Adenotonsillectomy in velopharyngeal valve mechanism

OTHER

We do adenotonsillectomy and show its effect in velopharyngeal valve

Procedure: adenotonsillectomy; Procedure: adenoidectomy; Procedure: tonsillectomy

Effect of Adenoidectomy in velopharyngeal valve mechanism

OTHER

We do adenoidectomy and show its effect in velopharyngeal valve

Procedure: adenoidectomy

Effect of tonsillectomy in velopharyngeal valve mechanism

OTHER

We do tonsillectomy and show its effect in velopharyngeal valve

Procedure: tonsillectomy

Interventions

adenotonsillectomy PROCEDURE

removal of adenoid,tonsil in one session

Effect of Adenotonsillectomy in velopharyngeal valve mechanism

adenoidectomy PROCEDURE

removal of adenoid

Effect of Adenoidectomy in velopharyngeal valve mechanism; Effect of Adenotonsillectomy in velopharyngeal valve mechanism

tonsillectomy PROCEDURE

removal of tonsil

Effect of Adenotonsillectomy in velopharyngeal valve mechanism; Effect of tonsillectomy in velopharyngeal valve mechanism

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children patients (aged from 4yrs to 12yrs) who will be undergone adenoidectomy or tonsillectomy or adenotonsillectomy

You may not qualify if:

• Clinical diagnosis of cleft palate.
• Clinical diagnosis of submucous cleft palate
• Neuromuscular disorders.
• Patients with craniofacial syndromes.
• Patient with mental retardation

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

ENT Department

Asyut, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 21948636 BACKGROUND

• 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.

  PMID: 21948641 BACKGROUND

• 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.

  PMID: 8515508 BACKGROUND

• 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.

  PMID: 15533160 BACKGROUND

• 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.

  PMID: 8484947 BACKGROUND

• 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.

  PMID: 3744698 BACKGROUND

• 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.

  PMID: 20157062 BACKGROUND

MeSH Terms

Conditions

Velopharyngeal Insufficiency

Interventions

Adenoidectomy; Tonsillectomy

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mohamed Azzam Abdel-Razek, Professor

  Assiut University ENT Department

  PRINCIPAL INVESTIGATOR

• Mahmoud Aly Ragae, Lecturer

  Assiut University ENT Department

  STUDY DIRECTOR

• Hanan Abd El Rashed Mohamed, Lecturer

  Assiut University ENT Department

  STUDY DIRECTOR

Central Study Contacts

Fatma Mohamed Abdallah, Resdient

CONTACT

01023373977; fatmamohamed18121995@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: We will do Adenotonsillectomy by three different technique

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 19, 2023
• Study Start: February 14, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

EG (1)