NCT05273853

Brief Summary

Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

February 18, 2022

Last Update Submit

March 1, 2022

Conditions

Hypernasality

Outcome Measures

Primary Outcomes (2)

  • Speech Outcome

    Change of a degree of Nasal Tone during speech

    1 month after operation

  • Speech Outcome

    Change of a degree of Nasal Tone during speech

    3 months after operation

Study Arms (1)

Patients with high risk of hypernasality

OTHER

In 1958, Gibb indicated an incidence of hypernasality (escape of air from nose as in patients with cleft palate) postadenoidectomy in approximately 1of 2000 cases. Closure pattern of velopharyngeal valve in children is veloadenoidal rather than velopharyngeal closure. Adenoid tissue is vital to velopharyngeal closure in children and its removal necessitates a change in the closure pattern of velopharyngeal valving. These changes are easily overcome if there is no anatomic abnormality

Procedure: Partial Adenoidectomy

Interventions

Partial AdenoidectomyPROCEDURE

Partial removal of adenoid

Patients with high risk of hypernasality

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient with symptoms of adenoid hypertrophy.
  • High risk to VPI:
  • Short palate.
  • Scarred palate after previous tonsillectomy.
  • Occult submucous cleft.
  • Deep pharynx.
  • Repaired cleft palate.

You may not qualify if:

  • Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

RECRUITING

Related Publications (1)

  • Rowe MR, D'Antonio LL. Velopharyngeal dysfunction: evolving developments in evaluation. Curr Opin Otolaryngol Head Neck Surg. 2005 Dec;13(6):366-70. doi: 10.1097/01.moo.0000186204.53214.62.

    PMID: 16282766RESULT

Study Officials

  • Mohammed AE Ahmed, Professor

    Sohag Faculty Of Medicine

    STUDY CHAIR

Central Study Contacts

Dina A Hasb Allah, Resident

CONTACT

+201286000163dina_ewaida_post@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Otolaryngology

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 10, 2022

Study Start

February 4, 2022

Primary Completion

August 4, 2022

Study Completion

December 1, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)