Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms
1 other identifier
interventional
60
1 country
1
Brief Summary
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 28, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedDecember 13, 2023
December 1, 2023
1.5 years
November 28, 2023
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
1\. Relief of nasal obstruction while preserving the function of velopharyngeal valve and assessment of the recurrence rate.
1 to 2 years .
Incidence of recurrence using fibro-optic evaluation
Relief of nasal obstruction of posterior nasal chona using fibro-optic evaluation and assessment of recurrence rate using also questionnaires sheets to all parents.
1 to 2 years .
Study Arms (2)
Endoscopic total adenoidectomy
ACTIVE COMPARATOREndoscopic partial adenoidectomy
ACTIVE COMPARATORInterventions
Subjects will be randomly assigned into two groups (30 patient each group): Group A will undergo endoscopic partial adenoidectomy using the 70◦ rigid endoscope trans-orally and shaver (microdebrider) ,by removing the upper (choanal) part only with leaving the lower part of the adenoid .(2) Group B will undergo total adenoidectomy ,by removing all the adenoid lymphoid tissue .
Eligibility Criteria
You may qualify if:
- all patients with adenoid hypertrophy causing airway obstruction.
You may not qualify if:
- \. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
- Systemic medical problems interfering with surgery.
- Refusal of parents to participate.
- \. Craniofacial abnormalities.
- \. Down syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AssiutU
Asyut, 71515, Egypt
Related Publications (3)
1. Jervis-Bardy, J.; Department of Otolaryngology, Arkansas Children's Hospital, cLittle Rock, AR, United States. Journal of Craniofacial SurgeryVolume 30, Issue 5, Pages E454 - E4602019.
BACKGROUND1. Kummer AW, Lee L. Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 27:271-281
BACKGROUNDSaunders 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: 15533160BACKGROUND
Central Study Contacts
Mohamed M Roshdy
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident investigator
Study Record Dates
First Submitted
November 28, 2023
First Posted
December 13, 2023
Study Start
September 1, 2022
Primary Completion
March 1, 2024
Study Completion
June 1, 2024
Last Updated
December 13, 2023
Record last verified: 2023-12