Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms

Adenoidal Hypertrophy Clinical Trial

Official title:

Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169384
• Other study ID #: Endoscopic adenoidectomy
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Mohamed M Ragheb
• Phone: 01010058868
• Email: Mohammedragheb95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• .all patients with adenoid hypertrophy causing airway obstruction.

Exclusion Criteria:

• 1. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.

• 2 . Systemic medical problems interfering with surgery.

• 3 . Refusal of parents to participate.

• 4. Craniofacial abnormalities.

• 5. Down syndrome.

Related Conditions & MeSH terms

• Adenoidal Hypertrophy
• Hypertrophy
• Recurrence

Intervention

Device:
• Endoscopic adenoidectomy
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 .

Locations

Country	Name	City	State
Egypt	AssiutU	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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.

1. Kummer AW, Lee L. Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 27:271-281

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .
Primary	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 .