EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure

Not Applicable

Not yet recruiting

• Conditions: Adenoid Hypertrophy
• Interventions: Procedure: Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)

• Registration Number: NCT05291312
• Lead Sponsor: Assiut University

Brief Summary

Is to evaluate the effect on Eustachian Tube (ET) and changes in middle ear pressure in early period after adenoidectomy by using Endoscopic Assisted Coblation Adenoidectomy (EACA) VS Conventional Curettage Adenoidectomy (CCA)

Detailed Description

Adenoid hypertrophy is a common condition in children causing symptoms such as mouth breathing, nasal discharge, snoring, sleep apnea, and hypo nasal speech. It also plays a role in the pathogenesis of rhinosinusitis, recurrent otitis media, and otitis media with effusion. Currently, adenoidectomy is one of the most commonly performed pediatric surgical procedures worldwide. Although there is still poor evidence in the literature, recurrent upper respiratory infections, otitis media with effusion, and obstructive sleep apnea syndrome are considered to be the main indications of adenoidectomy . Conventional curettage adenoidectomy (CCA) is a widely adopted method for over a hundred years. Conventional curettage adenoidectomy is performed blindly via adenoid curette; this may be associated with residual adenoid tissue existence and increased postoperative morbidity including, Eustachian tube dysfunction, inadvertent injury to peripheral tissue and postoperative bleeding . An ideal adenoidectomy technique should be safe, quick, easy, and provide decreased postoperative complication and morbidity .Recently Adenoidectomy can be carried out with several techniques such as electrocautery, bipolar coagulation, radiofrequency ablation, and coblation techniques .

Eustachian tube dis function (ETD) can develop due to surgical trauma , edema in surrounding tissues and clots in early period following adenoidectomy surgery performed with curettage technique .

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-20
• Last Update Submitted: 2022-03-20
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Study Start: 2022-05-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Pediatric patients presented with adenoid hypertrophy who undergoing primary adenoidectomy with or without tonsillectomy , with the following criteria:

• Age: between ( 5-14 years )
• With or without chronic tonsillitis
• Clinicaly Normal tympanic membrane without secretory otitis media .

Exclusion Criteria

• Patients with the following criteria will be excluded from the study :
• Patients with secretory otitis media .
• Previous adenoidectomy.
• Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.
• Recurrent upper respiratory tract infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic assisted coblation	Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)	-
conventional curettage	Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)	-

Primary Outcome Measures

Name	Time	Method
compare Endoscopic Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure .	one month	To compare and analyze changes in middle ear pressure in early period after Adenoidectomy by using Endoscopic assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy by using tympanogram