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UnknownNCT05291312

EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure

Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
5 Years – 14 Years
Healthy volunteers
Not accepted

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 .

Conditions

Interventions

TypeNameDescription
PROCEDUREAdenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)IN the (EACA) group slight head flexion position will be given to the patients and Boyle-Davis retractor will be placed to keep the mouth open. The soft palate will be elevated upward by inserting a plastic feeding catheter.. IN the (CCA) group, by orotracheal intubation , Boyle-Davis mouth retractor will be used to provide mouth opening

Timeline

Start date
2022-05-01
Primary completion
2024-10-01
Completion
2024-12-01
First posted
2022-03-22
Last updated
2022-03-22

Source: ClinicalTrials.gov record NCT05291312. Inclusion in this directory is not an endorsement.