EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05291312
• Collaborator: (none)
• Enrollment: 70
• Arms: 2
• Anticipated Duration (Months): 31

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Adenoid Hypertrophy	Procedure: Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: endoscopic assisted coblation	Procedure: Adenoidectomy 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
Other: conventional curettage	Procedure: Adenoidectomy 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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MMRafaat, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05291312
• Other Study ID Numbers: EACA AND CCA
• First Posted: Mar 22, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertrophy

Study Results

No Results Posted as of Mar 22, 2022