EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure
Primary Purpose
Adenoid Hypertrophy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)
Sponsored by
About this trial
This is an interventional screening trial for Adenoid Hypertrophy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
endoscopic assisted coblation
conventional curettage
Arm Description
Outcomes
Primary Outcome Measures
compare Endoscopic Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure .
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05291312
Brief Title
EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure
Official Title
Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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)
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Hypertrophy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endoscopic assisted coblation
Arm Type
Other
Arm Title
conventional curettage
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)
Intervention Description
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
Primary Outcome Measure Information:
Title
compare Endoscopic Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure .
Description
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
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Mamdouh, researcher
Phone
01004691815
Email
marinamamdoh6@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Hossam El Deen, Fellow
Phone
01005685075
12. IPD Sharing Statement
Citations:
PubMed Identifier
27107607
Citation
Turkoglu Babakurban S, Aydin E. Adenoidectomy: current approaches and review of the literature. Kulak Burun Bogaz Ihtis Derg. 2016 May-Jun;26(3):181-90. doi: 10.5606/kbbihtisas.2016.32815.
Results Reference
result
PubMed Identifier
4896109
Citation
Thornval A. Wilhelm Meyer and the adenoids. Arch Otolaryngol. 1969 Sep;90(3):383-6. doi: 10.1001/archotol.1969.00770030385023. No abstract available.
Results Reference
result
PubMed Identifier
30322828
Citation
Atilla MH, Kaytez SK, Kesici GG, Bastimur S, Tuncer S. Comparison between curettage adenoidectomy and endoscopic-assisted microdebrider adenoidectomy in terms of Eustachian tube dysfunction. Braz J Otorhinolaryngol. 2020 Jan-Feb;86(1):38-43. doi: 10.1016/j.bjorl.2018.08.004. Epub 2018 Sep 25.
Results Reference
result
PubMed Identifier
19732970
Citation
Caylakli F, Hizal E, Yilmaz I, Yilmazer C. Correlation between adenoid-nasopharynx ratio and endoscopic examination of adenoid hypertrophy: a blind, prospective clinical study. Int J Pediatr Otorhinolaryngol. 2009 Nov;73(11):1532-5. doi: 10.1016/j.ijporl.2009.07.018. Epub 2009 Sep 3.
Results Reference
result
PubMed Identifier
30885281
Citation
Bidaye R, Vaid N, Desarda K. Comparative analysis of conventional cold curettage versus endoscopic assisted coblation adenoidectomy. J Laryngol Otol. 2019 Apr;133(4):294-299. doi: 10.1017/S0022215119000227. Epub 2019 Mar 19.
Results Reference
result
PubMed Identifier
24930960
Citation
Elnashar I, El-Anwar MW, Basha WM, AlShawadfy M. Objective assessment of endoscopy assisted adenoidectomy. Int J Pediatr Otorhinolaryngol. 2014 Aug;78(8):1239-42. doi: 10.1016/j.ijporl.2014.04.031. Epub 2014 May 14.
Results Reference
result
PubMed Identifier
31046870
Citation
Juneja R, Meher R, Raj A, Rathore P, Wadhwa V, Arora N. Endoscopic assisted powered adenoidectomy versus conventional adenoidectomy - a randomised controlled trial. J Laryngol Otol. 2019 Apr;133(4):289-293. doi: 10.1017/S0022215119000550.
Results Reference
result
PubMed Identifier
9578120
Citation
Clemens J, McMurray JS, Willging JP. Electrocautery versus curette adenoidectomy: comparison of postoperative results. Int J Pediatr Otorhinolaryngol. 1998 Mar 1;43(2):115-22. doi: 10.1016/s0165-5876(97)00159-6.
Results Reference
result
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EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure
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