EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure

Adenoid Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05291312
• Other study ID #: EACA AND CCA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Marina Mamdouh, researcher
• Phone: 01004691815
• Email: marinamamdoh6[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Hypertrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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: 10.101 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Thornval A. Wilhelm Meyer and the adenoids. Arch Otolaryngol. 1969 Sep;90(3):383-6. — View Citation

Türkoglu 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one month