Adenoid HypertrophyNCT05291312
EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure
A study testing Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA) in people with Adenoid Hypertrophy, run by Assiut University.
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) Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Adenoid Hypertrophy
- What is being tested?
- Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Mohamed Hossam El Deen, Fellow contact
About this study
Official title: Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure
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)
Read the 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
- Adenoid Hypertrophy
- Being tested
- Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| endoscopic assisted coblation | Other | Not described Receives: Procedure: Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA) |
| conventional curettage | Other | Not described Receives: Procedure: Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MMRafaat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291312
- Sponsor's protocol ID
- EACA AND CCA
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27107607Thornval A. Wilhelm Meyer and the adenoids. Arch Otolaryngol. 1969 Sep;90(3):383-6. doi: 10.1001/archotol.1969.00770030385023. No abstract available.
PubMed 4896109Atilla 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.
PubMed 30322828Caylakli 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.
PubMed 19732970Bidaye 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.
PubMed 30885281Elnashar 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.
PubMed 24930960Juneja 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.
PubMed 31046870Clemens 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.
PubMed 9578120
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscope-Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure
- ClinicalTrials.gov ID
- NCT05291312
- Acronym / sponsor ID
- EACA AND CCA
- Conditions
- Adenoid Hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic assisted coblation | Other | Procedure: Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA) |
| conventional curettage | Other | Procedure: Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA) |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | conventional curettage, endoscopic assisted coblation |
Primary outcome
compare Endoscopic Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure .
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Results publication: PubMed 27107607Turkoglu 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 publication: PubMed 4896109Thornval A. Wilhelm Meyer and the adenoids. Arch Otolaryngol. 1969 Sep;90(3):383-6. doi: 10.1001/archotol.1969.00770030385023. No abstract available.
- Results publication: PubMed 30322828Atilla 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 publication: PubMed 19732970Caylakli 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 publication: PubMed 30885281Bidaye 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 publication: PubMed 24930960Elnashar 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 publication: PubMed 31046870Juneja 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 publication: PubMed 9578120Clemens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Hossam El Deen, Fellow contact
Questions about this trial
What is this clinical trial studying?
A study testing Adenoidectomy with endoscopic assisted coblation (EACA) and Adenoidectomy with conventional curettage (CCA) in people with Adenoid Hypertrophy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Mamdouh, researcher (01004691815, marinamamdoh6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare Endoscopic Assisted Coblation Adenoidectomy to Conventional Curettage Adenoidectomy in Terms of Postoperative Evaluation of Middle Ear Pressure . (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291312, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.